Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Heart rate, Poor quality product administered, Product preparation error
Clinical narrative: This is a spontaneous report from a contactable physician and a contactable consumer. This Physician reported similar events for ten patients. This is the second of ten reports. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 11Jan2021 11:00 (also reported as 13Feb2021) (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no family history and no prior vaccinations. The patient was given the injection prepared with 3 mL sterile water and not with 1.8 physiological solution on 11Jan2021. The first vial they diluted with 3mL of sterile water, which was given to 6 patients. They realized the issue, calculated the concentration, and then prepared another vial with the correct amount of diluent (1.8mL) however they still used sterile water, and gave partial doses to the patients to give them the full correct concentration. There was enough vaccine in that vial, that 4 additional patients were given 30mcg doses (of the vaccine mixed with sterile water). They are planning to revaccinate these individuals. On 28May2021, the physician reported the patient provided information regarding the reported events with the use of BNT162B2. The physician stated that the patient self-administrated EpiPen for self-identified "anaphylaxis" on 11Jan2021 (also reported as 13Feb2021). The patient was observed for 30 minutes at 3-5-minute intervals post vaccination with the door open to main vaccination event site. She did not alert the nursing pharmacy individual or state of any distress but self-administered her EpiPen. When she was evaluated 5 minutes later -no rash, no respiratory distress, heart rate regular -100 (concomitant with EpiPen administration), blood pressure 130. She was observed for another 20-30 minutes with no symptoms. Although the self-administered EpiPen was inappropriate, the physician felt he/she was not advised to peruse dose 2, as the patient reported "anaphylaxis", but no physical findings were noted. Emergency room visit was not involved. The physician did not consider BNT162B2 to have a causal effect to the event. The outcome of the anaphylaxis was recovered.   Information on the Batch/Lot number has been requested.  Follow-up (25Feb2021): New information reported from a contactable consumer included: new reporter and additional information about the primary reporter.   Information on the Batch/Lot number has been requested.  Follow-up (28May2021): New information received from a contactable physician in response to HCP letter sent includes: patient data, test data, event information (new event: anaphylaxis), causality. Case upgraded to serious.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the available information there is no evidence or argument to suggest a causal relationship between the reported event of anaphylaxis and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-2021082099 same drug and event, different patient