chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: sudden on set of fever / spiked a fever; Chills; headaches/mild headache; feeling very unwell; congestion/stuffy nose; respiratory symptoms; upper respiratory infection type (URI); mild sore throat; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EP6955) at the age of 61 years as dose 2, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 01, Lot number: EL3247, Anatomical Location: Arm left), administration date: 01Mar2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The patient experienced PYREXIA  with onset 02Aug2021 16:00, outcome "recovered", described as "sudden onset of fever / spiked a fever"; CHILLS  with onset 02Aug2021, outcome "recovered", described as "Chills"; HEADACHE with onset 02Aug2021, outcome "recovered", described as "headaches/mild headache"; MALAISE with onset 02Aug2021, outcome "recovered", described as "feeling very unwell"; NASAL CONGESTION  with onset 02Aug2021, outcome "recovering", described as "congestion/stuffy nose"; RESPIRATORY SYMPTOM  and UPPER RESPIRATORY TRACT with onset Aug2021, outcome "recovering", OROPHARYNGEAL PAIN with onset Aug2021, outcome "recovering", described as "mild sore throat". Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory symptom, Upper respiratory tract infection
Clinical narrative: sudden on set of fever / spiked a fever; Chills; headaches/mild headache; feeling very unwell; congestion/stuffy nose; respiratory symptoms; upper respiratory infection type (URI); mild sore throat; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EP6955) at the age of 61 years as dose 2, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 01, Lot number: EL3247, Anatomical Location: Arm left), administration date: 01Mar2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The patient experienced PYREXIA  with onset 02Aug2021 16:00, outcome "recovered", described as "sudden onset of fever / spiked a fever"; CHILLS  with onset 02Aug2021, outcome "recovered", described as "Chills"; HEADACHE with onset 02Aug2021, outcome "recovered", described as "headaches/mild headache"; MALAISE with onset 02Aug2021, outcome "recovered", described as "feeling very unwell"; NASAL CONGESTION  with onset 02Aug2021, outcome "recovering", described as "congestion/stuffy nose"; RESPIRATORY SYMPTOM  and UPPER RESPIRATORY TRACT with onset Aug2021, outcome "recovering", OROPHARYNGEAL PAIN with onset Aug2021, outcome "recovering", described as "mild sore throat". Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: He got the fever, it has reached 103.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 04Aug2021, outcome "recovering", described as "He got the fever, it has reached 103.5". The event "he got the fever, it has reached 103.5" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient stated, I took three of my teenager yesterday to get the COVID Vaccine. Well their ages are 13, 14 and 17 and my 14 year old, exactly 24 hours after taking the vaccine he got the fever, it has reached 103.5. I have given him Ibuprofen and I give him 500 (Further clarification was unknown) Ibuprofen and it didn't go down much, it just go down to 102 and then it went again to 103.5 (Hence Ibuprofen was captured as suspect) and I have given him Tylenol (treatment) and right now it's 101. I am like a little concern I don't know should I wait and see if it continues (voice not clear) or should I take him to the ER because I went through the similar situation when I took the first dose back in Mar and my temperature was 105. The patient was informed about Pfizer Medical information department and was provided with the number. Patient was advised to reach out to nearest Emergency room in case of any medical emergency  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pyrexia
Clinical narrative: Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy; Fever; Fatigue; Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy; Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 11:30 (Lot number: FC3180) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hormone replacement" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN taken for hormone replacement therapy; PROGESTERONE taken for hormone replacement therapy; BENADRYL. The following information was reported: OFF LABEL USE (non-serious) with onset 06Aug2021, outcome "recovering", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06Aug2021, outcome "recovering", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 06Aug2021, outcome "recovering", described as "Booster"; PYREXIA (non-serious) with onset 07Aug2021 14:00, outcome "recovering", described as "Fever"; FATIGUE (non-serious) with onset 07Aug2021 14:00, outcome "recovering", described as "Fatigue"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 07Aug2021 14:00, outcome "recovering" and all described as "Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy". The events "fever", "fatigue", "slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy", "slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy" and "slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pyrexia, fatigue, vaccination site swelling, vaccination site warmth, vaccination site pruritus.  Additional Information: Other medical history included given Novavax vaccine on 12Feb & 05Mar. Other medications in two weeks: Estrogen/progesterone Hormone replacement, Benadryl. Day 2-3: fever, fatigue, slight swelling at site 4x2 cm, Day 4: lower fever, resumed activities, swelling now at 10x6, Day 5: swelling at 14x10 cm, continued hot, itchy. Went to urgent treatment center. Given RX for amoxicillin 125 mg twice daily. Patient was not tested for covid prior to and post covid vaccine. No known allergies were reported.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy; Fever; Fatigue; Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy; Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 11:30 (Lot number: FC3180) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hormone replacement" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN taken for hormone replacement therapy; PROGESTERONE taken for hormone replacement therapy; BENADRYL. The following information was reported: OFF LABEL USE (non-serious) with onset 06Aug2021, outcome "recovering", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06Aug2021, outcome "recovering", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 06Aug2021, outcome "recovering", described as "Booster"; PYREXIA (non-serious) with onset 07Aug2021 14:00, outcome "recovering", described as "Fever"; FATIGUE (non-serious) with onset 07Aug2021 14:00, outcome "recovering", described as "Fatigue"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 07Aug2021 14:00, outcome "recovering" and all described as "Slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy". The events "fever", "fatigue", "slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy", "slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy" and "slight swelling at site 4x2 cm/ swelling now at 10x6/swelling at 14x10 cm, continued hot, itchy" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pyrexia, fatigue, vaccination site swelling, vaccination site warmth, vaccination site pruritus.  Additional Information: Other medical history included given Novavax vaccine on 12Feb & 05Mar. Other medications in two weeks: Estrogen/progesterone Hormone replacement, Benadryl. Day 2-3: fever, fatigue, slight swelling at site 4x2 cm, Day 4: lower fever, resumed activities, swelling now at 10x6, Day 5: swelling at 14x10 cm, continued hot, itchy. Went to urgent treatment center. Given RX for amoxicillin 125 mg twice daily. Patient was not tested for covid prior to and post covid vaccine. No known allergies were reported.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Musculoskeletal discomfort, Ocular discomfort, Pyrexia
Clinical narrative: Fever getting worse; Headache still worse; Feels pressure in neck, head and eyes; Feels pressure in neck, head and eyes; Feels pressure in neck, head and eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Lot number: FA7484) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "Fever getting worse"; HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "Headache still worse"; MUSCULOSKELETAL DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious), OCULAR DISCOMFORT (non-serious) all with onset Aug2021, outcome "unknown" and all described as "Feels pressure in neck, head and eyes". No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymph node pain, Pyrexia
Clinical narrative: Woke up with fever that got worse and worse as the day progressed; inside of her left arm pit, hurts like a song of a gun; Woke up with fever that got worse and worse as the day progressed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 15:30 (Lot number: FA7485) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 12Aug2021, outcome "recovering", LYMPH NODE PAIN (non-serious) with onset 12Aug2021, outcome "recovering" and all described as "inside of her left arm pit, hurts like a song of a gun"; CONDITION AGGRAVATED (non-serious) with onset 12Aug2021, outcome "unknown", described as "Woke up with fever that got worse and worse as the day progressed".  Clinical course: Patient didn't require emergency room or physician office. Patient really couldn't get out of bed, the fever escalated and now it is evading. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medically history (including any illness at time of vaccination): none. Family medical history was no as patient is aware of and everybody else in the family has been vaccinated.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Migraine, Pain in extremity, Pyrexia
Clinical narrative: headache; sore arm after the second dose/painful arm; had a 102°F temperature; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101070851 (Pfizer).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EP7533) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (The first shot was on 02Apr2021,Lot: EP6955.), administration date: 02Apr2021, when the patient was 60 years old, for COVID-19 immunisation, reaction(s): "sore arm". The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "had a 102°F temperature"; MIGRAINE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "migraine"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "sore arm after the second dose/painful arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Additional Context: The report is cross referenced to report ID: # (Name), from #, with the warm transfer of a caller reporting on the Pfizer Covid vaccine and who explains his fiance had the first dose on 2Apr2021 and the second dose on 23Apr2021 and stated after the second dose had a migraine, temperature of 102, and painful arm. This report was for his fiance. Patient name: (Name). Transferring agent provided the patient's first name as (Name) but the caller states on her card it was actually her legal name of (Name). Last name provided by the transferring agent: (Name), this was corrected to (Name) by the caller. patient's address was the same as the reporter, they reside together. Event of after the second dose: She had more of a reaction than he did. She had a migraine, temperature of 102, and painful arm. The events lasted about 2 days after the shot, she got bed rest and was ok. It was confirmed that this was only after the second. This information is provided from the patients card but was the same as the patient in the first report.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Aug2021 05:30 (Lot number: FC3180) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had been hospitalized from unknown allergic reaction" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. The following information was reported: PYREXIA (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "fever"; FEELING HOT (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "felt very hot with a fever"; PAIN (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "minimal energy"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "My arm where I was vaccinated, I could barely lift it up". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, feeling hot, pain, asthenia, loss of personal independence in daily activities.  Additional info :It was reported that the day after my first pfizer covid vaccination, I caught a fever, which is usually after the second dose, but after the first dose I felt very hot with a fever. Patient took vaccine at Pharmacy or Drug store and 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 and Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Aug2021 05:30 (Lot number: FC3180) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had been hospitalized from unknown allergic reaction" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. The following information was reported: PYREXIA (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "fever"; FEELING HOT (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "felt very hot with a fever"; PAIN (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "minimal energy"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "My arm where I was vaccinated, I could barely lift it up". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, feeling hot, pain, asthenia, loss of personal independence in daily activities.  Additional info :It was reported that the day after my first pfizer covid vaccination, I caught a fever, which is usually after the second dose, but after the first dose I felt very hot with a fever. Patient took vaccine at Pharmacy or Drug store and 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 and Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: her son got a fever after the 1st dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "her son got a fever after the 1st dose".  Additional information: The reporter stated that her son got a fever after the 1st dose. However, upon probing and gathering some information the caller disagrees and doesn't want to continue anymore due to the process.   No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Fever over 100 for 4 days in a row, chills, extreme lethargy, no appetite; Fever over 100 for 4 days in a row, chills, extreme lethargy, no appetite; Fever over 100 for 4 days in a row, chills, extreme lethargy, no appetite; Fever over 100 for 4 days in a row, chills, extreme lethargy, no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 18:30 (Lot number: FA7484) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), LETHARGY (non-serious), DECREASED APPETITE (non-serious) all with onset 01Aug2021 08:00, outcome "recovered" (2021) and all described as "Fever over 100 for 4 days in a row, chills, extreme lethargy, no appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lethargy, decreased appetite.  Additional information: Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: swelling and rashes on her arm; swelling and rashes on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), RASH (non-serious), outcome "unknown" and all described as "swelling and rashes on her arm". Additional information: She does not have the name, lot, ndc, or expiration date to provide Adverse Event (AE)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) was updated as a device combination product and dosage information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Since my second dose my menstrual cycle has been heavier and with severe cramps.; Since my second dose my menstrual cycle has been heavier and with severe cramps.; Since my second dose my menstrual cycle has been heavier and with severe cramps.; Also, for the past 15 years I had acne related to my cycle under control, but now it back with full force. I just can't; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot unknown=True,, lot unknown reason=Unable to locate, or read the details,, administration date=14May2021,, dose number=1,, vaccine location=Left arm}]), administration date: 14May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 20Jun2021, outcome "not recovered", described as "Since my second dose my menstrual cycle has been heavier and with severe cramps. "; MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 20Jun2021, outcome "not recovered" and all described as "Since my second dose my menstrual cycle has been heavier and with severe cramps."; ACNE (non-serious) with onset 20Jun2021, outcome "not recovered", described as "Also, for the past 15 years I had acne related to my cycle under control, but now it back with full force. I just can't". The events "since my second dose my menstrual cycle has been heavier and with severe cramps. ", "since my second dose my menstrual cycle has been heavier and with severe cramps.", "since my second dose my menstrual cycle has been heavier and with severe cramps." and "also, for the past 15 years i had acne related to my cycle under control, but now it back with full force. i just can't" were evaluated at the physician office visit. Therapeutic measures were taken as a result of heavy menstrual bleeding, menstrual disorder, dysmenorrhoea, acne.  Additional information: Other medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Covid was not tested prior and post vaccination. Vaccine Facility type was Hospital. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. Adverse event treatment included: Topical treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Fever/Her temperature was 100.4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 16:40 (Lot number: FC3183) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe migraine" (ongoing), notes: Verbatim: Severe migraine and vertigo; "vertigo" (ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 01Sep2021, outcome "unknown", described as "Fever/Her temperature was 100.4". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Reporter is other HCP. Patient stated she was calling because the information she has indicated to call to report a side effect if it is not listed on the paperwork. The paperwork she has does not list anything about getting a fever. She did not specify what paperwork she had. She was calling to report getting a fever, a temperature. Event Details: She mentioned the fever started about ten minutes ago. Her temperature was 100.4. Treatment/Intervention: None. Product Details: This was her first dose. She got it yesterday. Time the vaccination was given: 4:40 PM. Anatomical Location: Upper left arm. Patient did not receive any other vaccine within 4 weeks prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Headache, Investigation, Pyrexia
Clinical narrative: fever; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 29Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LENVIMA taken for endometrial cancer, start date: 01Jun2021; AMLODIPINE BESILATE taken for blood pressure management, start date: Aug2021. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 29Aug2021, outcome "recovered" (2021), described as "fever"; HEADACHE (non-serious) with onset 29Aug2021, outcome "recovered" (2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: EAP enrollment form states patient's diagnosis is endometrial cancer, ICD C54.1. Prescribed Lenvima 12mg daily, start 6/1/2021. Patient reports her blood pressure is "fairly stable" now that she's taking Amlodipine 2.5mg daily. start 8/2021-unknown end date Patient had the second COVID booster on Sunday, 8/29 (Pfizer), and she hasn't felt good since, with a fever and headache lasting a couple days. start 8/29/2021-unknown end date. Patient's healthcare provider. no relevant history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated she had 2 doses of the Pfizer COVID vaccine in Mar, 21 days apart. She is close to her 6 months time from the 2 dose. About 3 and a half weeks ago she had fever related to bleach water cleaner she used to clean her drinking water. She said she switched to bottle water and it went away. She thinks its tied to her bad water use. She has several negative COVID tests and she has been monitoring herself, she isolated herself as well. Caller wanted to know if she can take the booster dose or should she wait to get it due to her fever 3.5 weeks ago.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Flank pain, Pyrexia
Clinical narrative: Fever up to 100 degree F; Severe back pain radiating to bilateral flank. Moderate back pain with bilateral flank pain; Severe back pain radiating to bilateral flank. Moderate back pain with bilateral flank pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Sep2021 12:00 (Lot number: FC 3181) at the age of 51 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "Thyroid nodules" (unspecified if ongoing), notes: Thyroid nodules; "HTN" (unspecified if ongoing), notes: HTN. The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 14Sep2021 16:00, outcome "not recovered", described as "Fever up to 100 degree F"; BACK PAIN (non-serious), FLANK PAIN (non-serious) all with onset 14Sep2021 16:00, outcome "not recovered" and all described as "Severe back pain radiating to bilateral flank. Moderate back pain with bilateral flank pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, back pain, flank pain.  Additional information: The reporter is a nurse (patient). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Tylenol for the event, but it was not resolving the problem. She was not diagnosed with COVID-19 prior to vaccination prior to vaccination and had not been tested for COVID-19 since the vaccination. Her allergies were reported as none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she had fever 24 hours after the 2nd dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "she had fever 24 hours after the 2nd dose". Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient took tylenol as a treatment for adverse event (But when she took Tylenol, she felt fine)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration
Clinical narrative: Dose 1 administration date Sep2021/Dose 2 administration date 17Sep2021; Heavier menstrual cycle; Cramping than normal; Very uncomfortable; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 13:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetes" (unspecified if ongoing), notes: pre diabetes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: unknown), administration date: Sep2021, when the patient was 17 years old, for COVID-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset Sep2021, outcome "recovering", described as "Heavier menstrual cycle"; DYSMENORRHOEA (non-serious) with onset Sep2021, outcome "recovering", described as "Cramping than normal"; DISCOMFORT (non-serious) with onset Sep2021, outcome "recovering", described as "Very uncomfortable"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Sep2021 13:15, outcome "unknown", described as "Dose 1 administration date Sep2021/Dose 2 administration date 17Sep2021". The events "heavier menstrual cycle", "cramping than normal" and "very uncomfortable" were evaluated at the physician office visit. Therapeutic measures were taken as a result of heavy menstrual bleeding, dysmenorrhoea, discomfort.  Additional Information: On an unknown date in Sep2021, the patient experienced heavier menstrual cycle, cramping than normal and patient was very uncomfortable. The events result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified pain medication. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vision blurred
Clinical narrative: Trigger jChildhood Asthma; Loss of Muscle Control and Mass; Loss of Muscle Control and Mass; Brain Fog; Fatigue; constant balance and inner ear; Fatigue and constant balance and inner ear; sleeps 18 hours day; Memory loss; Blurred Vision; Weakness in Extremities; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FA7984) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Childhood Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ASTHMA (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Trigger jChildhood Asthma"; MUSCLE DISORDER (non-serious), MUSCLE MASS (non-serious) all with onset 10Aug2021, outcome "not recovered" and all described as "Loss of Muscle Control and Mass"; FEELING ABNORMAL (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Brain Fog"; FATIGUE (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Fatigue"; BALANCE DISORDER (non-serious) with onset 10Aug2021, outcome "not recovered", described as "constant balance and inner ear"; INNER EAR DISORDER (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Fatigue and constant balance and inner ear"; SOMNOLENCE (non-serious) with onset 10Aug2021, outcome "not recovered", described as "sleeps 18 hours day"; AMNESIA (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Memory loss"; VISION BLURRED (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Blurred Vision"; MUSCULAR WEAKNESS (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Weakness in Extremities". The events "trigger jchildhood asthma", "loss of muscle control and mass", "loss of muscle control and mass", "brain fog", "fatigue", "constant balance and inner ear", "fatigue and constant balance and inner ear", "sleeps 18 hours day", "memory loss", "blurred vision" and "weakness in extremities" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthma, muscle disorder, muscle mass, feeling abnormal, fatigue, balance disorder, inner ear disorder, somnolence, amnesia, vision blurred, muscular weakness.  Additional Information: Vaccine administration time was reported as 04:00 PM. Prior vaccination within 4 weeks and other medications in two weeks was reported as none. The patient did not had COVID prior vaccination. Patient did not have covid prior vaccination and has been tested for covid post vaccination. Facility type Vaccine was reported as pharmacy or drug store. AE resulted in: doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pain, Vomiting
Clinical narrative: Vomiting; Dizzy; not feeling well; Hurting/ pain; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP).  A 46 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Aug2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported VOMITING (non-serious) with onset 2021, outcome unknown; DIZZINESS (non-serious) with onset 2021, outcome unknown; MALAISE (non-serious) with onset 2021, outcome unknown; PAIN (non-serious) with onset 2021, outcome unknown. The events vomiting, dizzy, not feeling well, and hurting/ pain were evaluated at the emergency room visit.  The patient took the Pfizer first shot a few weeks back and she kind of got a bad reaction to the left side where she took the vaccine on the left, it was been like very hurting, she was in kind of in pain on that side to past few weeks and the they contacted because she took the vaccine at Facility name so, they contacted to them and they said that they were working on it and they gave reporter this number today to call because patient was been experiencing a lot of pain since, the first dose and she hasn't be able to get the second dose because of that and they went to the ER a few weeks ago, as well because she was vomiting and she was getting very dizzy and they went to the ER. Patient went to the ER because she was not feeling well and she need to be able to do like X-ray on the left side of her body just to make sure everything was fine the lungs and the everything because she was been having a lot of pain and like they just want to make sure her heart and kidney and everything were all fine the way they were supposed to be because she was experiencing a lot of pain. It was been almost like two months now and patient hadn't been able to take the second shot and they were just been little bit concerned because Facility name gave the wrong phone number. They need assistance with the medical bill she got from the ER because they had to go to NAME emergency hospital because she was not feeling well and they send them the bill and she didn't have a health insurance but also she still have a little bit of a lot of pain on the left side so, reporter think it's probably best to take like X-ray to see if everything is fine. Asked was she going to be continued in pain for four to six weeks. This was kind of an emergency she was been waiting for two months now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Hypothyroidism, Pain in extremity, Thyroid function test
Clinical narrative: diagnosed with hypothyroidism; joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist; pain in thumb, hand, fingers; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [12Dec2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Nov2021 (Lot number: FF2593) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: HYPOTHYROIDISM (disability, medically significant) with onset 10Dec2021, outcome "not recovered", described as "diagnosed with hypothyroidism"; ARTHRALGIA (non-serious) with onset 04Nov2021, outcome "not recovered", described as "joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist"; PAIN IN EXTREMITY (non-serious) with onset 04Nov2021, outcome "not recovered", described as "pain in thumb, hand, fingers". The events "diagnosed with hypothyroidism", "joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist" and "pain in thumb, hand, fingers" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (Nov2021) normal; (10Dec2021) diagnosed with hypothyroidism, notes: full panel; thyroid function test: (12Oct2021) positive; x-ray: (Nov2021) normal. Therapeutic measures were taken as a result of hypothyroidism, arthralgia, pain in extremity. Clinical course: 2 days after getting the Covid vaccine (on 04Nov2021), the joints in the patient's right shoulder started to be painful. At the time of report, patient continued to have excruciating joint pain in his right shoulder, elbow, thumb, hand, wrist, and fingers. Patient had an X-ray done as well as blood work, and those results have come back as normal. The doctor put him on Celecoxib 200MG & Prednisone 10MG. These medications have not helped him much. No Covid test post vaccination. Seriousness of 'excruciating joint pain in his right shoulder, elbow, thumb, hand, wrist, and fingers' from reporter was non-serious (Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No). Patient was diagnosed with hypothyroidism on 10Dec2021 after doing full panel blood work. Thyroid medication was prescribed.