chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: vaccine was administered subcutaneously instead of intramuscular according to her; This is a spontaneous report from a contactable registered nurse (patient) via Pfizer-sponsored program via medical information team. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730, Expiration date 31Jul2021), subcutaneously administered in the Left Upper Arm on 19Apr2021 (age at the time of vaccination 31-year-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6200, Expiration date 30Jun2021), via unknown route administered in the Left Upper Arm on 29Mar2021 at a single dose for COVID-19 immunization. Patient got the 2nd shot of the vaccine on 19Apr2021 and, she felt that the vaccine was not administered properly as she was bigger than the usual, vaccine was administered subcutaneously instead of intramuscular according to her. She stated that she is a big girl and does not think the needle reached her muscle. Reporter would like to know the efficacy of the covid vaccine if administered subcutaneously as opposed to intramuscularly. Do I still have the same percentage of coverage if I received the covid vaccine subcutaneously, instead of muscularly? No PQC present. Upon follow up on 19Apr2021 as per the reporter the report was serious with seriousness criteria-Other medically important condition. Report is not related to a study or program. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (19Apr2021): New information received from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included: reporter seriousness added, dose details lot number and expiration date added for both the doses.  Amendment: This follow-up report is also being submitted to amend previously reported Information: delete the off-label use event as this is a medication error based on the description of the event and was not off label use.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Inappropriate route of vaccination,Off label use. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He tested positive for COVID after he took his first dose; He tested positive for COVID after he took his first dose; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 21Mar2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient tested positive for COVID after he took his first dose. He inquired about the interval between the first and second dose and how long was the limit between the two doses. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath on an unspecified date. Clinical course: Pharmacist has a patient who took the 1st dose of Covid vaccine and then went to the Emergency Room with shortness of breath. The ER doctor would like to give patient Monoclonal Antibodies. They would like to know what to do about next dose. The outcome of the event was unknown.   No follow-up attempts possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus
Clinical narrative: itch; then a blister formed in the palm of her right hand and then changed to a cluster of blisters and then migrated to pinky and then up her arm.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in Arm Left on 03Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient experienced itch, then a blister formed in the palm of her right hand and then changed to a cluster of blisters and then migrated to pinky and then up her arm. Reporter stated her reaction started 8-10 days after the first dose and was still evident today. It was very painful and sensitive to touch. She bandaged it today because it felt better that way. She had some other systemic reactions but they were so little and she felt they were nothing to report and went away in a few days. Reporter would like to know if she should receive her second dose this Saturday. The events were considered as non-serious. The outcome of the events were reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Feeling hot, Nasal congestion
Clinical narrative: She started to feel like she was fainting; chest pain; she was seeing stars; she had trouble breathing; She was very hot; She also had a sore throat and some congestion; She also had a sore throat and some congestion; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 at 17:30 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first Pfizer covid-19 vaccine on 07Apr2021 and that night (as reported), patient had some troubling side effects; she had trouble breathing and was very hot. She also had a sore throat and some congestion. They thought these were very normal side effects; however, the side effects happened again on 12Apr2021, but it was worst. All of a sudden patient had trouble breathing, chest pain and she started to feel like she was fainting, she was seeing stars. She sat down, put her head down in her knees and the same thing stopped and it worked; it was about 5 to 10 minutes for her breathing to be okay again (for clarification). On an unspecified date, they called her health care providers and went to her urgent care location due to the events. They took her X-ray and EKG and was normal. They also did a Covid test which was negative. The reporter wanted to know if it is safe for the patient to get the second dose. The final outcome of the events she started to feel like she was fainting and she had trouble breathing was recovered (for clarification); while the other events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Syncope, Visual impairment, X-ray
Clinical narrative: She started to feel like she was fainting; chest pain; she was seeing stars; she had trouble breathing; She was very hot; She also had a sore throat and some congestion; She also had a sore throat and some congestion; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 at 17:30 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first Pfizer covid-19 vaccine on 07Apr2021 and that night (as reported), patient had some troubling side effects; she had trouble breathing and was very hot. She also had a sore throat and some congestion. They thought these were very normal side effects; however, the side effects happened again on 12Apr2021, but it was worst. All of a sudden patient had trouble breathing, chest pain and she started to feel like she was fainting, she was seeing stars. She sat down, put her head down in her knees and the same thing stopped and it worked; it was about 5 to 10 minutes for her breathing to be okay again (for clarification). On an unspecified date, they called her health care providers and went to her urgent care location due to the events. They took her X-ray and EKG and was normal. They also did a Covid test which was negative. The reporter wanted to know if it is safe for the patient to get the second dose. The final outcome of the events she started to feel like she was fainting and she had trouble breathing was recovered (for clarification); while the other events was unknown.  Information on lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Nasopharyngitis, Pain in extremity
Clinical narrative: positive for COVID-19; positive for COVID-19; Left Arm Sore; got sick; head cold; This is a spontaneous report received from a contactable consumer (reporting on herself). A 84-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734 and Expiration Date was not reported), via an unspecified route in Arm Left on 01Apr2021 11:15 as single dose for COVID-19 immunization. Medical history included food allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received her first dose of the BNT162B2 vaccine on 01Apr2021 and experience Left Arm Sore and reports that several days later, she got sick. She states that on 04Apr2021, she was around people who ended up testing positive for COVID-19 so she herself got tested, but it was inconclusive. She states she figured she was positive because she was around people who tested positive at the same time as she got sick. States they tested on 06Apr2021, and got their results on 08Apr or 09Apr2021. She states on 14Apr2021 she was retested and it came back positive for COVID-19. She states she was supposed to get her second dose on 22Apr2021 and would like to know if she was still okay to continue with that. Patient was concerned with how effective the shot will be if she were to proceed with getting it. She states that she does not feel sick with COVID-19 and reports having a "head cold" but that's it. She would like to know how much time she has to get her second dose of the Pfizer BioNTech COVID-19 vaccine if she received her first dose on 01Apr2021. She requesting guidance on how to reach her vaccina-tion provider for further guidance on possibly rescheduling her second dose of the Pfizer BioNTech COVID-19 vaccine. She states she was not given a phone number but was able to provide the vaccination location's address. Patient did not received any treatment. The outcome for event positive for covid-19, got sick, head cold was unknown and for event left arm sore was recovered on 14Apr2021.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: positive for COVID-19; positive for COVID-19; Left Arm Sore; got sick; head cold; This is a spontaneous report received from a contactable consumer (reporting on herself). A 84-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734 and Expiration Date was not reported), via an unspecified route in Arm Left on 01Apr2021 11:15 as single dose for COVID-19 immunization. Medical history included food allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received her first dose of the BNT162B2 vaccine on 01Apr2021 and experience Left Arm Sore and reports that several days later, she got sick. She states that on 04Apr2021, she was around people who ended up testing positive for COVID-19 so she herself got tested, but it was inconclusive. She states she figured she was positive because she was around people who tested positive at the same time as she got sick. States they tested on 06Apr2021, and got their results on 08Apr or 09Apr2021. She states on 14Apr2021 she was retested and it came back positive for COVID-19. She states she was supposed to get her second dose on 22Apr2021 and would like to know if she was still okay to continue with that. Patient was concerned with how effective the shot will be if she were to proceed with getting it. She states that she does not feel sick with COVID-19 and reports having a "head cold" but that's it. She would like to know how much time she has to get her second dose of the Pfizer BioNTech COVID-19 vaccine if she received her first dose on 01Apr2021. She requesting guidance on how to reach her vaccina-tion provider for further guidance on possibly rescheduling her second dose of the Pfizer BioNTech COVID-19 vaccine. She states she was not given a phone number but was able to provide the vaccination location's address. Patient did not received any treatment. The outcome for event positive for covid-19, got sick, head cold was unknown and for event left arm sore was recovered on 14Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: first dose of Pfizer Covid19 vaccination on 09Apr2021, tested positive for COVID-19 on 14Apr2021; This is a spontaneous report received from a contactable reporter (the patient).   A 29-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 09Apr2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, the patient tested positive for COVID-19, second dose of the vaccine is scheduled for 30Apr2021. Outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Blood test abnormal, Hepatitis
Clinical narrative: infection in his liver; there was a spike in the blood work; This is a spontaneous report received from a contactable nurse and a consumer.  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, expiration date: 31Jul2023) orally from Feb2021 to an unspecified date at 5 mg cycle (two times a day on days 1-21 of every 21 day) for advanced renal cell carcinoma. Medical history included high blood pressure. No known drug allergies. Concomitant medications were not reported. The patient went to his chemo doctor and he's having an infection in his liver so right now they want him to stop it for now until he has an appointment. There was a spike in the blood work, but he did have his COVID shot. So, there's a possibility it's from that. Action taken in response to the events for axitinib was unknown. Outcome of the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: The patient had underlying advanced renal cell carcinoma, and was recently on treatment with axitinib (INLYTA).  Based on information available, the reported liver infection with blood test abnormal were possibly due to co-suspect INLYTA, and unlikely causally related to the vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: glucose levels at fasting and after meal are higher than normal; This is a spontaneous report from a contactable consumer (patient) via a medical information team. A 53-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: unknown), via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patients historical vaccine included first dose of BNT162B2. The patient glucose levels at fasting and after meal were higher than normal in Apr2021. The outcome of the event was unknown. The patient underwent lab test which included blood glucose test which was higher than normal in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness was in arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose via an unspecified route of administration on an unspecified date as single dose, second dose via an unspecified route of administration on an unspecified date as single dose, for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced soreness was in arm, first shot barely sore for about 24 hours and second shot very sore for about 24 hours. Event took place after use of product. Outcome of the event was unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; This is a spontaneous report from a contactable consumer(patient). An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Unknown), first dose via an unspecified route of administration, administered in left arm on 31Mar2021 as single dose for covid-19 immunization. Patient was 83 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported. On an unspecified date reporter mentioned that muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade. She puts rubbing alcohol, a Salonpas patch, and extra stregnth Tylenol for it. She is not associating it with the vaccine, but would like to know if she can receive her 2nd dose on her right arm. She is scheduled for it on Wednesday, 21Apr2021. Therapeutic measures were taken as a result of events. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cognitive disorder, Feeling abnormal, Pyrexia, SARS-CoV-2 test
Clinical narrative: Brain fog; Cognitive issues; Fevers; Stated that he had a positive test to Covid; This is a spontaneous report from contactable consumer. A 61-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated that her husband's friend received his first dose of the Pfizer Covid19 vaccine on 25Mar2021 and was exposed to Covid-19 prior to getting the vaccine. Stated that he had a positive test to Covid on 02Apr2021 and he has been having significant Covid related brain fog, like cognitive issues and fevers. He rescheduled his second dose due to the infection and wanted to know if he should wait to take the second dose until he has no symptoms of the disease. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Swelling face
Clinical narrative: a pulling, kind of drawing feeling in her left cheek right below her eye. If you come out from her ear and down from the eye where it meets; her face is a little bit swollen; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: ER8731) via left arm on Saturday 17Apr2021 at 4pm at single dose for Covid-19 immunization. Patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (lot: ER8733) in left arm on 27Mar2021 at single dose for covid-19 immunization. On an unspecified date it was reported that the following odd side effect began: a pulling, kind of drawing feeling in her left cheek right below her eye. If you come out from her ear and down from the eye where it meets. Looks like her face is a little bit swollen. Reporter asked "Is that typical Is this normal or does she need to see a doctor" Its a weird feeling in that one place she can feel no matter what her positioning is. It is there all the time. Outcome of the events was unknown.  Response was Spoke from the attached PI: Non-Serious Adverse Events-Throughout the safety follow-up period to date, Bells palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bells palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuroinflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. LAB-# Revised: 06Apr2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache
Clinical narrative: brain fog/like a haze cannot think at a high level; headaches; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 07Apr2021, as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had COVID-19 in January 202. In Apr2021, the patient experienced brain fog which started a few days after receiving the vaccine. He experienced like a haze cannot think at a high level and it lasted for a while. Patient also had headaches and extreme exhaustion. He enquired whether this was normal and asked whether to receive the second vaccine dose or not. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Depressed mood, Dyspnoea, Speech disorder
Clinical narrative: Difficulty in speaking and breathing/ she can barely breath/ she cannot breathe; Upset; Difficulty in speaking and breathing; Whole body is on fire; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. At the time of report, the patient reported that she was upset and had difficulty in speaking and breathing. The patient mentioned that she could not breathe. The patient received first dose on Friday (Apr2021) and now she could barely breath. She was told to go to the emergency room and the breathing problems started 30 minutes later with other symptoms. She was completely healthy prior to getting the vaccine and after getting the vaccine, the patient felt like her whole body was on fire and had difficulty breathing in Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: he feels improved by "50% or more; This is a spontaneous report from a Pfizer-sponsored program. A contactable 61-year-old male consumer (Patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an Intramuscular route of administration on an unspecified date, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. states that last April he had what he believes was COVID-19 and states that he does not know for sure because he could not get tested. He reports having the initial symptoms for 2 weeks and reports 3 to 4 days later that his lungs were "fried" and subsequently had what felt like emphysema for 10 months and thought he was dying and also added that he received his second dose of the Pfizer BioNTech COVID-19 vaccine two Mondays ago and reports that the next day, on Tuesday, his symptoms "just completely disappeared" except for the lungs which he feels improved by "50% or more." Caller states that this was a good thing and calls it a "life changing event." Caller states that he has read reports online about people like him, referring to himself as a "long hauler", that received the vaccine and experience "some or complete remission" from symptoms, and states that he has read about "thousand of people" reporting this. Caller states that he wanted to let us know that the vaccine does not just prevent COVID-19 but provides "relief." Caller would like to know if he could get a third dose of the vaccine, as he feels that if he were to get another dose, he would be "returned to health."  The patient experienced he felt improved by "50% or more (therapeutic response unexpected) on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021435932 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable other hcp via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced rash in both arms lasted 24 hrs after first dose of vaccine. Outcome was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: he received his first dose, tested positive; Fever; fatigue; congestion; This is a spontaneous report from a contactable received consumer (reporting on himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was asking for guidance on timing of the second vaccine dose after testing positive for COVID following the first dose. Patient received his first dose, tested positive but had more severe symptoms with congestion, fever and fatigue and he was also supposed to go for his second dose on 26Apr2021. Patient asking the longest amount of time allowed between dose 1 and dose 2. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain in my right arm; It shoots up into my shoulder sometimes; This is a spontaneous report received from a contactable consumer (patient) via Medical information team. A 84-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 17Feb2021 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, about 1-2 weeks after receiving the 2nd dose I started having pain in my right arm, where I got my shot and it shoots up into my shoulder sometimes. This morning the patient stated he used my heating pad for the pain. Patient asked what should I do about this pain. Is it normal to have it weeks after the vaccine dose. It was reported that Pfizer person I was speaking to before you told me you would be able to tell me what to do about the pain and treatments. I have been on the telephone for over 90 min and don't really know any more than when I started calling. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: First dose 31MAR2021. Sore arm for a day.; Headache 12APR2021 lasted all week; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 31Mar2021 at single dose for COVID 19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced first dose 31mar2021 and had sore arm for a day and headache 12apr2021 lasted all week. Spoke to Cardiologist, just began blood thinner and changed blood thinner medication. Today the headache does not seem as bad maybe a little duller. Started to take Tylenol as therapeutic measures, as a result of first dose 31mar2021. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Dizziness, Investigation, Loss of consciousness, Road traffic accident
Clinical narrative: Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Vertigo positional
Clinical narrative: Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Seizure, Vertigo
Clinical narrative: Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat
Clinical narrative: Dry throat; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Solution for injection), via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunization. The patient was not certain but about the same time as had his first vaccine dose the patient began experiencing trouble with having a dry throat at night stating. The patient did not know if this was related to the vaccine or not. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the Pfizer Covid vaccine on30March2021 and tested positive for covid 16Apr2021; received the Pfizer Covid vaccine on30March2021 and tested positive for covid 16Apr2021; This is an initial spontaneous report from a contactable Consumer (patient). A 54-year-old female received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 16Apr2021 patient under went lab tests and procedures which included COVID-19 test, tested positive for covid. patient wants to know should she stick to getting her next dose of the vaccine 1, 2 days or wait after she tests negative for Covid 19. Patient callback At 4:12pm submitted to healthcare facility for Positive Covid 19 between doses. Caller dropped call so warm transfer not offered. These interim considerations state mRNA vaccines, including the Pfizer BioNTech COVID-19 vaccine, can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: received the Pfizer Covid vaccine on30March2021 and tested positive for covid 16Apr2021; received the Pfizer Covid vaccine on30March2021 and tested positive for covid 16Apr2021; This is an initial spontaneous report from a contactable Consumer (patient). A 54-year-old female received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 16Apr2021 patient under went lab tests and procedures which included COVID-19 test, tested positive for covid. patient wants to know should she stick to getting her next dose of the vaccine 1, 2 days or wait after she tests negative for Covid 19. Patient callback At 4:12pm submitted to healthcare facility for Positive Covid 19 between doses. Caller dropped call so warm transfer not offered. These interim considerations state mRNA vaccines, including the Pfizer BioNTech COVID-19 vaccine, can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: dose of vaccine 3/30/21 and subsequently tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The lab tests included COVID-19, result was positive on 30Mar2021On 30Mar2021, the patient tested positive for Covid. The patient was seeking advice whether to proceed with second dose on 20Apr2021. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: dose of vaccine 3/30/21 and subsequently tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The lab tests included COVID-19, result was positive on 30Mar2021On 30Mar2021, the patient tested positive for Covid. The patient was seeking advice whether to proceed with second dose on 20Apr2021. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Soreness in her arm, feet and leg after vaccination; Soreness in her arm, feet and leg after vaccination; This is a spontaneous report from a contactable female consumer (reporting for herself). A female patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 30Mar2021 as a single dose for COVID-19 immunization. The patient's medical history included blood clot in leg. The patient's concomitant medication included warfarin 5mg daily for history of a blood clot in her leg (per patient) and the patient did not realize she was supposed to notify the vaccination provider that she was on blood thinners prior to receiving the vaccine. The patient wanted to know if she should be concerned about being on a blood thinner and receiving the Pfizer COVID-19 vaccine tomorrow or why this was on the Fact Sheet. It was reported that vaccinating persons with increased bleeding risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. On an unknown date, the patient experienced soreness in her arm, feet and leg after the first dose of the Pfizer COVID-19 vaccine, she was asking if she would be sore after her second dose and how long that will last. The patient want to know if the timing of the second dose of the Pfizer COVID-19 vaccine must be 3 weeks after the first dose was given. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got a rash on my legs; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient was 51-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced a rash on her legs. The outcome of the event was unknown on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This is a spontaneous report from Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: grandson had first covax couple weeks ago and then went to a concert and now positive with the virus; grandson had first covax couple weeks ago and then went to a concert and now positive with the virus; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A male patient (grandson) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced grandson had first covax couple weeks ago and then went to a concert and now positive with the virus and contracted covid. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Her grandson was received the first Pfizer covid vaccine and then 5 days later went to a concert and contracted covid.  He had recovered from the covid illness, but caller wanted to know what he should do now about scheduling his second vaccine. first time consumer reported about her grandson had first COVAX couple weeks ago and then went to a concert and now positive with the virus and suppose to get the second COVAX. The seriousness reported as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.