chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Feeling abnormal
Clinical narrative: vaccinated and had COVID; vaccinated and had COVID; lost his smell and his taste; lost his smell and his taste; he was about as sick; felt like crap; This is a spontaneous report from a Pfizer sponsored Program via a contactable consumer or other non-healthcare professional (patients aunt). A 40-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as singe dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated and had covid, lost his smell and his taste and he was about as sick. The reporter mentioned that her 40-year-old nephew, who was vaccinated, was as sick as she was with COVID and she doesn't know why. First his wife got COVID, she was unvaccinated, then his teenage daughter who was 17-year-old got COVID and then (her nephew) got it. The patient lost his smell and his taste and he was about as sick as the reporter was, he had 10 days where he felt like crap. The reporter mentioned that her nephew was vaccinated and had then tested positive for COVID. This report was related to a study or program. Reporter seriousness for vaccinated and had COVID was reported as unspecified. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 Test: positive. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: vaccinated and had COVID; vaccinated and had COVID; lost his smell and his taste; lost his smell and his taste; he was about as sick; felt like crap; This is a spontaneous report from a Pfizer sponsored Program via a contactable consumer or other non-healthcare professional (patients aunt). A 40-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as singe dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated and had covid, lost his smell and his taste and he was about as sick. The reporter mentioned that her 40-year-old nephew, who was vaccinated, was as sick as she was with COVID and she doesn't know why. First his wife got COVID, she was unvaccinated, then his teenage daughter who was 17-year-old got COVID and then (her nephew) got it. The patient lost his smell and his taste and he was about as sick as the reporter was, he had 10 days where he felt like crap. The reporter mentioned that her nephew was vaccinated and had then tested positive for COVID. This report was related to a study or program. Reporter seriousness for vaccinated and had COVID was reported as unspecified. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 Test: positive. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation, Off label use, Vaccination site pain
Clinical narrative: she received Pfizer booster shot on yesturday; she received Pfizer booster shot on yesturday; sore arm; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old female patient received 3rd dose of bnt162b2 (Pfizer COVID-19 vaccine,Batch/Lot number was not reported), via an unspecified route of administration on 23Sep2021,at the age of 81 years old, as Dose 3 (Booster),single for covid-19 immunization and palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date to an unspecified date, at 100 mg for an unspecified indication.The patient medical history was not reported.Concomitant medication(s) included exemestane (AROMASIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced sore arm on Sep2021, she received pfizer booster shot on yesterday on 23Sep2021.The outcome of the event was unknown.The patient didn't receive any treatment for the event.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow up (24Sep2021): This is a follow up spontaneous report received from a contactable consumer. A contactable 81-year-old Female consumer (patient) reported for herself that she experienced side effects with ibrance.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: Clots were found in both legs; legs were more swollen than normal and very painful; legs were more swollen than normal and very painful; legs were more swollen than normal and very painful; This is a spontaneous report from a contactable Pfizer employee. A non-pregnant 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot unknown) intramuscularly in the left arm in Jan2021 (at 94-years-old); and the second dose of BNT162B2 (lot unknown) intramuscularly in the left arm in Jan2021 (at 94-years-old); both as single doses for COVID-19 immunisation. Medical history included allergies to shellfish, severe; elderly; and legs were swollen from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were unspecified. It was reported that after vaccines, the legs were more swollen than normal and very painful. Clots were found in both legs and the patient was now (as of 04Jun2021) receiving blood thinners regularly. The events were reported as non-serious and did not require hospitalization. The events required a physician office visit. The clinical outcomes of the events were not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Cardiac disorder, Coronary artery occlusion, Dizziness, Fatigue
Clinical narrative: calcium 1500; right coronary blockage; clotting; fainted, like syncope events; electrical blood issues; electrical in nature; Fatigue; Dizziness; in the triceps area in the upper arm near the shoulder; This is a spontaneous report from a contactable consumer (patient). This 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the triceps area in the upper arm, near the shoulder on 22Mar2021 (at 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or relevant family history. Concomitant medications included pitavastatin calcium (LIVALO) taken for 3 or 4 years for cholesterol and zolpidem tartrate (AMBIEN) from an unknown date for sleep. The patient previously received the first dose of BNT162B2 on 03Mar2021 (lot number FN6206) in the triceps area for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient stated he was calling regarding the Pfizer Covid vaccine and reporting some side effects that had occurred. The patient reported it started probably in Apr2021. He started to have fatigue and was kind of curious. He went to the internal medicine doctor and had an annual physical that was probably in Jul2021. He was referred to a cardiologist and it looked like he was going to have to have a stent put in his heart and also some other diagnostic monitoring, a LINQ device. It looked like somewhat electrical in nature, along with a right coronary blockage. The patient stated there were a lot of other complications with the right coronary blockages, electrical blood issues, those kinds of issues. The clotting was identified in Jul2021 but probably started before then, he couldn't say; the clotting was identified in Jul2021 but that was usually what causes blockages. Now (as of 28Sep2021), he had to have a LINQ device that was "kind of like" a Holter monitor. The LINQ device was "like" an internal Holter monitor and they were going to monitor his electrical activity. Also, based on a computerized tomography (CT) scan yesterday (as of 28Sep2021) of the heart, it looked like he was going to have to have a stent placed in the right coronary. The patient reported no new medications were started regarding the reported events. The patient reported he fainted in Apr2021 and again in Jul2021; further reporting they were like syncope events preceded by dizziness, which he reported still experiencing and had not gotten better. The patient reported needing an emergency room visit when he fainted, during which he was admitted to the emergency room and did not have to stay overnight. The clinical outcomes of fatigue and dizziness were not recovered; the outcomes of the other events were unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Syncope, Thrombosis
Clinical narrative: calcium 1500; right coronary blockage; clotting; fainted, like syncope events; electrical blood issues; electrical in nature; Fatigue; Dizziness; in the triceps area in the upper arm near the shoulder; This is a spontaneous report from a contactable consumer (patient). This 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the triceps area in the upper arm, near the shoulder on 22Mar2021 (at 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or relevant family history. Concomitant medications included pitavastatin calcium (LIVALO) taken for 3 or 4 years for cholesterol and zolpidem tartrate (AMBIEN) from an unknown date for sleep. The patient previously received the first dose of BNT162B2 on 03Mar2021 (lot number FN6206) in the triceps area for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient stated he was calling regarding the Pfizer Covid vaccine and reporting some side effects that had occurred. The patient reported it started probably in Apr2021. He started to have fatigue and was kind of curious. He went to the internal medicine doctor and had an annual physical that was probably in Jul2021. He was referred to a cardiologist and it looked like he was going to have to have a stent put in his heart and also some other diagnostic monitoring, a LINQ device. It looked like somewhat electrical in nature, along with a right coronary blockage. The patient stated there were a lot of other complications with the right coronary blockages, electrical blood issues, those kinds of issues. The clotting was identified in Jul2021 but probably started before then, he couldn't say; the clotting was identified in Jul2021 but that was usually what causes blockages. Now (as of 28Sep2021), he had to have a LINQ device that was "kind of like" a Holter monitor. The LINQ device was "like" an internal Holter monitor and they were going to monitor his electrical activity. Also, based on a computerized tomography (CT) scan yesterday (as of 28Sep2021) of the heart, it looked like he was going to have to have a stent placed in the right coronary. The patient reported no new medications were started regarding the reported events. The patient reported he fainted in Apr2021 and again in Jul2021; further reporting they were like syncope events preceded by dizziness, which he reported still experiencing and had not gotten better. The patient reported needing an emergency room visit when he fainted, during which he was admitted to the emergency room and did not have to stay overnight. The clinical outcomes of fatigue and dizziness were not recovered; the outcomes of the other events were unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Pain in extremity
Clinical narrative: her blood pressure has been going up and down; arm was hurting; This is a spontaneous report from a contactable consumer. A 63-years-old female patient 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 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer wanted to report since she got her first Pfizer covid vaccine on 17Feb, her blood pressure has been going up and down. When she wakes up in the morning, it is high. She is taking an extra blood pressure pill and is checking her blood pressure three times a day. When she first got the shot, her arm was hurting. The patient underwent lab tests and procedures which included blood pressure measurement: going up and down on an unspecified date, blood pressure measurement: in the morning, it is high on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infections; This is a spontaneous report from a contactable consumer or other non hcp. A 84-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: 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. The patient medical history and concomitant medications were not reported.  on an unspecified date the patient experienced bladder infections Therapeutic measures were taken as a result of bladder infections (cystitis). Outcome of the events was unknown.    Information of lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in arm on an unspecified date. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: diarrhea; arm soreness; This is a spontaneous report from a contactable consumer or other non healthcare professional (Patient). A 74-years-old male patient received first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6198) via an unknown route of administration on 08Mar2021 at 09:00 am as dose 1, single for COVID-19 immunisation. The patient medical history included arthritis. Concomitant medications were not reported. It was reported that the patient previously took Tylenol for arthritis. On 08Mar2021, the patient experienced diarrhoea, arm soreness that started about 3 hours after the vaccine, he had arthritis, and took Tylenol last night for pain relief. It was reported that diarrhea has started 3 hours after receiving the vaccine and diarrhea continued until the morning of 10Mar2021. The patient also reports arm soreness that started about 3 hours after the vaccine and has not resolved. He also has an upcoming knee replacement surgery (not scheduled yet) for his arthritis. The patient was asking if he can take any type of pain relief such as Tylenol, Tylenol PM, Ibuprofen because he takes pain medication for his arthritis. It was reported that the patient wants to know if there was a restriction on the pain medication. Patient also mentioned that he has surgery coming up. The patient was having a knee replacement and wants to know what affect the COVID shot will have with that, and also wants to know if he has to wait a period of time after he gets the shot before he has surgery. It was unknown whether the reporter was a healthcare professional or the prescribing HCP. It was reported that the patient received first dose on 08 Mar2021 and second dose was scheduled on 29Mar2021. The patient was asking if it's okay to take Tylenol because he took Tylenol last night. The patient would undergo knee replacement as well after the second dose but no definite schedule yet. The outcome of event diarrhoea was recovered on 10Mar2021 while outcome of arm soreness was not resolved. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Malaise, Nausea
Clinical narrative: fever; didn't feel good; nausea/Nauseated; sweating/sweating profusely; sore arm; chills/Teeth chattering; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular, Batch/Lot Number: EN6202, Expire Date: Unknown) administered in Arm Left on 25Feb2021 at 08:30 (at the age of 70-year-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19: she did have the virus, clarified as COVID-19, prior, blood pressure abnormal: take blood pressure medication, but she has taken that for years and blood cholesterol: she takes cholesterol medication. There were no concomitant medications. The Prior Vaccinations (within 4 weeks) reported as none. Reporter stated that she had her first shot about 2 weeks ago and she had what she thought was a bad reaction. She explained when she first had the shot, she had a little bit later sore arm which was fine and she was fine the rest of the day. That night, she might have had chills and her teeth were chattering a little bit. The next morning, she was feeling nauseated and then she began sweating profusely. She was sure she had a fever, but she did not take here temperature at the time. The whole day after that she didn't feel good. When probed for the outcome of these symptoms, she explains the sweatiness didn't last that long. She actually did have a fever on Friday, 26Feb2021, she did check it later on that day and it was 99. She clarifies after Friday, she was okay. On 25Feb2021 the patient experienced sore arm, chills/teeth chattering with outcome of unknown. On 26Feb2021 nausea/nauseated with, sweating/sweating profusely and didn't feel good. On an unspecified date patient experienced fever. The patient underwent lab tests and procedures which included body temperature: 99 on 26Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; didn't feel good; nausea/Nauseated; sweating/sweating profusely; sore arm; chills/Teeth chattering; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular, Batch/Lot Number: EN6202, Expire Date: Unknown) administered in Arm Left on 25Feb2021 at 08:30 (at the age of 70-year-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19: she did have the virus, clarified as COVID-19, prior, blood pressure abnormal: take blood pressure medication, but she has taken that for years and blood cholesterol: she takes cholesterol medication. There were no concomitant medications. The Prior Vaccinations (within 4 weeks) reported as none. Reporter stated that she had her first shot about 2 weeks ago and she had what she thought was a bad reaction. She explained when she first had the shot, she had a little bit later sore arm which was fine and she was fine the rest of the day. That night, she might have had chills and her teeth were chattering a little bit. The next morning, she was feeling nauseated and then she began sweating profusely. She was sure she had a fever, but she did not take here temperature at the time. The whole day after that she didn't feel good. When probed for the outcome of these symptoms, she explains the sweatiness didn't last that long. She actually did have a fever on Friday, 26Feb2021, she did check it later on that day and it was 99. She clarifies after Friday, she was okay. On 25Feb2021 the patient experienced sore arm, chills/teeth chattering with outcome of unknown. On 26Feb2021 nausea/nauseated with, sweating/sweating profusely and didn't feel good. On an unspecified date patient experienced fever. The patient underwent lab tests and procedures which included body temperature: 99 on 26Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: she developed a rash on her right hand on just 1 finger; Broke out on one finger on my right hand; now it's gone to my wrist; This is a spontaneous report from a contactable consumer (patient). A female patient of 65-years-old had received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in arm left on 18Feb2021 (at the age of 65-Years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history had included breathing better and concomitant medications were Fluticasone furoate, Vilanterol Triefenate (BREO ELLIPTA)and Tiotropium bromide (SPIRIVA) reported for the indication of breathing better .On March 2021 the patient had experienced a rash on her right hand on just 1 finger now it's gone to my wrist . She consulted her doctor about this and she was then prescribed with Prednisone for a few days and her last dose was Monday. She is scheduled for her 2nd dose tomorrow and wants to know if it's safe for her to take the vaccine. Consumer stated, "I have a question, I had the first Pfizer vaccine on 18Feb2021 and 10 days out, I broke out on one finger on my right hand but I had my vaccine on my left hand and I went to the doctor and doctor gave me some steroids to bring down the itching and calm things down and now it's gone to my wrist and my question is tomorrow I am due for my second Vaccine is it all right to still have the second vaccine?" The consumer stated, "Correct, it was not on the same arm it was on the opposite arm, on the opposite hand, yes I had the injection on my left arm and then I broke out on right arm." It's hard to read it, its like 19262, it's difficult to read the writing." Therapeutic measures were taken as a result of AE. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Gastrooesophageal reflux disease, Pain in extremity
Clinical narrative: something is stuck in chest; odd acid reflux burning; Very painful arm; sharp pains in chest that made me catch my breath; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration in arm left on 09Mar2021 at 08:45 AM (at the age of 54-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included known allergy: Melons. Past drug event included Tylenol w/codeine and experienced allergies. The patient's concomitant medications in two weeks included generic fexofenadine, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), both were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 09Mar2021 at 19:30, the patient experienced very painful arm. The evening of the vaccine she felt sharp pains in chest that made her catch her breath. Next morning, on 10Mar2021, after breakfast she started feeling what she described as an odd acid reflux burning but not like she had ever felt before. Also feeling like something was stuck in chest. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Diarrhoea, Dysarthria, Eye pain
Clinical narrative: lights very bright; Severe head and neck ache.; Severe head and neck ache.; severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); Nausea; diarrhea; extreme exhaustion; cough; eyes hurt; slurring speech; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 08Mar2021 (age at vaccination was 48 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included loratadine (CLARITINE), ibuprofen (MOTRIN IB), prednisone, aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA 11) and fluticasone all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 9:00 am, the patient experienced severe head and neck ache, very severe body aches (every joint hurt, could not move, even yawning hurt, teeth hurt, even finger joints), nausea, diarrhea, extreme exhaustion, cough, eyes hurt, slurring speech and lights very bright. 600mg motrin did not help, 1000mg Tylenol for next available dosing time did not work, nothing worked. The outcome of the events was not resolved.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Neck pain, Pain
Clinical narrative: lights very bright; Severe head and neck ache.; Severe head and neck ache.; severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); Nausea; diarrhea; extreme exhaustion; cough; eyes hurt; slurring speech; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 08Mar2021 (age at vaccination was 48 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included loratadine (CLARITINE), ibuprofen (MOTRIN IB), prednisone, aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA 11) and fluticasone all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 9:00 am, the patient experienced severe head and neck ache, very severe body aches (every joint hurt, could not move, even yawning hurt, teeth hurt, even finger joints), nausea, diarrhea, extreme exhaustion, cough, eyes hurt, slurring speech and lights very bright. 600mg motrin did not help, 1000mg Tylenol for next available dosing time did not work, nothing worked. The outcome of the events was not resolved.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: lights very bright; Severe head and neck ache.; Severe head and neck ache.; severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); Nausea; diarrhea; extreme exhaustion; cough; eyes hurt; slurring speech; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 08Mar2021 (age at vaccination was 48 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included loratadine (CLARITINE), ibuprofen (MOTRIN IB), prednisone, aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA 11) and fluticasone all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 9:00 am, the patient experienced severe head and neck ache, very severe body aches (every joint hurt, could not move, even yawning hurt, teeth hurt, even finger joints), nausea, diarrhea, extreme exhaustion, cough, eyes hurt, slurring speech and lights very bright. 600mg motrin did not help, 1000mg Tylenol for next available dosing time did not work, nothing worked. The outcome of the events was not resolved.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: Redness; soreness; This is a spontaneous report from a contactable consumer. An 81-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 27Feb2021 at 16:00 (at the age of 81-years) as dose 1, single for covid-19 immunization. The patient medical history included diabetes, cardiac failure congestive, hypertension. The patient had penicillin allergy. The patient had not received any other vaccine within 4 weeks. The patient had received other medications in two weeks. On 28Feb2021 at 08:30, the patient had redness that spread from 1 inch to 3 inches wide, and 8 inches long; soreness which was same as her flu shot; which lasted for 6 days. Patient received no treatment for the events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Mild fever; Kept me awake; Mild arm soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 36-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EL3248, Expiry date: unknown) intramuscular route of administration, administered in left arm on 10Mar2021 09:15 (age at vaccination: 36-Year-old) as dose 2, single for COVID-19 immunization (Workplace clinic). The patient medical history and concomitant medications were not reported. Not received any other vaccine in four weeks prior to vaccination. Patient had not tested for covid, prior and post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry date: unknown) via intramuscularly, administered in left arm on 19Feb2021 10:00 as dose 1, single for COVID-19 immunization. On 11Mar2021 at 03:00, the patient experienced mild fever (18-22 hours after injection), kept me awake and mild arm soreness. Did not take drugs to counteract. The patient had not received any treatments for the events. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain continuing to 3rd day after injection; sharp intermittent stabbing pains in the back; fatigue; headache; chills; right arm soreness and itchiness ongoing third day post injection; right arm soreness and itchiness ongoing third day post injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; Batch/lot number: EN6204) administered in right arm via an unspecified route of administration on 08Mar2021 at 12:15 PM (at the age of 66 years) as dose 1, single for covid-19 immunisation. The patient's medical history included diabetes. The patient had known allergies to Statins, Amlodipine, and blood pressure medications. Prior to vaccination, the patient did not have COVID. The patient did not test for COVID post vaccination. No other vaccines were administered in four weeks. Other concomitant medications in two weeks included LIVALO, ZINC, ESTER C, FISH OIL, 81 mg ASPIRIN taken for an unspecified indication, start and stop date were not reported. On 08Mar2021 at 14:30 PM, the patient experienced muscle pain continuing to 3rd day after injection, sharp intermittent stabbing pains in the back, fatigue, headache, chills during the first 24 hours, right arm soreness, and itchiness ongoing third day post injection. No covid prior vaccination and not tested for covid post vaccination. No treatment was received for all the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Muscle pain continuing to 3rd day after injection; sharp intermittent stabbing pains in the back; fatigue; headache; chills; right arm soreness and itchiness ongoing third day post injection; right arm soreness and itchiness ongoing third day post injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; Batch/lot number: EN6204) administered in right arm via an unspecified route of administration on 08Mar2021 at 12:15 PM (at the age of 66 years) as dose 1, single for covid-19 immunisation. The patient's medical history included diabetes. The patient had known allergies to Statins, Amlodipine, and blood pressure medications. Prior to vaccination, the patient did not have COVID. The patient did not test for COVID post vaccination. No other vaccines were administered in four weeks. Other concomitant medications in two weeks included LIVALO, ZINC, ESTER C, FISH OIL, 81 mg ASPIRIN taken for an unspecified indication, start and stop date were not reported. On 08Mar2021 at 14:30 PM, the patient experienced muscle pain continuing to 3rd day after injection, sharp intermittent stabbing pains in the back, fatigue, headache, chills during the first 24 hours, right arm soreness, and itchiness ongoing third day post injection. No covid prior vaccination and not tested for covid post vaccination. No treatment was received for all the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Influenza like illness, Oropharyngeal pain
Clinical narrative: flu-like symptoms; diarrhea; cough; runny nose; sore throat; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; expiry date-unknown; Batch/Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 08:00 as DOSE 1, SINGLE for covid-19 immunisation (age at the time of vaccination was 30 years). Medical history included polycystic ovaries(PCOS). Concomitant medications included metformin, nexium and birth control pills. No other vaccination received within 4 weeks prior to covid-19 vaccination. No covid prior to covid-19 vaccine. The patient experienced flu-like symptoms including cough, runny nose, sore throat, fever, fatigue, diarrhoea on 06Mar2021. No covid tested post vaccination. No known allergies. No treatment received. The clinical outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: flu-like symptoms; diarrhea; cough; runny nose; sore throat; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; expiry date-unknown; Batch/Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 08:00 as DOSE 1, SINGLE for covid-19 immunisation (age at the time of vaccination was 30 years). Medical history included polycystic ovaries(PCOS). Concomitant medications included metformin, nexium and birth control pills. No other vaccination received within 4 weeks prior to covid-19 vaccination. No covid prior to covid-19 vaccine. The patient experienced flu-like symptoms including cough, runny nose, sore throat, fever, fatigue, diarrhoea on 06Mar2021. No covid tested post vaccination. No known allergies. No treatment received. The clinical outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Movement disorder, Swelling
Clinical narrative: swollen lymph nodes; pain under left armpit (arm of injection); swollen; difficult to move my arm; This is a spontaneous report from a contactable consumer. This 53-year-old non-pregnant female consumer reported for herself that she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08Mar2021 at 17:00 (at 53-year-old), as dose number unknown, single for COVID-19 immunization. No other vaccine was received in four weeks. Other medications in two weeks were reported as none. It was reported that Covid prior vaccination and covid tested post vaccination was reported as no. Patient had no allergies and no medical history. On an unknown date patient had swollen lymph nodes and pain under left armpit (arm of injection), it was very swollen and uncomfortable and difficult to move arm. The event outcome was unknown.  No follow-up attempts were possible; information about batch/ lot number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: soreness in his left arm (arm of injection); headaches; chills; fever; feeling unwell/felt awful; This is a spontaneous report from a contactable Consumer or other non-health care professional (patient). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch no/lot number and expiration date: not reported) via an unspecified route of administration on 22Feb2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE; batch no/lot number and expiration date: not reported) via an unspecified route of administration on 25Jan2021 as dose 1, single for COVID-19 immunization. Patient wanted to know if the side effects that he was experiencing after the second dose can be attributed to the vaccine. It was reported that on an unspecified date in 2021, patient experienced soreness in his left arm (arm of injection) for a day or two then states it went away and from late last week on an unspecified date in 2021, he started experiencing headaches, chills, fever, and feeling unwell/felt awful. Seriousness of the case reported as no. The outcome of event soreness in his left arm (arm of injection) was recovered on an unspecified date in 2021 and another events outcome was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; swollen throat; cough; chest congestion; diarrhea; chills; tiredness; nausea; body ache; This is a spontaneous report from a contactable consumer. This 48-Year-old male consumer reported.  A 48-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6199, Expiration date: unknown), via unspecified route, administered in left arm on 05Mar2021 02:30 PM (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes thyroid disorder and concomitant medications were not reported. On 08Mar2021 02:00 am, after the vaccination, the patient experienced Headache, swollen throat, cough, chest congestion, diarrhoea, chills, tiredness, nausea, body ache. The reporter assessed all events as non-serious. No other vaccines taken in four weeks; no other medications taken in two weeks. Patient was not diagnosed with covid prior vaccination. And not tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pharyngeal oedema, Respiratory tract congestion
Clinical narrative: Headache; swollen throat; cough; chest congestion; diarrhea; chills; tiredness; nausea; body ache; This is a spontaneous report from a contactable consumer. This 48-Year-old male consumer reported.  A 48-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6199, Expiration date: unknown), via unspecified route, administered in left arm on 05Mar2021 02:30 PM (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes thyroid disorder and concomitant medications were not reported. On 08Mar2021 02:00 am, after the vaccination, the patient experienced Headache, swollen throat, cough, chest congestion, diarrhoea, chills, tiredness, nausea, body ache. The reporter assessed all events as non-serious. No other vaccines taken in four weeks; no other medications taken in two weeks. Patient was not diagnosed with covid prior vaccination. And not tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Limb discomfort, Myalgia
Clinical narrative: Low grade fever 98.8-99.1; Upset stomach; Muscle pain in Right arm; heavyness in moving; Right arm Tiredness; This is a spontaneous report from a contactable consumer (patient). This 59-years-old non-pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 09Mar2021 (at the age of 59 years) as dose 2, single for covid-19 immunisation. Medical history included osteoarthritis, axinal peripheral Neuropathy "cryptogenic". Known allergies: Sulfur, 600mg or more of aspirin. Concomitant medications in two weeks: ubidecarenone (COQ10 [UBIDECARENONE]), vaccinium myrtillus (MAXVISION), loratadine (ALLERCLEAR) and Clonazepam. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 19Feb2021 at 14:15 (at the age of 59 years) as dose 1, single for covid-19 immunisation. On 10Mar2021 at 05:00, the patient experienced low grade fever 98.8-99.1, upset stomach, muscle pain in right arm/heaviness in moving, right arm tiredness. The patient underwent lab tests and procedures which included body temperature: 98.8-99.1 on 10Mar2021 (Low grade fever). It was unknown if treatment for AE was received or not. The outcome of events was recovered with lasting effects in 2021.  No follow-up attempts are possible. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever 98.8-99.1; Upset stomach; Muscle pain in Right arm; heavyness in moving; Right arm Tiredness; This is a spontaneous report from a contactable consumer (patient). This 59-years-old non-pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 09Mar2021 (at the age of 59 years) as dose 2, single for covid-19 immunisation. Medical history included osteoarthritis, axinal peripheral Neuropathy "cryptogenic". Known allergies: Sulfur, 600mg or more of aspirin. Concomitant medications in two weeks: ubidecarenone (COQ10 [UBIDECARENONE]), vaccinium myrtillus (MAXVISION), loratadine (ALLERCLEAR) and Clonazepam. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 19Feb2021 at 14:15 (at the age of 59 years) as dose 1, single for covid-19 immunisation. On 10Mar2021 at 05:00, the patient experienced low grade fever 98.8-99.1, upset stomach, muscle pain in right arm/heaviness in moving, right arm tiredness. The patient underwent lab tests and procedures which included body temperature: 98.8-99.1 on 10Mar2021 (Low grade fever). It was unknown if treatment for AE was received or not. The outcome of events was recovered with lasting effects in 2021.  No follow-up attempts are possible. No further information is expected