chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: First dose had made me spot some between periods, too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 13:30 (Lot number: ER8731) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known Allergies: Penicillin and all derivatives" (unspecified if ongoing), notes: Known Allergies: Penicillin and all derivatives. Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Erythromycin, reaction(s): "drug allergy", notes: Known Allergies: Erythromycin; Epinephrine shot, reaction(s): "Drug allergy", notes: Known Allergies: Epinephrine shot. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset Apr2021, outcome "not recovered", described as "First dose had made me spot some between periods, too". The event "first dose had made me spot some between periods, too" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of intermenstrual bleeding.  Additional information included: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Acetaminophin within 2 weeks of vaccination. Reported Event: Her menstrual cycle was now 3 weeks+ long flow and never really stops. Cramps, spotting, clotting, the whole nine yards almost all month, every month since her second dose. First dose had made her spot some between periods, too. Yet she also still get heavy flow on what would normally be her'time of the month'. If she was lucky she might get up to a week after her 'time' flow-free, but never more and often less. She cannot go even one day without wearing a pad at least or she would be bleed through clothing. Tired, headache, cramps, even a bit of bloating throughout every month since vaccination. This sucks, it affects her daily life to detrimental proportions. This did not result in prolongation of hospitalization. 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.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Illness, Neck pain
Clinical narrative: Ears are ringing; His neck hurts and his spine and his chest; his back hurts and spine and neck; His neck hurts and his spine and his chest; his back hurts and spine and neck; His neck hurts and his spine and his chest; his back hurts and spine and neck; He is sick; He has no energy; all day long he was sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date Aug2021 (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: TINNITUS (non-serious) with onset Aug2021, outcome "unknown", described as "Ears are ringing"; NECK PAIN (non-serious), CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset Aug2021, outcome "unknown" and all described as "His neck hurts and his spine and his chest; his back hurts and spine and neck"; ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "He is sick"; ASTHENIA (non-serious) with onset Aug2021, outcome "unknown", described as "He has no energy"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "unknown", described as "all day long he was sleeping".  Additional information: Expiry Date of COVID 19 Vaccine was Unknown. Additional Context: Concern: Reporter stated, "My son just had the COVID shot not instant but day before and I guess all day long he was sleeping and now he just woke up he says his ears are ringing, his neck hurts and his spine and his chest." When paraphrased: Reporter stated, "Yes and his chest and he has easy disorders (Further clarification unknown) so you know we are checking out him because he was way underweight (Further clarification unknown hence not captured in tab) just like that, so I don't know if that has something to do with because he has no energy right now and he was hungry but hasn't eat because I guess he was sleeping all day but now I am trying to feed him but he does not, because his back hurts and spine and neck." Reporter was informed about role of Pfizer Drug Safety and asked for filling the safety report: Reporter stated, "No, he is sick."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Tinnitus
Clinical narrative: Ears are ringing; His neck hurts and his spine and his chest; his back hurts and spine and neck; His neck hurts and his spine and his chest; his back hurts and spine and neck; His neck hurts and his spine and his chest; his back hurts and spine and neck; He is sick; He has no energy; all day long he was sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date Aug2021 (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: TINNITUS (non-serious) with onset Aug2021, outcome "unknown", described as "Ears are ringing"; NECK PAIN (non-serious), CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset Aug2021, outcome "unknown" and all described as "His neck hurts and his spine and his chest; his back hurts and spine and neck"; ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "He is sick"; ASTHENIA (non-serious) with onset Aug2021, outcome "unknown", described as "He has no energy"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "unknown", described as "all day long he was sleeping".  Additional information: Expiry Date of COVID 19 Vaccine was Unknown. Additional Context: Concern: Reporter stated, "My son just had the COVID shot not instant but day before and I guess all day long he was sleeping and now he just woke up he says his ears are ringing, his neck hurts and his spine and his chest." When paraphrased: Reporter stated, "Yes and his chest and he has easy disorders (Further clarification unknown) so you know we are checking out him because he was way underweight (Further clarification unknown hence not captured in tab) just like that, so I don't know if that has something to do with because he has no energy right now and he was hungry but hasn't eat because I guess he was sleeping all day but now I am trying to feed him but he does not, because his back hurts and spine and neck." Reporter was informed about role of Pfizer Drug Safety and asked for filling the safety report: Reporter stated, "No, he is sick."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Movement disorder, Pain, Pyrexia
Clinical narrative: At 3am absolutely everything hurt with shooting pains; I had a fever and could barely move; I had a fever and could barely move; felt like my body started shutting down pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 14:15 (Lot number: FC3183) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reactive Airway Disease" (unspecified if ongoing); "Breastfeeding/4weeks Postpartum" (unspecified if ongoing); "Breastfeeding/4weeks Postpartum" (unspecified if ongoing); "In Jan2021, I was 14wks pregnant when I tested positive for Covid", start date: Jan2021 (unspecified if ongoing), notes: In Jan2021, I was 14wks pregnant when I tested positive for Covid; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: 1 month ago, I had postpartum endometritis which caused me to be hospitalized.; "I felt with the the uterus infection" (unspecified if ongoing), notes: no where near how I felt with the the uterus infection.; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: hospitalized for 3 days on heavy antibiotics.; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: Since the infection was resolved and I felt healthy and even started going back to the gym,. The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 21Aug2021 20:45, outcome "recovering", described as "felt like my body started shutting down pains"; PAIN (non-serious) with onset 22Aug2021 03:00, outcome "recovering", described as "At 3am absolutely everything hurt with shooting pains"; PYREXIA (non-serious), MOVEMENT DISORDER (non-serious) all with onset 22Aug2021 03:00, outcome "recovering" and all described as "I had a fever and could barely move". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, pyrexia, movement disorder. Therapeutic measures were taken as a result of pain. Additional information: Just over 6hrs after getting the first shot of vaccine patient felt like her body started shutting down. At 3am absolutely everything hurt with shooting pains. Patient had a fever and could barely move. At 4am I took Motrin. Patient did not receive other vaccine in four weeks. Patient receive Other medications in two weeks: Prenatal Vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: At 3am absolutely everything hurt with shooting pains; I had a fever and could barely move; I had a fever and could barely move; felt like my body started shutting down pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 14:15 (Lot number: FC3183) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reactive Airway Disease" (unspecified if ongoing); "Breastfeeding/4weeks Postpartum" (unspecified if ongoing); "Breastfeeding/4weeks Postpartum" (unspecified if ongoing); "In Jan2021, I was 14wks pregnant when I tested positive for Covid", start date: Jan2021 (unspecified if ongoing), notes: In Jan2021, I was 14wks pregnant when I tested positive for Covid; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: 1 month ago, I had postpartum endometritis which caused me to be hospitalized.; "I felt with the the uterus infection" (unspecified if ongoing), notes: no where near how I felt with the the uterus infection.; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: hospitalized for 3 days on heavy antibiotics.; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: Since the infection was resolved and I felt healthy and even started going back to the gym,. The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 21Aug2021 20:45, outcome "recovering", described as "felt like my body started shutting down pains"; PAIN (non-serious) with onset 22Aug2021 03:00, outcome "recovering", described as "At 3am absolutely everything hurt with shooting pains"; PYREXIA (non-serious), MOVEMENT DISORDER (non-serious) all with onset 22Aug2021 03:00, outcome "recovering" and all described as "I had a fever and could barely move". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, pyrexia, movement disorder. Therapeutic measures were taken as a result of pain. Additional information: Just over 6hrs after getting the first shot of vaccine patient felt like her body started shutting down. At 3am absolutely everything hurt with shooting pains. Patient had a fever and could barely move. At 4am I took Motrin. Patient did not receive other vaccine in four weeks. Patient receive Other medications in two weeks: Prenatal Vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: had a headache for approximately 1 day; had a fever and chills for approximately 4 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 20:45 (Lot number: FA7484) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "skin rashes, notes: Known allergies: Keflex caused skin rashes when I was a child. Vaccination history included: Bnt162b2 (Dose number:1, administration date 30Jul2021, administration time: 09:00 PM, Lot number: FA7484, vaccine location: Left arm), administration date: 30Jul2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 20Aug2021 23:00, outcome "recovered" (Aug2021), described as "had a headache for approximately 1 day"; PYREXIA (non-serious) with onset 20Aug2021 23:00, outcome "recovered" (Aug2021), described as "had a fever and chills for approximately 4 hours". Therapeutic measures were not taken as a result of headache, pyrexia.  Additional information: Patient did not receive any other vaccines within four weeks. Also, the patient did not receive any other medication within two weeks. Patient did not have covid prior to vaccination neither tested for covid post the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Burning sensation, Pruritus, Rash macular
Clinical narrative: I got little red bump on my body; They were itching and burning; They were itching and burning; Look little flee bites; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 09:30 (Lot number: Fc3180) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: pork" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: Fa7485 Lot unknown: False, Administration time: 09:30 AM, Dose number: 1, Vaccine location: Left arm), administration date: 18Jul2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset 08Aug2021 12:00, outcome "recovered" (2021), described as "I got little red bump on my body"; PRURITUS (non-serious), BURNING SENSATION (non-serious) all with onset 08Aug2021 12:00, outcome "recovered" (2021) and all described as "They were itching and burning"; ARTHROPOD BITE (non-serious) with onset 08Aug2021 12:00, outcome "recovered" (2021), described as "Look little flee bites". Therapeutic measures were not taken as a result of rash macular, pruritus, burning sensation, arthropod bite.  Additional information: Facility type vaccine was pharmacy or drug Store. Patient was not received other vaccine in four weeks. No any other medications in two weeks. Patient was not received treatment for AE. No COVID prior vaccination. Covid was not tested post vaccination. No other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hair texture abnormal, Nasopharyngitis, Pyrexia
Clinical narrative: Then, my hair is straight, it ain't no more, it will curl up and it just curls up; 103.1 fever; freezing; 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 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Lot number: EW0158) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Verbatim: gall bladder out" (unspecified if ongoing), notes: Verbatim: gall bladder out; "Verbatim: Kidney stones", start date: Feb2021 (unspecified if ongoing), notes: Verbatim: Kidney stones; "Verbatim: Diabetic" (unspecified if ongoing), notes: Verbatim: Diabetic; "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "so her arteries don't block up" (unspecified if ongoing), notes: so her arteries don't block up; "for heart attacks" (unspecified if ongoing), notes: for heart attacks; "Sugar" (unspecified if ongoing), notes: for sugar, diabetes; "Verbatim: Blockages" (unspecified if ongoing), notes: Verbatim: Blockages. Concomitant medication(s) included: MINOXIDIL taken for blood pressure abnormal (ongoing); ROSUVASTATIN taken for coronary artery disease (ongoing); METOPROLOL TARTRATE taken for blood pressure abnormal (ongoing); AMLODIPINE BESILATE taken for blood pressure abnormal (ongoing); GLIPIZIDE taken for diabetes mellitus, blood glucose abnormal, start date: Feb2021 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for myocardial infarction, start date: Feb2021 (ongoing); QUINAPRIL (ongoing). Vaccination history included: Bnt162b2 (1st dose, LOT: ER8727, Anatomical Location: left arm), administration date: 17Apr2021, when the patient was 77 years old, for Covid-19 immunisation, reaction(s): "103.1 fever", "hair texture abnormal", "hair loss", "freezing". The following information was reported: HAIR TEXTURE ABNORMAL (non-serious), outcome "unknown", described as "Then, my hair is straight, it ain't no more, it will curl up and it just curls up"; PYREXIA (non-serious), outcome "unknown", described as "103.1 fever"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "freezing". The patient underwent the following laboratory tests and procedures: body temperature: 103.1, notes: She had a 103.1 fever the next day, after both shots.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site vesicles
Clinical narrative: blistering around the injection site; injection site was a little bit red with a little bit of pain; hives; injection site was a little bit red with a little bit of pain; 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 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 (Lot number: FD8448) at the age of 55 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: VACCINATION SITE VESICLES (non-serious) with onset Aug2021, outcome "not recovered", described as "blistering around the injection site"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Aug2021, outcome "recovered" (Aug2021) and all described as "injection site was a little bit red with a little bit of pain"; URTICARIA (non-serious) with onset Aug2021, outcome "unknown", described as "hives". Additional information: Patient reported blistering around the injection site 2 days after receiving his first dose. He did not experience any side effects such as fever, headache, or diarrhea. Caller stated that, the injection site was "a little bit red with a little bit of pain, but the redness and pain went away, and he had left what he believed to be two hives on either side of what he believed to be the injection site that are filled with some kind of fluid like blisters. Patient was concerned because he had childhood friends who got blisters from other unspecified vaccines that turned into "brown spots that look like a belly button. He also wondered if this could be some sort of heat rash. The caller was a little concerned because he got the shot 2 days ago and he doesn't have any physical symptoms but he was getting a string of blisters at the area that the shot was administered.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood test, C-reactive protein, Electrophoresis protein
Clinical narrative: swollen lymph node under the shot arm; feel pain and weakness in her hands/pain has now spread to her feet; feel pain and weakness in her hands; inability to drive her car as she was unable to grasp the steering wheel; pain has now spread to her knees and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 38 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, Single), administration date: May2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "swollen lymph node under the shot arm"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "feel pain and weakness in her hands/pain has now spread to her feet"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "feel pain and weakness in her hands"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "inability to drive her car as she was unable to grasp the steering wheel"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain has now spread to her knees and feet". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pain in extremity, muscular weakness, loss of personal independence in daily activities, arthralgia.  Additional information: The reporter mentioned that the patient (her daughter) age 38 and in previously good health before receiving vaccine. Twenty-four hours after receiving the second dose she reported a swollen lymph node under the shot arm. Five days later she began to feel pain and weakness in her hands. The swollen lymph node returned to normal shortly thereafter. Her daughter's pain and weakness in her hands has slowly increased over the days and months. Today she reported an inability to drive her car as she was unable to grasp the steering wheel. The pain had now spread to her knees and feet. She was currently under the care at a rheumatologist. Her blood work had all been negative or insignificant for Rheumatoid Factor, Lyme Disease, Parvo, Celieac Panel, Serum protein electrophoresis, CRP, ESR, ANA, etc. He had her on a regimen of steroids and hydroxychloroquine. The patient's pain level, especially in the morning, was nearing a nine out of ten. She had never had COVID. Reporter queried if there was any treatment for resulted events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: i was curious if other people experienced itching basically everywhere and started between the fingers on both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 66 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, No events reported), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 16Mar2021, outcome "unknown", described as "i was curious if other people experienced itching basically everywhere and started between the fingers on both hands".  Additional information:The transcription analyst had reviewed the transcription quality for the below catalog ID.Transferred to Live Agent was reported as no.Transcription Analysis Attached was the PDF for the reference.No Error Category.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Tumour marker test
Clinical narrative: Chills; Fever of 100.4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jul2021 10:30 (Lot number: FAC780) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "removed a lymph node" (unspecified if ongoing), notes: removed a lymph node.; "Breast cancer" (unspecified if ongoing), notes: Taking Ibrance for his breast cancer. He got much better. Concomitant medication(s) included: IBRANCE taken for breast cancer (ongoing). The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever of 100.4". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was on the line reporting for her and her husband. She called about booster dose questions. Her husband was 78-year-old. She also shared with her that he was taking Ibrance and that his cancer markers went from 368 to 178 from Feb2020 to Jun2021. They dropped 190 points. He got the vaccine in Withheld. She knows it was Withheld, but does not know the address. He had no prescribing doctor. This was his second dose. Second dose: Pfizer FD8448, received on 19Aug2021, right arm. They got both doses at 10:30 am. He did not have to go the doctor or ER. With his first dose, he had chills and a fever of 100.4 the day after. It broke, and he got better. He was also taking Ibrance for his breast cancer. He got much better. History of all previous immunization with the Pfizer vaccine considered as suspect was not provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect was not provided. Prior Vaccinations (within 4 weeks) was not provided. Patient history was reported as no. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was not provided. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) was not provided. He had to get both vaccines in his right arm because when he was diagnosed with breast cancer, they removed a lymph node, and he cannot have a blood test or shots done in the arm. She does not have the NDC/lot/expiration for his Ibrance 75mg. He just threw it out because he was done with that cycle. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Paraesthesia, Urticaria
Clinical narrative: began experiencing neck and arm pain; hand and fingers felt tingly; a sharp pain in my arm and shoulder; a sharp pain in my arm and shoulder; hives forming all over, especially under my breasts and above my stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 16:00 (Lot number: FC3181) at the age of 39 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: NECK PAIN (non-serious) with onset 16Aug2021 16:00, outcome "not recovered", described as "began experiencing neck and arm pain"; PARAESTHESIA (non-serious) with onset 16Aug2021 16:00, outcome "recovering", described as "hand and fingers felt tingly"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 16Aug2021 16:00, outcome "not recovered" and all described as "a sharp pain in my arm and shoulder"; URTICARIA (non-serious) with onset 16Aug2021 16:00, outcome "not recovered", described as "hives forming all over, especially under my breasts and above my stomach". Therapeutic measures were not taken as a result of neck pain, paraesthesia, pain in extremity, arthralgia, urticaria.  Additional information included: It was reported that over the next few days patient's arm remained sore but the tingly decreased. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: chest pains; loss of breathe; dizziness; light headed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 16:45 (Lot number: FD8448) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Had a heart murmur for a brief period while an infant" (unspecified if ongoing), notes: Had a heart murmur for a brief period, while an infant. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Product: COVID 19, Brand: Pfizer , Lot number: Fa7984, administration time: 04:00 PM, Vaccine location: Left arm), administration date: 01Aug2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "chest pains"; DYSPNOEA (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "loss of breathe"; DIZZINESS (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "dizziness"; DIZZINESS (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "light headed". The events "chest pains", "loss of breathe", "dizziness" and "light headed" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of chest pain, dyspnoea, dizziness, dizziness.  Additional information: The patient had not received other vaccine in 4 weeks and other medications in 2 weeks. The patient was not covid prior vaccination, was the patient was not covid tested post vaccination and no allergies.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Headache, Muscle spasms, Night sweats
Clinical narrative: Headache; sharp ear pain in both ears; fever (102); night sweats; muscle cramps; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Vaccine location: Left Arm), administration date: 30Jul2021, when the patient was 33 years old, for COVID-19 Immunization, reaction(s): "muscle cramps", "arm pain". The following information was reported: HEADACHE (non-serious) with onset 21Aug2021, outcome "recovering", described as "Headache"; EAR PAIN (non-serious) with onset 21Aug2021, outcome "recovering", described as "sharp ear pain in both ears"; PYREXIA (non-serious) with onset 21Aug2021, outcome "recovering", described as "fever (102)"; NIGHT SWEATS (non-serious) with onset 21Aug2021, outcome "recovering", described as "night sweats"; MUSCLE SPASMS (non-serious) with onset 21Aug2021, outcome "recovering", described as "muscle cramps"; PAIN IN EXTREMITY (non-serious) with onset 21Aug2021, outcome "recovering", described as "arm pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, ear pain, pyrexia, night sweats, muscle spasms, pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine, other medications the patient received within 2 weeks of vaccination are Blood Pressure Meds. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache; sharp ear pain in both ears; fever (102); night sweats; muscle cramps; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Vaccine location: Left Arm), administration date: 30Jul2021, when the patient was 33 years old, for COVID-19 Immunization, reaction(s): "muscle cramps", "arm pain". The following information was reported: HEADACHE (non-serious) with onset 21Aug2021, outcome "recovering", described as "Headache"; EAR PAIN (non-serious) with onset 21Aug2021, outcome "recovering", described as "sharp ear pain in both ears"; PYREXIA (non-serious) with onset 21Aug2021, outcome "recovering", described as "fever (102)"; NIGHT SWEATS (non-serious) with onset 21Aug2021, outcome "recovering", described as "night sweats"; MUSCLE SPASMS (non-serious) with onset 21Aug2021, outcome "recovering", described as "muscle cramps"; PAIN IN EXTREMITY (non-serious) with onset 21Aug2021, outcome "recovering", described as "arm pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, ear pain, pyrexia, night sweats, muscle spasms, pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine, other medications the patient received within 2 weeks of vaccination are Blood Pressure Meds. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After shot 1 and 2 a rash appeared on abdomen around belly button area/flared up again 5-6 days after 2nd dose; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 13:00 (Lot number: Ew0172) at the age of 17 years as dose 1, single and administered in arm left, administration date 17Aug2021 13:00 (Lot number: Fc3182) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE; ACCUTANE; ESTARYLLA. The following information was reported: RASH (non-serious) with onset 01Aug2021 12:00, outcome "not recovered", described as "After shot 1 and 2 a rash appeared on abdomen around belly button area/flared up again 5-6 days after 2nd dose". Therapeutic measures were not taken as a result of rash.  Additional information: After shot 1 and 2 a rash appeared on abdomen around belly button area. It faded after a week but flared up again 5-6 days after 2nd dose. Patient was not have Covid prior to vaccination and not tested for Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Swelling face
Clinical narrative: My lymph node and left jaw all swollen as long my neck hurts; my neck is still swollen from the lymph node under my jaw; My lymph node and left jaw all swollen as long my neck hurts; my neck is still swollen from the lymph node under my jaw; My lymph node and left jaw all swollen as long my neck hurts; my neck is still swollen from the lymph node under my jaw; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Aug2021 (Lot number: FC3180) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), SWELLING FACE (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "My lymph node and left jaw all swollen as long my neck hurts; my neck is still swollen from the lymph node under my jaw".  Additional context: The patient wanted to know, " if the neck is still swollen from the lymph node under the jaw, if he/she should go ahead with the second (dose) shot or should him/her  hold on the second shot?" as it was due on that day at 6 o' clock.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: arm soreness; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 88 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jul2021 10:30 (Lot number: ER8736) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE taken for hyperthyroidism (ongoing); METOPROLOL taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE (ongoing). Vaccination history included: Flu shot, reaction(s): "Fever". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm soreness"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low grade fever".  Additional Information: Reporter stated with first dose of the Pfizer covid vaccine she and her mother had similar reaction like arm soreness and low fever then it went away, after the second dose she had body aches, which went away but for her mother its not going away. No Prior Vaccinations (within 4 weeks). The patient had a fever with the flu shot a couple of years ago. Reporter had no product or information and does not know NDC, lot or expiration date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapeutic response unexpected
Clinical narrative: having breathing problems/This went on for 7 months and then I got my vaccine on a Friday, and on Monday my breathing issues were gone instantly.; 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 49 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Lot number: EL9269) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breathing problems", start date: Sep2020 (ongoing), notes: This past Sep2020, She said, This was before the vaccine. She started having some breathing problem.; "chronic eye problems" (ongoing); "Glaucoma" (ongoing); "Eye inflammation" (ongoing). Concomitant medication(s) included: BROVANA taken for dyspnoea; ALBUTEROL HFA taken for dyspnoea; PRED FORTE taken for eye inflammation; TIMOLOL [TIMOLOL MALEATE] taken for glaucoma. Vaccination history included: Bnt162b2, for COVID-19 immunisation.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "having breathing problems/This went on for 7 months and then I got my vaccine on a Friday, and on Monday my breathing issues were gone instantly.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She is consumer 49 years old and she is calling about the Pfizer covid-19 vaccine. She had her second dose of vaccine in Feb2021 and she got an antibody test done this week, And it was negative. She also said, This past Sep2020, She said, This was before the vaccine. She started having some breathing problem. The day after the Covid vaccine, She never tested positive, Then, When she got her vaccine in Feb2021. She got it on a Friday and on Monday. Her breathing issues completely gone, canceling. They were all better and this week, She said the breathing problems returned and that's why. she asked for the antibody test. She thinks her immunity has faded away. On paraphrasing: Consumer stated, "The antibody test was this week. I had the antibody test this week and Yeah, It was negative. So just this week, I started feeling the way the before it was not bad that. Definitely something. I am having some breathing difficulties but it's not like I had  before."   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Pain, Pain in extremity
Clinical narrative: Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on; Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on; Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on; feels like a burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 19:00 (Lot number: FA7485) at the age of 29 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: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 13Aug2021, outcome "not recovered" and all described as "Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on"; BURNING SENSATION (non-serious) with onset 13Aug2021, outcome "not recovered", described as "feels like a burning sensation". Therapeutic measures were not taken as a result of pain in extremity, pain, arthralgia, burning sensation.  Additional information: it happens every few days. The patient did not have covid prior vaccination. The patient did not have covid test post vaccination. The patient did not had known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arms; low-grade fever; feels achy all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), administration date: 2021, for Covid-19 immunization, reaction(s): "headaches"; Bnt162b2, for Covid-19 immunization, reaction(s): "sore arms where the injection".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "sore arms"; PYREXIA (non-serious) with onset Aug2021, outcome "unknown", described as "low-grade fever"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "feels achy all over". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I was reporting the events, especially since their healthcare provider had warned them of the exact experiences they encountered. Event took place after use of product. She told me that she received her second shot yesterday (20Aug) and that her arm is very sore and that she is running a low-grade fever and just feels achy all over  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.