chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered at the right arm on 07Apr2021 10:45 (age at vaccination was 26 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lost vision on 07Apr2021 with outcome of recovered on an unspecified date, migraine on 07Apr2021 with outcome of recovered on an unspecified date, was unable to lift head on 07Apr2021 with outcome of recovered on an unspecified date, chest pain on 07Apr2021 with outcome of recovered on an unspecified date, and nausea on 07Apr2021 with outcome of recovered on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of lost vision, migraine, unable to lift head, chest pain, nausea that included migraine medication, ibuprofen, and nausea medication.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report received from Pfizer-sponsored  Program. A contactable consumer (patient) reported that a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 16Apr2021 05:20 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness in the arm in Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Grip strength decreased, Muscle spasms, Muscle twitching, Peripheral paralysis
Clinical narrative: paralysis went to my ring figure; Uncontrollable twitch in my thumb, in my hand; Could not control my pinky; My pinky kind of curls and it was like a cramp in it; I could not grab anything with my pinky and my ring figure; This is a spontaneous report from a contactable consumer reporting for him self.  A 52-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced paralysis went to my ring figure , uncontrollable twitch in my thumb, in my hand , could not control my pinky; my pinky kind of curls and it was like a cramp in it , I could not grab anything with my pinky and my ring figure all the events on an unspecified date with outcome of unknown.  All the reported events were considered Important Medical Events.  Course of the event: "I got my Pfizer shot on Saturday. On Sunday I had uncontrollable twitch in my thumb, in my hand. It was subtle when it started and then it gets worst. So it was subtle, it wasn't lot to begin and then over the course of next 24 hours it got worse and then it stopped. I mean that's not the end of the story. Once the twitching stopped then I could not control my pinky, so my twitching in my thumb stopped then my pinky finger is kind of just wanted to curl over like I have a permanent cramp in my pinky. My pinky kind of curls and it was like a cramp in it, so it was like I have no control over the pinky, either I could straight my pinky or I could make a fist out of my pinky that is it. I could not like close it half way or grip anything like that. 24 hours later that paralysis went to my ring figure, so up until it seems to get little better since this morning. I can control them a little bit but last night I could not hold anything with my finger, I could not control them. I could not grab anything with my pinky and my ring figure."   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Hypoaesthesia, Muscle twitching, Muscular weakness
Clinical narrative: paralysis went to my ring figure; Uncontrollable twitch in my thumb, in my hand; Could not control my pinky; My pinky kind of curls and it was like a cramp in it; I could not grab anything with my pinky and my ring figure; This is a spontaneous report from a contactable consumer reporting for him self.  A 52-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced paralysis went to my ring figure , uncontrollable twitch in my thumb, in my hand , could not control my pinky; my pinky kind of curls and it was like a cramp in it , I could not grab anything with my pinky and my ring figure all the events on an unspecified date with outcome of unknown.  All the reported events were considered Important Medical Events.  Course of the event: "I got my Pfizer shot on Saturday. On Sunday I had uncontrollable twitch in my thumb, in my hand. It was subtle when it started and then it gets worst. So it was subtle, it wasn't lot to begin and then over the course of next 24 hours it got worse and then it stopped. I mean that's not the end of the story. Once the twitching stopped then I could not control my pinky, so my twitching in my thumb stopped then my pinky finger is kind of just wanted to curl over like I have a permanent cramp in my pinky. My pinky kind of curls and it was like a cramp in it, so it was like I have no control over the pinky, either I could straight my pinky or I could make a fist out of my pinky that is it. I could not like close it half way or grip anything like that. 24 hours later that paralysis went to my ring figure, so up until it seems to get little better since this morning. I can control them a little bit but last night I could not hold anything with my finger, I could not control them. I could not grab anything with my pinky and my ring figure."   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in her mouth; This is a spontaneous report from contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation and started to receive palbociclib (IBRANCE) via an unspecified route of administration on an unspecified date ("for about five years") to an unspecified date at an unspecified dose and frequency for an unspecified indication. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On an unspecified date the patient experienced metallic taste in her mouth. The patient stated that she had been taking palbociclib for about 5 years and she completed her vaccination series of the Pfizer COVID-19 vaccine on 19Feb2021. She presented with a metallic taste in her mouth that ruined her taste and would not go away. The patient stated that she developed the metallic taste shortly after getting the second Pfizer COVID-19 shot, even though she had been on palbociclib for a long time. She called to inquire whether there were any reports of this reaction with palbociclib. The clinical outcome of the event metallic taste in her mouth was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; Little bit tired; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, NDC number: Unknown, UPC number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, when probed for the concern, consumer stated, "patient took it and positive for COVID-19 on this last Friday (on an unspecified date in Apr2021), isolation this coming Saturday and I had my first dose of the Pfizer vaccine on 08Apr2021, so I am made schedule on "06May2021" (not clarified) which was about two weeks after my symptoms would be gone and my isolation would be over, so patient just want to make sure to the vaccine the second dose of soon after patient had or something in the vaccine, so should patient take second vaccine soon after the virus or not. Patient was a little bit tired on an unspecified date in Apr2021." In response to further probing, consumer stated, "I don't think so actually it was fine." When probed for vaccine Lot number and expiration date, consumer stated, "Like the dose confirmation #7G613IX2Y2IEM2." The patient underwent lab test and procedure which included COVID-19: Positive on an unspecified date in Apr2021. The outcome of the events was unknown.  No Follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Dyspnoea, Pain, Palpitations
Clinical narrative: Severe rash on hand, wrist, knuckles/top of both of her hands; Shortness of breath; Heart Palpitations; Soreness; Low grade fever/temperature has been around 99.8 degrees Fahrenheit; hives; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151; Expiry date: Not reported), via an unspecified route of administration, administered in Deltoid Right on 07Apr2021 13:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history included neck surgery from 25Jan2021, covid-19 from 2020 to 2020, ongoing Allergic to Sulfa Drugs. The patient's concomitant medications were not reported. On 16Apr2021, she developed shortness of breath, heart palpitations, and a temperature of 98.1-99.8. She also had a rash on the top of both of her hands. She states the rash has improved but she still has the other symptoms. She went to the ED and was prescribed methylprednisolone on 18Apr2021 and also tested negative for Covid. It was reported that she started having a severe rash on her hand. It is on her wrist, hand, and knuckles. She also developed shortness of breath, heart palpitations, soreness, and a low grade fever. States her temperature has been around 99.8 degrees Fahrenheit. Also reported that all of her symptoms began on 16Apr2021. States that the rash was very bright red at one point; it's not as red now but the hives are still there. States all of her symptoms are persisting. Felt like she did a year ago when she had Covid 19, Low Grade Fever, Shortness of Breath, Heart Palpitations, Soreness, and Severe rash on hand, wrist, knuckles. The patient underwent lab tests and procedures which included covid-19: negative on 18Apr2021, body temperature: 99.8 fahrenheit on. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Severe rash on hand, wrist, knuckles/top of both of her hands; Shortness of breath; Heart Palpitations; Soreness; Low grade fever/temperature has been around 99.8 degrees Fahrenheit; hives; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151; Expiry date: Not reported), via an unspecified route of administration, administered in Deltoid Right on 07Apr2021 13:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history included neck surgery from 25Jan2021, covid-19 from 2020 to 2020, ongoing Allergic to Sulfa Drugs. The patient's concomitant medications were not reported. On 16Apr2021, she developed shortness of breath, heart palpitations, and a temperature of 98.1-99.8. She also had a rash on the top of both of her hands. She states the rash has improved but she still has the other symptoms. She went to the ED and was prescribed methylprednisolone on 18Apr2021 and also tested negative for Covid. It was reported that she started having a severe rash on her hand. It is on her wrist, hand, and knuckles. She also developed shortness of breath, heart palpitations, soreness, and a low grade fever. States her temperature has been around 99.8 degrees Fahrenheit. Also reported that all of her symptoms began on 16Apr2021. States that the rash was very bright red at one point; it's not as red now but the hives are still there. States all of her symptoms are persisting. Felt like she did a year ago when she had Covid 19, Low Grade Fever, Shortness of Breath, Heart Palpitations, Soreness, and Severe rash on hand, wrist, knuckles. The patient underwent lab tests and procedures which included covid-19: negative on 18Apr2021, body temperature: 99.8 fahrenheit on. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: they tested positive for Covid for the last 3 weeks; they tested positive for Covid for the last 3 weeks; This is a spontaneous report from a Pfizer-sponsored program.   A contactable consumer reported similar events for 02 patients. This is the 1st of 2 reports. This consumer reported for female patient that the unspecified age of female patient received dose 1 of bnt162b2 (COMIRNATY, solution for injection), (Batch/Lot Number: unknown) on 21Mar2021 via unspecified route of administration as single dose for covid-19 immunisation. The medical history and concomitant medication were not provided. Patient tested positive for Covid for the last 3 weeks. And patient was tested negative around 6/7April. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021442105 Same reporter/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Weak; Dizzy; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164) 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. He had a side effect of dizziness and he was weak yesterday. The weakness had improved and he got his strength back. He still has dizzy spells. He is wondering since his strength came back today if he should wait to see how he feels tomorrow before he goes to the ER. He also began to feel tired and weak that day, yesterday he felt dizzy, light headed and weak. Today he is still weak. He has heard of other people feeling tired for a few days but were fine after that. The outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Muscle fatigue, Nausea
Clinical narrative: muscle fatigue; Included fever of 101.3 F; chills; nausea; vomiting; intense headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had reaction from the 2nd dose of COVID-19 vaccine which included fever of 101.3 F, chills, muscle fatigue, nausea, vomiting and intense headache on an unspecified date which lasted for approximately 48 hours. The outcome of these events was recovered as it lasted for approximately 48 hrs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: muscle fatigue; Included fever of 101.3 F; chills; nausea; vomiting; intense headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had reaction from the 2nd dose of COVID-19 vaccine which included fever of 101.3 F, chills, muscle fatigue, nausea, vomiting and intense headache on an unspecified date which lasted for approximately 48 hours. The outcome of these events was recovered as it lasted for approximately 48 hrs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Rhinorrhoea
Clinical narrative: runny nose; I've been exposed to someone with covid; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 27-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 (Monday) (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient found out that she was exposed to someone with COVID. On an unspecified date, the patient experienced runny nose but no other symptoms but planned to get tested on Saturday. The patient asked whether being exposed to someone with COVID will prevent her from getting her second shot, even after she will test negative. The outcome was unknown for both the events.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report via Medical Information Team and from a Pfizer-sponsored program reported from a contactable consumer (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration on 03Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on 20Apr2021. She was supposed to get the second dose on 24Apr2021 and even though her HCP told her to skip it she was asking if she could still get it. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Dizziness, Fatigue, Lethargy
Clinical narrative: fever; congestion; lethargy; confusion; spacy dizziness; body aches; tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had congestion, lethargy, confusion, spacy dizziness, tired and body aches on an unspecified date in 2021. She had a fever that morning (21Apr2021) but it went down. The patient was not sure if her symptoms are normal or the severity was normal. The patient asked how long the symptoms should last finally. The outcome of congestion, lethargy, confusion, spacy dizziness, tired and body aches was unknown at the reporting time. The outcome of fever was recovered on 21Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: fever; congestion; lethargy; confusion; spacy dizziness; body aches; tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had congestion, lethargy, confusion, spacy dizziness, tired and body aches on an unspecified date in 2021. She had a fever that morning (21Apr2021) but it went down. The patient was not sure if her symptoms are normal or the severity was normal. The patient asked how long the symptoms should last finally. The outcome of congestion, lethargy, confusion, spacy dizziness, tired and body aches was unknown at the reporting time. The outcome of fever was recovered on 21Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Mental impairment, Myalgia, Paraesthesia
Clinical narrative: mental fogginess; blurred vision; Feverish/a fever of 102; Muscle ache; pins and needles in her upper arms and legs; Headache; This is a spontaneous report from a contactable healthcare professional (patient) received by Pfizer from Medical information Team. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. She had previously received the first dose of BNT162b2 for COVID-19 immunisation and experienced a little blurred vision. The patient's concomitant medications were not reported. A few hours after the second dose, the patient experienced a fever of 102. The fever went through the night and all though the next day and through the next night. She took tylenol and advil for the fever but the fever did not go away but did slightly reduce the fever. She had muscle aches when she had a fever. She had been feverish for two days and after that had blurred vision. She also experienced pins and needles in her upper arms and legs. She stated she had a mental fogginess that barely went away yesterday (unspecified date). At the time of reporting, the the blurred vision was still occurring. The patient went to an optometrist but they did not have an answer for her. The patient also reported a headache but said it could be due to trying to study with blurred vision. The event blurred vision was not resolved. The outcome of the other events was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported event mental fogginess  and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: mental fogginess; blurred vision; Feverish/a fever of 102; Muscle ache; pins and needles in her upper arms and legs; Headache; This is a spontaneous report from a contactable healthcare professional (patient) received by Pfizer from Medical information Team. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. She had previously received the first dose of BNT162b2 for COVID-19 immunisation and experienced a little blurred vision. The patient's concomitant medications were not reported. A few hours after the second dose, the patient experienced a fever of 102. The fever went through the night and all though the next day and through the next night. She took tylenol and advil for the fever but the fever did not go away but did slightly reduce the fever. She had muscle aches when she had a fever. She had been feverish for two days and after that had blurred vision. She also experienced pins and needles in her upper arms and legs. She stated she had a mental fogginess that barely went away yesterday (unspecified date). At the time of reporting, the the blurred vision was still occurring. The patient went to an optometrist but they did not have an answer for her. The patient also reported a headache but said it could be due to trying to study with blurred vision. The event blurred vision was not resolved. The outcome of the other events was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported event mental fogginess  and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: She tested positive for COVID-19; This is a spontaneous report received from a Pfizer-sponsored program. A contactable female Consumer reported for herself that: CEP ID: 159558. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown), dose 1 via an unspecified route of administration on 31Mar2021 at SINGLE DOSE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced she tested positive for covid-19 (covid-19) on 02Apr2021. The patient underwent lab tests and procedures which included covid-19: positive on 02Apr2021. Clinical course reported as Caller, got her first dose on March 31st. She tested positive for COVID-19 on April 2nd. She is scheduled to get the second dose on Wednesday (April 21st). She had the COVID-19 Test this morning and wants to know if she can get the second dose in case the result would be positive or not. The outcome of the event was unknown on an unspecified date.  Follow-up 01(21Apr2021): This is a follow up-spontaneous report received from a Medical Information Team. No new AE or SD is added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Received his first dose  of Pfizer covid vaccine on  March 23 and he tested positive a week later; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. The patient medical history, concomitant medications and past drug history were not reported. Reporter stated he already spoke to the safety department but did not have any reference number to provide. He received his first dose of Pfizer covid vaccine on 23Mar2021 and he tested positive a week later. On 12Apr2021 he tested negative. He wanted to know when he could get his second dose. The outcome of event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: having ringing in my ear, just a buzzing annoying thing; This is a spontaneous report from a non-contactable consumer (patient) via Medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. It was reported that patient have been experiencing ringing in ear, just a buzzing annoying thing on an unspecified date after the second dose of vaccine. The event was reported as non serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Panic disorder
Clinical narrative: panicking; can receive his shot when and if he gets out of the hospital on time; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 63-years-old male patient received first dose of bnt162b2(Pfizer COVID-19 Vaccine, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Reporter inquired about her husband who is currently in the hospital. He has his second shot of the Pfizer BioNTech COVID19 vaccine scheduled on Saturday. She is wondering if he can receive his shot when and if he gets out of the hospital on time. If he does not get out on time, what should he do. It was reported that he is panicking because the appointment is coming up. She says the hospitalization is not caused by the vaccine since he "gets like this when the weather changes" also states that she will ask his providing doctor the same question. Response was reporter referred back to HCP since she is asking for medical advice: Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. Therapeutic measures included Zpack. Outcome of the event was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: his hands just started shaking really bad; This is a spontaneous report from a contactable consumer (Parent) . A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# EW0151), via an unspecified route of administration on 10Apr2021 (at the age of 16-years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021 (one week after vaccination), patient hands just started shaking really bad. Patient experienced it again during an exam making it hard for him to write. Reported parent asked if this was normal and a common side effect or something she should be concerned about. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 on Monday the week later (5APR2021); This is a spontaneous report from a contactable consumer (mother). A 28 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on 01Apr2021 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. Patient (Son) received the first dose on a Thursday, 3 weeks ago (01Apr2021), and was scheduled to receive the second dose this Friday (23Apr2021). Patient tested positive for COVID-19 on Monday the week later (05Apr2021), but he was better now as reported. It was asked if patient can get the next dose. Seriousness reported as non-serious. 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: Back pain
Clinical narrative: back pain/she is having shooting pain in the upper back; This is a spontaneous report received from a contactable consumer(patient), self-reported. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates: unknown), via an unspecified route of administration, on 21Apr2021, as single dose for COVID-19 immunisation. Patient medical history included which was spinal stenosis and took ibuprofen, aspirin, or naproxen for back pain. Patient concomitant medication included which was Tylenol. Patient stated Tylenol does not help and wanted to know if can take naproxen or aspirin for the pain. On 21Apr2021 at morning, patient had shooting pain in the upper back, this was new for her. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Has the COVID; Has the COVID; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient (reporter's husband) had the COVID since an unspecified date. The outcome of the event was unknown. Information regarding the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in the joints of the feet, ankles, and wrist; pain happened on the right hand and feet; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing gout. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. On an unspecified date, the patient reported that in the last couple of days he had pain in the joints of the feet, ankles, and wrist and also mentioned that the vast majority of the unusual pain happened on the right hand and feet. Reporter asked what medication he can take for the joint pain and asked how long the possible side effect would last. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: light-pink circle at the injections site; This is a spontaneous report received from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unknown route of administration on 07Apr2021 as a single dose for Covid-19 immunization. Medical history included anaphylactic reaction to mango in the past and had to be at a hospital within 10 minutes and she blew up like a balloon. Concomitant medication included unspecified medications (reported as patient takes like 10 medications a day). She noticed around 14Apr2021 that she has a light-pink circle at the injections site, and it was not itchy or painful. Patient enquired whether it may be an interaction with her medications as she takes like 10 medications a day. Patient second dose was scheduled on the 28Apr2021. And her husband and daughter got the Pfizer COVID-19 vaccine on the same day, and had no injection site reactions, or any AEs. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metal taste in the mouth after eating any kind of meat; This is a spontaneous report from a contactable Physician via Pfizer sponsored program support. A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9269) on 05Feb2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205) on 26Feb2021 both doses via unspecified route of administration, administered in right arm, (at the age of 73-year-old) as single dose for COVID-19 immunisation. Medical history included Pneumonia. The patient concomitant medications were not reported. On an unspecified date in 2021 (after the second dose on 26Feb2021), the patient developed a metallic taste in her mouth, a metal taste anytime she ate meat which was mainly only with the meat. Patient had this metallic taste before with pneumonia which was on unspecified date, but this time she was unable to get rid of it. It stays with her after she eats any kind of meat and goes away only after eating any fruits, veggies, bread, fish was not bad either and she was fine. It could stay for hours. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Magnetic resonance imaging
Clinical narrative: Diplopia; This is a spontaneous report from a Pfizer sponsored program Pfizer RxPathways.   A contactable male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown) dose 1 via an unspecified route and administration, on an unspecified date as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, after the first shot patient developed diplopia. Not saying that the vaccine was the root cause, but some other variables were discarded with the MRI. Patient was wondering if there was any place where they could record these not regular side effects and even follow. For example, he was wondering if others had the same issue and if after sometime was rollback this type of side effects by them. The patient underwent lab tests and procedures which included MRI: Unknown result, some other variables were discarded with the MRI on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Dizziness, Headache, Pain in extremity
Clinical narrative: everything was spinning around me; lose balance; felt confused; light-headed/  dizzy; headache; pain in my arm; This is a spontaneous report received from a contactable consumer (reporting on herself). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took mercurochrome and experienced drug hypersensitivity. It was reported that she received the first dose of the BNT162B2 vaccine on Sunday (18Apr2021), that day she felt confused, light-headed, she had a headache and pain in her arm, but she considered that normal. At night, she woke up at 3 am (on 19Apr2021), she felt really dizzy, everything was spinning around her, she loose balance. she needed to go to the bathroom, but she had to walk holding herself in the walls, right now she still dizzy, she allergic to mercurochrome. Patient was 51 years old and asking when will it go away. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: everything was spinning around me; lose balance; felt confused; light-headed/  dizzy; headache; pain in my arm; This is a spontaneous report received from a contactable consumer (reporting on herself). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took mercurochrome and experienced drug hypersensitivity. It was reported that she received the first dose of the BNT162B2 vaccine on Sunday (18Apr2021), that day she felt confused, light-headed, she had a headache and pain in her arm, but she considered that normal. At night, she woke up at 3 am (on 19Apr2021), she felt really dizzy, everything was spinning around her, she loose balance. she needed to go to the bathroom, but she had to walk holding herself in the walls, right now she still dizzy, she allergic to mercurochrome. Patient was 51 years old and asking when will it go away. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer (Caregiver). A 21-year-old male patient (grandson) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at age of 21-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at age of 21-year-old for COVID-19 immunisation. Caller stated his grandson (21-year-old) received his second dose of the Pfizer COVID vaccine yesterday and this morning when he woke up he has been having chest pain on and off. caller wanted to know if that has been consistent with the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysstasia, Erythema, Fatigue
Clinical narrative: feeling unwell; nausea; redness; injection site swelling; little fever; joint pain; chills; muscle ache; headache; body ache; tiredness; couldn't hardly stand; This is a spontaneous report from a contactable consumer or other non hcp.  A 55-years-old male patient received bnt162b2 (BNT162B2solution for injection), dose 2 via an unspecified route of administration on 19Apr2021 12:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included blood pressure measurement and concomitant medications were not reported. On Tuesday,feeling unwell, nausea, redness, injection site swelling right where they gave me the shot, a little fever, joint pain, chills, muscle ache, headache, body ache, tiredness and rated his pain as 10/10. The patient had taken Acetaminophen, drank sprite, ate crackers, and laid down for about 2 hours. He also reported that back pain is still existent a couple of inches above his waist line and on one side, all the way across. Caller states he rates his back pain as a 4 or 3/10, is nauseous rating it 2/10, has pressure in his hands and swelling in his fingers. He was taking Acetaminophen for every 6 hours. The outcome of the vents was unknown.   No follow up attempts required as no further information is expected.