chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D, Vitamin D decreased, Weight
Clinical narrative: her Vitamin D has been low; arm being red and sore; arm being red and sore; arm is swollen and red; started to itch; 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 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 11:15 (Lot number: FE3592) at the age of 65 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diagnosed 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot FC3182), administration date: 02Sep2021, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Sep2021, outcome "not recovered" and all described as "arm being red and sore"; PERIPHERAL SWELLING (non-serious) with onset 26Sep2021, outcome "not recovered", described as "arm is swollen and red"; PRURITUS (non-serious) with onset 26Sep2021, outcome "not recovered", described as "started to itch"; VITAMIN D DECREASED (non-serious), outcome "not recovered", described as "her Vitamin D has been low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any Prior Vaccinations (within 4 weeks) of suspect vaccine. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Hives at injection site; Redness and hive at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Sep2021 17:00 (Lot number: EW0173) at the age of 12 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 number: 1, Batch/lot number : EW0182, Vaccine location : Left arm, Time: 16:30, Route of administration: Intramuscular), administration date: 19Aug2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE URTICARIA (non-serious) with onset 11Sep2021 20:00, outcome "recovered" (12Sep2021), described as "Hives at injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Redness and hive at injection site". Therapeutic measures were taken as a result of vaccination site urticaria, vaccination site erythema.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was application of cold compress and Zyrtec (Centirize HCl) via oral route and they cleared completely next day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Prior vaccinations (within 4 weeks) were none.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in the right forearm; shoulder joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8734) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in the right forearm"; ARTHRALGIA (non-serious), outcome "not recovered", described as "shoulder joint pain". The events "pain in the right forearm" and "shoulder joint pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of pain in extremity, arthralgia.  Additional information: One week after the first dose, the pain in the right forearm started till now (6 months). Later, he felt shoulder joint pain until now. The patient visited urgent care for arm pain and told the doctor he recently got COVID19 vaccine. The doctor said that the arm pain was due to the problem with his working gesture, like using computer for long time, so there was no treatment for the arm pain. Because he still have right lower arm and shoulder joint pains now and they happened just after he got vaccine, he believe that arm pain came from the vaccine. Prior to 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 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure via breast milk, Pyrexia
Clinical narrative: Vaccine exposure via breast milk; Fever and diarrhea in breastfeeding toddler; Fever and diarrhea in breastfeeding toddler; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 month-old patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 21Sep2021 15:30 (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: EXPOSURE VIA BREAST MILK (non-serious) with onset 22Sep2021, outcome "unknown", described as "Vaccine exposure via breast milk"; DIARRHOEA (non-serious), PYREXIA (non-serious) all with onset 22Sep2021, outcome "unknown" and all described as "Fever and diarrhea in breastfeeding toddler". Therapeutic measures were not taken as a result of exposure via breast milk, diarrhoea, pyrexia.  Additional information: Event Experienced: Vaccine exposure via breast milk (Vaccine exposure via breast milk), (Drug use in unapproved age group); Fever and diarrhea in breastfeeding toddler (Fever), (Diarrhea). Admission to hospital was not involved and notreceived any treatment as a result of adverse events. It was unknown whether patient was still experiencing events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: sore arm; sore injection site lasted for four days; tolerable small temperature raise in body temperature half a degree to a degree started twenty four hours later after injection and lasted for four days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Sep2021 (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: PAIN IN EXTREMITY (non-serious) with onset 07Sep2021, outcome "unknown", described as "sore arm"; VACCINATION SITE PAIN (non-serious) with onset 07Sep2021, outcome "unknown", described as "sore injection site lasted for four days"; PYREXIA (non-serious) with onset 07Sep2021, outcome "unknown", described as "tolerable small temperature raise in body temperature half a degree to a degree started twenty four hours later after injection and lasted for four days".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Feeling abnormal, Pain in extremity
Clinical narrative: sore arm; sore injection site lasted for four days; tolerable small temperature raise in body temperature half a degree to a degree started twenty four hours later after injection and lasted for four days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Sep2021 (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: PAIN IN EXTREMITY (non-serious) with onset 07Sep2021, outcome "unknown", described as "sore arm"; VACCINATION SITE PAIN (non-serious) with onset 07Sep2021, outcome "unknown", described as "sore injection site lasted for four days"; PYREXIA (non-serious) with onset 07Sep2021, outcome "unknown", described as "tolerable small temperature raise in body temperature half a degree to a degree started twenty four hours later after injection and lasted for four days".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: achiness; fever; chills; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Batch/Lot number: 30145BA) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; GABAPENTIN; LOSARTAN; LEVOTHYROXINE; AMLODIPINE. Vaccination history included: Bnt162b2 (First dose vaccine LOT# "EM98809"), administration date: 20Feb2021, for COVID-19 immunization; Bnt162b2 (Second dose Vaccine LOT#EN6206), administration date: 11Mar2021, for covid-19 immunization, reaction(s): "Fever". The following information was reported: PAIN (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "achiness"; PYREXIA (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When probed for the concern, consumer stated, that she had her Pfizer Booster Vaccination (Pfizer, Covid-19 Vaccine) yesterday and today she was fine until this evening. Now she got fever about 100 Degrees and kind of chills, Achy (ache).The patient did not receive any other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: achiness; fever; chills; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Batch/Lot number: 30145BA) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; GABAPENTIN; LOSARTAN; LEVOTHYROXINE; AMLODIPINE. Vaccination history included: Bnt162b2 (First dose vaccine LOT# "EM98809"), administration date: 20Feb2021, for COVID-19 immunization; Bnt162b2 (Second dose Vaccine LOT#EN6206), administration date: 11Mar2021, for covid-19 immunization, reaction(s): "Fever". The following information was reported: PAIN (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "achiness"; PYREXIA (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When probed for the concern, consumer stated, that she had her Pfizer Booster Vaccination (Pfizer, Covid-19 Vaccine) yesterday and today she was fine until this evening. Now she got fever about 100 Degrees and kind of chills, Achy (ache).The patient did not receive any other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain lasting more than two hours; Fever; 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 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 11:00 (Lot number: FC3592) at the age of 61 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Bnt162b2 (lot number=FD8448, Administration time=11:00 AM, Dose number=1, Vaccine location=Left arm), administration date: 05Sep2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Injection site pain lasting more than two hours"; PYREXIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were taken as a result of vaccination site pain, pyrexia, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications, the patient received within 2 weeks of vaccination: Levothyroxine at 125 mcg daily. No known allergies. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. The patient was treated with Aleve for reported events.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Erythema, Lymphadenopathy, Pruritus
Clinical narrative: Swollen armpit with soreness and knot; Itching of the scalp 2 areas of redness/Itching on face; Swollen armpit with soreness and knot; Itching of the scalp 2 areas of redness; Swollen armpit with soreness and knot; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 15:30 (Lot number: 30135BA) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: AXILLARY MASS (non-serious), AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 24Sep2021 16:00, outcome "recovering" and all described as "Swollen armpit with soreness and knot"; PRURITUS (non-serious) with onset 24Sep2021 16:00, outcome "recovering", described as "Itching of the scalp 2 areas of redness/Swollen armpit with "; ERYTHEMA (non-serious) with onset 24Sep2021 16:00, outcome "recovering", described as "Itching of the scalp 2 areas of redness". Therapeutic measures were not taken as a result of axillary mass, pruritus, axillary pain, erythema, lymphadenopathy.  Additional information: No other vaccine was taken by the patient in four weeks. Other medications in two weeks were taken. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Product use issue, Pruritus
Clinical narrative: Itching on Right Arm, on the outside of her arm; Flu Vaccine 09Aug2021/ Pfizer Covid Vaccine First Dose 09Aug2021; she didn't present her period since the first shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Aug2021 (Lot number: FD8498) at the age of 42 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 09Aug2021 (Batch/Lot number: unknown). Relevant medical history included: "Leep Procedure", start date: 2021, stop date: 2021; "Biopsy cervix", start date: 20Jul2021, stop date: 20Jul2021; "little bleeding from the biopsy" (unspecified if ongoing). Family history included: "she is fixed, she has had her tubes tied" (unspecified if ongoing). There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "she didn't present her period since the first shot."; PRURITUS (non-serious) with onset 09Aug2021, outcome "recovered" (09Aug2021), described as "Itching on Right Arm, on the outside of her arm"; PRODUCT USE ISSUE (non-serious) with onset 09Aug2021, outcome "unknown", described as "Flu Vaccine 09Aug2021/ Pfizer Covid Vaccine First Dose 09Aug2021". Therapeutic measures were not taken as a result of amenorrhoea, pruritus.  Additional information: Family medical history relevant to AE(s) were none. AE(s) following prior vaccinations were none. Prior vaccinations (within 4 weeks) were none. Ae(s) did not require a visit to emergency room or physician office. Time the vaccination was given was at afternoon to evening. The patient stated the biopsy was on 20Jul2021, and she doesn't know if she had a period in July, she was not positive of when she had her last period, it might have been the week prior to the biopsy. The patient stated she also had itching on her right arm on the outside of her arm. She had two different Band-Aids, so it could have been from the Band-Aids, but she hasn't had an allergy to them before. The patient stated it went away when she changed the Band-Aid.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Pain in neck; Pain in neck and arm including wrist; Pain in neck and arm including wrist; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Sep2021 12:45 (Lot number: 30145BA) at the age of 53 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes. Concomitant medication(s) included: INFLUENZA VACCINE, start date: 18Sep2021, stop date: 18Sep2021.  The following information was reported: NECK PAIN (non-serious) with onset 26Sep2021 11:00, outcome "recovering", described as "Pain in neck"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Sep2021 11:00, outcome "recovering" and all described as "Pain in neck and arm including wrist". Therapeutic measures were not taken as a result of neck pain, arthralgia, pain in extremity.  Additional information: Prior to vaccination, patient was diagnosed with COVID and Since the vaccination, patient has not been tested for COVID-19. case was assessed as non serious and patient was not Hospitalized.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Muscle spasms
Clinical narrative: Chest pain; Chest tightness; Chest cramping; Shortness of breath; Lightheaded/dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 12:00 (Lot number: FC3183) as dose 1, single and administered in arm left, administration date 12Sep2021 12:00 (Lot number: FF2587) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies: Naproxen". The following information was reported: CHEST PAIN (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Chest pain"; CHEST DISCOMFORT (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Chest tightness"; MUSCLE SPASMS (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Chest cramping"; DYSPNOEA (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 24Aug2021 20:30, outcome "not recovered", described as "Lightheaded/dizzy". The events "chest pain", "chest tightness", "chest cramping", "shortness of breath" and "lightheaded/dizzy" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of chest pain, chest discomfort, muscle spasms, dyspnoea, dizziness.  Additional information: Vaccine facility type was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies to Naproxen. Other medical history included Lyme Disease, Hypothyroidism, Fibromyalgia, Anxiety, Depression. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He also had a fever with the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: EL3302) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: Diagnosed about 15 years ago; "Blood pressure high" (unspecified if ongoing); "Heartburn" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing); PRILOSEC taken for dyspepsia (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot: EL1283, NDC: Unknown, Expiry Date:14Oct2021), administration date: 19Jan2021, when the patient was 51 years old, for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "He also had a fever with the 2nd dose".  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Headache; fatigue; diarrhea; mental foggy; sore in the area where shot was given; lightheaded; joints achy; This is a spontaneous report received from a contactable Other HCP. The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 12:45 (Lot number: 30145BA) at the age of 61 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "intermittent peritoneal dialysis" (unspecified if ongoing), notes: IPD; "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "fybromyalgia" (unspecified if ongoing). Concomitant medication(s) included: INSULIN RAPID; INSULIN N; PREDNISONE; IMURAN [AZATHIOPRINE]; THYROXINE. Past drug history included: Iodine; Zantac. The following information was reported: HEADACHE (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "fatigue"; DIARRHOEA (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "diarrhea"; FEELING ABNORMAL (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "mental foggy"; VACCINATION SITE PAIN (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "sore in the area where shot was given"; DIZZINESS (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "lightheaded"; ARTHRALGIA (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "joints achy". Therapeutic measures were not taken as a result of headache, fatigue, diarrhoea, feeling abnormal, vaccination site pain, dizziness, arthralgia.  Additional information: The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination as Insulin R and N, prednisone, Imuran, thyroxine, etc.. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; fatigue; diarrhea; mental foggy; sore in the area where shot was given; lightheaded; joints achy; This is a spontaneous report received from a contactable Other HCP. The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 12:45 (Lot number: 30145BA) at the age of 61 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "intermittent peritoneal dialysis" (unspecified if ongoing), notes: IPD; "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "fybromyalgia" (unspecified if ongoing). Concomitant medication(s) included: INSULIN RAPID; INSULIN N; PREDNISONE; IMURAN [AZATHIOPRINE]; THYROXINE. Past drug history included: Iodine; Zantac. The following information was reported: HEADACHE (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "fatigue"; DIARRHOEA (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "diarrhea"; FEELING ABNORMAL (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "mental foggy"; VACCINATION SITE PAIN (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "sore in the area where shot was given"; DIZZINESS (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "lightheaded"; ARTHRALGIA (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "joints achy". Therapeutic measures were not taken as a result of headache, fatigue, diarrhoea, feeling abnormal, vaccination site pain, dizziness, arthralgia.  Additional information: The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination as Insulin R and N, prednisone, Imuran, thyroxine, etc.. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Fatigue, Headache
Clinical narrative: Flashing lights in the far corner of right eye for 30 plus hours; fever of 101; headache; nausea; joint pain; weakness; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 10:00 (Lot number: EW0176) at the age of 61 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Foods" (unspecified if ongoing); "Known allergies: Chicken, beef" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: VIVELLE [ESTRADIOL]. The following information was reported: PHOTOPSIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "Flashing lights in the far corner of right eye for 30 plus hours"; PYREXIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "fever of 101"; HEADACHE (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "nausea"; ARTHRALGIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "joint pain"; ASTHENIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "weakness"; FATIGUE (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of photopsia, pyrexia, headache, nausea, arthralgia, asthenia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. Other medications the patient received within 2 weeks of vaccination: Vivelle Patch  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Photopsia, Pyrexia
Clinical narrative: Flashing lights in the far corner of right eye for 30 plus hours; fever of 101; headache; nausea; joint pain; weakness; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 10:00 (Lot number: EW0176) at the age of 61 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Foods" (unspecified if ongoing); "Known allergies: Chicken, beef" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: VIVELLE [ESTRADIOL]. The following information was reported: PHOTOPSIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "Flashing lights in the far corner of right eye for 30 plus hours"; PYREXIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "fever of 101"; HEADACHE (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "nausea"; ARTHRALGIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "joint pain"; ASTHENIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "weakness"; FATIGUE (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of photopsia, pyrexia, headache, nausea, arthralgia, asthenia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. Other medications the patient received within 2 weeks of vaccination: Vivelle Patch  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Sweating; Chills; Muscle aches; Diarrhea; Fever; Headache; This is a spontaneous report received from a 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 25Sep2021 11:00 (Lot number: 30135BA) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Pseudobulbar affect (PBA)" (unspecified if ongoing). Concomitant medication(s) included: NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE;QUINIDINE SULFATE DIHYDRATE]; SYNTHROID. The following information was reported: HYPERHIDROSIS (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Sweating"; CHILLS (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Chills"; MYALGIA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Muscle aches"; DIARRHOEA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Diarrhea"; PYREXIA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of hyperhidrosis, chills, myalgia, diarrhoea, pyrexia, headache.  Additional 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 had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sweating; Chills; Muscle aches; Diarrhea; Fever; Headache; This is a spontaneous report received from a 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 25Sep2021 11:00 (Lot number: 30135BA) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Pseudobulbar affect (PBA)" (unspecified if ongoing). Concomitant medication(s) included: NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE;QUINIDINE SULFATE DIHYDRATE]; SYNTHROID. The following information was reported: HYPERHIDROSIS (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Sweating"; CHILLS (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Chills"; MYALGIA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Muscle aches"; DIARRHOEA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Diarrhea"; PYREXIA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of hyperhidrosis, chills, myalgia, diarrhoea, pyrexia, headache.  Additional 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 had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, Pyrexia, Weight
Clinical narrative: Caller reported having a fever with the second 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 74 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6206) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; GABAPENTIN; LOSARTAN; LEVOTHYROXINE SODIUM; AMLODIPINE BESILATE. Vaccination history included: Bnt162b2 (1st dose, Lot #: EM98809), administration date: 20Feb2021, for covid-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Caller reported having a fever with the second vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient also received booster (LOT-30145BA) in Left arm on 26Sep2021 and experienced fever about 100 Degrees and kind of chills, Achy (ache) and wanted to know if this was common problem or not. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Intermittent, sharp, joint pain. Right hip beginning 25Sep2021 ending 26Sep2021; 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), administered in arm left, administration date 24Sep2021 11:45 (Lot number: PE3582) at the age of 39 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: ARTHRALGIA (non-serious) with onset 25Sep2021, outcome "recovered" (26Sep2021), described as "Intermittent, sharp, joint pain. Right hip beginning 25Sep2021 ending 26Sep2021". Therapeutic measures were not taken as a result of arthralgia.  Additional information: patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 nor been tested for Covid 19 since the vaccination. Patient did not have covid prior to vaccination nor tested. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Hypersensitivity, Nasal discomfort, Rhinorrhoea
Clinical narrative: Nose irritation/irritation in the nose; Runny nose; Itchy eyes; typical allergy reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP)from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 15:00 (Lot number: EW0191) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "seasonal Allergy" (unspecified if ongoing), notes: every spring he had several weeks of this kind of allergy attack; "Increase in weight" (unspecified if ongoing), notes: he has an increase in weight in but this was before the last dose, it started more than a year this has been going. Concomitant medication(s) included: FUROSEMIDE taken for swelling, stop date: Sep2021. Vaccination history included: Bnt162b2 (Dose:01, Anatomical location; left arm, Lot number: EK9231), administration date: 26Jan2021, when the patient was 79 years old, for Covid-19 immunization, reaction(s): "Joint swelling", "Peripheral swelling"; Bnt162b2 (Dose:02, Anatomical location; left arm, Lot number: EL9266), administration date: 16Feb2021, when the patient was 79 years old, for Covid-19 immunization, reaction(s): "Joint swelling", "Peripheral swelling". The following information was reported: NASAL DISCOMFORT (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Nose irritation/irritation in the nose"; RHINORRHOEA (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Runny nose"; EYE PRURITUS (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Itchy eyes"; HYPERSENSITIVITY (non-serious) with onset 23Sep2021, outcome "not recovered", described as "typical allergy reaction". Therapeutic measures were taken as a result of nasal discomfort, rhinorrhoea, eye pruritus, hypersensitivity.  Additional information: Other Products, Patient History and Investigation Assessment mentioned as No. He notes that he is not sure if it started the evening of the booster shot but it was definitely there by the next morning. This is why he is not sure about the connections with the event or the vaccine. Patient was not visited emergency room and physician office. The patient did not receive any other vaccine in four weeks. He has an increase in weight in but this was before the last dose, it started more than a year this has been going. Every spring he had several weeks of this kind of allergy attack. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101293536 similar report from same reporter
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Movement disorder, Musculoskeletal stiffness
Clinical narrative: chest pain/pain on both sides of my chest; stiffness in my back and neck to a point I couldn't move my neck in any direction; stiffness in my back and neck to a point I couldn't move my neck in any direction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 17-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 07:45 (Lot number: FE3592) at the age of 17 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose: 1, Batch/lot number: EW0186, Anatomical Location: Arm Left, Time: 01:30 PM), administration date: 21Aug2021, when the patient was 17 years old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 24Sep2021, outcome "recovering", described as "chest pain/pain on both sides of my chest"; MUSCULOSKELETAL STIFFNESS (non-serious), MOVEMENT DISORDER (non-serious) all with onset 24Sep2021, outcome "recovering" and all described as "stiffness in my back and neck to a point I couldn't move my neck in any direction". Therapeutic measures were not taken as a result of chest pain, musculoskeletal stiffness, movement disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: Aleve and ibuprofen. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. Since second shot, the patient has been experiencing most to all symptoms. It's been 5 days and was still feeling most of them, but biggest concern was chest pain. It has been constant since patient has got shot, and the pain comes in waves. The patient was experiencing pain on both sides of chest but more so commonly on right side. The patient felt pain when tried to move, and when breath or stretch too much. It not so bad that it was enabling ability to do things, it was just not normal nor comfortable in any way. Other than that, the only other odd thing patient had experienced 1-2 days after was a stiffness in back and neck to a point that couldn't move neck in any direction.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: red arm; 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 patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jan2021 (Lot number: EL3249) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "red arm"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the pfizer suspect were none. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. The patient received the first shot around 10:30-11:00 am. After the shot she only had a sore arm that lasted for about couple weeks and was red. Events did not require visit to emergency room or physician office.   No follow-up attempts are possible. No further information is expected.