chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Trouble with joints and muscles; Very tired; This is a spontaneous report from a contactable consumer or other non health care professional. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 at 13:50 as dose 2, single (age at vaccination 76-year-old) for covid-19 immunization (Protection against the virus) at hospital. Medical history included ongoing arthritis Verbatim: Arthritis, ongoing back disorder Verbatim: Other back issues, ongoing Sulpha drugs allergy from an unknown date (About 50 years because she was pregnant). The patient's concomitant medications were not reported. The patient routinely took shots in her back about every 3 months for Arthritis in her back and other back issues. She did not take these shots during the period she got the first or second dose of Pfizer COVID-19 Vaccine. Name unknown, thought some type of steroid or something but was not sure. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL8982) on 15Jan2021 at 13:50 in arm right as dose 1, single for covid-19 Imminisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations were none. The patient experienced trouble with joints and muscles and very tired on 07Feb2021. She reported onset of trouble with joints and muscles and being very tired starting 07Feb2021 at unknown time. She thought these events may be some side effects to the second dose of Pfizer COVID-19 Vaccine. She had preexisting condition of Arthritis in her joints and back, but not like this event. She had been more active, but this was more tired than normal. The patient did not require hospitalization, emergency room visit or physician office visit. The outcome for events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropathy, Fatigue
Clinical narrative: Trouble with joints and muscles; Very tired; This is a spontaneous report from a contactable consumer or other non health care professional. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 at 13:50 as dose 2, single (age at vaccination 76-year-old) for covid-19 immunization (Protection against the virus) at hospital. Medical history included ongoing arthritis Verbatim: Arthritis, ongoing back disorder Verbatim: Other back issues, ongoing Sulpha drugs allergy from an unknown date (About 50 years because she was pregnant). The patient's concomitant medications were not reported. The patient routinely took shots in her back about every 3 months for Arthritis in her back and other back issues. She did not take these shots during the period she got the first or second dose of Pfizer COVID-19 Vaccine. Name unknown, thought some type of steroid or something but was not sure. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL8982) on 15Jan2021 at 13:50 in arm right as dose 1, single for covid-19 Imminisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations were none. The patient experienced trouble with joints and muscles and very tired on 07Feb2021. She reported onset of trouble with joints and muscles and being very tired starting 07Feb2021 at unknown time. She thought these events may be some side effects to the second dose of Pfizer COVID-19 Vaccine. She had preexisting condition of Arthritis in her joints and back, but not like this event. She had been more active, but this was more tired than normal. The patient did not require hospitalization, emergency room visit or physician office visit. The outcome for events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Feeling abnormal, Headache
Clinical narrative: New Chronic Migraine; disease recurrence; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) in the left arm on 05Mar2021 at 14:30 (at the age of 51-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) in the left arm on 26Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine which was under control prior to vaccine. Concomitant medications included nortriptyline (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), butalbital; caffeine; paracetamol (FIORICET) and famotidine (MANUFACTURER UNKNOWN) for unknown indications from unknown start dates and unknown if ongoing. The patient previously took erythromycin (MANUFACTURER UNKNOWN), cetrimide (BACTRIAN), docetaxel (TAXOTERE), doxycycline (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN); and experienced drugs allergy. 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. On 05Mar2021 at 16:30, the patient experienced new chronic migraine with vertigo. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with multiple medications (unspecified). The clinical outcome of the event new chronic migraine and vertigo was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: New Chronic Migraine; disease recurrence; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) in the left arm on 05Mar2021 at 14:30 (at the age of 51-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) in the left arm on 26Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine which was under control prior to vaccine. Concomitant medications included nortriptyline (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), butalbital; caffeine; paracetamol (FIORICET) and famotidine (MANUFACTURER UNKNOWN) for unknown indications from unknown start dates and unknown if ongoing. The patient previously took erythromycin (MANUFACTURER UNKNOWN), cetrimide (BACTRIAN), docetaxel (TAXOTERE), doxycycline (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN); and experienced drugs allergy. 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. On 05Mar2021 at 16:30, the patient experienced new chronic migraine with vertigo. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with multiple medications (unspecified). The clinical outcome of the event new chronic migraine and vertigo was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Migraine, Vertigo
Clinical narrative: New Chronic Migraine; disease recurrence; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) in the left arm on 05Mar2021 at 14:30 (at the age of 51-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) in the left arm on 26Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine which was under control prior to vaccine. Concomitant medications included nortriptyline (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), butalbital; caffeine; paracetamol (FIORICET) and famotidine (MANUFACTURER UNKNOWN) for unknown indications from unknown start dates and unknown if ongoing. The patient previously took erythromycin (MANUFACTURER UNKNOWN), cetrimide (BACTRIAN), docetaxel (TAXOTERE), doxycycline (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN); and experienced drugs allergy. 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. On 05Mar2021 at 16:30, the patient experienced new chronic migraine with vertigo. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with multiple medications (unspecified). The clinical outcome of the event new chronic migraine and vertigo was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history (none-was perfectly healthy). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) all for unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 20:00 the patient experienced tinnitus. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia
Clinical narrative: I lost most of my sense of taste for two days; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration at left arm on 25Jan2021 at 07:00 PM (lot number: EL3247) (age at vaccination 67-year-old) as dose 1, single for COVID-19 immunisation. The patient had allergy to toradol. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any other medications within two weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 (early November). The patient medical history and concomitant medications were not reported. Since the vaccination, has the patient was not tested for COVID-19. The patient had lost most of the sense of taste for two days on 03Feb2021. The patient had not received any treatment for the event. The outcome of the event was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021226820 same drug and AE, different patient;US-PFIZER INC-2021226818 same drug and AE, different patient;US-PFIZER INC-2021226817 same drug and AE, different patient;US-PFIZER INC-2021226819 same drug and AE, different patient
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: I lost most of my sense of taste for two days; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration at left arm on 25Jan2021 at 07:00 PM (lot number: EL3247) (age at vaccination 67-year-old) as dose 1, single for COVID-19 immunisation. The patient had allergy to toradol. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any other medications within two weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 (early November). The patient medical history and concomitant medications were not reported. Since the vaccination, has the patient was not tested for COVID-19. The patient had lost most of the sense of taste for two days on 03Feb2021. The patient had not received any treatment for the event. The outcome of the event was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021226820 same drug and AE, different patient;US-PFIZER INC-2021226818 same drug and AE, different patient;US-PFIZER INC-2021226817 same drug and AE, different patient;US-PFIZER INC-2021226819 same drug and AE, different patient
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DRUG EXPOSURE DURING PREGNANCY; ARM WAS A LITTLE SORE; This spontaneous pregnancy report received from a patient concerned an unspecified age, race and ethnicity female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before The patient received covid-19  (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 patient received the vaccine while pregnant second trimester, 22 weeks (drug exposure during pregnancy) and experienced arm was a little sore. On JUN-2021 (greater than 28 days after vaccine administration), the patient got an antibody test which resulted negative (confirmed immunological vaccine failure). The date of the patient's last menstrual period was not reported and was having C-section next week, expected delivery date was SEP-2021. The pregnancy was continuing. The action taken with covid-19 was not applicable. The patient had not recovered from drug exposure during pregnancy, and the outcome of arm was a little sore and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191501.; Sender's Comments: V0: 20210860342-COVID-19 VACCINE- confirmed immunological vaccine failure This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DRUG EXPOSURE DURING PREGNANCY; ARM WAS A LITTLE SORE; This spontaneous pregnancy report received from a patient concerned an unspecified age, race and ethnicity female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before The patient received covid-19  (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 patient received the vaccine while pregnant second trimester, 22 weeks (drug exposure during pregnancy) and experienced arm was a little sore. On JUN-2021 (greater than 28 days after vaccine administration), the patient got an antibody test which resulted negative (confirmed immunological vaccine failure). The date of the patient's last menstrual period was not reported and was having C-section next week, expected delivery date was SEP-2021. The pregnancy was continuing. The action taken with covid-19 was not applicable. The patient had not recovered from drug exposure during pregnancy, and the outcome of arm was a little sore and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191501.; Sender's Comments: V0: 20210860342-COVID-19 VACCINE- confirmed immunological vaccine failure This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Exposure during pregnancy, Pain in extremity, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DRUG EXPOSURE DURING PREGNANCY; ARM WAS A LITTLE SORE; This spontaneous pregnancy report received from a patient concerned an unspecified age, race and ethnicity female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before The patient received covid-19  (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 patient received the vaccine while pregnant second trimester, 22 weeks (drug exposure during pregnancy) and experienced arm was a little sore. On JUN-2021 (greater than 28 days after vaccine administration), the patient got an antibody test which resulted negative (confirmed immunological vaccine failure). The date of the patient's last menstrual period was not reported and was having C-section next week, expected delivery date was SEP-2021. The pregnancy was continuing. The action taken with covid-19 was not applicable. The patient had not recovered from drug exposure during pregnancy, and the outcome of arm was a little sore and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191501.; Sender's Comments: V0: 20210860342-COVID-19 VACCINE- confirmed immunological vaccine failure This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Laboratory test, Lymphadenopathy, Ultrasound scan
Clinical narrative: Multiple large axillary lymph nodes; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the arm left on 27Jan2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included lymphedema and cutaneous mastocytosis. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient received other vaccines within four weeks prior to the COVID-19 vaccine and included second dose of varicella zoster vaccine (SHINGLES) for unknown indication on 15Dec2020. The patient previously took vancomycin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the arm left on 06Jan2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Apr2021, the patient experienced multiple large axillary lymph nodes three months after last injection. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 Vault saliva test and the result was negative. The clinical outcome of the event multiple large axillary lymph nodes three months after last injection was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Multiple large axillary lymph nodes; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the arm left on 27Jan2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included lymphedema and cutaneous mastocytosis. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient received other vaccines within four weeks prior to the COVID-19 vaccine and included second dose of varicella zoster vaccine (SHINGLES) for unknown indication on 15Dec2020. The patient previously took vancomycin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the arm left on 06Jan2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Apr2021, the patient experienced multiple large axillary lymph nodes three months after last injection. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 Vault saliva test and the result was negative. The clinical outcome of the event multiple large axillary lymph nodes three months after last injection was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Very bad headaches; Body stiffness; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and finasteride (MANUFACTURER UNKNOWN); all for unknown indication from unknown dates and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 at 00:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 01:00 the patient experienced very bad headaches, body stiffness and difficulty walking. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, body stiffness and difficulty walking and included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very bad headaches, body stiffness and difficulty walking were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Headache, Musculoskeletal stiffness
Clinical narrative: Very bad headaches; Body stiffness; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and finasteride (MANUFACTURER UNKNOWN); all for unknown indication from unknown dates and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 at 00:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 01:00 the patient experienced very bad headaches, body stiffness and difficulty walking. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, body stiffness and difficulty walking and included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very bad headaches, body stiffness and difficulty walking were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: blistering of fingers and swelling and palms of hands burning flare up; blistering of fingers bilaterally; palms of hands were burning; swelling of the fingers bilaterally; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer (patient) reported for herself that a 46-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP69SS, Expiry date,  number: unknown), via intramuscular, administered in left arm on 25Mar2021 (age at vaccination was 46 years) as dose 1, single for COVID-19 immunisation. The patient taking Pfizer BioNTech Covid 19 vaccine due to obesity and knew she had allergies where immune system compromised; not catch Covid. The patient medical history includes allergies and asthma; both ongoing. The patient stated that she does not think vaccine caused asthma because she had allergies and they did tests prior to the vaccine, PTSD (Post-traumatic stress disorder) from an unspecified date in 2010 and ongoing. No Concomitants reported and she takes other medications for other conditions. No further details provided. On 27Mar2021, the patient experienced blistering of fingers bilaterally, palms of hands were burning and swelling of the fingers bilaterally. Additional context reported as, a consumer who has a history of asthma that received the Pfizer BioNTech Covid 19 vaccine in April. The patient had a reaction with each injection. Stated that with the first injection that she caught Covid fingers which is blistering of fingers with swelling and the palms of her hands were burning. Stated that whenever her immune system kicks in that the blistering of fingers and swelling and palms of hands burning flare up. The patient went to the emergency room and reported it to VAERS. The patient reported that since she had reaction to first two doses will the booster vaccine benefit her. Wanted to know once over delta variant and well enough for booster should she attempt since she had two adverse reactions to two doses. Stated that on Jun2020 had CT of lungs had bilateral midlobe pulmonary nodules. The patient has them bilaterally upper and lower lobes and still to her middle lobes prior to the vaccine. Treatment was none for the symptoms of the hands.Outcome of the events were resolving.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Computerised tomogram, Condition aggravated, Peripheral swelling
Clinical narrative: blistering of fingers and swelling and palms of hands burning flare up; blistering of fingers bilaterally; palms of hands were burning; swelling of the fingers bilaterally; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer (patient) reported for herself that a 46-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP69SS, Expiry date,  number: unknown), via intramuscular, administered in left arm on 25Mar2021 (age at vaccination was 46 years) as dose 1, single for COVID-19 immunisation. The patient taking Pfizer BioNTech Covid 19 vaccine due to obesity and knew she had allergies where immune system compromised; not catch Covid. The patient medical history includes allergies and asthma; both ongoing. The patient stated that she does not think vaccine caused asthma because she had allergies and they did tests prior to the vaccine, PTSD (Post-traumatic stress disorder) from an unspecified date in 2010 and ongoing. No Concomitants reported and she takes other medications for other conditions. No further details provided. On 27Mar2021, the patient experienced blistering of fingers bilaterally, palms of hands were burning and swelling of the fingers bilaterally. Additional context reported as, a consumer who has a history of asthma that received the Pfizer BioNTech Covid 19 vaccine in April. The patient had a reaction with each injection. Stated that with the first injection that she caught Covid fingers which is blistering of fingers with swelling and the palms of her hands were burning. Stated that whenever her immune system kicks in that the blistering of fingers and swelling and palms of hands burning flare up. The patient went to the emergency room and reported it to VAERS. The patient reported that since she had reaction to first two doses will the booster vaccine benefit her. Wanted to know once over delta variant and well enough for booster should she attempt since she had two adverse reactions to two doses. Stated that on Jun2020 had CT of lungs had bilateral midlobe pulmonary nodules. The patient has them bilaterally upper and lower lobes and still to her middle lobes prior to the vaccine. Treatment was none for the symptoms of the hands.Outcome of the events were resolving.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: tiredness; headache; injection site pain; tiredness(full body pains); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 16:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergy to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021,1-2 days after the vaccination he had few symptoms like tiredness, headache & injection site pain. But since it's been 2 weeks(at the time of reporting) some days he still have few symptoms like mild headache, tiredness(full body pains). So the patient asked whether there was anything he need to worry about. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, full body pains and injection site pain were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: tiredness; headache; injection site pain; tiredness(full body pains); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 16:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergy to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021,1-2 days after the vaccination he had few symptoms like tiredness, headache & injection site pain. But since it's been 2 weeks(at the time of reporting) some days he still have few symptoms like mild headache, tiredness(full body pains). So the patient asked whether there was anything he need to worry about. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, full body pains and injection site pain were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Alopecia, Alopecia universalis
Clinical narrative: hair sloughed/slick bald head; alopecia areata which had been in remission for 5months; alopecia universalis; This is a spontaneous report from a contactable nurse (patient). This 64-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) intramuscular on 26Feb2021 as a single dose for COVID-19 immunization. Medical history included autoimmune disease, thyroid disease, and alopecia areata which had been in remission for 5 months (from an unspecified date). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient took unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not take any new medications at the time of shots. She had alopecia areata which had been in remission for 5 months. She had a full head of hair growing very well. After the first injection, seven to ten days later on 06Mar2021, the patient's hair sloughed. It took only two to three days to fall out completely to a slick bald head. The patient visited a doctor or other healthcare professional office/clinic in response to the events. The patient's diagnosis was upgraded to alopecia universalis. The patient was treated with steroid scalp injections and medications. The outcome of alopecia universalis and bald was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Based on the information provided, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) to reported events alopecia, disease recurrence and alopecia universalis, is possible.
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Alopecia, Alopecia universalis, Disease recurrence
Clinical narrative: hair sloughed/slick bald head; alopecia areata which had been in remission for 5months; alopecia universalis; This is a spontaneous report from a contactable nurse (patient). This 64-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) intramuscular on 26Feb2021 as a single dose for COVID-19 immunization. Medical history included autoimmune disease, thyroid disease, and alopecia areata which had been in remission for 5 months (from an unspecified date). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient took unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not take any new medications at the time of shots. She had alopecia areata which had been in remission for 5 months. She had a full head of hair growing very well. After the first injection, seven to ten days later on 06Mar2021, the patient's hair sloughed. It took only two to three days to fall out completely to a slick bald head. The patient visited a doctor or other healthcare professional office/clinic in response to the events. The patient's diagnosis was upgraded to alopecia universalis. The patient was treated with steroid scalp injections and medications. The outcome of alopecia universalis and bald was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Based on the information provided, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) to reported events alopecia, disease recurrence and alopecia universalis, is possible.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately following injection, with a matter of seconds, had dizziness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZERER8737) via an unspecified route of administration in the right arm on 08Apr2021 at 15:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis (nothing relevant. very healthy in general), one previous anaphylactic episode, which cause was unknown and known allergies to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE), from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Apr2021 at 15:00, immediately following vaccination, with a matter of seconds, the patient had dizziness. The dizziness persisted for 8 hours, on and off. The patient was concerned about getting second dose. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event, the patient had dizziness was resolved on 08Apr2021 at 23:00.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Immediately following injection, with a matter of seconds, had dizziness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZERER8737) via an unspecified route of administration in the right arm on 08Apr2021 at 15:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis (nothing relevant. very healthy in general), one previous anaphylactic episode, which cause was unknown and known allergies to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE), from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Apr2021 at 15:00, immediately following vaccination, with a matter of seconds, the patient had dizziness. The dizziness persisted for 8 hours, on and off. The patient was concerned about getting second dose. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event, the patient had dizziness was resolved on 08Apr2021 at 23:00.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Tiredness; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 11:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 the patient experienced headache, tiredness, fever and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, fever and fatigue were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Tiredness; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 11:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 the patient experienced headache, tiredness, fever and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, fever and fatigue were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Sensitive skin, Tinnitus
Clinical narrative: physical pain in temples, sensitive to the touch. Painful to touch, talk or chew.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: er8731) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 13:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The medical history included blood pressure high and allergy(unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 17Apr2021, the patient experienced physical pain in temples, sensitive to the touch and painful to touch, talk or chew. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events physical pain in temples, sensitive to the touch and painful to touch, talk or chew was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.