Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature increased, Chest discomfort, Circumstance or information capable of leading to medication error, Confusional state
Clinical narrative: When I went to get the vaccine, it was already drawn from the vial. The vial placed on the table was Moderna. I am not sure which vaccine I received; confused; a slightly elevated temperature which went from 99. to 100.2; Her ears were also red/Her ears are burning red; her whole face is red, ears are red, neck is starting to get red and front of chest is red; chest was purple; She felt hot; a rash all over her body/rash around the head and chest/She got a huge rash on her face, neck, and chest, forehead, cheeks, and nose; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 04Jun2021 around 15:30 or 15:45 pm (age at vaccination was 52 years) as 1st dose, single dose for COVID-19 immunization. The patient medical history included elevated blood pressure. The caller stated that she was diagnosed with elevated blood pressure in February or March this year. Stated her blood pressures was 138 or 140's or something like that. 148/90 or over 88. Sometimes it was 139. Concomitant medications included amlodipine with dose 5 mg 1x/day via oral route for elevated blood pressure. The patient took the Pfizer COVID vaccine because everyone required it. The patient experienced a rash all over her body and wanted to know if that was vaccine side effect or she needs to contact her HCP. On PRD 04Jun2021, it was reported that the caller wanted to know the expiry date and confirm the product under the lot number provided. She received the response stating that confirmed the product was a Pfizer COVID-19 vaccine. They also provided the expiration date: 30Sep2021. The caller had gone to the pharmacy to receive a COVID-19 vaccine. All her friends had received the Pfizer COVID-19 vaccine. Moderna caused many side effects. Her doctor also said it's belter she gets the Pfizer COVID-19 vaccine because she had elevated blood pressure. When she went to get the vaccine, it was already drawn from the vial. The vial placed on the table was Moderna. She was not sure which vaccine she received. The lady who gave her the vaccine told her it was the Pfizer COVID-19 vaccine. She can't trust them because the vaccine was not drawn from the vial in front of her. She had called the pharmacy three times already. They have been giving her different information each time. First, they said they don't have the Pfizer COVID-19 vaccine and then they said they do. She asked that why doesn't Pfizer create a policy to ensure that the vaccine should be drawn from the vial in front of the patient. She was not sure what they gave. They may be made her part of a study. She was very confused. There were two syringes filled in. She was not sure which vaccine did she receive. The caller reported rash around the head and chest right after receiving the vaccine. She also noticed few minutes post vaccination a slightly elevated temperature which went from 99. to 100.2. Her ears were also red. She received the response stating that they cannot verify which vaccine she had received as they had not witnessed the administration. Fever and rash had been reported with the Pfizer COVID-19 vaccine. The reaction could occur anywhere from minutes to a few days post vaccination. A reaction such as ears turning red has not been listed as side effect in the prescribing information. They didn't have the list of all the possible side effects associated with the vaccine. The asked her to speak to her HCP if the symptoms persist or didn't go away. Informed caller to contact someone at the pharmacy and report the event. Pfizer cannot control the policy and procedure of the pharmacy. It's best to report to ensure they don't repeat such mistakes again. On PRD 04Jun2021, it was reported that the caller called about the Pfizer vaccine EW0217. Caller stated she just got the vaccine at and the pharmacy refused to let her see the vial it was drawn out of. The guy had a bottle that said Moderna and wouldn't let her go to the back.  When she asked to see the Pfizer covid vaccine vial they told her they threw it out. She asked that why was the pharmacy refusing to let her see what they were giving her. She stated she honestly thought they did something but told her that they drew it in the back. She asked how she was supposed to know she got the Pfizer covid vaccine. She was told she was to get her second dose in 4 weeks, and the caller questioned 4 weeks stating the Pfizer second dose should be 3 weeks after first dose. Then stated getting the second dose 4 weeks after first dose was for Moderna, not Pfizer. She just got the vaccine. She reported her whole face was red, ears were red, neck started to get red and had a huge rash on the front of her chest. She got a huge rash on her face, neck, and chest, forehead, cheeks, and nose, it was all red. She didn't know if it was going to get worse. Her ears were burning red. Received vaccine half hour ago about 2:45. Her card did not say anything about the date of when she should get the second dose. She did not receive any treatment as it just happened half hour ago. She stated her ears were burning and were purple, red. She had never had purple ears before. The caller wanted to know if that was normal and whether she should go to her doctor's office because it was Friday. There was a Product complaint. The description of complaint included the caller received COVID-19 Vaccine Lot# EW0217. Caller was concerned she did not receive the Pfizer COVID vaccine. Vaccine facility refused to show her the vial stating it was discarded. Product strength and count size dispensed was not provided. No sample of the product was available to be returned as the vial was discarded. Packaging sealed and intact was not provided. On PRD 04Jun2021, it was reported that the caller just received the Pfizer Covid-19 Vaccine. She had a huge rash on her head and chest. Her ears are red. The caller had really called because she didn't like the way of administering the vaccine. The caller saw a Moderna vial on the table where she was vaccinated. She wanted to see the vial to the vaccine that she received. Did not produce the vial. The caller was concerned that she may have received the Moderna vaccine instead of the Pfizer. The agent also referred caller to the state department of health because they are the ones who distributed the vaccine. The caller stated that she was really not sure if she got the Pfizer vaccine. She believed it was the Moderna or whatever was in that syringe. There were 2 syringes. She didn't know what she was given. When she went to get the vaccine, she walked up to get the paper that had the vaccine information on it. She told them that was not what she wanted. She wanted the vaccine Pfizer made. She told them to provide her with Pfizer's information. She told him to use her right arm. She wanted to see the vial they drew the vaccine from because she saw a Moderna vial on top of the table half filled in. Someone at the pharmacy told the caller they drew up the vaccine in the back. He told the caller she had to trust him. The caller went to the back and asked the lady where the vial was, she drew the vaccine from. The caller stated they did not have the vial they drew her vaccine from but used another vial to show her how the vaccine looks. Caller was told this was the Moderna. They drew it and threw it away. Caller stated how was she supposed to know what they gave her. She simply asked could she see the vial the vaccine was in. The caller stated they gave the vaccine, and she walked out. Caller stated that the pharmacy could have given her a quadruple dose. She didn't see the lady. The lady could have put a random number on there. The caller stated that her ears got really red. Her chest was purple. It was kind of strange. She felt hot. When she got in the car, she looked really red. For the first 5 minutes, it looked like something was growing on her arm. Her face was red. She had to drink water to calm down. The caller confirmed that she told the previous Pfizer safety agent that she had the reaction. The safety agent told her that she should call Medical Information. The caller asked if the side effects were normal whether they really gave her a vaccine. She measured her temperature. Right now, the temperature was 99.3 at 4:15. 3 minutes later it was 99.2. Now it's 100.2. Her head was just hot after an hour and a half. When she checked her forehead it was 99.4. The caller stated shouldn't they have a blue top on the Pfizer vial. He showed her a small vial. He told her it was from the same lot. He asked the lady. The lady drew up the vaccine but said she didn't have it. The lady put the vial in the sharps box. The caller called last week, and they only had Moderna vaccines at that time. Her friend said Pfizer was better and it has less side effects. Caller stated her vaccination card does not say when she has to come back for her second dose. The lady told her to come back in 28 days. Caller knew that they come back in 28 days for the Moderna vaccine. The Pfizer vaccine was 21 days. Caller confirmed she received the first dose of the Pfizer Covid-19 Vaccine today around 2:30 or 2:45. Caller stated that Pfizer provides for guidelines. As a patient, she should see what vial the vaccine was drawn from. She has blood pressure and weight issues. Caller stated she took Amlodipine for blood pressure. Caller stated she hopeed they didn't give her a different kind of vaccine and she turned into a mutant or something. On PRD 04Jun2021, it was reported that the caller was concerned that she might not have been administered the Pfizer COVID 19 vaccine that she had requested. There was a Moderna vial on the table and they couldn't produce the Pfizer vial that my dose came from. She had an adverse reaction to the Pfizer COVID 19 vaccine. She had a huge rash on her face and chest, her ears were red. I received the shot at Walgreens and there was a Moderna vial on the table. She was not sure they gave her Pfizer or if they gave her some kind of experimental drug. They couldn't produce the Pfizer vial that her dose came from. The vaccine card that they gave her said Pfizer on it, but she didn't know that they were from her vial. She took high blood pressure medication. The outcome of the events was unknown.  Follow up#01 (04Jun2021), Follow up#02 (04Jun2021), Follow up#03 (04Jun2021) andcFollow up#04 (04Jun2021): New information received from a contactable consumer (patient) reported for herself included: Updated the lot number (EW0217), details regarding the adverse events, concomitant medication (Amlodipine), medical history (elevated blood pressure) and details of product complaint.