chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Thinking abnormal
Clinical narrative: her thinking has been off. Sometimes she cannot think of the word and then it finally comes to her went; Out of sorts in her head; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administrated in Arm Left on 13Feb2021 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization. Patient medical history included Medication allergies, Outpatient surgery from Dec2020, Cholesterol, Anxiety, Thyroid, Acid reflux, Hormones, Allergy to Sulfa, and Keflex, reaction to Keflex. Patient concomitant medications included levothyroxine as 0.25mg for Thyroid medication, Simvastatin as 5mg tablet for Cholesterol, Alprazolam (generic Xanax) as 0.25mg for Anxiety, Famotidine (Generic product) as 40mg tablet for Acid reflux, Estradiol as 0.5mg for Hormones, Progesterone as 100mg capsule for Hormones, Centrum Silver Multivitamin as Over the counter, Calcium with Magnesium and Zinc as Over the counter, Vitamin d, Vitamin C as Over the counter, Zinc as Over the counter, and Osteo Bi-Flex as Over the counter. On 13Feb2021, the patient experienced Out of sorts in her head, and on 14Feb2021 her thinking has been off. Sometimes she cannot think of the word and then it finally comes to her went. Patient neither visit to Emergency Room or Physician Office nor not hospitalized. The outcome of the event Out of sorts in her head was unknown, and her thinking has been off. Sometimes she cannot think of the word and then it finally comes to her went not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood pressure measurement, Cold sweat, Diarrhoea
Clinical narrative: Feeling real sluggish; Really sick; Nauseated; Diarrhea; feel hot; clammy; throwing up/Vomited; weak; Left arm is a little sore; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 14:00 (at the age of 69-years-old) as single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus in 2010, atrial fibrillation from 2016 and open heart surgery in 2016. Patient had no known allergies. There were no concomitant medications. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the covid vaccine. Caller stated that her left arm is a little sore but she was fine otherwise until 17Feb2021 around 17:00, at that time she got really sick, nauseated, vomited a little, had diarrhea, and was feeling real sluggish. She began to feel hot, weak, clammy and was throwing up. She asked if these are expected side effects from the vaccine. The patient underwent lab tests and procedures which included blood glucose and blood pressure measurement which was fine. The outcome of the event left arm is a little sore was not recovered while the outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Illness, Nausea, Pain in extremity, Sluggishness
Clinical narrative: Feeling real sluggish; Really sick; Nauseated; Diarrhea; feel hot; clammy; throwing up/Vomited; weak; Left arm is a little sore; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 14:00 (at the age of 69-years-old) as single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus in 2010, atrial fibrillation from 2016 and open heart surgery in 2016. Patient had no known allergies. There were no concomitant medications. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the covid vaccine. Caller stated that her left arm is a little sore but she was fine otherwise until 17Feb2021 around 17:00, at that time she got really sick, nauseated, vomited a little, had diarrhea, and was feeling real sluggish. She began to feel hot, weak, clammy and was throwing up. She asked if these are expected side effects from the vaccine. The patient underwent lab tests and procedures which included blood glucose and blood pressure measurement which was fine. The outcome of the event left arm is a little sore was not recovered while the outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling real sluggish; Really sick; Nauseated; Diarrhea; feel hot; clammy; throwing up/Vomited; weak; Left arm is a little sore; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 14:00 (at the age of 69-years-old) as single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus in 2010, atrial fibrillation from 2016 and open heart surgery in 2016. Patient had no known allergies. There were no concomitant medications. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the covid vaccine. Caller stated that her left arm is a little sore but she was fine otherwise until 17Feb2021 around 17:00, at that time she got really sick, nauseated, vomited a little, had diarrhea, and was feeling real sluggish. She began to feel hot, weak, clammy and was throwing up. She asked if these are expected side effects from the vaccine. The patient underwent lab tests and procedures which included blood glucose and blood pressure measurement which was fine. The outcome of the event left arm is a little sore was not recovered while the outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea; headache; This is a spontaneous report from a contactable other hcp (Patient).  A 57-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Age at vaccination: 57-years-old) as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history included multiple sclerosis, asthma both from an unknown date and unknown if ongoing. Concomitant medication included glatiramer acetate (GLATIRAMER ACETATE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/lot number: EL1284) in Arm left on 14Jan2021 (Age at vaccination: 57-years-old) for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Caller is a medical assistant who received her second dose of Pfizer-Biontech Covid19 vaccine on 05Feb2021. She reports nausea that lasted for 6 days following vaccination, but is more concerned about the consistent headache she has been experiencing since receiving the second dose. She is going on day 14 and now of having headaches, she states it comes and goes and could be mild to severe, which I have to treat. Upon date it was reported that Last dose 05Feb2021 and on 06Feb2021 she felt nausea for 5 days and still experiencing headaches, mostly on base of the skull. Patient did not receive any treatment for the events. Since the vaccination patient was not tested for COVID-19. The outcome for the event nausea was resolved on an unspecified date in 2021 and for remaining event outcome was reported as no resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer. This consumer reported for an 80-year-old female patient (reporter's mother). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Consumer said her 80-year-old mother experienced dizziness after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. She wanted to know if this reaction was a contraindication to getting the 2nd dose of the vaccine. Caller was calling about the Pfizer COVID 19 vaccine. She was calling about her mother who was 80 years old. she got the first vaccine a few weeks ago and she was getting ready to have her booster and she wanted to check on something. When she got the first vaccine she was fine the day of but the next morning she was really dizzy, when she got up, she went to the bathroom and had to hold on to the walls to get to the bathroom and back to bed and she laid back down in the bed and woke up a few hours later and she was fine, She looked at the slip regarding the vaccine possible allergic action and as she understands it dizziness was not on the primary list but then you read further down it was on the secondary list for potential allergic reactions. Her question was should she not be getting the booster. She did not know off the top of her head. She thinks it was around 22Jan2021. She did not have it on her calendar, she didn't go with her to the first one she was going with her to the second one which was tomorrow, they probably should had called a long time ago, they called just in time. She thought it would be close to 22Jan2021 some time that week. The next morning after the vaccine when she woke dizzy, and she managed to go to the bathroom and then back to bed and fell back asleep and a few hours later it was gone when she woke up. She was not sure exactly when it stated because she was sleeping but from the time she got up and was dizzy to the time she woke up was about 4-5 hours. She was on other medication, but it would not be those unless it interacted with the vaccine. She had been taking those a long time so it would not be those that caused unless there was an interaction with the vaccine. No further information provided. The clinical outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: peripheral vision has been blurry; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Right on 29Jan2021 (at the age of 75-years-old) as dose 1, single for covid-19 immunisation.  The patient medical history was not reported. The patient experienced peripheral vision has been blurry on an unspecified date. Patient received his 1st dose of the Pfizer Covid Vaccine 3 weeks ago and stated that for the last couple of weeks his peripheral vision has been blurry. Wants to know if there are any reported vision issues with the vaccine and if it's recommended for him to get his 2nd dose tomorrow because of this. Second dose was scheduled for the next day. Patient stated that in the last couple weeks, it seems like his peripheral vision is blurry, like it is not clear. Patient did not know if this is a coincidence or what, but he is wondering if Pfizer is aware of any incidents of something like that happening with the vaccine. Patient was wondering if there were recommendations about if he should get the second dose of the product, considered his symptoms. Patient confirmed that he had no other vaccines on the same day as the COVID vaccine and other than his normal prescriptions, there are no new scripts that he started recently, it is only medications he has been taking for a while. No further details were provided by the Patient. Outcome of the event was not recovered.   Follow-up (18Feb2021): This is a Follow-up spontaneous report from a contactable Consumer. This consumer reported included weight, height and clinical information.   No follow-up attempts are possible. No further information is expected.
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 second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. Medical history included migraine. The patient's concomitant medications were not reported. Caller stated that she had her Pfizer COVID-19 vaccine second dose today, and has a question. She says she get migraines, usually one week out of a month, and had a bad headache the last two days which she had this morning. She said she was not saying it was from the injection, but she would like to know if she was allowed to take Tylenol or her migraine medicine since she got the second dose of the vaccine today. She says she just wanted to know if she can take Tylenol, she doesn't know if the headache was from this, she had one and it went away for the last day and a half, and now she has one again. She said she took Tylenol last night, and took Tylenol again this morning and the headache went away, now she wanted to know if she can take Tylenol for it since she has a headache again. Caller wanted to know how long it usually take for the symptom to go away. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Little red in the injection site with minimal pain; Little red in the injection site with minimal pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported (reason for no lot number: consumer stated, "EN6200, that was all the information he has there, and it actually does not say a LOT#. He just figured it was)) as dose 1, single for covid-19 immunization (at the age of 71-years-old). The patient medical history and concomitant medication were not reported. It was reported by the patient that he received first dose of vaccine and stated that on 17Feb2021 he experienced little red in the injection site with minimal pain. The patient had not received any treatment for the events. He further stated that everything was fine and there has been no adverse reaction, no terrible symptoms except the injection site which was normal. However, this afternoon his doctor put him on antibiotic for injection in the tooth and that antibiotic was 500 mg of Amoxicillin and he was just wondering if it was safe to take. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; exhausted; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiry date: unknown) via unspecified route of administration, in left arm on 17Feb2021 16:15, as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included known allergies of latex from an unspecified date and unknown if ongoing. Concomitant medications were not reported. She did not take any other vaccine in four weeks or medications in two weeks. On 18Feb2021 10:00 AM, patient experienced chills, exhausted. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment was given as a result of the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Felt fatigued 24-30 hours after vaccination; slight headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration on 17Feb2021 at 10:00 (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies. On 18Feb2021 at 15:00, the patient experienced felt fatigued 24-30 hours after vaccination and slight headache. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache; Body aches; Fatigue; This is a spontaneous report from a contactable consumer. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 at 12:15 (at the age of 36 year) as dose 2, single for COVID-19 immunisation at Workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant at time of vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation. On 18Feb2021 at 09:00 AM patient experienced Headache, Body aches, Fatigue. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache; tiredness; chills without fever; Soreness at injection site; This is a spontaneous report from a contactable consumer or other non hcp.  A 40-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:15 (Batch/Lot Number: EL3247) as dose 2, single dose for covid-19 immunisation.  Medical history included covid-19 from Nov2020. There were no concomitant medications. The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID On 18Feb2021 18:00 the patient experienced, Headache, tiredness, and chills without fever, Soreness at injection site with outcome of recovered. No treatment was received.  Follow-up (26Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of Pfizer receipt date (PRD). reported information included.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia
Clinical narrative: Headache; achy muscles; during sleep for a very short bit hot/sweating; This is a spontaneous report from a contactable consumer (Patient).   A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:00 (age at vaccination 49 years) as dose 2, single for covid-19 immunisation. Medical history included blood pressure high. Concomitant medication(s) included losartan (LOSARTAN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); ibuprofen (ADVIL [IBUPROFEN]). The patient previously took demerol and experienced drug hypersensitivity. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (age at vaccination 49 years) as dose 1, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility type vaccine was Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 23:30 the patient experienced headache, achy muscles, during sleep for a very short bit hot/sweating. The patient did not receive any treatment for reported events. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 18Feb2021 12:30 (at the age of 57-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Neuropathy in legs from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 28Jan2021 13:00 (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chills on 18Feb2021 23:30 and headache on 19Feb2021 07:00. Patient did not receive treatment for adverse events. The outcome of chills was recovered, and headache was recovering.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: I am achy all over really bad; Fever; Don't feel good; This is a spontaneous report from a contactable consumer. This consumer (Patient) reported. A patient of unspecified age and gender 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 08Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously 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 on Jan2021 as dose 1, single for covid-19 immunisation. On an unspecified date on Feb2021, the patient experienced achy all over really bad, fever and patient don't feel good. The outcome of the events were unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This is a spontaneous report from a contactable consumer. This consumer (Patient) reported: suspect product details and Historical vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: just sore arm; little achy for a day or so; mild fatigue; sore muscle for a day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from a Pfizer-sponsored program. A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced just sore arm, little achy for a day or so, mild fatigue, sore muscle for a day. It was further reported that caller received 1st and 2nd dose of vaccine. and states that1st went well, just sore arm, little achy for a day or so. With the first shot of Pfizer COVID-19 Vaccine she had the regular symptoms that you would get from any vaccine, like a sore arm, a little achy or whatever for a day, no problem. Caller also stated that she experienced a mild fatigue, sore muscle for a day after the 1st dose. The clinical outcome of all events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Right on 09Feb2021 (at the age of 76-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban 5 mg tablet twice a day mouth (ELIQUIS) taken for Atrial fibrillation (started taking over a year ago) from an unspecified start date and ongoing. The caller reported that he normally has some dizziness but what he was experiencing now was more than normal in Feb2021. The outcome of event was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Circumstance or information capable of leading to medication error, Condition aggravated, Myalgia, Pain
Clinical narrative: Has a question about a possible interaction with Naproxen and the COVID vaccine; her muscles and joint pain are worse /her pain was worse; Injection site pain; Legs, back, shoulders, and pretty much everything hurts; stronger muscle and bone pain; stronger muscle and bone pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 10Feb2021 12:36 (at the age of 73-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes, arthritis, blood pressure. Concomitant medication(s) included metformin 500 mg twice a day taken for diabetes mellitus, start and stop date were not reported; lisinopril 10 mg once a day taken for blood pressure, start and stop date were not reported. The patient experienced stronger muscle and bone pain after the injection on 10Feb2021. She was due for her second dose on 03Mar2021. She had started taking Naproxen 500 mg twice daily and was wondering if there was a possible interaction with the vaccine. If so, when should she stop taking the medicine and when should she resume after receiving the second dose. She had read some place that Naproxen, an NSAID, might reduce the effectiveness of the COVID Vaccine. She was in such pain after the COVID Vaccine. Right afterwards her muscles and joint pain were worse. She needed to take Naproxen. Wanted to know how long she can be on Naproxen before her second dose. Her back and legs were in pain. She thought she could use heat pads. Tylenol does not work at all for muscle pain. She wanted to know if that was detrimental to the vaccine. She reported that injection site was not hurting after two days. Injection site was painful starting 11Feb2021 and she could lift her arm. After two days it subsided. The rest of her was not good. Her legs, back, shoulders, and pretty much everything hurts. Pain was terrible on 11Feb2021. She could not say she never had back pain before the COVID vaccine because she has arthritis. Her arthritis was under control. For some reason after the COVID Vaccine, her pain was worse. Started the Wednesday after the COVID vaccine and has continued. She said she has regular arthritis and not rheumatoid arthritis. The patient willingly took Naproxen. She stated asking her doctor for Prednisone would probably be worse. Stated sometimes doctors prescribed Prednisone and then has to be tapered off. Definitely read that Prednisone has an interaction and lowers the effectiveness of the COVID vaccine. She confirmed that she has not been prescribed Prednisone. The patient received treatment for stronger muscle and bone pain. The outcome of event vaccination site pain was recovering, stronger muscle and bone pain and for all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Has a question about a possible interaction with Naproxen and the COVID vaccine; her muscles and joint pain are worse /her pain was worse; Injection site pain; Legs, back, shoulders, and pretty much everything hurts; stronger muscle and bone pain; stronger muscle and bone pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 10Feb2021 12:36 (at the age of 73-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes, arthritis, blood pressure. Concomitant medication(s) included metformin 500 mg twice a day taken for diabetes mellitus, start and stop date were not reported; lisinopril 10 mg once a day taken for blood pressure, start and stop date were not reported. The patient experienced stronger muscle and bone pain after the injection on 10Feb2021. She was due for her second dose on 03Mar2021. She had started taking Naproxen 500 mg twice daily and was wondering if there was a possible interaction with the vaccine. If so, when should she stop taking the medicine and when should she resume after receiving the second dose. She had read some place that Naproxen, an NSAID, might reduce the effectiveness of the COVID Vaccine. She was in such pain after the COVID Vaccine. Right afterwards her muscles and joint pain were worse. She needed to take Naproxen. Wanted to know how long she can be on Naproxen before her second dose. Her back and legs were in pain. She thought she could use heat pads. Tylenol does not work at all for muscle pain. She wanted to know if that was detrimental to the vaccine. She reported that injection site was not hurting after two days. Injection site was painful starting 11Feb2021 and she could lift her arm. After two days it subsided. The rest of her was not good. Her legs, back, shoulders, and pretty much everything hurts. Pain was terrible on 11Feb2021. She could not say she never had back pain before the COVID vaccine because she has arthritis. Her arthritis was under control. For some reason after the COVID Vaccine, her pain was worse. Started the Wednesday after the COVID vaccine and has continued. She said she has regular arthritis and not rheumatoid arthritis. The patient willingly took Naproxen. She stated asking her doctor for Prednisone would probably be worse. Stated sometimes doctors prescribed Prednisone and then has to be tapered off. Definitely read that Prednisone has an interaction and lowers the effectiveness of the COVID vaccine. She confirmed that she has not been prescribed Prednisone. The patient received treatment for stronger muscle and bone pain. The outcome of event vaccination site pain was recovering, stronger muscle and bone pain and for all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: small amount of pain at injection site; This is a spontaneous report from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced small amount of pain at injection site on an unspecified date. Caller reports small amount of pain at injection site. The outcome for events unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: Nausea; Abdominal pain/Abdominal symptom; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age (Age: 28; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated she received her first COVID-19 Vaccine dose yesterday afternoon on 18Feb2021 and she was having really bad nausea and abdominal pain in Feb2021. She had a question. She asked if very bad nausea, and abdominal side effects are due to the COVID-19 Vaccine. Caller was advised she would be transferred to Pfizer Medical Information to have her question addressed. Serious: No. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the second dosage, my arm was sore for about three days; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12Feb2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccines included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization and experienced there was a mix up, and he is not sure if the product was administered correctly, said he asked person at facility of 1st dose, if he actually received vaccine, they said yes he did get vaccine but he doesn't think so and the patient received INFLUENZA (influenza shots), via an unspecified route of administration on an unspecified date for immunization and experienced sore arm. It was reported that, the patient thinks, he only received 2nd dose of covid vaccine and didn't believe he received 1st dose. Stated that, the caller has reason to believe, he did not get the first dose of Pfizer covid vaccine. Stated that, when he was at site where giving doses. Stated that, he had gotten many influenza shots, he always experience some after effect, like sore arm. At the time that he did it, he didn't feel anything, there was no mark or after effect like he got following an injection. At facility, the person administering the injection stated that, there seemed to be some sort of an issue with the hyper dermic needle. Looked at his arm there was no sign of injection, no pain in arm, nothing. Stated that, there was nothing, not a dot of blood or anything and the next day there was no soreness or anything. He received the 2nd dose of vaccine on last Friday. Stated that, on an unspecified date in 2021, after the second dosage, his arm was sore for about three days. Stated that, he wanted to know what implications are of not getting 1st dose. He was looking for information whether he did not receive the first dose and got the second dose. Stated that, he asked the person at facility, at the time of first dose, whether he actually received vaccine, they said yes, he got the vaccine, but he didn't think so. Enquired, how did he verify that, he actually got his first dose. Was there a test. He wanted to know whether he had full protection. Stated that, he believed, he only received one dose and that the first dose was not administered due to no side effects following first dose. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: pain on the same arm (right arm)/right arm soreness; injection site pain; When she tries to raise it or go outward, she has to use left arm to help push her right arm; this has been going on for many days like a muscle pain; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 31May2021), dose 1 intramuscular, administered in Arm Right on 12Feb2021 08:00 (age at vaccination 68 years) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included rotator cuff injury from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient not visited emergency room or physician office or emergency room for reported events. The patient experienced injection site pain on 12Feb2021, pain on the same arm (right arm)/right arm soreness on 16Feb2021, when she tries to raise it or go outward, she has to use left arm to help push her right arm, She states this has been going on for many days like a muscle pain on 2021. Reporter stated, she started experiencing pain on the same arm (right arm) but is not specific to the injection site which is still ongoing. She mentioned that she can bear the pain but is uncomfortable with it. She is asking if this is normal and for how long should she expect it. She is concerned because she has to receive another injection in the same arm in 2 weeks because she cannot do it on the other arm because of a rotator cuff injury. She is getting concerned, is this to be expected before she gets the second dose. she received her first Covid vaccine on the 12Feb2021. The only thing she had, and it wasn't even as big of a deal as she expected, was pain at the injection site, which started the date she got the shot. She states the injection site had gotten sore, of course, but laying on it hurt. Next day injection site was improved. The next day she didn't feel anything when she laid on it. right arm was getting more sore, not at the injection site. Below the injection site, hurts to the elbow. But her right arm got progressively more sore. She is not that worried, a little concerned if it's nothing but if it's something she wants to know. Her right arm pain is not getting any better. Wants verification that this is an expected side effect. Patient received treatment for reported events She only took Acetaminophen on 2 separate days, one each time. Took one on 18Feb2021 before she went to bed, doesn't know if it helped because she went to sleep. Considered using heat or ice but a shower makes it feel better temporarily. The outcome of event vaccination site pain was recovered on 13Feb2021, pain on the same arm (right arm)/right arm soreness was not recovered, rest of all events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Feeling abnormal, Insomnia, Nasopharyngitis
Clinical narrative: pain near where both of his kidneys are located; strong chills; At night when he is laying in bed, he cannot feel his feet. His feet are freezing and he cannot get them warm at all; Had a hard time sleeping. Only had an hour of sleeping; At night he has been really cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:00 (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination within 4 weeks the patient received Shingles shot. Patient reported he received first dose of vaccine on 16Feb. He had strong chills (on 17Feb2021) and pain near where both of his kidneys are located. Patient would like to know if this side effect was normal if it had been reported and when will symptoms go away. Felt like someone hit him in the kidneys. There was pain back there. At night when he was laying in bed, he could not feel his feet. His feet were freezing, and he could not get them warm at all. Real strong chills: Began the next day. Had a little bit of chill right now. Had gotten better as he moved around. Had a hard time sleeping. Only had an hour of sleeping. Pain in kidney area (on 19Feb2021): pain was on both sides. Feet Freezing and cannot get warm: Same time as chills. It was the first thing he noticed. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 17Feb2021 Day following the COVID-19 Vaccine had a CT scan. Was told the CT scan wouldn't matter with receiving the COVID-19 Vaccine. The clinical outcome of the event Chills was not recovered and remaining all other events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: pain near where both of his kidneys are located; strong chills; At night when he is laying in bed, he cannot feel his feet. His feet are freezing and he cannot get them warm at all; Had a hard time sleeping. Only had an hour of sleeping; At night he has been really cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:00 (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination within 4 weeks the patient received Shingles shot. Patient reported he received first dose of vaccine on 16Feb. He had strong chills (on 17Feb2021) and pain near where both of his kidneys are located. Patient would like to know if this side effect was normal if it had been reported and when will symptoms go away. Felt like someone hit him in the kidneys. There was pain back there. At night when he was laying in bed, he could not feel his feet. His feet were freezing, and he could not get them warm at all. Real strong chills: Began the next day. Had a little bit of chill right now. Had gotten better as he moved around. Had a hard time sleeping. Only had an hour of sleeping. Pain in kidney area (on 19Feb2021): pain was on both sides. Feet Freezing and cannot get warm: Same time as chills. It was the first thing he noticed. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 17Feb2021 Day following the COVID-19 Vaccine had a CT scan. Was told the CT scan wouldn't matter with receiving the COVID-19 Vaccine. The clinical outcome of the event Chills was not recovered and remaining all other events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.