chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: tested positive for COVID; Very fatigued; pain, right arm; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix. On 20th July 2021, 7 days after receiving Shingrix, the patient experienced pain in arm. On 17th August 2021, the patient experienced fatigue. On 31st August 2021, the patient experienced covid-19. On 31st October 2021, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the covid-19 was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the covid-19 and fatigue to be related to Shingrix. The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix in right arm and a week later she began to noticed some arm pain at the same arm of injection. Thirty five days after vaccination, the patient began to felt very fatigued. Forty nine days after vaccination, the patient was tested positive for COVID. All the symptoms continued and resolved at the end of October. The patient had been in contact with her health care professional regarding the arm pain and she did not thought it was an injection error but just a minor side effect from the vaccine and should went away with time. The reporter gave permission to contact her health care professional. The reporter consented to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Fatigue, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; Very fatigued; pain, right arm; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix. On 20th July 2021, 7 days after receiving Shingrix, the patient experienced pain in arm. On 17th August 2021, the patient experienced fatigue. On 31st August 2021, the patient experienced covid-19. On 31st October 2021, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the covid-19 was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the covid-19 and fatigue to be related to Shingrix. The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix in right arm and a week later she began to noticed some arm pain at the same arm of injection. Thirty five days after vaccination, the patient began to felt very fatigued. Forty nine days after vaccination, the patient was tested positive for COVID. All the symptoms continued and resolved at the end of October. The patient had been in contact with her health care professional regarding the arm pain and she did not thought it was an injection error but just a minor side effect from the vaccine and should went away with time. The reporter gave permission to contact her health care professional. The reporter consented to follow-up.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; Received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; Received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; Had a slight reaction nothing really, we had a little chills like that; This is a spontaneous report from a contactable consumer (patient).A 79-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in arm left on 14Sep2021 (at the age of 79 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was included High blood pressure and heart issues. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route on an unspecified date in 2021 (at the age of 79 years old) as dose 1, single for covid-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route on an unspecified date in 2021as dose 2, single (at the age of 79 years old)for covid-19 immunisation .Patient reported that he received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.On an unspecified date,h e had a slight reaction nothing really, he had a little chills like that. But he just received a call from the saying that they don't think that it was refrigerated properly and they do not know if the vaccine was effective. No treatment was received for chills. The lab test included blood work: unknown result on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101302981 Same reporter/drug/AE, different patient
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; Received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; Received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; Had a slight reaction nothing really, we had a little chills like that; This is a spontaneous report from a contactable consumer (patient).A 79-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in arm left on 14Sep2021 (at the age of 79 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was included High blood pressure and heart issues. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route on an unspecified date in 2021 (at the age of 79 years old) as dose 1, single for covid-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route on an unspecified date in 2021as dose 2, single (at the age of 79 years old)for covid-19 immunisation .Patient reported that he received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.On an unspecified date,h e had a slight reaction nothing really, he had a little chills like that. But he just received a call from the saying that they don't think that it was refrigerated properly and they do not know if the vaccine was effective. No treatment was received for chills. The lab test included blood work: unknown result on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101302981 Same reporter/drug/AE, different patient
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dehydration, Pain, Rash
Clinical narrative: Full Body Rash, Guillian Barr Syndrome and ended up at hospital on 10/14/22 - 11/3/21.   Was in ICU for 11 of those days.   Pneumonia,  Kidney Failure, blood clots in heart,  etc.   They listed SEPTIC SHOCK on discharge papers.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Facial pain, Fatigue, Feeling cold
Clinical narrative: Full Body Rash, Guillian Barr Syndrome and ended up at hospital on 10/14/22 - 11/3/21.   Was in ICU for 11 of those days.   Pneumonia,  Kidney Failure, blood clots in heart,  etc.   They listed SEPTIC SHOCK on discharge papers.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: Full Body Rash, Guillian Barr Syndrome and ended up at hospital on 10/14/22 - 11/3/21.   Was in ICU for 11 of those days.   Pneumonia,  Kidney Failure, blood clots in heart,  etc.   They listed SEPTIC SHOCK on discharge papers.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Intracardiac thrombus, Laboratory test, Pneumonia
Clinical narrative: Full Body Rash, Guillian Barr Syndrome and ended up at hospital on 10/14/22 - 11/3/21.   Was in ICU for 11 of those days.   Pneumonia,  Kidney Failure, blood clots in heart,  etc.   They listed SEPTIC SHOCK on discharge papers.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Renal failure, Septic shock
Clinical narrative: Full Body Rash, Guillian Barr Syndrome and ended up at hospital on 10/14/22 - 11/3/21.   Was in ICU for 11 of those days.   Pneumonia,  Kidney Failure, blood clots in heart,  etc.   They listed SEPTIC SHOCK on discharge papers.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdomen scan, Blood test, Borrelia test, Cognitive disorder, Computerised tomogram
Clinical narrative: She has lost weight; Trouble sleeping; Can no longer drive; Vaccine injured; Headache; Memory loss; Cognitive issues; Nerve pain throughout her body; Racing heart Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and WEIGHT DECREASED (She has lost weight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive) and VACCINATION COMPLICATION (Vaccine injured). At the time of the report, AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations), WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive), VACCINATION COMPLICATION (Vaccine injured) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medicines were reported No treatment medicines were reported I t was reported that patient went through Multiple tests such as MRIs, CT scans, blood tests.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Gastrointestinal disorder, Inflammatory marker test, Laboratory test, Magnetic resonance imaging
Clinical narrative: She has lost weight; Trouble sleeping; Can no longer drive; Vaccine injured; Headache; Memory loss; Cognitive issues; Nerve pain throughout her body; Racing heart Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and WEIGHT DECREASED (She has lost weight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive) and VACCINATION COMPLICATION (Vaccine injured). At the time of the report, AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations), WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive), VACCINATION COMPLICATION (Vaccine injured) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medicines were reported No treatment medicines were reported I t was reported that patient went through Multiple tests such as MRIs, CT scans, blood tests.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Seizure, Tachycardia, Visual impairment
Clinical narrative: She has lost weight; Trouble sleeping; Can no longer drive; Vaccine injured; Headache; Memory loss; Cognitive issues; Nerve pain throughout her body; Racing heart Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and WEIGHT DECREASED (She has lost weight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive) and VACCINATION COMPLICATION (Vaccine injured). At the time of the report, AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations), WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive), VACCINATION COMPLICATION (Vaccine injured) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medicines were reported No treatment medicines were reported I t was reported that patient went through Multiple tests such as MRIs, CT scans, blood tests.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Cognitive disorder, Headache, Impaired driving ability, Insomnia
Clinical narrative: She has lost weight; Trouble sleeping; Can no longer drive; Vaccine injured; Headache; Memory loss; Cognitive issues; Nerve pain throughout her body; Racing heart Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and WEIGHT DECREASED (She has lost weight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive) and VACCINATION COMPLICATION (Vaccine injured). At the time of the report, AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations), WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive), VACCINATION COMPLICATION (Vaccine injured) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medicines were reported No treatment medicines were reported I t was reported that patient went through Multiple tests such as MRIs, CT scans, blood tests.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Palpitations, Vaccination complication, Weight decreased
Clinical narrative: She has lost weight; Trouble sleeping; Can no longer drive; Vaccine injured; Headache; Memory loss; Cognitive issues; Nerve pain throughout her body; Racing heart Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and WEIGHT DECREASED (She has lost weight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations) and HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive) and VACCINATION COMPLICATION (Vaccine injured). At the time of the report, AMNESIA (Memory loss), COGNITIVE DISORDER (Cognitive issues), NEURALGIA (Nerve pain throughout her body), PALPITATIONS (Racing heart Palpitations), WEIGHT DECREASED (She has lost weight), INSOMNIA (Trouble sleeping), IMPAIRED DRIVING ABILITY (Can no longer drive), VACCINATION COMPLICATION (Vaccine injured) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medicines were reported No treatment medicines were reported I t was reported that patient went through Multiple tests such as MRIs, CT scans, blood tests.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 10/20/21-Patient says that her husband was here yesterday and was diagnosed with Covid.  Patient has had both of her Pfizer vaccines, 1 on January 7, 2021 the other on January 28, 2021.  Patient has started with a cough, congestion, mild headache, fever, body aches, chills and fatigue that started yesterday.  Patient states her temperature yesterday was 100.4.  Has been taking ibuprofen and Delsym to help.  Patient denies nausea, vomiting, diarrhea.  Still has her sense of taste and smell.  Patient does have a cough every few minutes. Review of Symptoms:   Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for congestion, postnasal drip and sore throat.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, COVID-19, Chills, Cough, Exposure to SARS-CoV-2
Clinical narrative: 10/20/21-Patient says that her husband was here yesterday and was diagnosed with Covid.  Patient has had both of her Pfizer vaccines, 1 on January 7, 2021 the other on January 28, 2021.  Patient has started with a cough, congestion, mild headache, fever, body aches, chills and fatigue that started yesterday.  Patient states her temperature yesterday was 100.4.  Has been taking ibuprofen and Delsym to help.  Patient denies nausea, vomiting, diarrhea.  Still has her sense of taste and smell.  Patient does have a cough every few minutes. Review of Symptoms:   Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for congestion, postnasal drip and sore throat.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 10/20/21-Patient says that her husband was here yesterday and was diagnosed with Covid.  Patient has had both of her Pfizer vaccines, 1 on January 7, 2021 the other on January 28, 2021.  Patient has started with a cough, congestion, mild headache, fever, body aches, chills and fatigue that started yesterday.  Patient states her temperature yesterday was 100.4.  Has been taking ibuprofen and Delsym to help.  Patient denies nausea, vomiting, diarrhea.  Still has her sense of taste and smell.  Patient does have a cough every few minutes. Review of Symptoms:   Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for congestion, postnasal drip and sore throat.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: 10/20/21-Patient says that her husband was here yesterday and was diagnosed with Covid.  Patient has had both of her Pfizer vaccines, 1 on January 7, 2021 the other on January 28, 2021.  Patient has started with a cough, congestion, mild headache, fever, body aches, chills and fatigue that started yesterday.  Patient states her temperature yesterday was 100.4.  Has been taking ibuprofen and Delsym to help.  Patient denies nausea, vomiting, diarrhea.  Still has her sense of taste and smell.  Patient does have a cough every few minutes. Review of Symptoms:   Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for congestion, postnasal drip and sore throat.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Immunisation, Lymphadenopathy, Off label use, Pyrexia
Clinical narrative: swollen lymph node under armpit (size of orange/grapefruit); chills; fever; off label use; booster; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 32-years-old female patient received third bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: 301258a, Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 06Oct2021 11:45 (at the age of 32), as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU, Batch/Lot number: ut7325la) via an unspecified route of administration, administered in right arm, taken for an unspecified indication, as dose 1, on 06Oct2021. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: el9266, Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 20Feb2021 (at the age of 32), as dose 1, single for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: en6205, Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 13Mar2021 (at the age of 32), as dose 2, single for COVID-19 immunization. The patient was not pregnant. The patient received FLU vaccine (Batch/Lot: ut7325la) in four weeks, as dose 1, on 06Oct2021. The patient was not received other medication in two weeks. The adverse events were not resulted in emergency room or physician office visit. Prior vaccination, the patient was not infected to COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient had no known allergies. On 07Oct2021 at 02:00, the patient experienced swollen lymph node under armpit (size of orange/grapefruit), chills, fever. The patient was not received treatment for the adverse events. The outcome of swollen lymph node under armpit (size of orange/grapefruit), chills, fever was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: feeling achy; This is a spontaneous report from a non-contactable consumer. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 14:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling achy on an unspecified date in Feb2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Dizziness, Fine motor skill dysfunction, Hypoaesthesia, Pain in extremity
Clinical narrative: left arm really sore; lightheaded/dizzy; left side of face felt flushed and funny like he had an analgesic; starting losing his taste; numbness in left side of face; left side of face tingling; biting self on left side; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was 30155BA and expiration date: not reported), via an unspecified route of administration, administered in left arm on 12Oct2021 (Age at vaccination was 37 year) as dose 1, single for covid-19 immunisation. Time of vaccination was 17:30 or 17:40. Medical history included covid-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines within four weeks prior to vaccination. On 12Oct2021, patient was really sore like a Tenatus-type shot, left arm almost immediately. Patient also states he was lightheaded and dizzy, the left side of his face felt flushed and funny like he had an analgesic, he started losing taste. They observed patient for like 45 minutes after they administered it at the minute clinic and then he went home. Patient states the dizziness stayed for a while, about a week, he gets it in spurts now. Patient had numbness in the left side of his face, loss of taste, left side of face tingling, he had biting himself on the left side, all of that was getting worse. The patient states he was advised to go to the emergency room since it is getting worse, he intends to go to urgent care and/or the emergency room today. The patient underwent lab tests and procedures which included computerized tomogram (CT) with unknown result. They said they would run a CT scan or something. The outcome of events pain in arm, lightheaded/dizzy was recovering and outcome of rest of events was not recovered.  Investigation Assessment: No  No follow up attempts are needed . No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sensory loss, Skin warm
Clinical narrative: left arm really sore; lightheaded/dizzy; left side of face felt flushed and funny like he had an analgesic; starting losing his taste; numbness in left side of face; left side of face tingling; biting self on left side; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was 30155BA and expiration date: not reported), via an unspecified route of administration, administered in left arm on 12Oct2021 (Age at vaccination was 37 year) as dose 1, single for covid-19 immunisation. Time of vaccination was 17:30 or 17:40. Medical history included covid-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines within four weeks prior to vaccination. On 12Oct2021, patient was really sore like a Tenatus-type shot, left arm almost immediately. Patient also states he was lightheaded and dizzy, the left side of his face felt flushed and funny like he had an analgesic, he started losing taste. They observed patient for like 45 minutes after they administered it at the minute clinic and then he went home. Patient states the dizziness stayed for a while, about a week, he gets it in spurts now. Patient had numbness in the left side of his face, loss of taste, left side of face tingling, he had biting himself on the left side, all of that was getting worse. The patient states he was advised to go to the emergency room since it is getting worse, he intends to go to urgent care and/or the emergency room today. The patient underwent lab tests and procedures which included computerized tomogram (CT) with unknown result. They said they would run a CT scan or something. The outcome of events pain in arm, lightheaded/dizzy was recovering and outcome of rest of events was not recovered.  Investigation Assessment: No  No follow up attempts are needed . No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Computerised tomogram, Dizziness, Flushing, Hypoaesthesia
Clinical narrative: left arm really sore; lightheaded/dizzy; left side of face felt flushed and funny like he had an analgesic; starting losing his taste; numbness in left side of face; left side of face tingling; biting self on left side; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was 30155BA and expiration date: not reported), via an unspecified route of administration, administered in left arm on 12Oct2021 (Age at vaccination was 37 year) as dose 1, single for covid-19 immunisation. Time of vaccination was 17:30 or 17:40. Medical history included covid-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines within four weeks prior to vaccination. On 12Oct2021, patient was really sore like a Tenatus-type shot, left arm almost immediately. Patient also states he was lightheaded and dizzy, the left side of his face felt flushed and funny like he had an analgesic, he started losing taste. They observed patient for like 45 minutes after they administered it at the minute clinic and then he went home. Patient states the dizziness stayed for a while, about a week, he gets it in spurts now. Patient had numbness in the left side of his face, loss of taste, left side of face tingling, he had biting himself on the left side, all of that was getting worse. The patient states he was advised to go to the emergency room since it is getting worse, he intends to go to urgent care and/or the emergency room today. The patient underwent lab tests and procedures which included computerized tomogram (CT) with unknown result. They said they would run a CT scan or something. The outcome of events pain in arm, lightheaded/dizzy was recovering and outcome of rest of events was not recovered.  Investigation Assessment: No  No follow up attempts are needed . No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injury, Pain in extremity, Paraesthesia
Clinical narrative: left arm really sore; lightheaded/dizzy; left side of face felt flushed and funny like he had an analgesic; starting losing his taste; numbness in left side of face; left side of face tingling; biting self on left side; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was 30155BA and expiration date: not reported), via an unspecified route of administration, administered in left arm on 12Oct2021 (Age at vaccination was 37 year) as dose 1, single for covid-19 immunisation. Time of vaccination was 17:30 or 17:40. Medical history included covid-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines within four weeks prior to vaccination. On 12Oct2021, patient was really sore like a Tenatus-type shot, left arm almost immediately. Patient also states he was lightheaded and dizzy, the left side of his face felt flushed and funny like he had an analgesic, he started losing taste. They observed patient for like 45 minutes after they administered it at the minute clinic and then he went home. Patient states the dizziness stayed for a while, about a week, he gets it in spurts now. Patient had numbness in the left side of his face, loss of taste, left side of face tingling, he had biting himself on the left side, all of that was getting worse. The patient states he was advised to go to the emergency room since it is getting worse, he intends to go to urgent care and/or the emergency room today. The patient underwent lab tests and procedures which included computerized tomogram (CT) with unknown result. They said they would run a CT scan or something. The outcome of events pain in arm, lightheaded/dizzy was recovering and outcome of rest of events was not recovered.  Investigation Assessment: No  No follow up attempts are needed . No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Pt received Moderna Vaccines on 12/28/20 and 01/25/21. Pt presented to the ED on 11/12/21 from a SNF due to complaints of multiple seizures and AMS. Pt found to be COVID positive. Oxygen saturation was at 79%, so pt required supplemental oxygen.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Mental status changes, SARS-CoV-2 test positive, Seizure
Clinical narrative: Pt received Moderna Vaccines on 12/28/20 and 01/25/21. Pt presented to the ED on 11/12/21 from a SNF due to complaints of multiple seizures and AMS. Pt found to be COVID positive. Oxygen saturation was at 79%, so pt required supplemental oxygen.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Confusional state, SARS-CoV-2 test positive, Seizure like phenomena
Clinical narrative: Pt received Moderna Vaccines on 12/28/20 and 01/25/21. Pt presented to the ED on 11/12/21 from a SNF due to complaints of multiple seizures and AMS. Pt found to be COVID positive. Oxygen saturation was at 79%, so pt required supplemental oxygen.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin I, Vomiting
Clinical narrative: I vomited several times; exhaustion, experienced severe fatigue; pain in my arm, shoulder; discomfort in my arm and chest; discomfort in my arm and chest; pain in my heart; I thought I might be having a heart attack; I had a pretty bad headache; I had diarrhea and arm pain; I had diarrhea and arm pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: FF2590), via an unspecified route of administration, administered in arm left on 26Oct2021 16:45 as DOSE 3 (BOOSTER), SINGLE (at the age of 49-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient previously took codeine and experienced known allergies: codeine. Concomitant medications included estradiol, fenofibrate, valaciclovir hydrochloride (VALTREX), rosuvastatin (ROSUVASTATIN), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 15:30 as DOSE 1, SINGLE (at the age of 48-year-old), second dose BNT162B2 (BNT162B2, Solution for injection, Lot number: ER2613), via an unspecified route of administration, administered in arm left on 25Mar2021 15:30 as DOSE 2, SINGLE (at the age of 48-year-old), both doses for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. On 27Oct2021 (also reported as Wednesday), the patient had a pretty bad headache. On 27Oct2021, the patient had diarrhea and arm pain. On 28Oct2021, She woke up Thursday morning at 2:30 AM with pain in heart went to the ER because she thought she might be having a heart attack, discomfort in my arm and chest. The ER doctor stated that her heart was a muscle, and it was a reaction to the vaccine. He told me to take ibuprofen every 4-6 hours. On 29Oct2021, friday through Sunday, the patient continued to have diarrhea, exhaustion and pain in arm, shoulder and heart. On 31Oct2021, the patient had vomited several times early Sunday morning and experienced severe fatigue all day Sunday and Monday. I still have pain and felt moderately fatigued. She took a covid test on Sunday and it came back negative last night. The patient had a doctor appointment today to follow up regarding my heart issue. The adverse event was treated with Aleve. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result (2 blood test (Troponin-I)), chest x-ray and EKG: unknown result. On 31Oct2021, the patient had sars-cov-2 test: negative (nasal Swab). Therapeutic measures were taken as a result for all the events. Outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Blood test, Chest X-ray, Chest discomfort
Clinical narrative: I vomited several times; exhaustion, experienced severe fatigue; pain in my arm, shoulder; discomfort in my arm and chest; discomfort in my arm and chest; pain in my heart; I thought I might be having a heart attack; I had a pretty bad headache; I had diarrhea and arm pain; I had diarrhea and arm pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: FF2590), via an unspecified route of administration, administered in arm left on 26Oct2021 16:45 as DOSE 3 (BOOSTER), SINGLE (at the age of 49-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient previously took codeine and experienced known allergies: codeine. Concomitant medications included estradiol, fenofibrate, valaciclovir hydrochloride (VALTREX), rosuvastatin (ROSUVASTATIN), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 15:30 as DOSE 1, SINGLE (at the age of 48-year-old), second dose BNT162B2 (BNT162B2, Solution for injection, Lot number: ER2613), via an unspecified route of administration, administered in arm left on 25Mar2021 15:30 as DOSE 2, SINGLE (at the age of 48-year-old), both doses for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. On 27Oct2021 (also reported as Wednesday), the patient had a pretty bad headache. On 27Oct2021, the patient had diarrhea and arm pain. On 28Oct2021, She woke up Thursday morning at 2:30 AM with pain in heart went to the ER because she thought she might be having a heart attack, discomfort in my arm and chest. The ER doctor stated that her heart was a muscle, and it was a reaction to the vaccine. He told me to take ibuprofen every 4-6 hours. On 29Oct2021, friday through Sunday, the patient continued to have diarrhea, exhaustion and pain in arm, shoulder and heart. On 31Oct2021, the patient had vomited several times early Sunday morning and experienced severe fatigue all day Sunday and Monday. I still have pain and felt moderately fatigued. She took a covid test on Sunday and it came back negative last night. The patient had a doctor appointment today to follow up regarding my heart issue. The adverse event was treated with Aleve. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result (2 blood test (Troponin-I)), chest x-ray and EKG: unknown result. On 31Oct2021, the patient had sars-cov-2 test: negative (nasal Swab). Therapeutic measures were taken as a result for all the events. Outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Electrocardiogram, Fatigue, Headache, Immunisation
Clinical narrative: I vomited several times; exhaustion, experienced severe fatigue; pain in my arm, shoulder; discomfort in my arm and chest; discomfort in my arm and chest; pain in my heart; I thought I might be having a heart attack; I had a pretty bad headache; I had diarrhea and arm pain; I had diarrhea and arm pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: FF2590), via an unspecified route of administration, administered in arm left on 26Oct2021 16:45 as DOSE 3 (BOOSTER), SINGLE (at the age of 49-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient previously took codeine and experienced known allergies: codeine. Concomitant medications included estradiol, fenofibrate, valaciclovir hydrochloride (VALTREX), rosuvastatin (ROSUVASTATIN), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 15:30 as DOSE 1, SINGLE (at the age of 48-year-old), second dose BNT162B2 (BNT162B2, Solution for injection, Lot number: ER2613), via an unspecified route of administration, administered in arm left on 25Mar2021 15:30 as DOSE 2, SINGLE (at the age of 48-year-old), both doses for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. On 27Oct2021 (also reported as Wednesday), the patient had a pretty bad headache. On 27Oct2021, the patient had diarrhea and arm pain. On 28Oct2021, She woke up Thursday morning at 2:30 AM with pain in heart went to the ER because she thought she might be having a heart attack, discomfort in my arm and chest. The ER doctor stated that her heart was a muscle, and it was a reaction to the vaccine. He told me to take ibuprofen every 4-6 hours. On 29Oct2021, friday through Sunday, the patient continued to have diarrhea, exhaustion and pain in arm, shoulder and heart. On 31Oct2021, the patient had vomited several times early Sunday morning and experienced severe fatigue all day Sunday and Monday. I still have pain and felt moderately fatigued. She took a covid test on Sunday and it came back negative last night. The patient had a doctor appointment today to follow up regarding my heart issue. The adverse event was treated with Aleve. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result (2 blood test (Troponin-I)), chest x-ray and EKG: unknown result. On 31Oct2021, the patient had sars-cov-2 test: negative (nasal Swab). Therapeutic measures were taken as a result for all the events. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: is now experiencing problems with her leg. States that it goes numb; stiffens up / whole body will stiffen up; she can not walk; This is a spontaneous report from a contactable consumer or other non hcp (patient) via regulatory authority.  A female patient of an unspecified age received 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 in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she took 1st dose of Covid vaccine on Saturday and on an unknown date in 2021, experienced problems with her leg. Stated that it goes numb, stiffens up and she could not walk. Also stated that her whole body would stiffen up at night. She wanted to speak to someone as she was trying to decide if she could take the 2nd dose. Also stated that if she had a reaction to the 2nd dose and if this did not clear up with her legs she would get legal involved. 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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Burning sensation, Condition aggravated, Gait inability
Clinical narrative: is now experiencing problems with her leg. States that it goes numb; stiffens up / whole body will stiffen up; she can not walk; This is a spontaneous report from a contactable consumer or other non hcp (patient) via regulatory authority.  A female patient of an unspecified age received 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 in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she took 1st dose of Covid vaccine on Saturday and on an unknown date in 2021, experienced problems with her leg. Stated that it goes numb, stiffens up and she could not walk. Also stated that her whole body would stiffen up at night. She wanted to speak to someone as she was trying to decide if she could take the 2nd dose. Also stated that if she had a reaction to the 2nd dose and if this did not clear up with her legs she would get legal involved. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.