chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Vaccination site pain
Clinical narrative: feeling some pain in the injection site like it throbbes where he got the shot; no energy; feel sick/felt very sick; pain/pains were worse; headaches; aches/ache all over; quizzy; like a severe case of the flu, dry heat for like 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours), ASTHENIA (no energy), MALAISE (feel sick/felt very sick), PAIN (pain/pains were worse) and HEADACHE (headaches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 041L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, MONTELUKAST SODIUM (SINGULAIR), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), FAMOTIDINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours). On 19-Sep-2021, the patient experienced PAIN (pain/pains were worse), HEADACHE (headaches), MYALGIA (aches/ache all over) and NAUSEA (quizzy). On 21-Sep-2021, the patient experienced ASTHENIA (no energy) and MALAISE (feel sick/felt very sick). On 22-Sep-2021, the patient experienced VACCINATION SITE PAIN (feeling some pain in the injection site like it throbbes where he got the shot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours), ASTHENIA (no energy), MALAISE (feel sick/felt very sick), PAIN (pain/pains were worse), HEADACHE (headaches) and VACCINATION SITE PAIN (feeling some pain in the injection site like it throbbes where he got the shot) was resolving and MYALGIA (aches/ache all over) and NAUSEA (quizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Body temperature: 100.6 (High) Degrees Fahrenheit. On 20-Sep-2021, Body temperature: 101.4 (High) Degrees Fahrenheit.         Patient  got the booster dose because he is travelling in October and that requires for them to get a booster shot.   This case was linked to MOD-2021-328256, MOD-2021-328226 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient reported about 2 weeks ago she noticed that on her left arm down to her fingers it's a numb feeling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Patient reported about 2 weeks ago she noticed that on her left arm down to her fingers it's a numb feeling) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included METFORMIN, LISINOPRIL, LOSARTAN, CARVEDILOL, APIXABAN (ELIQUIS), OMEPRAZOLE and POTASSIUM for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced HYPOAESTHESIA (Patient reported about 2 weeks ago she noticed that on her left arm down to her fingers it's a numb feeling). At the time of the report, HYPOAESTHESIA (Patient reported about 2 weeks ago she noticed that on her left arm down to her fingers it's a numb feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: started experiencing a headache while waiting in the observation room for 15 minutes; fever; chills; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (started experiencing a headache while waiting in the observation room for 15 minutes), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced HEADACHE (started experiencing a headache while waiting in the observation room for 15 minutes), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEADACHE (started experiencing a headache while waiting in the observation room for 15 minutes), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that the fever comes back as soon as the effect of the Tylenol wears off.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (have to get a doctor) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (have to get a doctor). At the time of the report, vaccination complication (have to get a doctor) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose after 12 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose after 12 hours after puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose after 12 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose after 12 hours after puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Eye pruritus, Eyelids pruritus, Feeling hot, Formication
Clinical narrative: it is like it is working on my nerves; my head starts hurting; my eyes itch; my eyelids itch; I have arms crawling symptoms/I have legs crawling symptoms; itching everywhere; my mouth gets really dry; it messes with my speech; it feels like you are hot/it feels like your skin is hot; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (it is like it is working on my nerves), HEADACHE (my head starts hurting), EYE PRURITUS (my eyes itch), EYELIDS PRURITUS (my eyelids itch) and FORMICATION (I have arms crawling symptoms/I have legs crawling symptoms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (Eleven years ago patient had a stroke, and she can't use her right arm). Concomitant products included BUPROPION, LEVETIRACETAM, WARFARIN and SIMVASTATIN for an unknown indication.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (it is like it is working on my nerves), HEADACHE (my head starts hurting), EYE PRURITUS (my eyes itch), EYELIDS PRURITUS (my eyelids itch), FORMICATION (I have arms crawling symptoms/I have legs crawling symptoms), PRURITUS (itching everywhere), DRY MOUTH (my mouth gets really dry), SPEECH DISORDER (it messes with my speech) and FEELING HOT (it feels like you are hot/it feels like your skin is hot). At the time of the report, NERVOUS SYSTEM DISORDER (it is like it is working on my nerves), HEADACHE (my head starts hurting), EYE PRURITUS (my eyes itch), EYELIDS PRURITUS (my eyelids itch), FORMICATION (I have arms crawling symptoms/I have legs crawling symptoms), PRURITUS (itching everywhere), DRY MOUTH (my mouth gets really dry), SPEECH DISORDER (it messes with my speech) and FEELING HOT (it feels like you are hot/it feels like your skin is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got the first shot on 30Aug2021. For a while patient did fine. The next week on the 07Sep2021, patient took her medicine, Bupropion and levetiracetam in the morning. Thirty minutes to an hour, patient felt like "it was working on her nerves". It only happens when patient takes this medicine, and patient has taken them for 11 years and it never happened before.   Patient is scheduled for second dose on 27Sep2021.  No treatment medication was mentioned.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nervous system disorder, Pruritus, Speech disorder
Clinical narrative: it is like it is working on my nerves; my head starts hurting; my eyes itch; my eyelids itch; I have arms crawling symptoms/I have legs crawling symptoms; itching everywhere; my mouth gets really dry; it messes with my speech; it feels like you are hot/it feels like your skin is hot; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (it is like it is working on my nerves), HEADACHE (my head starts hurting), EYE PRURITUS (my eyes itch), EYELIDS PRURITUS (my eyelids itch) and FORMICATION (I have arms crawling symptoms/I have legs crawling symptoms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (Eleven years ago patient had a stroke, and she can't use her right arm). Concomitant products included BUPROPION, LEVETIRACETAM, WARFARIN and SIMVASTATIN for an unknown indication.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (it is like it is working on my nerves), HEADACHE (my head starts hurting), EYE PRURITUS (my eyes itch), EYELIDS PRURITUS (my eyelids itch), FORMICATION (I have arms crawling symptoms/I have legs crawling symptoms), PRURITUS (itching everywhere), DRY MOUTH (my mouth gets really dry), SPEECH DISORDER (it messes with my speech) and FEELING HOT (it feels like you are hot/it feels like your skin is hot). At the time of the report, NERVOUS SYSTEM DISORDER (it is like it is working on my nerves), HEADACHE (my head starts hurting), EYE PRURITUS (my eyes itch), EYELIDS PRURITUS (my eyelids itch), FORMICATION (I have arms crawling symptoms/I have legs crawling symptoms), PRURITUS (itching everywhere), DRY MOUTH (my mouth gets really dry), SPEECH DISORDER (it messes with my speech) and FEELING HOT (it feels like you are hot/it feels like your skin is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got the first shot on 30Aug2021. For a while patient did fine. The next week on the 07Sep2021, patient took her medicine, Bupropion and levetiracetam in the morning. Thirty minutes to an hour, patient felt like "it was working on her nerves". It only happens when patient takes this medicine, and patient has taken them for 11 years and it never happened before.   Patient is scheduled for second dose on 27Sep2021.  No treatment medication was mentioned.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (minimal discomfort) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (minimal discomfort). At the time of the report, DISCOMFORT (minimal discomfort) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: Ab test came back negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Ab test came back negative) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced ANTIBODY TEST NEGATIVE (Ab test came back negative). At the time of the report, ANTIBODY TEST NEGATIVE (Ab test came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Antibody test: negative (Negative) test showed no Ab levels against COVID-19.         Patient had already discussed Ab test results with both Cardiologist and Family Physician. Patient was scheduled to receive monoclonal Ab treatment on 22Sep2021. No concomitant drugs were reported. No treatment drugs were reported.   This case was linked to MOD-2021-035928, MOD-2021-329925 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Cardiac failure congestive, Dyspnoea, Fibrin D dimer, Hepatic enzyme
Clinical narrative: Congestive heart failure; short of breath; Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure), DYSPNOEA (short of breath) and MYOCARDITIS (Myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria death and medically significant), DYSPNOEA (short of breath) (seriousness criterion death) and MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant). The patient died on 28-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Brain natriuretic peptide: elevated (High) BNP is elevated. On an unknown date, Fibrin D dimer: elevated (High) D-dimer  elevated. On an unknown date, Hepatic enzyme: elevated (High) liver enzymes elevated.         No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Company Comment: This case concerns a consumer of unknown gender and age with no relevant medical history who experienced serious fatal unexpected events of cardiac congestive failure dyspnea, and myocarditis after receiving a second dose of the Moderna Covid 19 vaccine. Autopsy was not performed. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a consumer of unknown gender and age with no relevant medical history who experienced serious fatal unexpected events of cardiac congestive failure dyspnea, and myocarditis after receiving a second dose of the Moderna Covid 19 vaccine. Autopsy was not performed. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Congestive heart failure; short of breath; Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure), DYSPNOEA (short of breath) and MYOCARDITIS (Myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria death and medically significant), DYSPNOEA (short of breath) (seriousness criterion death) and MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant). The patient died on 28-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Brain natriuretic peptide: elevated (High) BNP is elevated. On an unknown date, Fibrin D dimer: elevated (High) D-dimer  elevated. On an unknown date, Hepatic enzyme: elevated (High) liver enzymes elevated.         No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Company Comment: This case concerns a consumer of unknown gender and age with no relevant medical history who experienced serious fatal unexpected events of cardiac congestive failure dyspnea, and myocarditis after receiving a second dose of the Moderna Covid 19 vaccine. Autopsy was not performed. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a consumer of unknown gender and age with no relevant medical history who experienced serious fatal unexpected events of cardiac congestive failure dyspnea, and myocarditis after receiving a second dose of the Moderna Covid 19 vaccine. Autopsy was not performed. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash pruritic, Sleep deficit
Clinical narrative: developed a severe rash on both thighs, both outer biceps, left and right torso; is extremely uncomfortable and painful; caused a severe lack of sleep; The rash is extremely itchy; has burning sensations; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Jul2021 13:30 (Age at vaccination 37 years old) (Batch/Lot Number: EW0191) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing Other medical history: High blood pressure. Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported.  Historical vaccine product COVID 19, brand Pfizer, lot number ER8736, lot unknown False, administration date 09Jun2021, at 01:30 PM, dose number 1, vaccine location Left arm for covid 19 immunisation. treatment with Steroid shot, Valtex, Prednisone, Bacatracin. Patient does not have covid prior vaccination nor covid tested post vaccination. on 07Jul2021 12:00 A Day after her second shot patient developed a severe rash on both thighs, both outer biceps, left and right torso. Patient have been to urgent care twice to receive medications for the rash. It is extremely uncomfortable and painful. It is almost at the second week now and has crippled her morale l and has caused a severe lack of sleep. It has also spread to her right hand. The rash is extremely itchy and has burning sensations. Therapeutic measures were taken as a result of developed a severe rash on both thighs, both outer biceps, left and right torso (rash), is extremely uncomfortable and painful (rash), caused a severe lack of sleep (sleep deficit), the rash is extremely itchy (rash pruritic), has burning sensations (burning sensation). Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Illness, Immunisation, Myalgia
Clinical narrative: 3 shot 17Aug21; 3 shot 17Aug21; Shot site itchy blister with a pimple like center; Shot site itchy blister with a pimple like center; Very sick for 2 days; High fever; Worst headache for several days; Muscle/joint aches; Muscle/joint aches; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC 3181) after complete initial immunization, via an unspecified route of administration on 17Aug2021 as dose 3 (booster), single for COVID-19 immunization. The medical history included transient ischaemic attack in Feb2019 (two years ago) and subsequent problems with blood pressure. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC 9581), via an unspecified route of administration on 09Mar2021 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 620), via an unspecified route of administration on 02Mar2021 as dose 2, single both for COVID-19 immunization. The patient mentioned she felt bad for 1day after taking the 2nd dose. On an unspecified date in 2021 after third shot patient was very sick for 2 days, shot site itchy blister with a pimple like center, high fever, worse headache ever for several days and muscle/joint aches. She stayed in bed for 2 days and she could not take care of herself. Outcome of the events "very sick for 2 days" and "worst headache for several days" recovered in unspecified date in 2021 and for other events it was unknown.  Follow-up (02Sep2021): The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (01Sep2021), this case now contains all required information to be considered valid.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pyrexia, Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: 3 shot 17Aug21; 3 shot 17Aug21; Shot site itchy blister with a pimple like center; Shot site itchy blister with a pimple like center; Very sick for 2 days; High fever; Worst headache for several days; Muscle/joint aches; Muscle/joint aches; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC 3181) after complete initial immunization, via an unspecified route of administration on 17Aug2021 as dose 3 (booster), single for COVID-19 immunization. The medical history included transient ischaemic attack in Feb2019 (two years ago) and subsequent problems with blood pressure. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC 9581), via an unspecified route of administration on 09Mar2021 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 620), via an unspecified route of administration on 02Mar2021 as dose 2, single both for COVID-19 immunization. The patient mentioned she felt bad for 1day after taking the 2nd dose. On an unspecified date in 2021 after third shot patient was very sick for 2 days, shot site itchy blister with a pimple like center, high fever, worse headache ever for several days and muscle/joint aches. She stayed in bed for 2 days and she could not take care of herself. Outcome of the events "very sick for 2 days" and "worst headache for several days" recovered in unspecified date in 2021 and for other events it was unknown.  Follow-up (02Sep2021): The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (01Sep2021), this case now contains all required information to be considered valid.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Polymerase chain reaction
Clinical narrative: Have been spotting (menstruating) after not having had a period in 2.5 years; This is a spontaneous report from a contactable consumer or other non hcp.   A 56-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:00 as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:00 (Batch/Lot Number: ERB733) as dose 1, single for covid-19 immunisation. Medical history and concomitants were not reported. It was reported that, the patient experienced have been spotting after not having had a period in 2.5 years on 23Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 28Jul2021 Nasal Swab.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Memory impairment, Nervous system disorder, Tremor
Clinical narrative: Neurological issues; Shaking hands; major brain fog. Can't remember what I just said or if I just spoke; Can't remember what I just said or if I just spoke; Shortness of breath; This is a spontaneous report from a contactable other-HCP (patient herself). A 31-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 03Aug2021 18:30 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility type Vaccine was reported as Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccine in four weeks. Patient had COVID-19 prior to vaccination. Patient was not tested for COVID-19, post vaccination. Patient medical history included migraine, COVID-19 and dyspnoea (as bad as she had during covid). The concomitant medications were reported as none. The patient did not take other vaccine in four weeks and other medications in two weeks. The patient did not covid tested post vaccination and not had allergies. On 04Aug2021 20:00 the patient experienced neurological issues, shaking hands, major brain fog, could not remember what she just said or if she just spoke and shortness of breath. It was reported that shortness of breath was as bad as she had during covid. It was unknown if treatment received for events. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: Tremendous head pressure; Mental confusion and cloudy; Random sharp pain randomly throughout head; Dizziness; Headache; Nausea; Extreme exhausation; This is a spontaneous report from a contactable consumer (patient himself). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 25Jun2021 10:00 (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication. The patient previously took cefazil and duracef [cefixime] and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jun2021 the patient experienced tremendous head pressure, mental confusion and random sharp pain randomly throughout head, dizziness, headache, nausea, extreme exhausation. Adverse events resulted in physician office visit. Therapeutic measures were taken as a result of adverse events as patient had received steroids. The patient underwent lab tests and procedures which included magnetic resonance imaging with unknown results on an unspecified date. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was resolved on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nausea, Pain
Clinical narrative: Tremendous head pressure; Mental confusion and cloudy; Random sharp pain randomly throughout head; Dizziness; Headache; Nausea; Extreme exhausation; This is a spontaneous report from a contactable consumer (patient himself). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 25Jun2021 10:00 (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication. The patient previously took cefazil and duracef [cefixime] and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jun2021 the patient experienced tremendous head pressure, mental confusion and random sharp pain randomly throughout head, dizziness, headache, nausea, extreme exhausation. Adverse events resulted in physician office visit. Therapeutic measures were taken as a result of adverse events as patient had received steroids. The patient underwent lab tests and procedures which included magnetic resonance imaging with unknown results on an unspecified date. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was resolved on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: Headache; Sore throat; Fever; little cough; Chills; like you have a flu or something and I have the same kind of feeling after I received  shingles vaccine; happened right away like 12 hours later; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported, Expiration date: Unknown) via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunisation. Patient also received varicella zoster vaccine (SHINGRIX, Lot number: not reported, Expiration date: Unknown) on an unspecified date for shingles. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced Headache, Fever, little cough, sore throat, Chills like you have a flu or something and I have the same kind of feeling after I received shingles vaccine, that happened right away like 12 hours later. Patient got first Pfizer vaccine last Thursday and yesterday, started feeling bad like headache, Sore throat. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Sore throat; Fever; little cough; Chills; like you have a flu or something and I have the same kind of feeling after I received  shingles vaccine; happened right away like 12 hours later; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported, Expiration date: Unknown) via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunisation. Patient also received varicella zoster vaccine (SHINGRIX, Lot number: not reported, Expiration date: Unknown) on an unspecified date for shingles. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced Headache, Fever, little cough, sore throat, Chills like you have a flu or something and I have the same kind of feeling after I received shingles vaccine, that happened right away like 12 hours later. Patient got first Pfizer vaccine last Thursday and yesterday, started feeling bad like headache, Sore throat. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye pain, Feeling abnormal, Feeling drunk
Clinical narrative: low grade fever/103° fever; chills; muscle aches; was exposed; dull headache; congestion; eyeballs hurt; rash; leg is active at night; feeling dizzy and fuzzy "like I've been drinking kind of thing."; feeling dizzy and fuzzy "like I've been drinking kind of thing."; feeling dizzy and fuzzy "like I've been drinking kind of thing."; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 09Aug2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low grade fever/103 degree fever, chills and muscle aches on 11Aug2021, was exposed (exposure to sars-cov-2), dull headache, congestion, eyeballs hurt, rash, leg is active at night, feeling dizzy and fuzzy "like i've been drinking kind of thing" on an unspecified date in Aug2021. It was reported that, she was exposed prior to getting the vaccine and wasn't aware of it if she got COVID before the shot or 5 days after the first dose and wanted to know if patients with previous exposure to COVID-19 infection could still take the second shot. She was not sure if she had side effects from the vaccine or COVID-19. Patient wanted to know how long did these side effects last. Patient stated that, as of today 13Aug2021 she still had dull headache, low grade fever, congestion and her eyeballs hurt. She also had a rash and her leg was active at night. She was feeling dizzy and fuzzy like she had been drunk kind of thing. Caller also stated that for 2 days after the vaccine she had 103 degree fever, chills, muscle aches for 2 days. Headache had not gone away and seems like everything was kind a lingering. She wanted to know if it was typical for 1% of people to experience the side effects for a week. The patient underwent lab tests and procedures which included pyrexia: 103 degree on an unspecified date. The outcome of the events low grade fever/103 degree fever, chills and muscle aches was recovered on an unspecified date, dull headache was not recovered and for events was exposed, congestion, eyeballs hurt, rash, leg is active at night and feeling dizzy and fuzzy "like i've been drinking kind of thing." it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Myalgia, Pyrexia, Rash
Clinical narrative: low grade fever/103° fever; chills; muscle aches; was exposed; dull headache; congestion; eyeballs hurt; rash; leg is active at night; feeling dizzy and fuzzy "like I've been drinking kind of thing."; feeling dizzy and fuzzy "like I've been drinking kind of thing."; feeling dizzy and fuzzy "like I've been drinking kind of thing."; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 09Aug2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low grade fever/103 degree fever, chills and muscle aches on 11Aug2021, was exposed (exposure to sars-cov-2), dull headache, congestion, eyeballs hurt, rash, leg is active at night, feeling dizzy and fuzzy "like i've been drinking kind of thing" on an unspecified date in Aug2021. It was reported that, she was exposed prior to getting the vaccine and wasn't aware of it if she got COVID before the shot or 5 days after the first dose and wanted to know if patients with previous exposure to COVID-19 infection could still take the second shot. She was not sure if she had side effects from the vaccine or COVID-19. Patient wanted to know how long did these side effects last. Patient stated that, as of today 13Aug2021 she still had dull headache, low grade fever, congestion and her eyeballs hurt. She also had a rash and her leg was active at night. She was feeling dizzy and fuzzy like she had been drunk kind of thing. Caller also stated that for 2 days after the vaccine she had 103 degree fever, chills, muscle aches for 2 days. Headache had not gone away and seems like everything was kind a lingering. She wanted to know if it was typical for 1% of people to experience the side effects for a week. The patient underwent lab tests and procedures which included pyrexia: 103 degree on an unspecified date. The outcome of the events low grade fever/103 degree fever, chills and muscle aches was recovered on an unspecified date, dull headache was not recovered and for events was exposed, congestion, eyeballs hurt, rash, leg is active at night and feeling dizzy and fuzzy "like i've been drinking kind of thing." it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: low grade fever/103° fever; chills; muscle aches; was exposed; dull headache; congestion; eyeballs hurt; rash; leg is active at night; feeling dizzy and fuzzy "like I've been drinking kind of thing."; feeling dizzy and fuzzy "like I've been drinking kind of thing."; feeling dizzy and fuzzy "like I've been drinking kind of thing."; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 09Aug2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low grade fever/103 degree fever, chills and muscle aches on 11Aug2021, was exposed (exposure to sars-cov-2), dull headache, congestion, eyeballs hurt, rash, leg is active at night, feeling dizzy and fuzzy "like i've been drinking kind of thing" on an unspecified date in Aug2021. It was reported that, she was exposed prior to getting the vaccine and wasn't aware of it if she got COVID before the shot or 5 days after the first dose and wanted to know if patients with previous exposure to COVID-19 infection could still take the second shot. She was not sure if she had side effects from the vaccine or COVID-19. Patient wanted to know how long did these side effects last. Patient stated that, as of today 13Aug2021 she still had dull headache, low grade fever, congestion and her eyeballs hurt. She also had a rash and her leg was active at night. She was feeling dizzy and fuzzy like she had been drunk kind of thing. Caller also stated that for 2 days after the vaccine she had 103 degree fever, chills, muscle aches for 2 days. Headache had not gone away and seems like everything was kind a lingering. She wanted to know if it was typical for 1% of people to experience the side effects for a week. The patient underwent lab tests and procedures which included pyrexia: 103 degree on an unspecified date. The outcome of the events low grade fever/103 degree fever, chills and muscle aches was recovered on an unspecified date, dull headache was not recovered and for events was exposed, congestion, eyeballs hurt, rash, leg is active at night and feeling dizzy and fuzzy "like i've been drinking kind of thing." it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Muscle twitching, Pain in extremity
Clinical narrative: severe leg pain behind my knee; excruciating headaches; had random muscle twitching and sensations all over body in random places; had random muscle twitching and sensations all over body in random places; This is a spontaneous report from a contactable other Health Care Professional (patient). A 45-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 45-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 28Jul2021 at 12:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication received within 2 weeks of vaccination, start and stop date were not reported. The patient previously took morphine and experienced allergy. 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 was not tested for COVID-19. On 30Jul2021 at 12:00 PM, the patient experienced severe leg pain behind my knee, excruciating headaches, had random muscle twitching and sensations all over body in random places. Reported that the shot followed by 3 days experienced events. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Steroids. No seriousness criteria were reported. The outcomes of event were not recovered.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during 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.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Caller states that she has not had a period in two months.; This is a spontaneous report received rom a contactable consumer (patient). 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 26Jun2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller states that the caller received the vaccine sometime around 26Jun2021 and has not had her period since, and she wants to know if this was normal. Caller states that she has not had a period in two months. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected