chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Herpes zoster, Pain
Clinical narrative: Shingles flare up is located on her right midriff/was experiencing a flare up of the pain of the shingles she had many years ago in the exact same spots as last time; Intense burning in original site of shingles; Pain brings on dizziness and a lightheaded feeling; Pain brings on dizziness and a lightheaded feeling where she must lay down and rest; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL1283; Expiration date was not reported) via an unspecified route of administration in the right arm on 15Jan2021 07:00AM (at the age of 67-years-old) at a single dose for COVID-19 immunization (the reported indication was "to prevent COVID Flu") at a hospital. The vaccine was not administered at a facility. Medical history included shingles from an unknown date and unknown if ongoing (date was reported to be many years ago). The patient's concomitant medication included unspecified thyroid pill (thyroid medication), no product name was provided. History of all previous immunizations was not provided. There were no additional vaccines administered on same date of Pfizer suspect. There were no prior vaccinations within four weeks. The were no adverse events that follow prior vaccinations. The patient has no relevant medical family history. No relevant tests were done. On 16Jan2021, the patient had very adverse reaction to COVID-19 vaccine, she experienced shingles flare up located on her right midriff; she was having flare up of the pain of the shingles she had many years ago in the exact same spots as last time and was having flares off and on all day. She also experienced instense burning in original site of shingles and pain that brings on dizziness and a lightheaded feeling where she must lay down and rest on 16Jan2021. The adverse events did not require visit to physician or other healthcare professional office/ clinic. The outcome of the events was not recovered. It was reported that it has been two weeks and symptoms have not gone away. The patient was querying about the second dose of COVID-19 vaccine that will be given in the next five or six days.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Herpes zoster, Pain, Skin burning sensation
Clinical narrative: Shingles flare up is located on her right midriff/was experiencing a flare up of the pain of the shingles she had many years ago in the exact same spots as last time; Intense burning in original site of shingles; Pain brings on dizziness and a lightheaded feeling; Pain brings on dizziness and a lightheaded feeling where she must lay down and rest; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL1283; Expiration date was not reported) via an unspecified route of administration in the right arm on 15Jan2021 07:00AM (at the age of 67-years-old) at a single dose for COVID-19 immunization (the reported indication was "to prevent COVID Flu") at a hospital. The vaccine was not administered at a facility. Medical history included shingles from an unknown date and unknown if ongoing (date was reported to be many years ago). The patient's concomitant medication included unspecified thyroid pill (thyroid medication), no product name was provided. History of all previous immunizations was not provided. There were no additional vaccines administered on same date of Pfizer suspect. There were no prior vaccinations within four weeks. The were no adverse events that follow prior vaccinations. The patient has no relevant medical family history. No relevant tests were done. On 16Jan2021, the patient had very adverse reaction to COVID-19 vaccine, she experienced shingles flare up located on her right midriff; she was having flare up of the pain of the shingles she had many years ago in the exact same spots as last time and was having flares off and on all day. She also experienced instense burning in original site of shingles and pain that brings on dizziness and a lightheaded feeling where she must lay down and rest on 16Jan2021. The adverse events did not require visit to physician or other healthcare professional office/ clinic. The outcome of the events was not recovered. It was reported that it has been two weeks and symptoms have not gone away. The patient was querying about the second dose of COVID-19 vaccine that will be given in the next five or six days.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Just got a rash on my arm, all the way down to my hand and up to my armpit; This is a spontaneous report from a contactable other healthcare professional (the patient, Certified Nursing Assistant). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Feb2021 at age of 19-year-old at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for PCOS from an unspecified date. The patient stated she would just like to report a reaction to the Pfizer. She just got a rash on her arm, all the way down to her hand and up to her armpit (Feb2021). The patient took Benadryl, she went to the emergency care last night (05Feb2021). The outcome of the event was unknown. The reporter considered there was a causal relationship between the drug and the event.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever up to 100 (degree) Farenheit; Tiredness; Feeling weak; This is a spontaneous report from a contactable physician reporting for herself. This 62-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number EN5318, intramuscularly on the left arm on 03Feb2021 at 11:00 AM (at the age of 62-year old) at single dose for COVID-19 immunization outside a church. Relevant medical history was none. Historical vaccination included first dose of the same vaccine intramuscularly in the left arm  on 13Jan2021 at single dose for COVID-19 immunization. Family history included an aunt died from encephalomyelitis disseminate in 1975. Concomitant medication included cyanocobalamin (VIT B12) from 2019 and ongoing orally. On 04Feb2021 at 06:00 AM the patient experienced fever up to 100 degree Farenheit, tiredness and feeling weak. On 02Feb2021 the patient had a PCR test for COVID with negative result. On 03Feb2021 at 3 PM the patient received metamizole (NOVAMISULFON) 1 tablet orally to treat an unspecified event. Treatment for the above events was reported as "No". The patient recovered from the events. The patient commented "Expected side effect of vaccine, personally easy to react to vaccines with fever".  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever up to 100 (degree) Farenheit; Tiredness; Feeling weak; This is a spontaneous report from a contactable physician reporting for herself. This 62-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number EN5318, intramuscularly on the left arm on 03Feb2021 at 11:00 AM (at the age of 62-year old) at single dose for COVID-19 immunization outside a church. Relevant medical history was none. Historical vaccination included first dose of the same vaccine intramuscularly in the left arm  on 13Jan2021 at single dose for COVID-19 immunization. Family history included an aunt died from encephalomyelitis disseminate in 1975. Concomitant medication included cyanocobalamin (VIT B12) from 2019 and ongoing orally. On 04Feb2021 at 06:00 AM the patient experienced fever up to 100 degree Farenheit, tiredness and feeling weak. On 02Feb2021 the patient had a PCR test for COVID with negative result. On 03Feb2021 at 3 PM the patient received metamizole (NOVAMISULFON) 1 tablet orally to treat an unspecified event. Treatment for the above events was reported as "No". The patient recovered from the events. The patient commented "Expected side effect of vaccine, personally easy to react to vaccines with fever".  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: itchy throat; an allergic type cough; This is a spontaneous report from a contactable other HCP.   A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 9265) on 03Feb2021 at 09:45 at single dose via an unspecified route of administration on right arm  for COVID-19 immunization .Relevant medical history included asthma, supraventricular tachycardia, Premature ventricular contractions and seasonal and drug allergy. Concomitant medications included atenolol, loratadine (CLARITIN [LORATADINE]), acetylsalicylic acid (ASPIRIN 81), magnesium. Approximately 15 minutes after the vaccine patient began to develop an itchy throat with an allergic type cough that lasted about an hour. The cough subsided but the itchy throat continued through the day. Patient took 25 mg Benadryl twice (every 6 hrs) at the advice of her doctor and that stopped the symptoms. The next day patient did not presented  itchy throat or cough and did not need to take any more Benadryl. The patient recovered from the events on an unspecified date.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergic cough, Throat irritation
Clinical narrative: itchy throat; an allergic type cough; This is a spontaneous report from a contactable other HCP.   A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 9265) on 03Feb2021 at 09:45 at single dose via an unspecified route of administration on right arm  for COVID-19 immunization .Relevant medical history included asthma, supraventricular tachycardia, Premature ventricular contractions and seasonal and drug allergy. Concomitant medications included atenolol, loratadine (CLARITIN [LORATADINE]), acetylsalicylic acid (ASPIRIN 81), magnesium. Approximately 15 minutes after the vaccine patient began to develop an itchy throat with an allergic type cough that lasted about an hour. The cough subsided but the itchy throat continued through the day. Patient took 25 mg Benadryl twice (every 6 hrs) at the advice of her doctor and that stopped the symptoms. The next day patient did not presented  itchy throat or cough and did not need to take any more Benadryl. The patient recovered from the events on an unspecified date.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Hypersensitivity, Migraine with aura, Pain in jaw, Physical examination abnormal
Clinical narrative: got shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose last Tuesday (Feb2021) and she got shingles yesterday (Feb2021). The outcome of the event was unknown.   Information about lot/ batch number has been requested
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash vesicular, Skin weeping, Toothache
Clinical narrative: got shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose last Tuesday (Feb2021) and she got shingles yesterday (Feb2021). The outcome of the event was unknown.   Information about lot/ batch number has been requested
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: got shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose last Tuesday (Feb2021) and she got shingles yesterday (Feb2021). The outcome of the event was unknown.   Information about lot/ batch number has been requested
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in that arm when lifting it/The soreness is in the right arm; has pain in that arm when lifting it, at the injection site; This is a spontaneous report from a Pfizer Sponsored Program. A contactable Nurse (patient) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EH9899), via an unspecified route of administration at right arm as a single dose on 05Jan2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received influenza vaccine (FLU VACCINE VII, NDC, Lot, and expiry unknown) in Oct2020 and it encapsulated and she still has a small bump on her left arm, this is why she is not sure what arm to use. No additional Vaccines Administered on same date of the Pfizer suspect. The patient reporting on the COVID vaccine and who explains she got the first shot 3 weeks ago. She is schedule to have second dose this afternoon but has pain in that arm when lifting it, at the injection site on an unknown date in Jan2021. Patient wants to know what to do. Patient wanted to know is it ok to get the other shot, should she have it in the same area or on the other side, and is this normal this long after the first shot. The soreness is in the right arm on 05Jan2021. It was explained the arm got a little worse the next day then calm down and has stayed the same since that time. Treatment: She has been alternating hot and cold on the injection site. The outcome of pain in arm was not recovered and vaccination site pain was unknown. Event pain in that arm when lifting it was reported as Related.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain in that arm when lifting it/The soreness is in the right arm; has pain in that arm when lifting it, at the injection site; This is a spontaneous report from a Pfizer Sponsored Program. A contactable Nurse (patient) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EH9899), via an unspecified route of administration at right arm as a single dose on 05Jan2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received influenza vaccine (FLU VACCINE VII, NDC, Lot, and expiry unknown) in Oct2020 and it encapsulated and she still has a small bump on her left arm, this is why she is not sure what arm to use. No additional Vaccines Administered on same date of the Pfizer suspect. The patient reporting on the COVID vaccine and who explains she got the first shot 3 weeks ago. She is schedule to have second dose this afternoon but has pain in that arm when lifting it, at the injection site on an unknown date in Jan2021. Patient wants to know what to do. Patient wanted to know is it ok to get the other shot, should she have it in the same area or on the other side, and is this normal this long after the first shot. The soreness is in the right arm on 05Jan2021. It was explained the arm got a little worse the next day then calm down and has stayed the same since that time. Treatment: She has been alternating hot and cold on the injection site. The outcome of pain in arm was not recovered and vaccination site pain was unknown. Event pain in that arm when lifting it was reported as Related.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Feeling bad; shingles; This is a spontaneous report from a contactable consumer(patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 81-year-old, intramuscular, administered in left arm on 22Jan2021 09:30 (Lot Number: EL3302) as single dose for COVID-19 immunisation. Medical history included asthma (diagnosed several years ago) and she was not having any problems with that and she has actually been doing really well with it because she has stayed inside so much. The patient's concomitant medications were not reported. The patient has no prior vaccinations within the 4 weeks. The patient received the first COVID-19 vaccine on 22Jan2021. She started experiencing shingles on 12Feb2021 (reported as three weeks later). She was scheduled for the second vaccine on 12Feb2021, however she postponed that because of the shingles. She was feeling bad on an unspecified date and does not know what she should do. The event shingles resulted in physician office visit. She did have blood work done on an unspecified date and everything was normal. She did take Valtrex for 2 or 3 days as treatment for the event shingles, but she had a reaction to that had a lot of achiness and joint pain, so she didn't take the full dose. The outcome of the events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Feeling abnormal, Herpes zoster
Clinical narrative: Feeling bad; shingles; This is a spontaneous report from a contactable consumer(patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 81-year-old, intramuscular, administered in left arm on 22Jan2021 09:30 (Lot Number: EL3302) as single dose for COVID-19 immunisation. Medical history included asthma (diagnosed several years ago) and she was not having any problems with that and she has actually been doing really well with it because she has stayed inside so much. The patient's concomitant medications were not reported. The patient has no prior vaccinations within the 4 weeks. The patient received the first COVID-19 vaccine on 22Jan2021. She started experiencing shingles on 12Feb2021 (reported as three weeks later). She was scheduled for the second vaccine on 12Feb2021, however she postponed that because of the shingles. She was feeling bad on an unspecified date and does not know what she should do. The event shingles resulted in physician office visit. She did have blood work done on an unspecified date and everything was normal. She did take Valtrex for 2 or 3 days as treatment for the event shingles, but she had a reaction to that had a lot of achiness and joint pain, so she didn't take the full dose. The outcome of the events was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site swelling, Pain
Clinical narrative: left hand was numb as was my lower arm; sore all over; This is a spontaneous report from a contactable consumer (patient). A 70-year-old (age at vaccination) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 10:30 as single dose for COVID-19 immunisation. Medical history included overweight, and he was in good health. Other medical history was reported as none. The patient did not have allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient went home and rested and had none of what was listed at all. He mentioned his activities as worked on-line then went outside on sunny 70-degree afternoon and cut the font lawn for about 90 mins, using his walk-behind 21 in 4-wheel drive lawn mower and again he had no issue. Since this was the first time to cut the lawn this year, he was sore all over when he went to bed about 21:00 on 24Feb2021 but he considered this normal. Shot location was nominal and there was no swelling. On 25Feb2021, he woke up around 2:00 and noticed that his left hand was numb as was his lower arm. He was a side sleeper on his left side and occasionally, his arm/hand would go to sleep and all he had go do was move it to get the circulation going back to normal. However, that time the left hand stayed numb and remained numb most of the morning and did not subside until the afternoon. The events reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Pain
Clinical narrative: left hand was numb as was my lower arm; sore all over; This is a spontaneous report from a contactable consumer (patient). A 70-year-old (age at vaccination) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 10:30 as single dose for COVID-19 immunisation. Medical history included overweight, and he was in good health. Other medical history was reported as none. The patient did not have allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient went home and rested and had none of what was listed at all. He mentioned his activities as worked on-line then went outside on sunny 70-degree afternoon and cut the font lawn for about 90 mins, using his walk-behind 21 in 4-wheel drive lawn mower and again he had no issue. Since this was the first time to cut the lawn this year, he was sore all over when he went to bed about 21:00 on 24Feb2021 but he considered this normal. Shot location was nominal and there was no swelling. On 25Feb2021, he woke up around 2:00 and noticed that his left hand was numb as was his lower arm. He was a side sleeper on his left side and occasionally, his arm/hand would go to sleep and all he had go do was move it to get the circulation going back to normal. However, that time the left hand stayed numb and remained numb most of the morning and did not subside until the afternoon. The events reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster, Ophthalmological examination, Vaccination failure
Clinical narrative: Shingles around right eye; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 19Feb2021 15:30 (Batch/Lot Number: EZ9263) as single dose for covid-19 immunisation. Medical history included hypertension, elevated cholesterol, essential tremor and penicillin allergy. Concomitant medication included propranolol, meloxicam, atorvastatin calcium and enalapril. The patient experienced shingles around right eye on 24Feb2021. Symptoms began day 4 post-COVID jab. This occurred despite SHINGRIX jabs x2 in 2018. Event resulted in physician's office visit/ urgent care. Valacyclovir and gabapentin was given as treatment. Outcome of the event was not recovered. Patient did not have covid prior to vaccination and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles around right eye; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 19Feb2021 15:30 (Batch/Lot Number: EZ9263) as single dose for covid-19 immunisation. Medical history included hypertension, elevated cholesterol, essential tremor and penicillin allergy. Concomitant medication included propranolol, meloxicam, atorvastatin calcium and enalapril. The patient experienced shingles around right eye on 24Feb2021. Symptoms began day 4 post-COVID jab. This occurred despite SHINGRIX jabs x2 in 2018. Event resulted in physician's office visit/ urgent care. Valacyclovir and gabapentin was given as treatment. Outcome of the event was not recovered. Patient did not have covid prior to vaccination and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Shingles around right eye; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 19Feb2021 15:30 (Batch/Lot Number: EZ9263) as single dose for covid-19 immunisation. Medical history included hypertension, elevated cholesterol, essential tremor and penicillin allergy. Concomitant medication included propranolol, meloxicam, atorvastatin calcium and enalapril. The patient experienced shingles around right eye on 24Feb2021. Symptoms began day 4 post-COVID jab. This occurred despite SHINGRIX jabs x2 in 2018. Event resulted in physician's office visit/ urgent care. Valacyclovir and gabapentin was given as treatment. Outcome of the event was not recovered. Patient did not have covid prior to vaccination and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeding disorder, Headache
Clinical narrative: tinnitus; joint pain; headache; extreme fatigue; chills; then fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in left arm on 26Feb2021 at 07:15 AM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 05Feb2021 at 07:00 AM at single dose for COVID-19 immunization. Medical history included high blood pressure, arthritis. Patient had known allergies. Concomitant medications included lisinopril, calcium, ergocalciferol (VITAMIN D[ERGOCALCIFEROL]), naproxen sodium (ALEVE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 26Feb2021 at 08:00 PM, patient experienced headache, extreme fatigue, tinnitus, chills, joint pain, then fever. No treatment was received. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Tinnitus
Clinical narrative: tinnitus; joint pain; headache; extreme fatigue; chills; then fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in left arm on 26Feb2021 at 07:15 AM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 05Feb2021 at 07:00 AM at single dose for COVID-19 immunization. Medical history included high blood pressure, arthritis. Patient had known allergies. Concomitant medications included lisinopril, calcium, ergocalciferol (VITAMIN D[ERGOCALCIFEROL]), naproxen sodium (ALEVE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 26Feb2021 at 08:00 PM, patient experienced headache, extreme fatigue, tinnitus, chills, joint pain, then fever. No treatment was received. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: tinnitus; joint pain; headache; extreme fatigue; chills; then fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in left arm on 26Feb2021 at 07:15 AM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 05Feb2021 at 07:00 AM at single dose for COVID-19 immunization. Medical history included high blood pressure, arthritis. Patient had known allergies. Concomitant medications included lisinopril, calcium, ergocalciferol (VITAMIN D[ERGOCALCIFEROL]), naproxen sodium (ALEVE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 26Feb2021 at 08:00 PM, patient experienced headache, extreme fatigue, tinnitus, chills, joint pain, then fever. No treatment was received. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; joint pain; headache; extreme fatigue; chills; then fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in left arm on 26Feb2021 at 07:15 AM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 05Feb2021 at 07:00 AM at single dose for COVID-19 immunization. Medical history included high blood pressure, arthritis. Patient had known allergies. Concomitant medications included lisinopril, calcium, ergocalciferol (VITAMIN D[ERGOCALCIFEROL]), naproxen sodium (ALEVE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 26Feb2021 at 08:00 PM, patient experienced headache, extreme fatigue, tinnitus, chills, joint pain, then fever. No treatment was received. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Thrombosis, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer(Patient). A 83-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Formulation, Batch/Lot Number: EN6200), via an unspecified route of administration on Arm left on 17Feb2021 10:00 AM as single dose for covid-19 immunisation. Medical history included colitis ulcerative. Concomitant medications included mesalamine (MESALAMINE). Patient had no past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. post Covid vaccine patient did not test for Covid. The Device Date given was 25Apr2021. The patient received treatment for raised blood thinner as Elequis 5mg. On 20Feb2021 at 10:00 (Three days after injection), the patient suffered severe pain in the right leg. She went to ER next day and blood clot was discovered behind right knee and later she subsequently had been seen by hematologist. The outcome of the events was not recovered.  Follow-up attempts are required. Further information was expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer(Patient). A 83-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Formulation, Batch/Lot Number: EN6200), via an unspecified route of administration on Arm left on 17Feb2021 10:00 AM as single dose for covid-19 immunisation. Medical history included colitis ulcerative. Concomitant medications included mesalamine (MESALAMINE). Patient had no past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. post Covid vaccine patient did not test for Covid. The Device Date given was 25Apr2021. The patient received treatment for raised blood thinner as Elequis 5mg. On 20Feb2021 at 10:00 (Three days after injection), the patient suffered severe pain in the right leg. She went to ER next day and blood clot was discovered behind right knee and later she subsequently had been seen by hematologist. The outcome of the events was not recovered.  Follow-up attempts are required. Further information was expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. She received the first dose of COVID-19 vaccine on 30Jan2021. A week and a half after (Feb2021), she developed shingles. The second dose was due 20Feb2021. She spoke with the doctor earlier that morning and she asked if she could have the second vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Malaise
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. She received the first dose of COVID-19 vaccine on 30Jan2021. A week and a half after (Feb2021), she developed shingles. The second dose was due 20Feb2021. She spoke with the doctor earlier that morning and she asked if she could have the second vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (Lot Number: En6198), via an unspecified route of administration, administered in left arm on 25Feb2021 18:00 (at the age of 45-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC); and dexlansoprazole (DEXILANT). No other vaccine in four weeks. The patient previously took amoxicillin and experienced allergies. No covid prior vaccination. No covid tested post vaccination. The patient experienced shingles on 27Feb2021 14:00. The event resulted in doctor or other healthcare. Therapeutic measures were taken as a result of shingles which included Valtrex 1000 mg and gabepentin 300mg. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Ear, nose and throat examination, Tinnitus
Clinical narrative: severe tinnitus; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 25Feb2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 66-years-old) for COVID-19 immunisation. The patient was administered in a pharmacy/drug store. Medical history included type 2 diabetes, gastroparesis, chronic headaches, fibromyalgia, dry eyes and inflammation, osteoarthritis, hypothyroidism, high blood pressure, high cholesterol, high triglycerides, urinary frequency, arteriosclerosis of the aorta, lactose intolerance, and allergies to sulfa drugs. The patient had concomitant medications included too many to list. The patient was not covid tested post vaccination. The patient previously took methyldopa (ALDOMET) and experienced allergies. Three days after her first COVID-19 vaccine (28Feb2021) she developed severe tinnitus and has remained ever since. The event resulted in a doctor visit. The event was considered a disability. The patient did not receive a treatment for the event. The patient has not recovered from the event.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: severe tinnitus; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 25Feb2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 66-years-old) for COVID-19 immunisation. The patient was administered in a pharmacy/drug store. Medical history included type 2 diabetes, gastroparesis, chronic headaches, fibromyalgia, dry eyes and inflammation, osteoarthritis, hypothyroidism, high blood pressure, high cholesterol, high triglycerides, urinary frequency, arteriosclerosis of the aorta, lactose intolerance, and allergies to sulfa drugs. The patient had concomitant medications included too many to list. The patient was not covid tested post vaccination. The patient previously took methyldopa (ALDOMET) and experienced allergies. Three days after her first COVID-19 vaccine (28Feb2021) she developed severe tinnitus and has remained ever since. The event resulted in a doctor visit. The event was considered a disability. The patient did not receive a treatment for the event. The patient has not recovered from the event.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Pt died
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: a rash developed on his head and face/ diagnosed with shingles; headache; fatigue; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A male patient of an unspecified age (age: 42, unit: unknown) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced mild symptoms such as headache, fatigue. On 15Feb2021, a rash developed on his head and face. He visited the emergency room (ER) on 16Feb2021 and was diagnosed with shingles. The ER doctor told the patient it was possibly related to the vaccine, but there was no way of knowing for sure. 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, COVID19
Symptoms: Fatigue, Headache, Herpes zoster
Clinical narrative: a rash developed on his head and face/ diagnosed with shingles; headache; fatigue; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A male patient of an unspecified age (age: 42, unit: unknown) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced mild symptoms such as headache, fatigue. On 15Feb2021, a rash developed on his head and face. He visited the emergency room (ER) on 16Feb2021 and was diagnosed with shingles. The ER doctor told the patient it was possibly related to the vaccine, but there was no way of knowing for sure. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Computerised tomogram spine, Echocardiogram, Electroencephalogram
Clinical narrative: I lost consciousness shortly after getting up at 6:00 AM on 3/13/2021. I hit my head on a metal drawer handle. Since I was bleeding from the back of my head (behind ear) and disoriented, my husband called 911. EM personnel determined I was amnesic and needed medical care. I was taken to the emergency room. The 2.5 cm laceration on my head needed 8 staples to suture it. I spent two night at the hospital, had a series of lab tests and received X-ray chest, CT cervical spine, transthoracic echocardiogram and EEG. I suffered no broken bones.  This event occurred after I had received my second dose of the Moderna COVID 19 vaccine the day before.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head injury, Laboratory test, Loss of consciousness, Suture insertion, Syncope
Clinical narrative: I lost consciousness shortly after getting up at 6:00 AM on 3/13/2021. I hit my head on a metal drawer handle. Since I was bleeding from the back of my head (behind ear) and disoriented, my husband called 911. EM personnel determined I was amnesic and needed medical care. I was taken to the emergency room. The 2.5 cm laceration on my head needed 8 staples to suture it. I spent two night at the hospital, had a series of lab tests and received X-ray chest, CT cervical spine, transthoracic echocardiogram and EEG. I suffered no broken bones.  This event occurred after I had received my second dose of the Moderna COVID 19 vaccine the day before.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Chest X-ray, Computerised tomogram spine, Disorientation, Echocardiogram
Clinical narrative: I lost consciousness shortly after getting up at 6:00 AM on 3/13/2021. I hit my head on a metal drawer handle. Since I was bleeding from the back of my head (behind ear) and disoriented, my husband called 911. EM personnel determined I was amnesic and needed medical care. I was taken to the emergency room. The 2.5 cm laceration on my head needed 8 staples to suture it. I spent two night at the hospital, had a series of lab tests and received X-ray chest, CT cervical spine, transthoracic echocardiogram and EEG. I suffered no broken bones.  This event occurred after I had received my second dose of the Moderna COVID 19 vaccine the day before.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electroencephalogram, Haemorrhage, Head injury, Laboratory test, Loss of consciousness
Clinical narrative: I lost consciousness shortly after getting up at 6:00 AM on 3/13/2021. I hit my head on a metal drawer handle. Since I was bleeding from the back of my head (behind ear) and disoriented, my husband called 911. EM personnel determined I was amnesic and needed medical care. I was taken to the emergency room. The 2.5 cm laceration on my head needed 8 staples to suture it. I spent two night at the hospital, had a series of lab tests and received X-ray chest, CT cervical spine, transthoracic echocardiogram and EEG. I suffered no broken bones.  This event occurred after I had received my second dose of the Moderna COVID 19 vaccine the day before.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin laceration, Suture insertion
Clinical narrative: I lost consciousness shortly after getting up at 6:00 AM on 3/13/2021. I hit my head on a metal drawer handle. Since I was bleeding from the back of my head (behind ear) and disoriented, my husband called 911. EM personnel determined I was amnesic and needed medical care. I was taken to the emergency room. The 2.5 cm laceration on my head needed 8 staples to suture it. I spent two night at the hospital, had a series of lab tests and received X-ray chest, CT cervical spine, transthoracic echocardiogram and EEG. I suffered no broken bones.  This event occurred after I had received my second dose of the Moderna COVID 19 vaccine the day before.