chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nervousness, Tinnitus
Clinical narrative: humming of my ears and head and that is really scaring me; ''because'' of distance it sounds like air conditioner or something; I am really nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Nov2021, outcome "unknown", described as "humming of my ears and head and that is really scaring me; ''because'' of distance it sounds like air conditioner or something"; NERVOUSNESS (non-serious) with onset Nov2021, outcome "unknown", described as "I am really nervous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: When paraphrased the concern, consumer stated, " Yes, a humming kind of a (incomplete sentence), 'because' of distance it sounds like air conditioner or something and it is really scary and it started up after I had the booster vaccination, Pfizer booster."
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is a bit sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (167798). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second dose), for Covid-19 Immunization, reaction(s): "flu symtoms after my second original Covid vaccination". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is a bit sore".  Additional information: Reporter reported that he got his Pfizer Covid booster today. Arm was a bit sore, but so far no other side effects (got some mild flu symptoms after his second original Covid vaccination, but rather have those side-effects than the virus).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: he his having homoerotic dreams that he did not have before getting the vaccines; states they started after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: 301458A) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABNORMAL DREAMS (non-serious) with onset Oct2021, outcome "unknown", described as "he his having homoerotic dreams that he did not have before getting the vaccines; states they started after the first dose".  Additional Information: Investigation Assessment: Not Provided. Patient had reported that he was having homoerotic dreams that he did not have before getting the vaccines and they started after the first dose. It has impacted his marriage, stated he was really having an issue with the fantasies he was experiencing.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms after my second original Covid vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old 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: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms after my second original Covid vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain
Clinical narrative: After 2nd dose I will let you know as time continues but 24 hours later I have chronic pain all over my body, joints the worse, can't walk.; After 2nd dose I will let you know as time continues but 24 hours later I have chronic pain all over my body, joints the worse, can't walk. This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 16:30 (Lot number: 32030BD) at the age of 56 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 number: 1, Product: COVID 19, Brand: Pfizer, lot number: 30125BA, dose Administration date: 24Oct2021, Administration time: 01:00 PM, Vaccine location: Right arm), administration date: 24Oct2021, when the patient was 56 years old, for Covid-19 Immunization, reaction(s): "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.", "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.", "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.", "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.". The following information was reported: GAIT INABILITY (non-serious), PAIN (non-serious) all with onset 15Nov2021, outcome "unknown" and all described as "After 2nd dose, she will let you know as time continues but 24 hours later she had chronic pain all over her body, joints the worse, can't walk.".  Additional Information: After 2nd dose, the patient will let you know as time continues but 24 hours later she had chronic pain all over her body, joints the worse, can't walk. The patient has not had Covid prior to vaccination and post-vaccination. No other vaccines were administered in four weeks. She has not received treatment for events, she did not test with the Covid test post-vaccination. She had no Covid vaccination prior.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: sharp pain in her stomach; feeling a really tightening in the top of her stomach, like a knot per say; 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 50 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Nov2021 11:30 (Lot number: 330268D) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (ongoing), notes: diagnosed like 30 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:01, Lot: 320308D), administration date: 25Oct2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 15Nov2021, outcome "not recovered", described as "sharp pain in her stomach"; ABDOMINAL DISCOMFORT (non-serious) with onset 15Nov2021, outcome "not recovered", described as "feeling a really tightening in the top of her stomach, like a knot per say".  Additional information: Is report related to a study or programme- No. No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Vomiting
Clinical narrative: He vomited on 14Nov.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 9-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 16:30 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), administered in arm, administration date 10Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VOMITING (non-serious) with onset 14Nov2021, outcome "recovered" (14Nov2021), described as "He vomited on 14Nov.". Therapeutic measures were not taken as a result of vomiting.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 1 day after; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 18:15 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2021 06:45, outcome "recovered" (10Nov2021), described as "sore arm for 1 day after". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks, no other medications in two weeks, no treatment ae, no covid prior vaccination, no covid tested post vaccination. There was known allergies: seasonal allergies and no other medical history.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Lot number: EW017) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1997 (ongoing); "Osteoarthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Batch/lot number: EW0150, Location: upper left arm), administration date: 06Apr2021, when the patient was 82 years old, for Covid-19 immunization, reaction(s): "left a blood red spot on her arm the size of a dime and bumping on that spot", "left a blood red spot on her arm the size of a dime and bumping on that spot", "had a sore left arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore left arm".  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Polymenorrhoea
Clinical narrative: menstrual cycle started full week earlier than due; Administration date=06May2021, dose number=1/administration date=08Nov2021, dose number=2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Lot number: FG3527) at the age of 44 years as dose 2, 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 1, single, Batch/Lot No: ew0176, Location of injection: Arm Left), administration date: 06May2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Nov2021, outcome "unknown", described as "Administration date=06May2021, dose number=1/administration date=08Nov2021, dose number=2"; POLYMENORRHOEA (non-serious) with onset 13Nov2021, outcome "recovering", described as "menstrual cycle started full week earlier than due". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of polymenorrhoea.  Additional Information :Patient had not received any other vaccines within 4 weeks before COVID vaccine and previously patient had diagnosed with COVID-19 POSITIVE and not tested for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nightmare, Tinnitus
Clinical narrative: sickest; nightmare; Tinnitus/her ears started ringing really bad.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 (Lot number: EW0179) at the age of 30 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 (1st dose, Lot Number: EW0179, Left arm), administration date: 18Jun2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset Jul2021, outcome "recovered", described as "sickest"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus/her ears started ringing really bad."; NIGHTMARE (non-serious) with onset Jul2021, outcome "unknown", described as "nightmare". The event "tinnitus/her ears started ringing really bad." was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Inappropriate schedule of product administration, Overdose
Clinical narrative: dizzy; health raced like if I was running for my life and thought I was going to pass out. The worst feeling ever.; I was given 2 shots of the vaccine in the same day; I was given 2 shots of the vaccine in the same day; 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 38 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 17:00 (Lot number: FF2530) at the age of 38 years as dose 1, single and administered in arm left, administration date 12Nov2021 17:00 (Lot number: FF2530) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 2021, outcome "unknown" and all described as "I was given 2 shots of the vaccine in the same day"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "health raced like if I was running for my life and thought I was going to pass out. The worst feeling ever.".  Additional Information: Pharmacist administered both dose of covid-19 vaccine without notifying me he was. He only told me after the fact that I was already poked. I felt like cattle and not sure of the effectiveness of this process since every article I read there has to be a couple of weeks between doses. There was not an observation period after the vaccine either.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: I read it from the vaccine that one of the side effect on the paper that is on heart/noticed every beat in arteries/I am not going, able to live with this kind of heartbeat forever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 (Lot number: ER8730) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: LISINOPRIL taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset 23May2021, outcome "unknown", described as "I read it from the vaccine that one of the side effect on the paper that is on heart".  Additional Information:The patient did not remember the exact date, was right after she took the second shot, she realized that. She noticed every beat in arteries said that she not going, able to live with this kind of heartbeat forever. She was not taking any medication for the problem. She went to the doctor twice about the problem and they claim that, they not seen the reason why this problem was happening.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine; She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 (Lot number: EW0176) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD", start date: Mar2021 (unspecified if ongoing), notes: Patient Medical start date: Mar2021, Patient Medical comments: Verbatim: COPD; "Covid-19", start date: Feb2021 (unspecified if ongoing), notes: She had Covid back in February prior to the vaccine. She got vertigo bad with covid virus when she had it back in Feb2021.; "She got vertigo bad with covid virus", start date: 2021 (unspecified if ongoing), notes: She got vertigo bad with covid virus when she had it back in Feb2021.; "had surgery in Apr2021", start date: Apr2021 (unspecified if ongoing), notes: had surgery in Apr2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 07Apr2021 at 08:40am, Lot: ER8729, Expiration: unknown, Clinic Site: (withheld)), administration date: 07Apr2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "had headaches with first two doses of covid vaccine".  The following information was reported: HEADACHE (non-serious), DIZZINESS (non-serious) all with onset 2021, outcome "unknown" and all described as "She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine".  Additional Information: Prior vaccination, the patient did not receive any vaccination within 4 weeks. The patient had no relevant family medical history. No relevant tests were done. She had Covid back in February prior to the vaccine. She got vertigo bad with covid virus when she had it back in Feb2021 and was prescribed meclizine by her doctor. States she took meclizine after experiencing dizziness after the covid vaccine and it did not help a whole lot. She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101573064 similar report from same reporter;US-PFIZER INC-202101594340 1st dose, BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Pain in extremity
Clinical narrative: prednisone administered to her 7-year-old daughter interacts with the first dose; Little sore arm; 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 7 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "postnasal drip symptoms" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE ACETATE. The following information was reported: DRUG INTERACTION (non-serious) with onset 2021, outcome "unknown", described as "prednisone administered to her 7-year-old daughter interacts with the first dose"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Little sore arm".  Additional information included: Prednisone was administered to her 7-year-old daughter interacted with the first dose of the Pfizer-BioNTech COVID-19 vaccine that she received a day before reporting. The mother explained due to her daughter's postnasal drip symptoms from her allergy, she gave her 10 ml of prednisone yesterday and 5 ml today. She explained her daughter had no reactions to the vaccines besides a little sore arm.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swollen, itchy, hot spot under my injection site.; Swollen, itchy, hot spot under my injection site.; body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:00 (Lot number: Ff2590) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing), notes: Other medical history: Hashimotos thyroiditis; "Nickle Allergy" (unspecified if ongoing), notes: Known allergies: Nickle. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EW0158, prev dose lot unknown: False, prev dose administration date: 08Apr2021, prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 08Apr2021, when the patient was 39 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er8727, prev dose lot unknown: False, prev dose dose number: 1), for Covid-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 14Nov2021, outcome "not recovered" and all described as "Swollen, itchy, hot spot under my injection site."; PAIN (non-serious) with onset 14Nov2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 14Nov2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of injection site swelling, injection site pruritus, pain, fatigue.  Additional information: No other vaccine in four weeks and other medications in two weeks was levothyroxine. It was reported that, patient was swollen, itchy, hot spot under her injection site. 3 inches by 2 inches. She first noticed it about 36 hours after her booster shot. Its been about 20 hours since that and it was still there. She experienced body aches and fatigue before that. No covid prior vaccination and not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Malaise, Vomiting
Clinical narrative: Feeling sick with the stomach; Really bad pain; pain in the stomach; Diarrhea; Vomiting; Feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "not recovered", described as "Feeling sick with the stomach"; ABDOMINAL PAIN UPPER (non-serious) with onset Nov2021, outcome "not recovered", described as "Really bad pain; pain in the stomach"; DIARRHOEA (non-serious) with onset Nov2021, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset Nov2021, outcome "not recovered", described as "Vomiting"; MALAISE (non-serious) with onset Nov2021, outcome "not recovered", described as "Feeling sick".  Additional information: My wife went to get her booster shot (Clarified as COVID-19 Vaccine) last week on Thursday and then she started feeling sick Friday and then Friday she started feeling sick and then till today she is feeling sick with the stomach, really bad pain, diarrhea and vomiting. She got no headache, cold or nothing, it is just the pain in the stomach."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Mar2021 13:20 (Lot number: EP6955) as dose 2, single and intramuscular, administration date 09Mar2021 13:20 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heartburn", start date: 01Nov2020 (ongoing), notes: Pertinent details: Correctly Taking Famotidine 2x daily; "Acid Reflux", start date: 01Nov2020 (ongoing), notes: Acid Reflux, Pertinent details: Correctly Taking Famotidine 2x daily. Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease, start date: Jul2021 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Mild soreness at site of injection".  Additional information: Patient did not experience any side effects from first two shots except for mild soreness at site of injection. The vaccination facility type was workplace clinic. Prior vaccinations was none.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: administered a full vial of the purple cap covid vaccine as a single dose; sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient in his 50's received bnt162b2 (BNT162B2), administered in deltoid left, administration date 13Nov2021 (Lot number: FD0809) 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: OVERDOSE (non-serious) with onset 13Nov2021, outcome "unknown", described as "administered a full vial of the purple cap covid vaccine as a single dose"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "sore arm".  Additional information: Reporter reported that Patient was inadvertently administered a full vial of the purple cap covid vaccine as a single dose. What are the recommendations for proceeding with the second vaccination in series? the nurse had not done these vaccines before and didn't want to wait for the other nurse to come explain it, so she just grabbed a vial and administered the full vial without diluting. The patient reported he had a sore arm for only a day and then it was fine. No other AEs reported. He was planning on getting the second dose at the scheduled interval. She has not heard anything new from the patient and he has not gotten his second dose yet. He was due for it, but since he has not come in yet she's not sure if he was waiting. The patient had not reported any adverse events to them since the overdose event. Phone answered by reporter who provided an update. She said the patient is still doing well so no new adverse events to report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Depression, Insomnia
Clinical narrative: anxiety; depression; insomnia; anxiety, depression and insomnia have all intensified; 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 female patient received bnt162b2 (COMIRNATY) (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: "Depression" (unspecified if ongoing), notes: She has a history of depression and anxiety; "Anxiety" (unspecified if ongoing), notes: She has a history of depression and anxiety. The patient's concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "anxiety"; DEPRESSION (non-serious), outcome "unknown", described as "depression"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "anxiety, depression and insomnia have all intensified".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Having altered smell and taste; Having altered smell and taste; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EL9266) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing), notes: Verbatim: Autoimmune disease; "Allergies" (unspecified if ongoing), notes: Verbatim: Allergies; "COVID-19" (unspecified if ongoing), notes: Verbatim: if Covid prior vaccination: Yes. Concomitant medication(s) included: VENLAFAXINE; HYDROXYCHLOROQUINE. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 28Feb2021, outcome "not recovered" and all described as "Having altered smell and taste". Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional information: Had no seriousness criteria-resulted in death, no seriousness criteria was life threatening, no seriousness criteria-caused/prolonged hospitalization, no seriousness criteria was disabling/incapacitating, no seriousness criteria caused congenital anomaly/birth defect, had no other vaccine in four weeks, other medications in two weeks included: low ogestrel, los. Patient was not able to stand to be within certain smells. Coffee, meat, onions, white wine, soda, and all fried food  were just some examples. He was impaired to the point he could not eat some meals with her family. Not received  treatment ae, had covid prior vaccination, had not covid tested post vaccination. no timestamp: 16nov2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test positive, Fatigue, Headache, Pain in extremity
Clinical narrative: Headaches; fatigue; extreme arm Soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "extreme arm Soreness". 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.  Follow-up activities Closed : As Reporter Denied for further contact. No further information expected. (Reporter does not wish to be contacted for follow-up).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Feeling worn down; Fall asleep prior to meeting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female 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: Bnt162b2 (Dose Number: 1, product=COVID 19, brand unknown=True, brand name unknown=COVID19 Vaccine), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Feeling worn down"; SOMNOLENCE (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Fall asleep prior to meeting".  Additional information: Clinical course: It was reported that fully vaccinated individual reported feeling worn down after attending football game and other event. Caused them to fall asleep prior to meeting. They were worried it was covid but I never got it confirmed from them whether or not it was. Patient submitted an AE for this before, but have not seen the follow up, and she was worried it didn't go through or forgot. Colleague said that they went to a college football game and then another event over weekend of 24Sep2021 and then were really worn down in the following couple of days. They accidentally fell asleep at one point. Patient unsure what vaccine they have, and believe they were tested for covid following this but patient unsure the results. Patient also not certain of other symptoms. Individual seems to have made a full recovery based on interactions with them. Patient awareness date is Monday 27Sep2021, but she was not sure if anyone else heard. Again, believe submitted for this before, but just did not hear a follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: diarrhea; nausea; headache(next day); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Nov2021 15:00 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (ongoing); "Tubes out in ears" (unspecified if ongoing), notes: put in about age 3; "headaches" (unspecified if ongoing); "stomach issues" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: DIARRHOEA (non-serious) with onset 15Nov2021, outcome "recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 09Nov2021, outcome "recovered", described as "headache(next day)"; NAUSEA (non-serious) with onset 10Nov2021, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of diarrhoea, headache, nausea.  Additional Information: Patient did not have any other vaccine in four weeks. She had no known allergies and did not have covid prior and post vaccination. Patient received second dose on 01Dec2021 10:45 with Lot number: FK5127 in the right arm, intramuscularly. Patient did not have a bowel movement for few days and diarrhoea symptoms went away within 24 hrs. No symptoms after second dose.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity
Clinical narrative: Slight Soreness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jan2021 18:00 (Lot number: EN5318) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild Hypothyroidism", start date: 2019 (ongoing), notes: Take Synthroid (Levothyroxine); "Ulcerative colitis", start date: 2019 (ongoing), notes: Use Remicade & 10 wks infusion. immunosuppressed due to the use of the TNF blocker REMICADE for UC; "CA R+ Breast", start date: 2002, stop date: Jul2002, notes: Lumpectomy- no lymphs involvement- 4 chemo + radiation, No recurrence 19 years; "Pain" (ongoing); "Anti-inflammatory", start date: 2020 (ongoing); "immunosuppressed" (unspecified if ongoing), notes: immunosuppressed due to the use of the TNF blocker REMICADE for UC. Concomitant medication(s) included: CELECOXIB taken for antiinflammatory therapy, start date: 2020 (ongoing); ACETAMINOPHEN taken for pain; SYNTHROID taken for hypothyroidism (ongoing); REMICADE taken for colitis ulcerative, start date: 05Jul2021. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Slight Soreness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter considered the Pfizer product had a casual effect to the adverse event. Patient received dose 2 (Batch/Lot number: EL9269) on 19Feb2021 18:00 and dose 3 (Batch/Lot number: FF2588) on 07Sep2021 15:00. Use of medications that suppress the immune system (e.g., high dose of corticosteroids, cyclosporine, methotrexate, azathioprine and biologic therapies like rituximab and etanercept) Infliximab (Remicade) TNF blocker. Vaccination Facility Type: Pharmacy or Drug Store. Prior Vaccinations (within 4 weeks) was none. Relevant Tests was none. Specific Relevant Test for Thromboembolic events with Thrombocytopenia was none. Reporter stated that she was reporting this because she was one of those auto-immune patients not studied or not studied well in Covid vaccine testing/trials. Reporter thought this might be useful to get a feel for how booster reacted after 8+ weeks post Remicade. Reporter also sated that the autoimmune patients are some of many health groups you did little to no studies on when testing this drug. It was strictly because of the immunosuppression from medication that she took the third vaccine. Patient had no response to the first one, except a sore arm and a mild fever for a few hours on the second. When she received the third shot she was 8 weeks from her Remicade infusion, an her reaction was much greater.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: hair breakage; excessive hair loss; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TRICHORRHEXIS (non-serious), outcome "unknown", described as "hair breakage"; ALOPECIA (non-serious), outcome "unknown", described as "excessive hair loss". 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-202101599235 same reporter/drug/event, different pt;US-PFIZER INC-202101595686 same reporter/drug/event, different pt
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Restlessness, Weight decreased
Clinical narrative: Restless; Feet is so cold;  can''t warm up and when I get them warm, there is sweat; lost seven pounds; 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 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 16Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose: 02), administration date: 13Apr2021, for COVID-19 Immunization.  The following information was reported: RESTLESSNESS (non-serious) with onset 2021, outcome "unknown", described as "Restless"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Feet is so cold; can't warm up and when I get them warm, there is sweat"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost seven pounds".  Additional Information: Side effect: Consumer stated, "Okay, I am restless. Now my feet is so cold. I can't warm up and when I get them warm, there is sweat and I have lost seven pounds."  Follow-up (18Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eating disorder, Parosmia
Clinical narrative: After my second dose, this problem intensified to the point I cannot stand to be within certain smells. Coffee, meat, onions, white wine, soda, and all fried food are just some examples; I am impaired to the point I can't eat some meals with my family.; After my second dose, this problem intensified to the point I cannot stand to be within certain smells. Coffee, meat, onions, white wine, soda, and all fried food are just some examples; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EN6207) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing), notes: hypertension, depression, autoimmune disease, allergies; "depression" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "allergies" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination. Concomitant medication(s) included: OGESTREL-28; VENLAFAXINE; HYDROXYCHLOROQUINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose brand unknown: False, Prev dose Lot number: EL9266, Pev dose lot number: False, Prev dose vaccine location: Right arm), administration date: 26Feb2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "After my first dose, I started having altered smell and taste.", "After my first dose, I started having altered smell and taste.". The following information was reported: PAROSMIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "After my second dose, this problem intensified to the point I cannot stand to be within certain smells. Coffee, meat, onions, white wine, soda, and all fried food are just some examples"; EATING DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "I am impaired to the point I can't eat some meals with my family.". Therapeutic measures were taken as a result of parosmia, eating disorder, condition aggravated.  Additional information: Reported seriousness was non-serious. Patient had no Known allergies. Patient did not received other vaccine in four weeks. The patient received Ae treatment with Prednisone/Atarax. The patient not been tested for COVID-19 since the vaccination. Patient received other medication within 2 weeks of vaccination included los.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Menstruation irregular
Clinical narrative: irregular menstrual cycle/2 hours after injection started menstruating. This was 7 days earlier than my cycle should have started; lower back pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW0153) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 15Apr2021, outcome "unknown", described as "irregular menstrual cycle/2 hours after injection started menstruating. This was 7 days earlier than my cycle should have started"; BACK PAIN (non-serious) with onset 15Apr2021, outcome "unknown", described as "lower back pain"; HEADACHE (non-serious) with onset 15Apr2021, outcome "unknown", described as "headache".  Additional Information: Event Narrative: I received the Pfizer vaccine first dose 15Apr2021, and 2 hours after injection started menstruating. This was 7 day earlier than my cycle should have started and I have very regular, predictable cycle. I am not on any birth control or medication. The main side effect was lower back pain and headache.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101640778 Same patient, same product in different dose, partial same event