chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fatigue, Hyperventilation, Increased viscosity of bronchial secretion
Clinical narrative: fatigue; unable to get up on his own; heavy breathing; thick mucus; increased confusion; Weakness; severe muscle weakness; unable to sleep; aches and pains; arm was sore; This is a spontaneous report from a contactable consumer (patient's son). A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown) via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 (at the age of 93-year-old) as 1st dose, single dose for COVID-19 immunization in hospital. Medical history included muscle relaxant, blood pressure or cholesterol and broken neck from 1978 to an unknown date and unknown if ongoing. Concomitant medications included ongoing atorvastatin calcium 10mg taken once daily by mouth for blood pressure or cholesterol taking for a while, ongoing propafenone hydrochloride 150mg taken one twice daily by mouth, taking for a while, ongoing baclofen 10mg taken one five times daily by mouth as muscle relaxant taking for years, ongoing diltiazem HCL 180mg taken once daily by mouth, taking for long time, ongoing mirtazapine 30mg taken one at bedtime by mouth, taking for a while, ongoing citalopram HBR 20mg take once daily by mouth, taking for a while. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced unable to sleep, aches and pains, arm was sore, on 25Jan2021, experienced weakness, severe muscle weakness, on 26Jan2021, experienced increased confusion and on an unspecified date, experienced fatigue, unable to get up on his own, heavy breathing and thick mucus. But his father has tremendously decreased. Mentions his father was previously independent, using a walker, going to exercise class by himself and totally fine. Now after receiving the vaccine his father is unable to sleep, has aches and pains, was experiencing increased confusion and profound weakness. Adds his father can't get up on his own and has to be guided to use the walker if he can get up. They did call his HCP and were advised not to get the second dose and to make sure patient was eating and drinking. He was scheduled to receive the second dose on 14Feb2021 but he was unsure if he will get it. Adds his father had been water walking everyday and this wasn't like him. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: fatigue; unable to get up on his own; heavy breathing; thick mucus; increased confusion; Weakness; severe muscle weakness; unable to sleep; aches and pains; arm was sore; This is a spontaneous report from a contactable consumer (patient's son). A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown) via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 (at the age of 93-year-old) as 1st dose, single dose for COVID-19 immunization in hospital. Medical history included muscle relaxant, blood pressure or cholesterol and broken neck from 1978 to an unknown date and unknown if ongoing. Concomitant medications included ongoing atorvastatin calcium 10mg taken once daily by mouth for blood pressure or cholesterol taking for a while, ongoing propafenone hydrochloride 150mg taken one twice daily by mouth, taking for a while, ongoing baclofen 10mg taken one five times daily by mouth as muscle relaxant taking for years, ongoing diltiazem HCL 180mg taken once daily by mouth, taking for long time, ongoing mirtazapine 30mg taken one at bedtime by mouth, taking for a while, ongoing citalopram HBR 20mg take once daily by mouth, taking for a while. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced unable to sleep, aches and pains, arm was sore, on 25Jan2021, experienced weakness, severe muscle weakness, on 26Jan2021, experienced increased confusion and on an unspecified date, experienced fatigue, unable to get up on his own, heavy breathing and thick mucus. But his father has tremendously decreased. Mentions his father was previously independent, using a walker, going to exercise class by himself and totally fine. Now after receiving the vaccine his father is unable to sleep, has aches and pains, was experiencing increased confusion and profound weakness. Adds his father can't get up on his own and has to be guided to use the walker if he can get up. They did call his HCP and were advised not to get the second dose and to make sure patient was eating and drinking. He was scheduled to receive the second dose on 14Feb2021 but he was unsure if he will get it. Adds his father had been water walking everyday and this wasn't like him. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose; sore throat; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jan2021 15:00 (Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing.  Concomitant medication included dapagliflozin propanediol monohydrate (FARXIGA), fenofibrate and dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported. The patient experienced runny nose, sore throat and headache on 02Feb2021. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: experienced chills, fatigue; experienced chills, fatigue; felt lousy/wasn't able to go to work because she doesn't feel well; muscle pain; she doesn't feel well; This is a spontaneous report from a Non-contactable consumer (Patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration Date: not reported), via unspecified route on an unknown date at single dose for covid-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that the patient got first shot last Saturday and after a few hours she experienced chills, fatigue and muscle pain and yesterday she felt lousy and got chills again. This morning she wasn't able to go to work because she doesn't feel well. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: body ache; mild chills; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 62-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 13Jan2021 at 16:15 (at the age of 62-years-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included docusate and naproxen sodium (NAPROSYN). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 22Dec2020 at 16:15 (at the age of 62-years-old) as single dose for covid-19 immunisation. On 14Jan2021 at 19:00, the patient experienced body ache, mild chills and no fever. The patient took acetominophen with relief. The outcome of the event was recovered on an unknown date. Therapeutic measures were taken as a result of body ache and mild chills.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal sounds abnormal
Clinical narrative: diarrhea; Borborygmi; This is a spontaneous report from a contactable physician. This 87-year-old male physician reported for himself that an 87-year-old male patient received first dose of BNT162B2 (solution for injection, lot number: EL3302, Expiration Date: Unknown), via an unspecified route of administration on 08Jan2021 in his left arm at about 2:00PM at single dose for COVID-19 immunization. The Patient Medical history included Hypertension, GERD. Concomitant medications were not included. that the patient received second dose of BNT162B2 (solution for injection, lot number: EL9263, Expiration Date: Unknown), via an unspecified route of administration on 29Jan2021 in his left arm in his left arm at about 12:30PM. at single dose for COVID-19 immunization. On Jan2021 Borborygmi (clarified as belly gurgling) and he also experienced diarrhea. He said it is annoying to hear his belly gurgling. He said the Borborygmi and diarrhea started 10 days after his first COVID-19 Vaccine shot. The Patient reported he had a phone call with his doctor on Monday, 01Feb2021, due to snow, and his doctor put him on probiotics. He said he was getting better with taking the probiotic. The outcome of the event was resolving.  Relatedness of drug to reactions was reported as related for diarrhea and Borborygmi.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity, Therapeutic response unexpected
Clinical narrative: I got the vaccine yesterday and I have only had arm soreness as a negative side effect.; Cough; breathing is very clear today even though I have asthma/My nose would frequently swell shut and now my nose is very clear/now after the vaccine the rash is gone/My eyes would water a lot and now my eyes feel almost normal today; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included A\allergies, respiratory infection, asthma and rash. The patient's concomitant medications were not reported.  The patient experienced "i got the vaccine yesterday and i have only had arm soreness as a negative side effect" cough and "breathing is very clear today even though i have asthma/my nose would frequently swell shut and now my nose is very clear/now after the vaccine the rash is gone/my eyes would water a lot and now my eyes feel almost normal today". It was reported that when the patient heard vaccines were being developed, she heard they were not including pregnant women or people with severe seasonal allergies. She informs that she might be an interest specifically for a study. Her allergies are in the 39,000 range. She got the vaccine yesterday and she has only had arm soreness as a negative side effect. However, she had had some very good side effects as well. Last night she coughed up a lot of old nodules from a respiratory infection she had a year ago. Her breathing is very clear today even though she has asthma. Her nose would frequently swell shut and now her nose is very clear. Her skin was broken out before the vaccine, so much so that she used a different arm because of the rash and now after the vaccine the rash is gone and is only a little pink where it was before. Her eyes would water a lot and now her eyes feel almost normal today. When she told her friend about this, she said her mom actually coughed up a lot of old infection nodules as well. Outcome of the events were unknown.   Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got a rash on my chest, back, and neck. No other symptoms other than being about to see the rash; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration, on 07Jan2021, as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 07Jan2021, about an hour after the vaccination, the patient experienced rash on her chest, back, and neck. No other symptoms other than being about to see the rash. On 04Feb2021, tomorrow, the patient due to get her second shot. The patient wanted to double check that it would be ok after having the reaction to the first one. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Asthenia, Fall, Muscular weakness, Myalgia
Clinical narrative: Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down; felt so weak that he could not lift himself to get up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).  A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2020 to an unknown date; he also mentioned that he had COVID-19 back in July but has already recovered. The patient's concomitant medications were not reported. On an unspecified date in Jan 2021, the following day, he woke up and his tongue was swollen. He got excited and called doctor and he went in. He went to get dressed and as he went in, he fell down. Then he is trying to get up and cannot get up. He layed there for 1/2 hour. He could not get up. He was trying and trying. His wife had to call neighbors to help him get up. He did not want to go to the hospital and wait for 2-3 hours. He took some Benadryl and a couple of Aspirin and fell asleep. The following day when he woke up, his mouth was not swollen and he was able to get up and around. His muscles hurt and he felt like a weakling. The clinical outcome of tongue became swollen, fell down, felt so weak that he could not lift himself to get up was resolved and the outcome of other events was unknown.  He is scheduled to get second dose on 24Feb2021. He would like to know if he should get it or not. He was an EMT in Fire Department before he retired. That day when it happened, he really felt old. No further details provided. The seriousness of the events was reported as non-serious.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down; felt so weak that he could not lift himself to get up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).  A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2020 to an unknown date; he also mentioned that he had COVID-19 back in July but has already recovered. The patient's concomitant medications were not reported. On an unspecified date in Jan 2021, the following day, he woke up and his tongue was swollen. He got excited and called doctor and he went in. He went to get dressed and as he went in, he fell down. Then he is trying to get up and cannot get up. He layed there for 1/2 hour. He could not get up. He was trying and trying. His wife had to call neighbors to help him get up. He did not want to go to the hospital and wait for 2-3 hours. He took some Benadryl and a couple of Aspirin and fell asleep. The following day when he woke up, his mouth was not swollen and he was able to get up and around. His muscles hurt and he felt like a weakling. The clinical outcome of tongue became swollen, fell down, felt so weak that he could not lift himself to get up was resolved and the outcome of other events was unknown.  He is scheduled to get second dose on 24Feb2021. He would like to know if he should get it or not. He was an EMT in Fire Department before he retired. That day when it happened, he really felt old. No further details provided. The seriousness of the events was reported as non-serious.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm of course was aching, Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient reported   A 78-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in upper left arm on 01Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced her arm was aching. The patient reported that she received the first dose of the Pfizer vaccine on 01Feb2021, but patient was questioning how many don't have any issues and no symptoms. Reporter stated, she thinks it was normal. It's not going to be effective, she was expecting something, That's kind a good. The patient had a sore arm on the first day, and it subsided, it went away. it's a tiny sore. The patient was a little concerned because she did not have a reaction, that tend to worry. she was not experienced any symptoms except for her arm of course was aching, it was gone away now, is it still effective if there are no symptoms. The patient clarified her arm aching is very slight now. The outcome of the event was resolving.  Information about Lot and Batch has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: However after the second shot he had flu like symptoms for 24 hours; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. This consumer (patient's daughter) reported.   A 85-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd, dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received first dose of Pfizer COVID vaccine and had no symptoms. On an unspecified date 2021, after second shot, patient experienced flu like symptoms for 24 hours and then itself resolved. The outcome of the event was recovered on an unspecified date 2021.   No follow-up attempts are possible. Information about lot/Batch cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Nausea, Vomiting
Clinical narrative: nausea; vomiting; dizziness; rapid heart rate (139 beats/min)/heart rate was elevated; This is a spontaneous report from a contactable pharmacist. A 46-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5813), intramuscularly in the left arm on 02Feb2021 at 11:00 as a single dose for COVID-19 immunization. The patient's medical history included history of reacting to flu vaccines and flu-like symptoms. The patient's concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of the vaccination. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. It was unknown if the patient tested positive for COVID-19. It was reported that, on 02Feb2021 at 11:00 PM, approximately 12 hrs after inoculation, the patient experienced nausea, vomiting, dizziness and rapid heart rate (139 beats/min). The patients heart rate was elevated for 2 hrs. The treatment received for the events was unknown. On 02Feb2021, the patient underwent lab tests and procedures which included heart rate and resulted as 139 beats/min, rapid. The outcome of the events was recovered.  The reporter classified the events as non-serious and seriousness criteria that resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect was reported as no.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain in extremity, Rash
Clinical narrative: Rash on left forearm; Chills; swollen lymph nodes; Sore right arm; This is a spontaneous report from a contactable other hcp (patient herself). A 55-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 29Jan2021 at 13:30 (at the age of 55-years-old) as a single dose for covid-19 immunisation. Medical history included first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) administered in left arm on 08Jan2021 (at the age of 55-years-old) 13:30 for covid-19 immunisation, hypothyroidism, GERD, and unspecified allergies. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication received within 2 weeks of vaccination on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 30Jan2021 at 12: 00 AM, the patient experienced, Chills, swollen lymph nodes, Sore right arm, Rash on left forearm on day 4 and 5 post 2nd vaccine. No treatment was received for adverse event. The reporter assessed adverse events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Gait disturbance, Loss of personal independence in daily activities, Malaise
Clinical narrative: extreme weakness and malaise; extreme weakness and malaise; inability to ambulate; no appetite; She requires complete assistance with even basic Activities of daily living; This is a spontaneous report from a contactable other hcp (nurse, patient's daughter). A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, within 6 days the patient experienced extreme weakness and malaise, inability to ambulate, no appetite and she requires complete assistance with even basic activities of daily living. She was previously independent and ambulatory. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eyelids pruritus, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; Sore arm at injection site with arm movement or palpation; Sore arm at injection site with arm movement or palpation; Sore arm at injection site with arm movement or palpation; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient (non-pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EU), via an unspecified route of administration, administered in Deltoid Left on 02Feb2021 at 13:15 as 1st dose single for COVID-19 immunization. Age at the time of vaccination was reported as 57. Other vaccine same date and details was reported as (02Feb2021, EU5318, Dose 1, L deltoid). Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing DMII, hypothyroidism from an unknown date and unknown if ongoing hypothyroid, metabolic syndrome from an unknown date and unknown if ongoing, polycystic ovaries from an unknown date and unknown if ongoing PCOS. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took griseofulvin and wellbutrin and experienced drug hypersensitivity. Location of injection information is available for all vaccines received on the same date. On 03Feb2021 at 04:30 patient experienced itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts (Itchy skin, Itching both hands, Itchy scalp, Eyelids pruritus, Localized itching, Swelling and Urticaria) and Sore arm at injection site with arm movement or palpation (Vaccination site pain, Pain upon movement and Trigger point pain). Treatment received for the adverse event was unknown. Seriousness criteria was reported as No. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; Sore arm at injection site with arm movement or palpation; Sore arm at injection site with arm movement or palpation; Sore arm at injection site with arm movement or palpation; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient (non-pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EU), via an unspecified route of administration, administered in Deltoid Left on 02Feb2021 at 13:15 as 1st dose single for COVID-19 immunization. Age at the time of vaccination was reported as 57. Other vaccine same date and details was reported as (02Feb2021, EU5318, Dose 1, L deltoid). Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing DMII, hypothyroidism from an unknown date and unknown if ongoing hypothyroid, metabolic syndrome from an unknown date and unknown if ongoing, polycystic ovaries from an unknown date and unknown if ongoing PCOS. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took griseofulvin and wellbutrin and experienced drug hypersensitivity. Location of injection information is available for all vaccines received on the same date. On 03Feb2021 at 04:30 patient experienced itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts (Itchy skin, Itching both hands, Itchy scalp, Eyelids pruritus, Localized itching, Swelling and Urticaria) and Sore arm at injection site with arm movement or palpation (Vaccination site pain, Pain upon movement and Trigger point pain). Treatment received for the adverse event was unknown. Seriousness criteria was reported as No. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Malaise, Pain in extremity
Clinical narrative: She is feeling sick; her arm was very sore; headache; she doesn't feel good and is tired; she doesn't feel good and is tired; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable 53-year-old female Nurse reported for herself.  A 53-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: EL9265 and expiration date: 31May2021) via an unspecified route of administration, administered in left deltoid on 29Jan2021 at 10-10:30am (at the age of 53-year-old) as single dose for COVID-19 immunization. The patient medical history included a shingles in Nov2020, breast cancer, it is non-metastatic triple negative and Covid virus where she had headache, was sick for 2 full weeks and then on the 3rd week she felt better. The patient's concomitant medications were not reported. The patient did not had allergies. The patient did not have any illness at time of vaccination. On 30Jan2021, the patient's arm was sore and very sore when she touches it the first day after, she put a cold compress and felt much better the next day and headache is felt like when she had covid previously and feels like she is at the tail end of having the virus. She doesn't feel good and feeling so tired because of all of this. The patient has taken treatment of Excedrin migraine for the headaches also taken Tylenol and when she got desperate, she took a sumatriptan, a product used for migraines. The patient did not diagnose with COVID-19 since the vaccination. The outcome of event arm was very sore is recovering. The outcome of events Headache and doesn't feel good and tired is not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Fatigue; sore arm; stiffness through out day; difficulty walking due to pain; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old male patient received BNT162B2(BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, sore arm, stiffness through out day, difficulty walking due to pain. The outcome of the events were unknown.  No follow-up attempts are possible. Information about batch/Lot number can not be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Insomnia, Myalgia
Clinical narrative: Severe chills; rapid heart rate; muscle aches; fever; insomnia; headache; This is a spontaneous report from a contactable pharmacist (patient) reporting herself.  A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1283), dose 2 via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 11:30 (at the age of 58-year-old) as SINGLE DOSE for covid-19 immunization. The patient received first dose of bnt162b2 (Lot number: unknown) on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism and seasonal allergy. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol (ESTRADIOL); progesterone (PROGESTERONE); citalopram (CITALOPRAM); thyroid (ARMOUR THYROID); levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID 19 prior to vaccination. On 04Feb2021 at 01:00, the patient experienced severe chills, rapid heart rate, muscle aches, fever, insomnia and headache. The patient reported the seriousness s as non-serious. The Patient has not received any treatment for the adverse event. Since the vaccination, patient not been tested for COVID-19. The outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chills; rapid heart rate; muscle aches; fever; insomnia; headache; This is a spontaneous report from a contactable pharmacist (patient) reporting herself.  A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1283), dose 2 via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 11:30 (at the age of 58-year-old) as SINGLE DOSE for covid-19 immunization. The patient received first dose of bnt162b2 (Lot number: unknown) on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism and seasonal allergy. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol (ESTRADIOL); progesterone (PROGESTERONE); citalopram (CITALOPRAM); thyroid (ARMOUR THYROID); levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID 19 prior to vaccination. On 04Feb2021 at 01:00, the patient experienced severe chills, rapid heart rate, muscle aches, fever, insomnia and headache. The patient reported the seriousness s as non-serious. The Patient has not received any treatment for the adverse event. Since the vaccination, patient not been tested for COVID-19. The outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Headache, Lymphadenopathy
Clinical narrative: under arm started to burn, went and looked and glands had swollen up to golf ball size; under arm started to burn; Pain in joints; headache on right side; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration administered in right arm on 02Feb2021 11:00 as a single dose for covid-19 immunization. Medical history included asthma, gluten allergy, fructose allergy, lactose allergy. Concomitant medications included calcium, tea, green, diindolylmethane (DIM), Asthma inhaler and Vit. 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. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unknown date as a single dose for covid-19 immunization. On 03Feb2021, the patient experienced pain in joints and headache on right side. In the evening at about 5:30, under arm started to burn, and glands had swollen up to golf ball size. No treatment was received for the adverse events. Seriousness of the events was assessed as non-serious by reporter. The outcome of the events was resolving.  Follow-up attempts have been completed and no further information is expected.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain to left arm from deltoid to fingertips; Swelling and pain to left arm from deltoid to fingertips; This is a spontaneous report from a contactable nurse (patient also).  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3248) via Intramuscular route of administration, administered in left arm on 03Feb2021 at 08:45 AM as 1st dose single for covid-19 immunisation in hospital. The patient medical history included hypertension. The patient had allergies with eggs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19. The patient's concomitant medications included lisinopril, HCTZ and fexofenadine (within 2 weeks). On 03Feb2021, 09:00 AM, the patient experienced swelling and pain to left arm from deltoid to fingertips. The patient did not receive treatment for the adverse event. At the time of this report events outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Lymphadenopathy, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Swollen lymph nodes; Nausea; vomiting; lack of appetite for 11 days; This is a spontaneous report from a contactable other health professional (patient) via COVID-19 Vaccine Adverse Event Self-Reporting Solution. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, /Lot Number: EL9262, expiration date not reported), via an unspecified route of administration, administered in left arm on 24Jan2021 14:45 (age at the time of vaccination 29-year-old) as 1st dose, single for covid-19 immunisation at workplace clinic. Patient had no medical history. The patient concomitant medications received within 2 weeks of vaccination include multivitamins. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Jan2021, the patient experienced swollen lymph nodes, nausea, vomiting, lack of appetite for 11 days. It was unknown if the patient was pregnant. The patient underwent lab tests and procedures which included sars-cov-2 test, nasal swab with negative result on 31Jan2021. The case was considered as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: minor injection site discomfort; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patent received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL 3246), via an unspecified route of administration n left arm on 12Jan2021 at 03:15 AM as 1st dose single for COVID-19 immunization. Medical history included HIV +, high blood pressure, shoulder replacement, hip replacement, knee replacement. Concomitant medications included dolutegravir sodium (TIVICAY), emtricitabine, tenofovir alafenamide fumarate (DESCOVY), hydrochlorothiazide, rosuvastatin. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient dd not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 03Feb2021 at 08:00 AM (after first dose), patent experienced minor injection site discomfort. No treatment was received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. Patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL 82982), via an unspecified route of administration n left arm on 02Feb2021 at 03:00 PM as 2nd dose, single dose for COVID-19 immunization and experienced minor injection site discomfort, Joint pain, achy all over, weakness, little bit of fever, chills, no appetite. This lasted 1.5 days. The outcome of the event was recovered.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: fatigue; severe headache; light chills; This is a spontaneous report from a contactable consumer or other non health professional (Patient). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) dose 2, via an unspecified route of administration, administered in Arm Left on 02Feb2021 (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received INFLUENZA vaccines within 4 weeks prior to the COVID vaccine in left arm on 07Jan2021 for immunisation. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) via an unspecified route of administration, administered in Left arm on 13Jan2021 02:45 pm (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient wouldn't consider this adverse, just the predicted side effects, fatigue, severe headache, light chills on 03Feb2021 at 06:00 am. The headache was continued 2 days after vaccination. The patient not received treatment for the adverse event. Since the vaccination, the patient was not tested for COVID-19. The reporter assessed the events as non serious. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: aches; fatigue; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Patent previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced aches & fatigue same day that he received 2nd dose of vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold; runny nose; cough; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date (a week after the vaccination), the patient experienced cold, runny nose and cough. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: He is asking if its okay for him to take Oxycontin for his back pain.; This is a spontaneous report received from a non-contactable consumer (patient) via Pfizer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced back pain. Patient enquired whether if its okay for him to take Oxycontin for his back pain. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.