chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Little tired; Little headaches; 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. Other Case identifier(s): US-PFIZER INC-2021541961 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RABIES VACCINE, administration date 14Feb2021. Vaccination history included: Bnt162b2 (Dose 1, LOT Number: EL3247, Expiration date May 2021), administration date: Jan2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Little tired"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Little headaches". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: The received her 1st dose in Jan2021 and her 2nd dose on 11Feb2021. Consumer stated, "No, just those little headaches, I just felt a little tired but I was fine. Three days later, on 14Feb2021 she received a series of rabies vaccinations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Eating disorder, Illness, Pain
Clinical narrative: I was very sick; I could not eat all day after the shot; Diarrhea; I couldn't stop urinating; The urine just kept flowing; I was really in pain I was confused; I was really in pain I was confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0182) at the age of 69 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Verbatim: Hay fever" (unspecified if ongoing), notes: Verbatim: Hay fever; "Chronic obstructive pulmonary disease" (unspecified if ongoing), notes: Verbatim: COPD. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; ONDANSETRAN; COUMADIN; ERGOCALCIFEROL; BREO ELLIPTA; CALCIUM CARBONATE; FLONASE [FLUTICASONE PROPIONATE]; FAMOTIDINE; MELATONIN; ONDANSETRON taken for nausea. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was very sick"; EATING DISORDER (non-serious), outcome "unknown", described as "I could not eat all day after the shot"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "I couldn't stop urinating; The urine just kept flowing"; PAIN (non-serious), CONFUSIONAL STATE (non-serious), outcome "unknown" and all described as "I was really in pain I was confused".  Additional information: The patient was also the reporter. Reporter seriousness for the events was unspecified. Covid-19 Vaccine manufacturer: Unspecified, NDC number of Covid-19 Vaccine: Unknown, UPC number of Covid-19 Vaccine: Unknown, Expiry Date of Covid-19 Vaccine: Unknown. Dates for Concomitant Products: (Start: Unspecified Stop: Unspecified). Patient History of Asthma, Hay fever, COPD. Investigation Assessment: No. Vaccine name: Pfizer Covid 19 vaccine. Consumer stated, she had the shot yesterday and was very sick last night. She could not eat all day after the shot and she had not eaten before either but she had the diarrhea and she couldn't stop urinating. The urine just kept flowing and she was not living with her children. Last night she was screaming for her daughter because she is a nurse and she kept yelling for her and she didn't know what to do. Consumer was informed about Pfizer Medical information department and was provided with the number. Consumer was informed about the role of Pfizer drug safety. Consumer stated she felt like this close, everything was a mess, its mountain here she did not know what to do. She was living in a facility. She never check. She knew that's strange. The patient did not give information on ethnicity. Consumer stated she was not aware what was going on. She was home, she thought of her daughter she kept calling for her. But she didn't know that she (Incomplete sentence), she was really in pain she was confused.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: I was very sick; I could not eat all day after the shot; Diarrhea; I couldn't stop urinating; The urine just kept flowing; I was really in pain I was confused; I was really in pain I was confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0182) at the age of 69 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Verbatim: Hay fever" (unspecified if ongoing), notes: Verbatim: Hay fever; "Chronic obstructive pulmonary disease" (unspecified if ongoing), notes: Verbatim: COPD. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; ONDANSETRAN; COUMADIN; ERGOCALCIFEROL; BREO ELLIPTA; CALCIUM CARBONATE; FLONASE [FLUTICASONE PROPIONATE]; FAMOTIDINE; MELATONIN; ONDANSETRON taken for nausea. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was very sick"; EATING DISORDER (non-serious), outcome "unknown", described as "I could not eat all day after the shot"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "I couldn't stop urinating; The urine just kept flowing"; PAIN (non-serious), CONFUSIONAL STATE (non-serious), outcome "unknown" and all described as "I was really in pain I was confused".  Additional information: The patient was also the reporter. Reporter seriousness for the events was unspecified. Covid-19 Vaccine manufacturer: Unspecified, NDC number of Covid-19 Vaccine: Unknown, UPC number of Covid-19 Vaccine: Unknown, Expiry Date of Covid-19 Vaccine: Unknown. Dates for Concomitant Products: (Start: Unspecified Stop: Unspecified). Patient History of Asthma, Hay fever, COPD. Investigation Assessment: No. Vaccine name: Pfizer Covid 19 vaccine. Consumer stated, she had the shot yesterday and was very sick last night. She could not eat all day after the shot and she had not eaten before either but she had the diarrhea and she couldn't stop urinating. The urine just kept flowing and she was not living with her children. Last night she was screaming for her daughter because she is a nurse and she kept yelling for her and she didn't know what to do. Consumer was informed about Pfizer Medical information department and was provided with the number. Consumer was informed about the role of Pfizer drug safety. Consumer stated she felt like this close, everything was a mess, its mountain here she did not know what to do. She was living in a facility. She never check. She knew that's strange. The patient did not give information on ethnicity. Consumer stated she was not aware what was going on. She was home, she thought of her daughter she kept calling for her. But she didn't know that she (Incomplete sentence), she was really in pain she was confused.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Ovulation disorder
Clinical narrative: Got a period; it was weird several days ago thought she was ovulating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 11:00 (Lot number: EW0153) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Vaccination Time: 11:00, NDC number: Unknown, Expiry Date: Jul2021, Anatomical Location: Right arm), administration date: 19Mar2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: OVULATION DISORDER (non-serious) with onset 2021, outcome "unknown", described as "it was weird several days ago thought she was ovulating"; MENSTRUAL DISORDER (non-serious) with onset 12May2021, outcome "unknown", described as "Got a period".  Additional information: The patient reported that she was 55 years old and thought she was done with getting a period. The patient had not had a period since the beginning of jul2020. It was weird several days ago the patient thought she was ovulating. The patient got a period yesterday, 12May2021. The patient wanted to report this event. Got a period: it had been 10 months and the patient thought she was done with menopause and got a period. The patient stated the lot was not very clear, looks like EP7534. Patient stated she was unsure if it was a p or an o. The patient clarifies the lot for the first dose was the letter p. Patient sees the similarities in the person's handwriting on the vaccination card where the person wrote the letter p for Pfizer. The patient confirms she was certain the lot for the first dose is EP7534. The patient did not require emergency room visit for AEs. The patient had no prior vaccinations. No relevant tests.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: No Stamina; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single and administration date 08Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "No Stamina".  Additional information: Caller states after she had the first vaccination, she noticed that she didn't have the stamina she had prior to that vaccination. Caller states she went ahead and got the second one and it has been a really long time and she still is not back to herself.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: After dose one, my period arrived 8 days early; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (unspecified if ongoing); "Mild allergy to asparagus (facial hives)" (unspecified if ongoing), notes: facial hives. Concomitant medication(s) included: LANTUS; HUMALOG. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "After dose one, my period arrived 8 days early".  Additional information: Patient did not take any other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Gingival blister, Skin exfoliation
Clinical narrative: Skin sloughed off her gums; water blister between her teeth and gum line; Anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 09:00 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOUTHWASHGUM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: SKIN EXFOLIATION (non-serious) with onset 30Jan2021, outcome "unknown", described as "Skin sloughed off her gums"; GINGIVAL BLISTER (non-serious) with onset 30Jan2021, outcome "unknown", described as "water blister between her teeth and gum line"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Anxiety". The events "skin sloughed off her gums" and "water blister between her teeth and gum line" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin exfoliation, gingival blister, anxiety.  Additional information: It was reported that patient went to the dentist, also she had changed mouthwash before this because she couldn't get normal her normal one, and the dentist said to watch it for a week. She says the dentist sent her to an oral surgeon, who she saw twice, and they put her on a prescribed mouthwash that is basically steroids and something else. She says her gums are still not healing, so she thought maybe it could be just her nerves, since this year has been awful for everyone. She says from her everyday life, and also her husband lost his job around the time she got her vaccine, she thought being emotional might have something to do with it. She says she went to see her doctor and she went on an anxiety medication, Valium basically, she takes 2.5mg of 5mg a day when she needs it. She says that she has been using salt water and baking soda rinses, has been eating bland foods, no nada, no acidic foods. She says she was wondering so she typed it in Google and saw it could be possible from COVID vaccine but she is not seeing it listed on side effect list. She says something about how it has been pretty stressful, and they originally had her gargle with salt water because if it was a reaction that messed up her gums that will heal it, which she did for a couple weeks, and it improved after first couple weeks, and then they put her on Diazepam combined with the salt water and she used the prescription mouthwash, but it hasn't healed all the way.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Somnolence, Vaccination site pain
Clinical narrative: First dose: No burning, a little soreness in arm; First dose: Was just tired; had no energy and was real sleepy; had no energy and was real sleepy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 15:00 (Lot number: EN6202) at the age of 63 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: VACCINATION SITE PAIN (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "First dose: No burning, a little soreness in arm"; FATIGUE (non-serious) with onset 05Apr2021, outcome "recovered" (Apr2021), described as "First dose: Was just tired"; SOMNOLENCE (non-serious), ASTHENIA (non-serious) all with onset 05Apr2021, outcome "recovering" and all described as "had no energy and was real sleepy".  Additional information: The patient reported no burning, a little soreness in arm after first dose Pfizer Covid Vaccine. Caller stated this began on 06Apr2021, the next day after receiving the first dose Pfizer Covid Vaccine. Caller states this went away about less than three days after it began. Caller states she recovered pretty good. Caller reports she was just tired after receiving first dose Pfizer Covid Vaccine. The patient just slept that Monday, 05Apr2021 and Tuesday, 06Apr2021, caller stayed in bed for two days. Caller had no energy and was real sleepy. Caller states this began the Monday caller received first dose Pfizer Covid Vaccine, 05Apr2021. When caller came home from receiving first dose Pfizer Covid Vaccine, caller laid in bed all day that Monday and the following Tuesday. Wednesday, 07Apr2021, caller felt somewhat better and got out and took care of some business and came back home kind of tired. Caller states she recovered from being tired. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were given. No AE(s) following prior vaccinations. Relevant tests were none.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: flu like symptoms for 3+ days; Headache; Upset stomach; Sore Body; Tired; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 14:00 (Lot number: ER8733) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 26Mar2021 15:00, outcome "recovered with sequelae" (2021), described as "flu like symptoms for 3+ days"; HEADACHE (non-serious) with onset 26Mar2021 15:00, outcome "recovered with sequelae" (2021), described as "Headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Mar2021 15:00, outcome "recovered with sequelae" (2021), described as "Upset stomach"; PAIN (non-serious) with onset 26Mar2021 15:00, outcome "recovered with sequelae" (2021), described as "Sore Body"; FATIGUE (non-serious) with onset 26Mar2021 15:00, outcome "recovered with sequelae" (2021), described as "Tired". Therapeutic measures were not taken as a result of influenza like illness, headache, abdominal discomfort, pain.  Additional information: Facility type vaccine was at public health clinic/veterans administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No treatment for adverse events has been received. Patient did not receive any other medications within 2 weeks prior to the COVID vaccine. No known allergies and relevant history.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: She presnted symptoms related to UTI; 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 Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "She presnted symptoms related to UTI".  Additional information: Patient stated that 3 months later the same issue occurred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: Whole Body in tremendous pain everything hurt; Very Tired; no energy; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 14:00 (Lot number: ER 8731) at the age of 40 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 (lot number=ER8733, administration time=02:00 PM, dose number=1, vaccine location=Left arm), administration date: 26Mar2021, when the patient was 40 years old, for Covid-19 immunisation, reaction(s): "Headache", "Upset stomach", "Tired", "Sore Body", "FLU like symptoms". The following information was reported: PAIN (non-serious), outcome "recovered with sequelae", described as "Whole Body in tremendous pain everything hurt"; FATIGUE (non-serious), outcome "recovered with sequelae", described as "Very Tired"; ASTHENIA (non-serious), outcome "recovered with sequelae", described as "no energy". Therapeutic measures were not taken as a result of pain, fatigue, asthenia.  Additional information: Facility type vaccine was at public health clinic/facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No treatment had received for adverse events. Patient did not receive any other medications within 2 weeks prior to the COVID vaccine. No known allergies and relevant history.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling on the right foot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 30Mar2021, when the patient was 77 years old, for Covid-19 Immunization, reaction(s): "pain in right upper inner thigh". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 07May2021, outcome "not recovered", described as "swelling on the right foot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: tired; achy; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  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: FATIGUE (non-serious), outcome "recovered", described as "tired"; PAIN (non-serious), outcome "recovered", described as "achy". Additional information: The reporter was a retired nurse, patient is her sister. The reporter was discussing medical history when she mentioned family and friends. The reporter stated that her kids and son-in-law and sister and friends got the Pfizer Covid-19 Vaccine too and got one day of being tired and achy and then bounced back to normal. Report 3 was caller reporting on her sister. The reporter did not want to file a report. The reporter stated that these people did not really have problems other than the expected things. One had a slight headache, one was tired, one had a temperature of 100. The reporter had nothing really to speak of. The reporter did not distinguish which person had which symptom, and does not provide any additional identifiers. No additional information provided.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction
Clinical narrative: Panicking because does not see a time listed of when supposed to go get second dose tomorrow; 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 23Apr2021 (Lot number: EW0158) 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: PANIC REACTION (non-serious) with onset May2021, outcome "unknown", described as "Panicking because does not see a time listed of when supposed to go get second dose tomorrow".  Additional information: She is scheduled to get her second dose tomorrow, but she does not have a time listed and she is panicking. She is wondering what to do, what she is supposed to do. She does not see a second does appointment time on the paper either she received.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Nauseous; I had it in my left arm which that hurt; I had pain that radiated down my arm into my thumb and my index finger; I started getting pain up into my neck; I had pain that radiated down my arm into my thumb and my index finger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset May2021, outcome "unknown", described as "Nauseous"; VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "unknown", described as "I had it in my left arm which that hurt"; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset May2021, outcome "unknown" and all described as "I had pain that radiated down my arm into my thumb and my index finger"; NECK PAIN (non-serious) with onset May2021, outcome "unknown", described as "I started getting pain up into my neck". Therapeutic measures were not taken as a result of nausea, vaccination site pain, pain in extremity, neck pain, pain.  Additional information: NDC and UPC number, Expiry Date of Covid-19 vaccine was unknown, No patient history and investigation assessment reported. Consumer stated, "I just want to ask, I had the Pfizer vaccine (Covid-19 Vaccine) on Monday for the Covid. So and then I had about 11 O'clock in the morning and probably about 7 O'clock at night I just started getting extreme nauseous. I had it in my left arm which that hurt but then I started getting pain up into my neck and I had pain that radiated down my arm into my thumb and my index finger. So, did they may be hit a nerve when they put in the shot." Consumer stated no treatment received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: First dose: shot site a little bit pink and sore; First dose: shot site a little bit pink and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2021 14:35 (Lot number: EC1283) at the age of 91 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: she take a bunch of medicine.  She takes for her thyroid, and for her High Blood Pressure.; "flu shot" (unspecified if ongoing); "thyroid" (ongoing), notes: she take a bunch of medicine. She takes for her thyroid; "eyes" (ongoing), notes: She uses drops for her eyes. The patient's concomitant medications were not reported. Past drug history included: Tylenol for headaches, notes: She normally doesn't get headaches and doesn't take Tylenol often, so when she does take it, it is effective and she hardly takes it. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Jan2021, outcome "recovered" (17Jan2021) and all described as "First dose: shot site a little bit pink and sore".  Additional Information: Patient was 91 years old and a retired secretary. She is calling about the Covid-19 shot. She got 2 shots. She received her first dose on 14Jan2021, and 2nd dose on 02Feb2021. About 2 and a half weeks apart. After her first dose, the 1st site, the shot site was no more than after a flu shot. After her 2nd dose, the shot site was more red and more swollen. She also experienced a rash that was gone in 10 days. she also experienced little bits of aches and pain. She clarified that after the 1st dose the site was a little bit pink and sore: for 2-3 days, lasted couple days, and expected nothing.she normally takes Tylenol for headaches, but she didn't have a headache with the vaccines.Dose suggested was 500mg, she takes 2 at a time.She hasn't taken them all, there were 24. She needed to get her magnifying glass to read the label, she blames it on old age. She take a bunch of medicine. She takes for her thyroid, and for her High Blood Pressure. She uses drops for her eyes. Patient hadn't taken any prior Vaccinations (within 4 weeks) and hadn't  PMH (including any illness at time of vaccination) & no relevant test.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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: VERTIGO (non-serious), outcome "recovering", described as "Severe vertigo".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: Has a bump where they placed the vaccine; Arm hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 13:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose , Vaccine Name: Pfizer COVID vaccine, Route, Anatomical Location: by injection to left arm, Date: thinks 29 MAR 2021, not sure), for Covid-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 01May2021, outcome "not recovered", described as "Has a bump where they placed the vaccine"; PAIN IN EXTREMITY (non-serious) with onset 01May2021, outcome "unknown", described as "Arm hurting".  Additional Information: Caller's husband had his second dose 2 weeks ago and has a bump where they placed the vaccine, and it is getting bigger and his arm hurts. On 01MAY2021. States the other day he woke up with bump, caller thought it would go away, but it's hurting a lot, he touches it and it hurts. When asked for start date of arm hurting, caller provides the first one lasted 3 days,  she wasn't sure if it would go away for him or not.Her husband's is getting bigger and hurting more. Time the Vaccination Was Given: in between 12:30 and 13:00, it was during lunchtime. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. The adverse events has not resulted in Emergency Room and Physician Office visit. Prior Vaccinations (within 4 weeks) was reported as no. Adverse events following prior vaccinations was no. Patient's Medical History (including any illness at time of vaccination). Relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) was no. Family Medical History Relevant to adverse events was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Real sick when they got their second dose of the Covid-19 vaccine; 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 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st shot of covid vaccine), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Real sick when they got their second dose of the Covid-19 vaccine".  Additional information: The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Fatigue, Headache, Pain
Clinical narrative: Being tired; Achy; Slight headache; Had a temperature of 100; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male 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: FATIGUE (non-serious), outcome "recovered", described as "Being tired"; PAIN (non-serious), outcome "recovered", described as "Achy"; HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "Had a temperature of 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number of Pfizer Covid-19 Vaccine was not provided. Investigation Assessment was not provided. Caller was unwilling to complete the report. Caller was discussing medical history when she mentioned family and friends. Caller stated that her kids and son-in-law and sister and friends got the Pfizer Covid-19 Vaccine too and got one day of being tired and achy and then bounced back to normal.   RA Communication: caller did not want to file a report.  She states that these people did not really have problems other than the expected things.  One had a slight headache, one was tired, one had a temperature of 100.  She has nothing really to speak of.  Caller does not distinguish which person had which symptom, and does not provide any additional identifiers.  No additional information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: poop was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Smell metal" (unspecified if ongoing), notes: Caller also confirms this started two days ago, before receiving his vaccine. The patient's concomitant medications were not reported. The following information was reported: FAECES DISCOLOURED (non-serious), outcome "unknown", described as "poop was red".  Additional information: Caller states her son is 12 and he had the vaccine, the first dose, this morning and it was around 0900 and he came down about 20 minutes ago, he had gone to the bathroom and told her his poop was red and he could taste metal. Caller asking if Pfizer has seen these types of side effects, is this normal? Caller speaks to son when he confirms that the patient could smell metal, not taste it. Caller also confirms this started two days ago, before receiving his vaccine. Caller states well this makes her feel better. Caller states they can cancel it, she doesn't need to worry. Caller states she was kind of worried that she needed to get him checked out and now she will get him checked out but now she knows it's not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: terrible malaise; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "terrible malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms after first dose vaccination.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms after first dose vaccination." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I have had reaction and I am feeling pretty ill after the shot; This is a spontaneous report received from a contactable reporter The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0176) 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: MALAISE (non-serious), outcome "unknown", described as "I have had reaction and I am feeling pretty ill after the shot".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: For the first time my legs swelled up little bit and my feet and this time I got the last shot; my feet is still swollen and my leg is still swollen; 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) (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 (1st dose), for Covid-19 immunisation, reaction(s): "my legs swelled up little bit and my feet".  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "For the first time my legs swelled up little bit and my feet and this time I got the last shot; my feet is still swollen and my leg is still swollen".  Additional information: patient got the side effect like legs were swelled up, when patient took the Pfizer shot, for the first-time patient legs swelled up little bit and feet was still swollen, and leg was still swollen. NDC, UPC numbers for the Pfizer dose was unspecified expiry dates was unknown. consumer was informed about the Pfizer medical information and provided with number; further probing could not be done as consumer hanged up the call abruptly hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Discoloured vomit, Feeling abnormal, Laziness
Clinical narrative: Feels really awful; She is achy/achy all over; Her arm hurt/arm hurts; Nausea; Diarrhea; I threw up. Not only that, it was brown; feel lazy; I threw up; I threw up it was brown and my stomach hurt too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 12May2021 (Lot number: EW176) at the age of 72 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels really awful"; PAIN (non-serious), outcome "unknown", described as "She is achy/achy all over"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm hurt/arm hurts"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; DISCOLOURED VOMIT (non-serious), outcome "unknown", described as "I threw up. Not only that, it was brown"; LAZINESS (non-serious), outcome "unknown", described as "feel lazy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "I threw up; I threw up it was brown and my stomach hurt too".  Additional information: Patient wanted to know about food she stay away from food or she can eat anything. Patient was looking for the card and didn't know where the card was. Patient had a vaccination last night and wanted to know if I had a major problem now. Patient never threw up and not from years in time. She also wanted to know If I go to emergency room.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Feels really awful; She is achy/achy all over; Her arm hurt/arm hurts; Nausea; Diarrhea; I threw up. Not only that, it was brown; feel lazy; I threw up; I threw up it was brown and my stomach hurt too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 12May2021 (Lot number: EW176) at the age of 72 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels really awful"; PAIN (non-serious), outcome "unknown", described as "She is achy/achy all over"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm hurt/arm hurts"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; DISCOLOURED VOMIT (non-serious), outcome "unknown", described as "I threw up. Not only that, it was brown"; LAZINESS (non-serious), outcome "unknown", described as "feel lazy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "I threw up; I threw up it was brown and my stomach hurt too".  Additional information: Patient wanted to know about food she stay away from food or she can eat anything. Patient was looking for the card and didn't know where the card was. Patient had a vaccination last night and wanted to know if I had a major problem now. Patient never threw up and not from years in time. She also wanted to know If I go to emergency room.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Neuralgia, Pain, Pain in extremity
Clinical narrative: slight pain (minimal) down in both of her legs; I just got the pain from the vaccine; I had like slight nerve pain that my leg suffered the first time; I could barely walk; 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 61 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: EN6204) at the age of 61 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "slight pain (minimal) down in both of her legs"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "I just got the pain from the vaccine"; NEURALGIA (non-serious) with onset 2021, outcome "unknown", described as "I had like slight nerve pain that my leg suffered the first time"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "I could barely walk". Therapeutic measures were taken as a result of pain. Additional information: Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021 and she experienced a slight pain (minimal) down in both of her legs. Then she received the second dose on 17Apr20I just got the pain from the vaccine 21 and the next day she started experiencing a severe pain down her both legs and the pain has not gone away, she also had back pain but it's a little bit better, during the call she mentioned that she didn't have muscle or joint pain, that she had nerve pain. She has gone to many doctors, her life is affected negatively, she said that they should care people better. She would like to know why is she experiencing this pain. Patient have been talking Advil and Tylenol almost every single day. Patient think she just skipped 2 days when she do not have to do too much."  No follow-up attempts are possible. No further information is expected.