Dear Colleagues!  This is Asrar Qureshi’s Blog Post #754 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to for publishing your contributions here.

USFDA maintains that currently available data for Pfizer-BioNTech and Moderna vaccines shows that the vaccines are safe by and large.

A CDC study published in Lancet Infectious Diseases says that self-reported data was reviewed by the researchers. Patients were advised to report adverse events on two systems: VAERS – Vaccine Adverse Event Reporting System, and v-safe tracker.

Of the 340,522 reports made to VAERS, 92% were non-serious, 6.6% were serious, and 1.3% were deaths. The most common adverse events reported were headaches (20%), fatigue (17%), and fever (16%). Among serious events, shortness of breath (15%) was the most commonly reported one.

Headache (56%) and fatigue (46%) were the most commonly reported symptoms among participants in the v-safe tracking system.

Fierce Pharma reported, “that U.S. experts concluded there is a likely association between rare cases of heart inflammation and mRNA vaccines.” The FDA said it will move quickly to add a label warning that young adults and adolescents are susceptible to the side effect. The latest ruling comes in response to reports of young people, mostly males, developing myocarditis – inflammation of the heart, or pericarditis – inflammation of heart’s membrane – mostly after a second dose of mRNA vaccines. The CDC reported 309 hospitalizations on this count; no deaths reported.

As mentioned earlier, the case for release of Pfizer documents was filed by PHMP. Dr. David Healy, a member of PHMP says, “I don’t have an issue with this vaccine or any vaccine, ok? I am quite pro vaccines. My issue is actually with the science. Now in this case, it is access to data… Pfizer on the other hand says ‘well no you are not going to see the evidence, we are not going to let you see it. That’s not science.”

One of the documents that have been released is specifically about adverse events.

The 38-page report details the adverse events reported to Pfizer between December 1, 2020, to February 28, 2021. The number of doses shipped by that time worldwide has been redacted (hidden). It appears that 42,086 adverse events were reported in this time. Of these, 1,223 are listed as fatal with another 9,400 listed as unknown adverse events.

Dr. Dale Kalina, an infectious diseases expert comments, “The events themselves are not necessarily related to the vaccine. It is just part of the reporting process. And it is a requirement.”

The report mentioned above is ‘Cumulative Analysis of Post-authorization Adverse Events Report’. Table 1 is General Overview, which gives these statistics about 42,086 reported side effects.

  • Female                        29,914
  • Male                              9,182
  • No data                         2,990
  • AEs reported in the age group 31 – 50 years             13,886
  • General and Administration site:                                51,335
  • Nervous system:                                                         25,957
  • Musculoskeletal and connective tissue:                     17,283
  • Gastrointestinal:                                                          14,096
  • Skin and sub-cutaneous tissue:                                      8,476
  • Respiratory, thoracic, and mediastinal                           8,848
  • Infections and Infestations                                              4,610
  • Injury, poisoning, procedural                                         5,590

Some patients had multiple events, and therefore these numbers cannot be added straight.

Table 2 shows adverse events reported in 2% or more patients from the same cohort of 42,086 patients. I have done editing to make it brief.

  • Lymphadenopathy                              4.7%
  • Tachycardia                                        2.6%
  • Nausea                                                12.3%
  • Diarrhea                                              4.5%
  • Vomiting                                             4.0%
  • Pyrexia (fever)                                    18.2%
  • Fatigue                                                 17.4%
  • Chills                                                  13.1%
  • Vaccine site pain                                12.3%
  • Pain                                                     8.8%
  • Malaise (being unwell                        6.9%
  • Asthenia (weakness)                           5.4%
  • Drug ineffective                                  5.2%
  • Influenza like illness                           2.0%
  • Myalgia (muscle pain)                        11.7%
  • Pain in extremity                                9.4%
  • Arthralgia (joint pain)                         8.4%
  • Headache                                            24.1%
  • Dizziness                                            8.8%
  • Dyspnea (difficulty in breathing)       4.9%

274 cases of pregnant women receiving vaccines are included. The adverse events were –  spontaneous abortion (23), premature birth with neonatal death (2), spontaneous abortion with intrauterine death (2). No outcome provided for the rest of the pregnancies.

133 cases of exposure to vaccine during breastfeeding were reported; 116 breastfed children had no clinical adverse event. Of the 17 AEs reported – fever, infant irritability, infantile vomiting, diarrhea, insomnia, and illness, were included.

This discussion is not concluded yet. I request that the interpretation of above data should be kept pending till more information is presented.

To be Concluded……

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