chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Body temperature, Fatigue, Influenza like illness
Clinical narrative: she had terrible stomach cramps; stomach upset; tired; low grade fever; flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 23Jan2021 at 09:00 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and family history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not underwent any lab investigation. Caller, reporting on the BNT162B2 shot and who got the first shot on 23Jan2021 and want to know if any one else has these side effects. After the first vaccine, by Tuesday she was experiencing a low grade fever and flu like symptoms on 25Jan2021. The next day on 26Jan2021 she was better but tired. On the following day she was better. She explained that she knew that was side effects. A week later on 06Feb2021 she had terrible stomach cramps and stomach upset that have lasted for 3 weeks. She explained she was getting better but then after the second dose the events came back in full force. She explained that she has had loose stools and was going all day long to the bathroom. She has never had this problem, actually always has the opposite problem. She wanted to know if we have had any other reports like this. The stomach cramps are almost like mensural cramps all day long. She also has stomach upset and every time she eats, it goes right through her. The patient did not visit to emergency room and physician office. Caller did not mention testing positive for COVID during the call, only that this only happens when she has a virus. The events were assessed as non-serious by the reporter. Outcome of the events low grade fever, tired and flu like symptoms were recovered on 27Jan2021 and not recovered for other events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she had terrible stomach cramps; stomach upset; tired; low grade fever; flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 23Jan2021 at 09:00 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and family history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not underwent any lab investigation. Caller, reporting on the BNT162B2 shot and who got the first shot on 23Jan2021 and want to know if any one else has these side effects. After the first vaccine, by Tuesday she was experiencing a low grade fever and flu like symptoms on 25Jan2021. The next day on 26Jan2021 she was better but tired. On the following day she was better. She explained that she knew that was side effects. A week later on 06Feb2021 she had terrible stomach cramps and stomach upset that have lasted for 3 weeks. She explained she was getting better but then after the second dose the events came back in full force. She explained that she has had loose stools and was going all day long to the bathroom. She has never had this problem, actually always has the opposite problem. She wanted to know if we have had any other reports like this. The stomach cramps are almost like mensural cramps all day long. She also has stomach upset and every time she eats, it goes right through her. The patient did not visit to emergency room and physician office. Caller did not mention testing positive for COVID during the call, only that this only happens when she has a virus. The events were assessed as non-serious by the reporter. Outcome of the events low grade fever, tired and flu like symptoms were recovered on 27Jan2021 and not recovered for other events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pyrexia, Rash morbilliform
Clinical narrative: measles like rash on left chest; low grade fever; chills; 2nd shot, swollen glands in neck; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: El), via an unspecified route of administration in left arm on 11Feb2021 at 11:45 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COPD (chronic obstructive pulmonary disease). Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunisation. The patient did not have any known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not test for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks. It was reported that the patient experienced 2nd shot, swollen glands in neck on 11Feb2021 at 16:00, second day (12Feb2021), low grade fever and chills, third day (13Feb2021), measles like rash on left chest. All gone now. The patient underwent lab test and procedures which included body temperature: low grade fever on 12Feb2021. No treatment was received for the adverse events. The outcome of the events was recovered on an unspecified date in Feb2021.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Feeling very tired; lethargic; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm right at the age of 53 years old on 15Feb2021 08:45 at single dose for covid-19 immunisation. Medical history included diabetes diabetes and HBP (high blood pressure). No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247) via an unspecified route of administration, administered in arm left at the age of 53 years old on 26Jan2021 09:45 at single dose for covid-19 immunisation. The patient experienced feeling very tired and lethargic. The patient noticed the symptoms about 2hrs after the second dose on 15Feb2021. On the next day 16Feb2021 the symptoms were worse but later that evening all symptoms were gone on 16Feb2021 and the patient was back to normal. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on 16Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested for COVID-19/tested positive with symptoms; tested for COVID-19/tested positive  with symptoms; This is spontaneous report from a contactable consumer (patient). This consumer reported similar events for himself and his wife. This is a 1st of 2 reports. A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) 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 was due to receive the second dose on 14Feb2021. He was asked to go get tested for COVID-19. He tested negative that day, but he also tested positive the next day on 15Feb2021. He specified he had "minor coughing, headaches and fever". He added he was in quarantine for 14 days. The outcome of event was unknown.     information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168265 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lethargy, Oropharyngeal pain
Clinical narrative: lethargic; sore throat; headache; body aches; tired; chills; This is a spontaneous report from a contactable consumer . A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,)via an unspecified route of administration on 12Feb2021 16:45 ( as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported.chills on 12Feb2021 and, headache on 13Feb2021 and body aches on 13Feb2021 and, tired on 13Feb2021 and, sore throat on 14Feb2021 and, lethargic  on an unspecified date and The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 15Feb2021 streptococcus test: negative  on 15Feb2021 and I have been taking ibuprofen and Tylenol and tacking Cepachol to help with the headaches and sore throat but as I am typing this both of these symptoms and lethargic still exist. When I was at urgent care, the nurse did say that side effects/symptoms can last 4-5 days. and outcome of the events for chills and pain and fatigue was unknown and headache and lethargic was not recovered
Sex: U
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Streptococcus test
Clinical narrative: lethargic; sore throat; headache; body aches; tired; chills; This is a spontaneous report from a contactable consumer . A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,)via an unspecified route of administration on 12Feb2021 16:45 ( as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported.chills on 12Feb2021 and, headache on 13Feb2021 and body aches on 13Feb2021 and, tired on 13Feb2021 and, sore throat on 14Feb2021 and, lethargic  on an unspecified date and The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 15Feb2021 streptococcus test: negative  on 15Feb2021 and I have been taking ibuprofen and Tylenol and tacking Cepachol to help with the headaches and sore throat but as I am typing this both of these symptoms and lethargic still exist. When I was at urgent care, the nurse did say that side effects/symptoms can last 4-5 days. and outcome of the events for chills and pain and fatigue was unknown and headache and lethargic was not recovered
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (Patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection) via an unspecified route of administration on 16Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient previously took relpax and also a monthly injection called emgality. She wanted to know if her medications are contraindicated with the vaccine or if they reduce the efficacy of the vaccine. She questioned that, is it safe to take them and is there a time period on when to get them after being vaccinated with the Pfizer COVID-19 vaccine. She also said that she hasn't taken both medications. There is no information in the Pfizer BioNTech COVID-19 vaccine Prescribing Information about a potential interaction or administration with Relpax or Emgality. The patient experienced headache on an unspecified date with outcome of unknown.
Sex: F
Vaccine: COVID19
Symptoms: Paresis, Pyrexia
Clinical narrative: In the middle of the night she woke up and she cannot move her arm; She had low grade fever; This is a spontaneous report from a contactable consumer via sponsored program. A female patient of an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration on 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 woke up in the middle of the night and was not able to move her arm She had low grade fever then took some Tylenol for the pain in her arm. The outcome of events were unknown.  Information about lot/ batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever (99.0F-99.8F); This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EN 5318), via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:45 as single dose for covid-19 immunisation at Workplace clinic. Historical vaccination included at age of 41 years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EN 5318) via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:45 AM as single dose for covid-19 immunisation at Workplace clinic. The patient medical history and concomitant medications were not reported. On 16Feb2021, the patient experienced low grade fever (99.0f-99.8f). Approximately 12 hours following the injection on 16Feb2021, I had a low grade fever (99.0F-99.8F) which lasted for approximately 12 hours. The patient underwent lab tests and procedures which included body temperature: (99.0f-99.8f) fahrenheit on 16Feb2021. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovered.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Vaccination site pain
Clinical narrative: slight redness to injection site; slight pain when they pressed down in that area; there is a little bump; This is a spontaneous report from a contactable consumer. A 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: E18982), via an unspecified route of administration, in the right arm on 06Feb2021 08:40 AM (at the age of 82-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications. The patient did not receive any other recent vaccinations. The patient did not underwent any lab investigation. Consumer was calling about the BNT162B2 vaccine, to say congratulations and thanks for saving the nation. He said that he was 84 years old, and he had his first vaccination this past Saturday, as did his wife who is 82. He said that they only thing he would like to report was a slight concern that the only reactions they had were slight redness at the site and slight pain when they pressed down in that area, no other side effects. He says he was concerned whether the vaccines were effective in their bodies.Caller said that their vaccine cards were handwritten and they got the same LOT. Caller said NDC/EXP were not provided on their handwritten vaccine cards. He said they got their first dose at 08:40 AM 06Feb2021, and he got his in his left arm and his wife got hers in her right arm. AE slight pain at the site treatment: Caller said that they didnot do anything to treat this, and it went away, also the slight redness went away, there was a little bump. Caller said it was not bad, it was good that their side effects were small and not massive at all, and it was a little thing but they are concerned if their reaction could be considered unusual, like some people, or if should it could be a stronger dosage. He said at the time their vaccines were done in cars, so he has no knowledge of temperature or amount of dosage, though he was sure it was right and it was good they didnot have side effects from it, he wondered about the dosage could they be less effective in their bodies? Caller declines to be transferred to another unit for his question, and said that after they get their second dose on the 17th, if they donot feel anything they would call medical information with their questions. No treatment was received for the event vaccination site pain. Outcome of the events vaccination site pain and injection site redness were recovered on an unspecified date and unknown for other event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021195657 same reporter/drug/event, different patient
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Pruritus
Clinical narrative: left arm sore; left arm has a large lump like a 50 cent piece; left arm itching; This is a spontaneous report from a contactable consumer (patient reported herself). A 75-year-old female patient received BNT162B2 (Pfizer Covid shot, Formulation: Solution for injection, Batch/lot number: Not Provided, Expiry Date/NDC number: Not Provided) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left arm sore, left arm has a large lump like a 50 cent piece and left arm itching. Caller stated that she received her first shot on 25Jan2021 and that her arm was sore which went away in a few days. Stated that she received the second shot early on 09Feb2021 because she was scheduled to have surgery. Stated that the spot where she received it is sore, has a large lump like a 50 cent piece and is itching. Stated that she went to the doctor and he put her on Benadryl and Zyrtec over the counter for allergies. Wanted to know if it will be safe to go and have surgery if she had this going on. Stated it was sore and she had terrible itching. Wanted to know if she was on the right track. Stated that she would start testing for surgery on Monday. Wanted to know Pfizer's opinion and if had others are calling with same. Clarified that it was for the left arm for both shots. Clarified that it was for Pfizer Covid shot. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itching; This is a spontaneous report from a contactable consumer or non-hcp (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in arm left on 03Feb2021 at 13:50 (at the age of 74-years) as single dose for COVID-19 immunization. Medical history included, thyroid disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing. Patient's Medical History (including any illness at time of vaccination) included Allergy to Amoxicillin. She has been diagnosed with that for a long time. She doesn't have the product to provide NDC, lot, and expiry. She hasn't had Amoxicillin since the first time when it made her sick. Concomitant medication(s) included levothyroxine taken for thyroid disorder from an unspecified start date and ongoing; metoprolol taken for cardiac disorder from an unspecified start date and ongoing (started taking it probably three years ago. She was not sure if Metoprolol was for her blood pressure. Her heart was beating very fast and this pill regulates it); alendronate sodium taken for bone health from an unspecified start date and ongoing; aspirin was taken for an unspecified indication from an unspecified start date and ongoing; Vitamin d was taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itching on 04Feb2021 at 18:00 and hives on 05Feb2021 at 04:00. Course of events as follows: She broke out in hives bad. She still has them. She got the shot on 03Feb2021 and still has hives. On the fourth her hands started itching. On Friday the fifth she broke out a little and still had the itch. Then on the sixth it got worst. Then on the seventh she couldn't stand it anymore and went to the outpatient clinic. She was still broken out and was going to the doctor that afternoon. The hives are still there and expanding. She did get Prednisone at the outpatient clinic. It is the fifth day of taking it and it hasn't helped. It is 20mg and she takes two tablets a day. Prednisone is in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She has misplaced the vaccine card. She doesn't have NDC, lot, or expiry to provide for the vaccine. The outcome of events  were not recovered.  Description of Product Complaint: Description of complaint: While providing adverse event for COVID19 Vaccine caller the hives are still there and expanding. She got Prednisone (20mg, count size: 10 pills) at the outpatient clinic. It was the fifth day of taking it and it hasn't helped. It was 20mg and she takes two tablets a day. Prednisone was in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She was about to take last pill and won't have any left to send. Packaging was sealed and intact  Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Rash, Vasculitis
Clinical narrative: Hives; Itching; This is a spontaneous report from a contactable consumer or non-hcp (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in arm left on 03Feb2021 at 13:50 (at the age of 74-years) as single dose for COVID-19 immunization. Medical history included, thyroid disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing. Patient's Medical History (including any illness at time of vaccination) included Allergy to Amoxicillin. She has been diagnosed with that for a long time. She doesn't have the product to provide NDC, lot, and expiry. She hasn't had Amoxicillin since the first time when it made her sick. Concomitant medication(s) included levothyroxine taken for thyroid disorder from an unspecified start date and ongoing; metoprolol taken for cardiac disorder from an unspecified start date and ongoing (started taking it probably three years ago. She was not sure if Metoprolol was for her blood pressure. Her heart was beating very fast and this pill regulates it); alendronate sodium taken for bone health from an unspecified start date and ongoing; aspirin was taken for an unspecified indication from an unspecified start date and ongoing; Vitamin d was taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itching on 04Feb2021 at 18:00 and hives on 05Feb2021 at 04:00. Course of events as follows: She broke out in hives bad. She still has them. She got the shot on 03Feb2021 and still has hives. On the fourth her hands started itching. On Friday the fifth she broke out a little and still had the itch. Then on the sixth it got worst. Then on the seventh she couldn't stand it anymore and went to the outpatient clinic. She was still broken out and was going to the doctor that afternoon. The hives are still there and expanding. She did get Prednisone at the outpatient clinic. It is the fifth day of taking it and it hasn't helped. It is 20mg and she takes two tablets a day. Prednisone is in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She has misplaced the vaccine card. She doesn't have NDC, lot, or expiry to provide for the vaccine. The outcome of events  were not recovered.  Description of Product Complaint: Description of complaint: While providing adverse event for COVID19 Vaccine caller the hives are still there and expanding. She got Prednisone (20mg, count size: 10 pills) at the outpatient clinic. It was the fifth day of taking it and it hasn't helped. It was 20mg and she takes two tablets a day. Prednisone was in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She was about to take last pill and won't have any left to send. Packaging was sealed and intact  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: headache; tired; sore right arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EL9264) via an unspecified route of administration right arm on 01Feb2021 at 08:15 AM (at the age of 71-years-old) at single dose for COVID -19 immunisation. Medical history included high cholesterol and allergy to Beta iodine. No other vaccine in four weeks was received. No other medications taken in two weeks. On 01feb2021, she experienced sore right arm 18 hours after shot, also experienced headache and very tired on the same day at 10:00 AM. Events lasted for 24 hours. She did not COVID prior vaccination and there was no COVID tested post vaccination. She did not have fever. She did not receive treatment for the events. Outcome of events pain in extremity and fatigue was recovered on 02Feb2021 and headache recovered on an unknown date in Feb2021.  No follow-up attempts are possible. No further information was expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Body temperature, Chills, Fatigue
Clinical narrative: On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself.  She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm.  The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Malaise, Pain, Pain in extremity
Clinical narrative: On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself.  She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm.  The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself.  She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm.  The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Bad chills; body aches; extreme tiredness; Some injection site soreness; Bounced off a headache at times; This is a spontaneous report from a contactable other health care professional. A 61-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in left arm at the age of 61-years (non-pregnant at the time of vaccination), on 10Feb2021 at 11:45 AM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and ascorbic acid, colecalciferol, nicotinamide, panthenol, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride tocopheryl acetate (MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) at an unknown dose, daily. The patient previously took doxycycline and amoxicillin and experienced drug allergy with both the drugs. The patient previously took first dose of bnt162b2 (Lot number: EL3249), via an unspecified route of administration in left arm at the age of 61-years (non-pregnant at the time of vaccination) on 20Jan2021 at 11:45 AM for COVID-19 immunisation. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced bad chills, body aches, extreme tiredness, some injection site soreness and bounced off a headache at times on 10Feb2021 at 09:15 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick as a dog/ they were both sick for 2 days; This is a spontaneous report from a contactable consumer (patient father). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller states that his granddaughter was a Nurse practitioner and she had both of her covid vaccine shots, and his daughter she also got the vaccine, they were both sick as a dog/ they were both sick for 2 days on an unspecified date. The outcome of the event was reported as unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Injection site erythema, Pain
Clinical narrative: slight redness to injection site; slight pain; COVID-19 vaccination; This is a spontaneous report from a contactable consume (patients). This consumer reported similar events for 2 patients (Himself and wife) this report is for 1st of 2 patient. A 84-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E18982, Expiration date: UNKNOWN) in left arm on 06Feb2021 at 08:40 as a single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient experienced slight redness to injection site, slight pain and covid-19 vaccination on 06Feb2021. The reported said that their vaccine cards are handwritten and they got the same LOT, he provides unknown number PF1202, which he thinks means Pfizer with an ID number they may have given him and he says NDC/EXP were not provided on their handwritten vaccine cards. The patient was not given treatment for AE slight pain and it went away, also the slight redness went away, there was a little bump. The reporter said it was not bad, it was good that their side effects were small and not massive at all, and it was a little thing but they are concerned if their reaction could be considered unusual, like some people, or if should it could be a stronger dosage. He says at the time their vaccines were done in cars, so he has no knowledge of temperature or amount of dosage, and says that after they get their second dose on the 17th. The outcome of the event slight redness to injection site was recovered on Mar2021 and other outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza, Pain
Clinical narrative: So-full blown flu attack last night around 9pm Body aches; So-full blown flu attack last night around 9pm Body aches; headache; chills; exhaustion; I woke up around midnight and was awake for hours; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Feb2021 10:00 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation. The reporter stated that so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion on 15Feb2021 21:00. I took extra strength Tylenol and went right to bed. I woke up around midnight and was awake for hours! I took 2 more Tylenol and eventually went back to sleep. I feel much better this morning not 100%. I took an ALEVE. Therapeutic measures were taken as a result of so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion and I woke up around midnight and was awake for hours and included treatment with Tylenol and ALEVE. The outcome of the event was reported as recovering.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: So-full blown flu attack last night around 9pm Body aches; So-full blown flu attack last night around 9pm Body aches; headache; chills; exhaustion; I woke up around midnight and was awake for hours; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Feb2021 10:00 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation. The reporter stated that so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion on 15Feb2021 21:00. I took extra strength Tylenol and went right to bed. I woke up around midnight and was awake for hours! I took 2 more Tylenol and eventually went back to sleep. I feel much better this morning not 100%. I took an ALEVE. Therapeutic measures were taken as a result of so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion and I woke up around midnight and was awake for hours and included treatment with Tylenol and ALEVE. The outcome of the event was reported as recovering.   Information on the lot/batch number has been requested.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Bladder dysfunction, Catatonia, Dysgraphia
Clinical narrative: Had no memory of what transpired during the episode; extremely weak; almost catatonic; lost control of bowel and bladder; lost control of bowel and bladder; couldn't write; slept for almost 24hrs/ Very sleep; This is a spontaneous report received from a contactable consumer (patient) and contactable nurse. A 95-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3302), via an unspecified route of administration on Arm Left on 09Feb2021 17:30 as single dose for COVID-19 immunisation. Medical history included chronic anemia and AFIB (atrial fibrillation. The patient known allergies was reported as none. Concomitant medications included levothyroxine sodium (L-THYROXINE); omeprazole; acetylsalicylic acid (ASPIRIN) at 81 mg; calcium carbonate, magnesium carbonate (TUMS) and iron; all are received within two weeks of vaccination. The patient was not received other vaccines within four weeks. The patient had no COVID prior to vaccination. The patient was not tested COVID post vaccination. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261) on 19Jan2021 17:30 on left arm for COVID-19 immunization. On 10Feb2021, after 20+ hours, the patient became extremely weak, almost catatonic, lost control of bowel and bladder, couldn't write, slept for almost 24 hrs. Improved next day and restored almost 90% by 2nd day. Had no memory of what transpired during the episode. The nurse further stated that, 20hrs after each shot, she become very sleep, weak, lost bladder control, and didn't want to communicate. The patient was not received any treatment for the events. The outcome of the events was reported as recovered on Feb2021. The Nurse considered the Pfizer product had a casual effect to the adverse event.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder, Sleep disorder
Clinical narrative: Had no memory of what transpired during the episode; extremely weak; almost catatonic; lost control of bowel and bladder; lost control of bowel and bladder; couldn't write; slept for almost 24hrs/ Very sleep; This is a spontaneous report received from a contactable consumer (patient) and contactable nurse. A 95-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3302), via an unspecified route of administration on Arm Left on 09Feb2021 17:30 as single dose for COVID-19 immunisation. Medical history included chronic anemia and AFIB (atrial fibrillation. The patient known allergies was reported as none. Concomitant medications included levothyroxine sodium (L-THYROXINE); omeprazole; acetylsalicylic acid (ASPIRIN) at 81 mg; calcium carbonate, magnesium carbonate (TUMS) and iron; all are received within two weeks of vaccination. The patient was not received other vaccines within four weeks. The patient had no COVID prior to vaccination. The patient was not tested COVID post vaccination. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261) on 19Jan2021 17:30 on left arm for COVID-19 immunization. On 10Feb2021, after 20+ hours, the patient became extremely weak, almost catatonic, lost control of bowel and bladder, couldn't write, slept for almost 24 hrs. Improved next day and restored almost 90% by 2nd day. Had no memory of what transpired during the episode. The nurse further stated that, 20hrs after each shot, she become very sleep, weak, lost bladder control, and didn't want to communicate. The patient was not received any treatment for the events. The outcome of the events was reported as recovered on Feb2021. The Nurse considered the Pfizer product had a casual effect to the adverse event.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Body temperature, Diarrhoea
Clinical narrative: She explains that she has had loose stools and is going all day long to the bathroom; terrible stomach cramps; stomach upset; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266) via an unspecified route of administration at right arm on 13Feb2021 10:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications reported as none. On 23Jan2021, the patient received her first dose. Patient stated that after she received her second dose of the Pfizer BioNTech COVID-19 vaccine, "a week and a half or 10 days later" experienced "terrible stomach cramps and loose stools" and they "feel like menstrual cramps. Patient states that after she received her first dose of the vaccine, she experienced these same symptoms so she stopped eating fruits and vegetables and stopped taking her vitamins to see if they were the cause; however, after the second dose she again had these symptoms. She explains she was getting better but then after the second dose the events came back in full force. She explains that she has had loose stools and is going all day long to the bathroom. She has never had this problem, actually always has the opposite problem. She wants to know if we have had any other reports like this. The stomach cramps are almost like mensural cramps all day long. She also has stomach upset and every time she eats, it goes right through her. Treatment: It was explained that she has not reported this to the doctor. Caller state she has just been dealing with the side effects. Caller did not mention testing positive for COVID during the call, only that this only happens when she has a virus. The outcome of the events was unknown.