chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test positive, Tonsillar hypertrophy
Clinical narrative: He has his second Pfizer vaccine on Friday 7th, his tonsil are swollen again, very swollen; almost touching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 07May2021 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Single), administration date: 09Apr2021, for covid-19 immunization, reaction(s): "Tonsillitis streptococcal", "Swollen tonsils". The following information was reported: TONSILLAR HYPERTROPHY (non-serious) with onset May2021, outcome "not recovered", described as "He has his second Pfizer vaccine on Friday 7th, his tonsil are swollen again, very swollen; almost touching". The event "he has his second pfizer vaccine on friday 7th, his tonsil are swollen again, very swollen; almost touching" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tonsillar hypertrophy.  Additional information: The reporter calling for his son, he stated on (09Apr2021) his receives the Pfizer vaccine and on next day 10Apr(Confirmed as 10Apr2021) his lymph node swollen, tonsil were swollen and by that evening at about 10 O'clock, It was so badly swollen, so took him to emergency care and they did a strep test on him and the strep test came back positive, so they prescribed him amoxicillin, So he finished the course of amoxicillin then on 04May2021 (Confirmed as 07May2021) his tonsil were swollen again then he goes back to the doctor and they did another strep test but did not find strep and they gave him Methylprednisolone and Azithromycin. So he just finish his last course yesterday. Treatment for Adverse Effect were received Amoxicillin, Methylprednisolone (4mg, orally), Azithromycin (250mg, orally tablet). Date for first shot: 09Apr2021. Start date of adverse effect 10Apr2021 Date for second shot: 07May2021. Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: I became severely nauseated; had a bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 09:45 (Lot number: EW0161) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Asthma" (unspecified if ongoing); "hypoglycemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "IBS" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "known allergy: extensive allergies" (unspecified if ongoing); "known allergy: fruits" (unspecified if ongoing); "known allergy: nature" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Nsaids, reaction(s): "known allergies: NSAIDs". The following information was reported: NAUSEA (non-serious) with onset 01May2021 22:00, outcome "not recovered", described as "I became severely nauseated"; HEADACHE (non-serious) with onset 01May2021 22:00, outcome "not recovered", described as "had a bad headache". Therapeutic measures were not taken as a result of nausea, headache.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Minutes after dose 1 patient became severely nauseated and had a bad headache. Patient was put on watch for an hour before being released.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased
Clinical narrative: ANA level result was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "LUPUS" (unspecified if ongoing), notes: The Mother has a friend who has LUPUS. The patient's concomitant medications were not reported. The following information was reported: ANTINUCLEAR ANTIBODY INCREASED (non-serious), outcome "unknown", described as "ANA level result was high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter added in the past, her Daughter experienced drug induced LUPUS from minocycline and was on Prednisone for 2 years, when she was 16 years old and has been fine ever since. She discovered this when they went to the dermatologist. Her Daughter's head was shedding from the COVID-19 and the Mother asked about her hair, blood work was ordered and completed and the dermatologist reported the ANA level result was high and advised to see a Rheumatologist. The Mother has a friend (patient) who has LUPUS. The Mother shared with her female friend (patient) what her daughter was experiencing and the patient reported the same thing happened to her after she got her Pfizer COvid-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lymphadenopathy, Mammogram, SARS-CoV-2 antibody test
Clinical narrative: swollen lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 : unknown manufacture), administration date: 28Feb2021, for immunization, reaction(s): "No adverse event"; Covid-19 vaccine (Dose 2: unknown manufacture.), administration date: 21Mar2021, for immunization, reaction(s): "No adverse event". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss and hair thinning shortly after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 82 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Route, Anatomical Location: right upper arm , Caller state she had them both in the beginning of last year, 2021.), administration date: 2021, for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "hair loss and hair thinning shortly after receiving the vaccine". Therapeutic measures were not taken as a result of alopecia.  Additional Information: Patient doctor and her dermatologist have already told her this might be related to the Pfizer-BioNTech COVID-19.All started not long after her second shot. Event had gotten definitely worse. AE(s) did not required a visit to emergency room, physician office,it had been a gradual thing that was getting more and more apparent. Patient had no prior vaccination within 4 weeks and had no AE following prior vaccinations. Patient had no family history relevant to AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200056623 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: menstrual irregularities; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual irregularities".  Additional information: Agent states her case number is #. Agent relays she has a caller on the line that is a HCP that has a patient that has had the 1st and 2nd dose of Pfizer Covid 19 vaccine. Agent relays that after the vaccine the patient had irregularities with her menstrual cycle. Agent relays that his question is if she can get the booster dose, is it alright for her to get that booster dose. Agent relays the callers license number.  Caller states that is a version of it. Caller is asking if the call handler can provide some information on that. Caller states this is turning into a marathon call, that just to be read the disclaimer it took over 5 minutes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: severe ongoing complications related to the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "severe ongoing complications related to the Covid vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Eye oedema
Clinical narrative: eye irritation; very large puffing eye that I could not open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE IRRITATION (non-serious), outcome "unknown", described as "eye irritation"; EYE OEDEMA (non-serious), outcome "unknown", described as "very large puffing eye that I could not open". The events "eye irritation" and "very large puffing eye that i could not open" were evaluated at the physician office visit. Therapeutic measures were taken as a result of eye irritation, eye oedema.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (PRD/SRD (18Feb2022): Follow-up activities closed. Batch/lot number not available.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, 'MANUFACTURER UNKNOWN'), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick after 2nd dose".  Additional Information: Reporter (Patients wife) was reporting about the Covid 19 Vaccine. Reporter stated that she got the shot last Mar and Apr. She got marble sized lumps under her arm after the 1st shot, and after the 2nd shot on 16Apr2021 she got a grapefruit sized lump and it's still there. Stated that she doesn't have any health insurance, but she did go to one doctor who looked at some cells under a microscope and said that she didn't see any cancer or anything. Caller states that she has not had any blood tests done because she can't afford it. During the call, Reporter stated that her husband got sick after his 2nd dose, but she did not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Body height, Immunisation, Nipple pain
Clinical narrative: Booster; booster shot that I had in my left arm affecting my left breast; since I had the immunization my nipple on my left breast is so sensitive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FK9896) at the age of 68 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Aortic valve replacement" (unspecified if ongoing), notes: Medical Condition: Consumer stated, "I have had a aortic valve replacement." (Captured in tab). Concomitant medication(s) included: WARFARIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NIPPLE PAIN (non-serious), outcome "unknown", described as "booster shot that I had in my left arm affecting my left breast; since I had the immunization my nipple on my left breast is so sensitive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nipple pain. Booster shot that the patient had in left arm affecting the patient's left breast; since the patient had the immunization nipple on patient's left breast was so sensitive.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: bad side effect after second vaccine/nausea; felt tired/zombie-like; massive headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Apr2021 12:00 (Lot number: EW0169) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Partial autonomic seizure", start date: 01Mar2015 (ongoing), notes: Illness/AE: Partial autoimmune seizure, Onset date:01Mar2015, Stop date: ongoing; "Hypothyroidism", start date: 01Jan2005 (ongoing), notes: Illness/AE: Hypothyroidism, Onset date:01Jan2005, Stop date: ongoing. Concomitant medication(s) included: KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE] taken for autonomic seizure, start date: 2015 (ongoing); LAMICTAL XR taken for autonomic seizure, start date: 2015 (ongoing); LEVOTHYROXIN taken for hypothyroidism, start date: 2005 (ongoing); PRENATAL + DHA taken for pregnancy, start date: Aug2021 (ongoing); B6 taken for pregnancy, start date: Oct2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date / Time, Date: 30Mar2021, Time (24hr): 12:00 PM CST(approx), Site and Route of injection, Anatomical Site of injection: Rt arm, intramuscular, Batch/Lot number: lot ER8734), administration date: 30Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 22Apr2021, outcome "unknown", described as "bad side effect after second vaccine/nausea"; FATIGUE (non-serious) with onset 22Apr2021, outcome "unknown", described as "felt tired/zombie-like"; HEADACHE (non-serious) with onset 22Apr2021, outcome "recovered" (May2021), described as "massive headaches". Therapeutic measures were taken as a result of headache. Additional information: Family history was reported as follows: The patient's mother had High Blood pressure and kidney problems. The patient's sister had diabetic type 1 at the age 7 (1991). The patient stated that her father had heart attack in 2017 due to high BP and cholesterol. Her grandmother (Mother's Side) had breast cancer and died at age 41 and grandfather had Congestive heart failure and died at age of 81. Her other grandfather from father's side had heart attack and stroke and died in Oct2001. Her uncle died due to heart attack in Jun2021. Her aunt died in 2020 due to heart attack and overweight/obese. The patient reported that she was not pregnant at the time of first and second vaccine. Had bad side effect after second vaccine/nausea (hung over toiled 4 hours after shot, over toilet for approx. 2 hours) felt tired/zombie like, massive headaches which she took migraine medicine (maxalt). Headaches lasted 2 weeks. Symptoms started within hours after vaccine. Patient was pregnant from 15Sep2021 and due date was 22Jun2022. No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: My lymph node in my right armpit has swelled immensely and is severely painful; My lymph node in my right armpit has swelled immensely and is severely painful; fatigue is moderate; the muscle of the injection site is moderately sore; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 23-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Feb2022 (Lot number: FJ6369) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Right), administration date: 26Apr2021, when the patient was 23 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right), administration date: 06Apr2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 06Feb2022, outcome "recovering" and all described as "My lymph node in my right armpit has swelled immensely and is severely painful"; FATIGUE (non-serious) with onset 06Feb2022, outcome "recovering", described as "fatigue is moderate"; VACCINATION SITE PAIN (non-serious) with onset 06Feb2022, outcome "recovering", described as "the muscle of the injection site is moderately sore". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, fatigue, vaccination site pain. Additional information included a covid tested post vaccination was not performed and since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Chills, Dyspnoea, Feeling abnormal
Clinical narrative: he got sick with chills; he got sick with chills; a burning up fever; body pain; shortness of breath; His legs are on fire/His head is on fire.; his body is hurting all over including his chest; He feels miserable.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown , single for covid-19 immunisation. Relevant medical history included: "insulin dependent diabetic" (unspecified if ongoing), notes: insulin dependent diabetic; "60% blockage already on his heart" (unspecified if ongoing), notes: 60% blockage already on his heart; "he had Covid before" (unspecified if ongoing), notes: he had Covid before; "Kidneys are shot" (unspecified if ongoing), notes: Kidneys are shot; "The caller had the antibody infusion" (unspecified if ongoing), notes: The caller had the antibody infusion so he had to wait 90 days to get the vaccine. The patient took concomitant medications. The following information was reported: CHILLS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "he got sick with chills"; PYREXIA (non-serious), outcome "unknown", described as "a burning up fever"; PAIN (non-serious), outcome "unknown", described as "body pain"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; BURNING SENSATION (non-serious), outcome "unknown", described as "His legs are on fire/His head is on fire. "; CHEST PAIN (non-serious), outcome "unknown", described as "his body is hurting all over including his chest"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He feels miserable. ".  Additional Information: The patient was on blood thinners, and they still gave the vaccine to him. He is waiting for his arm to heal up to start dialysis treatment. Description of Product Complaint: The reporter on the line reporting that after getting the Pfizer COVID-19 vaccine he got sick with chills, a burning up fever, his body is hurting all over including his chest, and he is having shortness of breath. It sounds like the vaccine gave him Covid, and he had Covid before. The caller had the antibody infusion, so he had to wait 90 days to get the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: he got sick with chills; he got sick with chills; a burning up fever; body pain; shortness of breath; His legs are on fire/His head is on fire.; his body is hurting all over including his chest; He feels miserable.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown , single for covid-19 immunisation. Relevant medical history included: "insulin dependent diabetic" (unspecified if ongoing), notes: insulin dependent diabetic; "60% blockage already on his heart" (unspecified if ongoing), notes: 60% blockage already on his heart; "he had Covid before" (unspecified if ongoing), notes: he had Covid before; "Kidneys are shot" (unspecified if ongoing), notes: Kidneys are shot; "The caller had the antibody infusion" (unspecified if ongoing), notes: The caller had the antibody infusion so he had to wait 90 days to get the vaccine. The patient took concomitant medications. The following information was reported: CHILLS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "he got sick with chills"; PYREXIA (non-serious), outcome "unknown", described as "a burning up fever"; PAIN (non-serious), outcome "unknown", described as "body pain"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; BURNING SENSATION (non-serious), outcome "unknown", described as "His legs are on fire/His head is on fire. "; CHEST PAIN (non-serious), outcome "unknown", described as "his body is hurting all over including his chest"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He feels miserable. ".  Additional Information: The patient was on blood thinners, and they still gave the vaccine to him. He is waiting for his arm to heal up to start dialysis treatment. Description of Product Complaint: The reporter on the line reporting that after getting the Pfizer COVID-19 vaccine he got sick with chills, a burning up fever, his body is hurting all over including his chest, and he is having shortness of breath. It sounds like the vaccine gave him Covid, and he had Covid before. The caller had the antibody infusion, so he had to wait 90 days to get the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Pruritus, Rash
Clinical narrative: Severe rash and itching; Severe rash and itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 (Lot number: FF8841) at the age of 82 years as dose 3 (booster), single, administered in arm right, administration date 15Feb2021 (Lot number: EN6201) as dose 2, single and administered in arm right, administration date 28Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Vaccine Name: Flu shot, Manufacturer: , Lot Number: Unknown, Route: Unknown, Anatomical Location: Right arm). The following information was reported: PRURITUS (non-serious), RASH (non-serious) all with onset 28Jan2021, outcome "not recovered" and all described as "Severe rash and itching". The event "severe rash and itching" and "severe rash and itching" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, rash.  Follow-up (09Feb2022): This is a spontaneous follow-up report received from a contactable consumer. This 81-year-old male consumer reported that: Updated information included: Patient Details. Lab data. Start Date/Time, Stop Date/Time, Lot #, Anatomical Location of all doses, Vaccine Facility Information. Onset Date/Time, Outcome of Event of all AEs.  Follow-up (09Feb2022): This is a spontaneous follow-up report received from the same contactable consumer. Additional information included all 3 shots, the last one on 08Jul2021. After each one, within 2 days started to break out in a terrible rash and itching. Also after each shot, the rash was worst. The first and second  had was on his back, front from the waste on up plus on both arms. Lasted about 6-8weeks. The 3rd one was the same plus on his legs to the top of his feet.  Follow-Up (14Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Pruritus, Rash, Vaccine positive rechallenge
Clinical narrative: Severe rash and itching; Severe rash and itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 (Lot number: FF8841) at the age of 82 years as dose 3 (booster), single, administered in arm right, administration date 15Feb2021 (Lot number: EN6201) as dose 2, single and administered in arm right, administration date 28Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Vaccine Name: Flu shot, Manufacturer: , Lot Number: Unknown, Route: Unknown, Anatomical Location: Right arm). The following information was reported: PRURITUS (non-serious), RASH (non-serious) all with onset 28Jan2021, outcome "not recovered" and all described as "Severe rash and itching". The event "severe rash and itching" and "severe rash and itching" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, rash.  Follow-up (09Feb2022): This is a spontaneous follow-up report received from a contactable consumer. This 81-year-old male consumer reported that: Updated information included: Patient Details. Lab data. Start Date/Time, Stop Date/Time, Lot #, Anatomical Location of all doses, Vaccine Facility Information. Onset Date/Time, Outcome of Event of all AEs.  Follow-up (09Feb2022): This is a spontaneous follow-up report received from the same contactable consumer. Additional information included all 3 shots, the last one on 08Jul2021. After each one, within 2 days started to break out in a terrible rash and itching. Also after each shot, the rash was worst. The first and second  had was on his back, front from the waste on up plus on both arms. Lasted about 6-8weeks. The 3rd one was the same plus on his legs to the top of his feet.  Follow-Up (14Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Rash, SARS-CoV-2 test
Clinical narrative: swollen eyes; rash present on neck and shoulders; debilitating headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 15:45 (Lot number: FK5127) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dairy allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D3. The following information was reported: EYE SWELLING (non-serious) with onset 22Jan2022 18:00, outcome "recovered", described as "swollen eyes"; RASH (non-serious) with onset 22Jan2022 18:00, outcome "recovered", described as "rash present on neck and shoulders"; HEADACHE (non-serious) with onset 22Jan2022 18:00, outcome "recovered", described as "debilitating headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eye swelling, rash. Therapeutic measures were not taken as a result of headache.  Additional Information: No other vaccine in four weeks. Other medications in two weeks: Vitamin C, Vitamin D3. The patient received the first dose on Friday afternoon. By Saturday afternoon she had a debilitating headache. Sunday, she had swollen eyes and rash present on neck and shoulders, no signs of respiratory distress. Benadryl had to be given for 48 hours every 4 hours to help reduce rash and eye swelling. Throughout the week rash present on body. No covid prior vaccination. Covid tested post vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: light headed/dizzy; a little confused sometimes; monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round; monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jan2022 10:30 (Lot number: FJ5682) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bipolar 2" (unspecified if ongoing); "depression" (unspecified if ongoing); "GAD" (unspecified if ongoing); "PMDD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "allergies to Avocado" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included: LAMICTAL. The following information was reported: POLYMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 17Jan2022, outcome "recovering" and all described as "monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round"; DIZZINESS (non-serious), outcome "not recovered", described as "light headed/dizzy"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "a little confused sometimes". The patient reported that monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round. The second round was 3 days ago, and she was still light headed, dizzy, and a little confused sometimes. Therapeutic measures were not taken as a result of polymenorrhoea, heavy menstrual bleeding, dizziness, confusional state. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypoacusis, SARS-CoV-2 test
Clinical narrative: hard of hearing; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (086396).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "kidney stones" (unspecified if ongoing); "gastric issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Feb2022, outcome "unknown" and all described as "tested positive for COVID"; HYPOACUSIS (non-serious), outcome "unknown", described as "hard of hearing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Feb2022) positive.  Additional information: The reporter was taking encorafenib (Braftovi) and she was tested positive for COVID-19 with home test and at the clinic she also tested positive. It was also reported that her husband had also had the vaccine and had showed all the little symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: breakthrough case of Covid-19; breakthrough case of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 56-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "Limitedscleroderma" (unspecified if ongoing); "Adult asthma" (unspecified if ongoing); "reynaud's phenomenon" (unspecified if ongoing), notes: Echolacea, and Reynaud's phenomenon. All of which were prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough case of Covid-19".  Clinical Course: Underlying health conditions: GERD, Limited Scleroderma, Adult Asthma, Echolacea, and Reynaud's phenomenon. All of which were prior to vaccination. Issue: She has a mild case of Covid 19, and is currently quarantining and has not needed hospitalization at this time   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Optic ischaemic neuropathy, SARS-CoV-2 test
Clinical narrative: Lost vision on my right eye; Diagnosed with ischemic optic neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 18Jan2021, when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: BLINDNESS (disability) with onset 04Oct2021, outcome "not recovered", described as "Lost vision on my right eye"; OPTIC ISCHAEMIC NEUROPATHY (disability) with onset 04Oct2021, outcome "not recovered", described as "Diagnosed with ischemic optic neuropathy". The events "lost vision on my right eye" and "diagnosed with ischemic optic neuropathy" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of blindness, optic ischaemic neuropathy. Addition information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Hospitalization Prolonged was none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Sneezing, Urticaria
Clinical narrative: I'm experiencing chronic (5 months) body itching; hives; redness; rashes; sneezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (medically significant) with onset Aug2021, outcome "not recovered", described as "I'm experiencing chronic (5 months) body itching"; URTICARIA (medically significant) with onset Aug2021, outcome "not recovered", described as "hives"; ERYTHEMA (medically significant) with onset Aug2021, outcome "not recovered", described as "redness"; RASH (medically significant) with onset Aug2021, outcome "not recovered", described as "rashes"; SNEEZING (medically significant) with onset Aug2021, outcome "not recovered", described as "sneezing". Therapeutic measures were taken as a result of pruritus, urticaria, erythema, rash, sneezing. Addition information: The patient wonder known whether he need to take a booster shot (whether is it a Moderna's requirement). It was reported that: I've been taking Zyrtec (anti-histamine) and it greatly helps me so much, but after 24 hours, my body starts itching and redness again all over my body, then I have to take Zyrtec to relieve the itchiness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Gait disturbance, Myalgia, Vaccination site pain
Clinical narrative: now experiencing chest pain; he is having a hard time walking; muscle pain; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administration date 09Feb2022 (Lot number: FL3197) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, ), administration date: 17May2021, when the patient was 14 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2, ), administration date: 07Jun2021, when the patient was 14 years old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10Feb2022, outcome "not recovered", described as "now experiencing chest pain"; GAIT DISTURBANCE (non-serious) with onset 10Feb2022, outcome "unknown", described as "he is having a hard time walking"; MYALGIA (non-serious) with onset 10Feb2022, outcome "unknown", described as "muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 10Feb2022, outcome "unknown", described as "pain at the injection site". Therapeutic measures were taken as a result of chest pain, gait disturbance, myalgia, vaccination site pain.  Additional information: It was reported She says she does not have her son's vaccine card with her to provide NDC/LOT/EXP for the first two doses. Stated her son started having chest pain this morning, and when she called him he said he still has pain but did not say if it was worse or the same. She says she told him to take regular Tylenol that she has at home and put some ice on the pain on his leg, which is muscle pain on the right side. She says he is having a hard time walking and putting pressure on it, he has pain that is pretty bad pain. She says the chest pain, muscle pain, and injection site pain all started today because yesterday when she asked he said nothing hurt, it started this morning. She also stated that the whole family got COVID, and they had all got booster, and her son got to 6 months already so just in case, he got COVID booster. Caller clarifies that they had all gotten the booster dose last month except her son, and says then we all got infected, in the last couple weeks ago the family all tested positive except him.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Dizziness, Hypertension
Clinical narrative: severe dizziness; high BP 180/90; legs feeling like on ''fire''; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2022 08:45 (Lot number: 33036BD) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number: EL 1284, administrator route=Intramuscular, Left arm), administration date: 29Dec2020, when the patient was 51 years old, for COVID-19 immunization, reaction(s): "Nausea", "Vomiting", "multiple episodes of diarrhea", "weight dropped from 107 lb to 104lb in 2 days", "could not work the day of vaccine administration". The following information was reported: DIZZINESS (non-serious) with onset 09Feb2022, outcome "unknown", described as "severe dizziness"; HYPERTENSION (non-serious) with onset 09Feb2022, outcome "unknown", described as "high BP 180/90"; BURNING SENSATION (non-serious) with onset 09Feb2022, outcome "unknown", described as "legs feeling like on ''fire''". The events "severe dizziness", "high bp 180/90" and "legs feeling like on ''fire''" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, hypertension, burning sensation.  Additional information: Vaccination facility: Doctor's office/urgent care. No other vaccine in four weeks. Patient received treatment for events with Observation. Patient had no covid prior vaccination. patient was not tested for covid post vaccination. had no Known allergies. It was reported patient could not work the day of vaccine administration.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mood altered, Somnolence
Clinical narrative: so sleepy; tired; fatigue; not in the mood to talk to anyone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "so sleepy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MOOD ALTERED (non-serious), outcome "unknown", described as "not in the mood to talk to anyone".  Additional information: Clinical course: It was reported that patient was so sleepy and tired after the first dose of the Pfizer. The patient cannot be falling asleep halfway through the day and want to confirm that she was calling about the covid vaccine. Wants to know why she is so sleepy, is this a known side effect. Has Pfizer heard a lot about fatigue after the vaccine. The patient was not in the mood to talk to anyone. She was going to get her lawyer after she gets off the phone. Patient concern was why (incomplete sentence) she get the shot, the Pfizer. She should have got the Moderna. Why she always sleepy, all the time now. Is that one of the side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.