chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever (99); very tired; Chills; muscle pain; Joint pain; headache; Sore arm; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Apr2021 at 16:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. 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. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and nigella sativa seed oil (black cumin seed oil) (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient previously took Aspirin and experienced allergy to it. The patient previously 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 21Mar2021 at 16:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 11Apr2021, within a few minutes, the patient experienced injection site pain. On 12Apr2021 at 09:00, the patient experienced low grade fever (99) after 18 hours, tired, chills, muscle pain by 24 hours, joint pain, headache by 27 hours, very tired, and sore arm. Therapeutic measures were not taken for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent. On 12Apr2021, the patient underwent body temperature and the result was 99 (unspecified units). The clinical outcome of the event injection site pain, low grade fever (99), chills, muscle pain was resolved in Apr2021, joint pain and headache was resolved on 13Apr2021, very tired was resolved on 14Apr2021 and sore arm was resolved on 15Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles ( Zoster Herpes) within 24 hours of vaccine on same side and close to location of shot.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 62-years), administered in left arm on 11Apr2021 at 16:30 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from an unknown date and un-known if ongoing. Concomitant medications included krill oil (KRILL OIL) and probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient had covid prior vaccination and had not been tested for covid post vaccination. The patient had no known allergies. On 12Apr2021 at 20:00, the patient experi-enced developed shingles (zoster herpes) within 24 hours of vaccine on same side and close to loca-tion of shot. The treatment was received for the adverse event with valaciclovir. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome for the events was reported as not recovered.  No follow up attempts are possible; information about lot/batch cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Flushing, Headache
Clinical narrative: Tight throat; my face got flush; swollen lymph node in left arm pit; fever; chills; joint pain; muscle aches; head ache; nausea; diarrhea; Slight allergic reaction; This is a spontaneous report from a non-contactable consumer. A 31-yea-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0151, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:45 (age at vaccination 31-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no medical history. The concomitant medications were not reported. No covid prior vaccination and No covid tested post vaccination. Known Allergies: No. No other vaccine in four weeks. The patient historical vaccine includes first dose of BNT162B2 (Solution for injection, Lot number ER8733) on 31Mar2021 05.00 PM (age at vaccination 31-year-old) administered in left arm for COVID-19 immunisation. It was reported that on 21Apr2021 at 02.00 patient had Slight allergic reaction approximately 20 minutes after 2nd dose. Tight throat and my face got flush. Woke up the next morning with a swollen lymph node in left arm pit. Symptoms include fever, chills, joint pain, muscle aches, head ache, nausea, and diarrhea. Patient had not received any treatment for events. The outcome of the events was not recovered.   No Follow-up attempts are possible. No Further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: Tight throat; my face got flush; swollen lymph node in left arm pit; fever; chills; joint pain; muscle aches; head ache; nausea; diarrhea; Slight allergic reaction; This is a spontaneous report from a non-contactable consumer. A 31-yea-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0151, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:45 (age at vaccination 31-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no medical history. The concomitant medications were not reported. No covid prior vaccination and No covid tested post vaccination. Known Allergies: No. No other vaccine in four weeks. The patient historical vaccine includes first dose of BNT162B2 (Solution for injection, Lot number ER8733) on 31Mar2021 05.00 PM (age at vaccination 31-year-old) administered in left arm for COVID-19 immunisation. It was reported that on 21Apr2021 at 02.00 patient had Slight allergic reaction approximately 20 minutes after 2nd dose. Tight throat and my face got flush. Woke up the next morning with a swollen lymph node in left arm pit. Symptoms include fever, chills, joint pain, muscle aches, head ache, nausea, and diarrhea. Patient had not received any treatment for events. The outcome of the events was not recovered.   No Follow-up attempts are possible. No Further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Tight throat; my face got flush; swollen lymph node in left arm pit; fever; chills; joint pain; muscle aches; head ache; nausea; diarrhea; Slight allergic reaction; This is a spontaneous report from a non-contactable consumer. A 31-yea-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0151, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:45 (age at vaccination 31-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no medical history. The concomitant medications were not reported. No covid prior vaccination and No covid tested post vaccination. Known Allergies: No. No other vaccine in four weeks. The patient historical vaccine includes first dose of BNT162B2 (Solution for injection, Lot number ER8733) on 31Mar2021 05.00 PM (age at vaccination 31-year-old) administered in left arm for COVID-19 immunisation. It was reported that on 21Apr2021 at 02.00 patient had Slight allergic reaction approximately 20 minutes after 2nd dose. Tight throat and my face got flush. Woke up the next morning with a swollen lymph node in left arm pit. Symptoms include fever, chills, joint pain, muscle aches, head ache, nausea, and diarrhea. Patient had not received any treatment for events. The outcome of the events was not recovered.   No Follow-up attempts are possible. No Further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak on left thigh; This is a spontaneous report from a non-contactable pharmacist. This 35-year-old female pharmacist (patient) reported for herself that:  A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 26Mar2021 17:30 as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 26Feb2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Apr2021, the patient experienced shingles outbreak on left thigh. Event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the event. The clinical outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Menstrual cycle was 15 days longer than normal after receiving vaccination, period has included abnormally heavy bleeding compared to usual cycles.; Menstrual cycle was 15 days longer than normal after receiving vaccination, period has included abnormally heavy bleeding compared to usual cycles.; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 27-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:45 (at the age of 27-years-old) as dose 1, single for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported. The patient previously took almond and experienced drug hypersensitivity. Patient received vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced Menstrual cycle was 15 days longer than normal after receiving vaccination, period has included abnormally heav08Apry bleeding compared to usual cycles. on 08Apr2021 08:00. No treatment was received for the events. The outcome of the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on my face; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8727, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:00 (Age at vaccination 51-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history was not reported. Concomitant medications included gabapentin (GABAPENTIN), bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6199, Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 16:00 (Age at vaccination 51-years-old) as dose 1, single for covid-19 immunisation. On 12Apr2021 12:00, the patient had experienced 4 days after my 2nd vaccine, I started to present Shingles on my face. Events required visit to doctor or other healthcare professional office/clinic visit. The patient received anti-viral meds and prednisone as treatment for the event. Therapeutic measures were taken for the events. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received gabapentin, wellbutrin other medications in two weeks. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal spotting began 2 days after vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: Rr8729) via an unspecified route of administration, administered in arm left on 13Apr2021 (at the age of 34-year-old) at dose 1, single for covid-19 immunisation. Medical history included Known allergies: Onions. Concomitant medication included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient did not have other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient has not tested for covid post vaccination. On 15Apr2021 the patient experienced vaginal spotting began 2 days after vaccination. No other medical reasoning behind the occurrence. Patient did not receive treatment for the adverse event. Outcome of the event was resolved on an unspecified date in Apr2021.  Follow-up (19Jul2021): No follow up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: Triggered mild symptoms of HSV1; This is a spontaneous report from a contactable consumer (patient herself). A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in right arm on 13Apr2021 16:30 (age at vaccination: 34-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration on 23Mar2021 04:30 PM, (age at vaccination: 38-years) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Facility type vaccine was pharmacy or drug store. Patients medical history included ulcerative colitis, IBS (Irritable bowel syndrome) and Hsv-1 (Herpes simplex virus conjunctivitis) from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient had no known allergies. No other vaccine in four weeks was administered to patient. Other medications were administered within 2 weeks (details not available). In 15Apr2021 15:00, patient triggered mild symptoms of HSV1. No treatment was received as a result of the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the event was recovering.   No follow-up attempts are required. Information about Lot/Batch number has been obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Swelling face, Teething
Clinical narrative: 12 hours after sec.dose vacc.severe pain in lt side of the theeth in upper jaw and lt side of the nose. Analgesics work only 1,5 h. Next day swelling left side of the face with bruce bellow lt eye.Dgn; 12 hours after sec.dose vacc.severe pain in lt side of the theeth in upper jaw and lt side of the nose. Analgesics work only 1,5 h. Next day swelling left side of the face with bruce bellow lt eye.Dgn; 12 hours after sec.dose vacc.severe pain in lt side of the theeth in upper jaw and lt side of the nose. Analgesics work only 1,5 h. Next day swelling left side of the face with bruce bellow lt eye.Dgn; This is a spontaneous report from a contactable physician (patient). A 69-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER 8730), via an intramuscular route on 28Mar2021 at 11:30 (at the age of 69-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included breast cancer on 2017, hypothyroidism (minimal changes), known allergies to Quinolones. The patient concomitant medications included Tamoxifen20mg, levothyroxine sodium (EUTHYROX) 25 microgram for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL 9269), via an intramuscular route on 06Mar2021 at 09:30 as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 01:00, the patient experienced 12 hours after second dose of vaccine severe pain in side of the teeth in upper jaw and side of the nose. Analgesics work only 1.5 h. Next day swelling left side of the face with bruce bellow lt eye. Dgn, with herpes zoster without skin changes, than post herpetic neuralgia. Seen by dentist and ENT specialist. Still in pain worse at night but now on and off. Patient received treatment for events with valacyclovir, gabapentin, prednisolone. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Swelling, Throat tightness
Clinical narrative: At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; This is a spontaneous report from a contactable consumer or other non hcp. A adult Non pregnant female (Reported as 49 years) patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Mar2021 13:15 (Batch/Lot Number: En6206) as DOSE 1, SINGLE for covid-19 immunization. The patient Medical history included hypertension, blood cholesterol increased, palindromic rheumatism, Hay fever Allergies all from an unknown date and unknown if ongoing. There were no concomitant medications.  Patient had no other vaccine in four weeks . Patient was not tested Covid prior or post vaccination. Patient had known allergies known sensitivities, but not allergies. Patient had medications in two weeks. On 15Mar2021 1 1/2hrs after receiving vaccine, Patient experienced lower left lip, on left side only, got tingly and swelled ,throat tightened and started to swell, but patient could still get air. This was mild swelling, but enough for concern. Patient immediately took 1, 25MG Benadryl Liqui Gel, and continued that dosing for almost 48hrs. Adverse event start time was 14:30.  It was reported that No treatment for AE. She also went back to vaccine observation area, and contacted Primary care Dr via patient portal messaging. Patient Also had another episode on 07Apr2021 woke up in middle of night with same symptoms & took Benadryl again. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Herpes zoster, Muscular weakness, Neuralgia
Clinical narrative: arm weakness; sore arm; fatigue; felt crazy; felt the pain of my shingles; felt the pain of my shingles; nerve pain I've been experiencing in my left neck/shoulder area; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 20Apr2021 11:00 (at the age of 31-year-old) at dose 2, single for covid-19 immunisation. Medical history included vitamin d deficient, herpes zoster from 2015 to 2018 (I previously had shingles between 2015-18 but there was no rash, no redness, nothing there at all). Concomitant medication included levocetirizine dihydrochloride (XYZAL); multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. Patient did not have COVID prior vaccination. Patient has not tested for covid post vaccination. Patient did not have other vaccine in four weeks. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on an unspecified date in Mar2021 11:00 at dose 1, single for covid-19 immunisation and experienced sore arm. On 21Apr2021 08:00 the patient experienced sore arm, fatigue, felt crazy, felt the pain of my shingles, nerve pain i've been experiencing in my left neck/shoulder area, On 23Apr2021 arm weakness. Adverse event: I had no reaction to first dose other than sore arm day of and second day. Second dose sore arm and fatigue first day but the second day I felt crazy because I felt the pain of my shingles in all five places that I previously had shingles between 2015-18 but there was no rash, no redness, nothing there at all. And the nerve pain I've been experiencing in my left neck/shoulder area was the worst it's ever felt. Day three after second vaccine is just arm weakness and fatigue. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: arm weakness; sore arm; fatigue; felt crazy; felt the pain of my shingles; felt the pain of my shingles; nerve pain I've been experiencing in my left neck/shoulder area; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 20Apr2021 11:00 (at the age of 31-year-old) at dose 2, single for covid-19 immunisation. Medical history included vitamin d deficient, herpes zoster from 2015 to 2018 (I previously had shingles between 2015-18 but there was no rash, no redness, nothing there at all). Concomitant medication included levocetirizine dihydrochloride (XYZAL); multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. Patient did not have COVID prior vaccination. Patient has not tested for covid post vaccination. Patient did not have other vaccine in four weeks. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on an unspecified date in Mar2021 11:00 at dose 1, single for covid-19 immunisation and experienced sore arm. On 21Apr2021 08:00 the patient experienced sore arm, fatigue, felt crazy, felt the pain of my shingles, nerve pain i've been experiencing in my left neck/shoulder area, On 23Apr2021 arm weakness. Adverse event: I had no reaction to first dose other than sore arm day of and second day. Second dose sore arm and fatigue first day but the second day I felt crazy because I felt the pain of my shingles in all five places that I previously had shingles between 2015-18 but there was no rash, no redness, nothing there at all. And the nerve pain I've been experiencing in my left neck/shoulder area was the worst it's ever felt. Day three after second vaccine is just arm weakness and fatigue. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cranial nerve injury, Deafness unilateral, Dysgeusia, Heart rate
Clinical narrative: permanent damage to the cranial nerve that goes to the mouth; secondary hearing loss; permanent burning and a bitter taste in her mouth; bitter taste in her mouth; Hearing loss on the left side with tinnitus; The second shot made it worse.; The initial case was missing the following minimum criteria: No Adverse Event. Upon receipt of follow-up information on 03Sep2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 16Feb2021 10:00 (Batch/Lot Number: EN6200) as single dose, second dose on 09Mar2021 (Batch/Lot Number: EN6199) as single dose (age at vaccination 65 year old), both via an unspecified route of administration for covid-19 immunisation. Medical history and concomitant medications unknown. Patient explained that she has sustained what appears to be permanent damage to the cranial nerve that goes to the mouth. She has permanent burning and a bitter taste in her mouth that makes it painful to talk. She is miserable and hurts all the time. This started within 36-48 hours after the first shot (Feb2021). After the second shot it was amplified 100 times and it has stayed terrible ever since. The second shot made it worse. The nerve damage has spread throughout her mouth. It's to the tip of her tongue, lips, it's tingling, painful, and she has difficulty talking.  It is very aggravating to do it. She also feels that she has had secondary hearing loss. She has hearing loss on the left side with increased tinnitus in the left ear. She started to have buzzing in the ear after the first shot, but the second shot just made it worse. She is having this crippling problem with her mouth. She is a teacher and she has to talk. It is very painful. The nerve goes to the tongue into lips and through her jaw; her jaw is damaged.  She also has this persistent bitter painful taste in mouth. She cannot eat 90% of what she used to it. She can only eat very bland things. Most times she does eat very much. Her mouth hurts all the time except when she is sleeping. She has seen the doctor several times since this, but there is no real treatment due to it being nerve damage in the mouth. There is no real fix. She commented there is medication that can be prescribed, but it would just make sleepy and stupid. It would sloe the nerve impulses down. Name of medication not specified or provided by caller. She mentioned this is an untreatable side effect; it's very serious and life altering. Stated this is life altering and untreatable.     Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Tinnitus
Clinical narrative: permanent damage to the cranial nerve that goes to the mouth; secondary hearing loss; permanent burning and a bitter taste in her mouth; bitter taste in her mouth; Hearing loss on the left side with tinnitus; The second shot made it worse.; The initial case was missing the following minimum criteria: No Adverse Event. Upon receipt of follow-up information on 03Sep2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 16Feb2021 10:00 (Batch/Lot Number: EN6200) as single dose, second dose on 09Mar2021 (Batch/Lot Number: EN6199) as single dose (age at vaccination 65 year old), both via an unspecified route of administration for covid-19 immunisation. Medical history and concomitant medications unknown. Patient explained that she has sustained what appears to be permanent damage to the cranial nerve that goes to the mouth. She has permanent burning and a bitter taste in her mouth that makes it painful to talk. She is miserable and hurts all the time. This started within 36-48 hours after the first shot (Feb2021). After the second shot it was amplified 100 times and it has stayed terrible ever since. The second shot made it worse. The nerve damage has spread throughout her mouth. It's to the tip of her tongue, lips, it's tingling, painful, and she has difficulty talking.  It is very aggravating to do it. She also feels that she has had secondary hearing loss. She has hearing loss on the left side with increased tinnitus in the left ear. She started to have buzzing in the ear after the first shot, but the second shot just made it worse. She is having this crippling problem with her mouth. She is a teacher and she has to talk. It is very painful. The nerve goes to the tongue into lips and through her jaw; her jaw is damaged.  She also has this persistent bitter painful taste in mouth. She cannot eat 90% of what she used to it. She can only eat very bland things. Most times she does eat very much. Her mouth hurts all the time except when she is sleeping. She has seen the doctor several times since this, but there is no real treatment due to it being nerve damage in the mouth. There is no real fix. She commented there is medication that can be prescribed, but it would just make sleepy and stupid. It would sloe the nerve impulses down. Name of medication not specified or provided by caller. She mentioned this is an untreatable side effect; it's very serious and life altering. Stated this is life altering and untreatable.     Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Oropharyngeal pain, SARS-CoV-2 test, Stomatitis
Clinical narrative: Mouth sores/lesions along gum and causing throat pain on same side; Mouth sores/lesions along gum and causing throat pain on same side; Possible cold sore virus reactivated after 20+ years.; This is a spontaneous report from a contactable consumer (patient). A 56 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in Left Arm on 22Apr2021 at 15:00 (56-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. Patient was non-pregnant at time of vaccination. The patient's medical history included known allergies: Penicillin, sulfur, mushrooms. There were no concomitant medications within two weeks of vaccination. Facility type vaccine was reported as Public Health Clinic. The patient had not received any other vaccine in four weeks prior to Covid vaccination. The patient was not diagnosed with Covid prior vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in Left Arm on 28Mar2021 (56-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 24Apr2021 at 15:00 (48 hours after 2nd vaccine), the patient had experienced mouth sores/lesions along gum and causing throat pain on same side, possible cold sore virus reactivated after 20 plus years. No treatment received for the events. On an unknown date in 2021, the patient underwent lab test and procedure which included sars-cov-2 test (Nasal swab): negative. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: I've started experiencing a change in my menstrual cycle.; experienced spotting for 10 days and now my period is late; experienced spotting for 10 days and now my period is late; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 18-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 18-Year) in left arm on 09Apr2021 at 11:30 AM as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered in left arm on 17Mar2021 at 12:30 PM for COVID-19 immunization. No known allergies were reported. The patient received no other vaccine in four weeks; and no other medications in two weeks. The patient had COVID test type post vaccination (Nasal Swab). The patient not tested COVID prior vaccination. On 18Apr2021 the patient experienced a change in her menstrual cycle; experienced spotting for 10 days and her period was late. The patient reported that "she had started experiencing a change in her menstrual cycle. This is the first change she had ever experienced with it, so it was relatively out of the norm. She experienced spotting for 10 days and till then her period was late." The patient received no treatment for the adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 22Apr2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash to face, neck, legs, head and chest/whole body in itchy rash; This is a solicited report based on the information received by Pfizer (Manufacturer Control No:21K-163-3859870-00).  A contactable 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), via intramuscular route of administration on 07Apr2021 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization; and patient also received adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous route of administration, from an unspecified date 1999 to ongoing, as a 40mg / 0.4ml for Rheumatoid arthritis. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER2613), via intramuscular route of administration, on 19Mar2021 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced Itchy rash to face, neck, legs, head and chest/whole body in itchy rash. The patient received steroid shot and took prednisone for five days and resolved. She was hospitalized for less than two hours and she mentioned that she was in and out on 10Apr2021. She had a cortisone shot for the itching and took prednisone for five days. The action taken in response to the event for adalimumab was dose not changed. The outcome of the event was recovered on 11Apr2021.  1)HUMIRA Causality as per reporter (Drug/Vaccine): Not Related Causality as per Mfr.(Drug/Vaccine): No reasonable possibility  2) COVID-19 VACCINE(COVID-19 VACCINE)(Injection)(COVID-19 VACCINE),ER2613,EN6208 Causality as per reporter (Drug/Vaccine) : Probable  No follow-up attempts are needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Causality for the event "Itchy rash" was updated and the event was considered as serious (Medically significant).; Sender's Comments: The event Rash pruritic is considered possibly related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), based on temporal association and profile of the product.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Throat irritation, Throat tightness
Clinical narrative: persistent headache; constructed, scratchy throat; constructed, scratchy throat; This is a spontaneous report from a contactable consumer. This consumer (Patient) reported that, a 61-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:30 (Batch/Lot Number: ER8727) as dose 2, single (at age of 61-years old) for covid-19 immunization. The patient did not have Known allergies and other medical history. No covid prior vaccination and no covid tested post vaccination. There was no other vaccine in four weeks and other medications in two weeks. The patient previously took first dose of BNT162B2, Solution for injection via an unspecified route of administration, administered in Right arm on 05Mar2021 12:30 PM (Batch/Lot Number: EN6206) as single dose (at age of 61-years old) for covid-19 immunization. The patient experienced persistent headache, constructed, scratchy throat on 27Mar2021 22:30. It was reported that, she has had a persistent headache since 36 hours after the shot. It was sometimes worse (splitting). Her husband and she both have had a constructed, scratchy throat since taking the shot. Really should warn people. It was now over 30 days. The patient did not receive any treatment for events. The outcome of the events was not resolved at time of reporting.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Illness, Influenza like illness, Oropharyngeal pain, Seasonal allergy
Clinical narrative: Sore throat; He's still coughing; he has allergies to seasonal allergies; He was sick for at least 5 days; He had flu symptoms after getting the vaccine; This is a spontaneous report from a contactable consumer or other non hcp (parent).   A 23-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. caller called to let you know my sons received first dose and reaction to it. He was sick for at least 5 days. He had flu symptoms after getting the vaccine. fine now. Hes going to get the second one. Hes still coughing. he has allergies to seasonal allergies. Im allergic/have allergies all year round. I already reported this information on my son. His PCP told me to take him to urgent care which I did. The doctor felt it was the side effects from the vaccine. He has Sore throat too but they said that could be a side effect as well. Adverse events Sore throat, coughing, seasonal allergies resulted in emergency room visit. The outcome for the event he was sick for at least 5 days and he had flu symptoms after getting the vaccine was resolved on an unspecified date and for coughing outcome was reported as not resolved and for remaining events outcome was reported as unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Severe pain in whole body; headache; weakness; chest pain; This is a spontaneous report from a contactable consumer (reported herself). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via intramuscular, administered in arm left on 28Apr2021 10:30 (age at vaccination was 38-year-old) as dose 2, single for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, known allergies: Walnuts from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ofatumumab (KESIMPTA) taken for an unspecified indication, start and stop date were not reported received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: unknown), via an unspecified route of administration on 07Apr2021 10:15 (age at vaccination was 37-year-old) as dose 1, single for covid-19 immunisation. The patient experienced severe pain in whole body, headache, weakness and chest pain on 28Apr2021 23:15. Post vaccination, the patient was tested for COVID test and the test result was negative on an unknown date. The treatment received for the events was unknown. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylatic reaction; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 46 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot number ER8735) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included connective tissue disorder from an unknown date and unknown if ongoing .she has a lot of history with allergies to drugs. In 2009, for the H1N1 pandemic, she got the vaccine and then she had Bells Palsy. After that, she got an autoimmune disease which may or may not have been due to the vaccine. she got the Varicella vaccine and she got a racing heart and could not breathe and she had to sit in the emergency room. A year ago, she got the tetanus vaccine and had no reaction. She takes antihistamines to that. She states she and her sister have Ehlers Danlos, which is a connective tissue disorder.she did not visit an emergency rom of physician's office. The patient's concomitant medications were not reported. The patient experienced anaphylatic reaction on an unspecified date with outcome of unknown.    Follow-up (18Aug2021): Follow-up attempts completed. No further information expected.  Follow-up(27Aug2021): This is a follow-up spontaneous report received by a contactable consumer. This female consumer(patient) reported in response to Non-HCP letter which includes that: The first dose was taken on 01May20212021 at 03:30 PM The Site and Route of injection is Right Deltoid and Route of administration is Intramuscular. The concomitant medications included, Levothyroxine 100 mcg since 2009, Modafinil 50, Vitamin D3 2000IU/day for thyroid since 2009, Famotidine for GERD. Patients medical history included Ehlers Danlos, Multiple Sclerosis and Low thyroid since 2009.Family medical history relevant to AE(s), Her sister had facial swelling after dose 2, Bronchospasm or chest tightness on 05Jan2021.Treatment taken with Benadryl 50mg 1 time.Also have a different indication of rash that wont go away. Started 5-5 Looks like eczema but doesn't respond to cream. Gets worse in sun.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Mobility decreased, Pain
Clinical narrative: sore and unable to raise his arm; sore and unable to raise his arm; This is a spontaneous report from a contactable consumer (consumers wife) or other non health care professional, from a Pfizer sponsored program.  A 90-year-old male patient (reporters husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via intramuscular, administered in left arm on 21Jan2021 12:30 (at the age of 90-years-old) as dose 1, single for covid-19 immunization. The patient medical history included heart problem (Family Medical History Relevant to AE: Family had a few heart problem), Afib from 1999 and ongoing (Illness/AE: Afib Onset date: 1999 pertinent Details: Not sure a few years). Concomitant medications included rivaroxaban (XARELTO, 20 mg, oral, start Date: 7 yrs ago) taken for atrial fibrillation from an unspecified start date and ongoing, atenolol (50 mg, oral, start Date: 7 yrs ago) taken for atrial fibrillation from an unknown date, lisinopril (20 mg, oral) taken for atrial fibrillation from an unknown date. It was reported that, reporter and her husband received both of the Covid19 vaccines. They received the first dose last 21Jan2021. The reporter said her husband is a doctor. Her husband had a terrible reaction after getting the first dose. He became ill after his first shot. He was sore and unable to raise his arm. Couldn't do surgery or see patients for a few days. The patient underwent lab tests and procedures which included EKG (electrocardiogram): fine on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible: information about lot/batch number/expiry date cannot be obtained.