chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Cognitive disorder, Confusional state, Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: EN6206) at the age of 62 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EN6200, Dose no: 1), administration date: 10Mar2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "A little dizziness". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "A little funny in the head for a short period of time"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arms"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Diminished strength for 10-12 days"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "we had some cognitive dysfunction"; AMNESIA (non-serious), outcome "unknown", described as "amnesia"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confusion"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "she didn't remember getting vaccinated". Additional information: Investigation Assessment was No. After their second vaccine dose they both felt, and random stuff they don't care about like which doesn't concern him. They both had dizziness at first and felt a little funny in their head. His wife reportedly had some amnesia. We felt a little of this with number 2, but no where near this. She had some amnesia and confusion, she didn't remember getting vaccinated. Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: EN6206) at the age of 62 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EN6200, Dose no: 1), administration date: 10Mar2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "A little dizziness". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "A little funny in the head for a short period of time"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arms"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Diminished strength for 10-12 days"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "we had some cognitive dysfunction"; AMNESIA (non-serious), outcome "unknown", described as "amnesia"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confusion"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "she didn't remember getting vaccinated". Additional information: Investigation Assessment was No. After their second vaccine dose they both felt, and random stuff they don't care about like which doesn't concern him. They both had dizziness at first and felt a little funny in their head. His wife reportedly had some amnesia. We felt a little of this with number 2, but no where near this. She had some amnesia and confusion, she didn't remember getting vaccinated. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: extended menstrual cycles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose1, single), for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 06Dec2021, outcome "recovering", described as "extended menstrual cycles". The event "extended menstrual cycles" was evaluated at the physician office visit. Therapeutic measures were taken as a result of oligomenorrhoea with Progesterone.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: 5 or 6 migraines over the next 6 weeks, about 1 every week starting when I had the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 08:00 (Lot number: ER8735) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 02Apr2021, when the patient was 55 years old, for COVID-19 Immunisation. The following information was reported: MIGRAINE (non-serious) with onset 22Apr2021, outcome "recovered with sequelae" (2021), described as "5 or 6 migraines over the next 6 weeks, about 1 every week starting when I had the 2nd dose". Therapeutic measures were not taken as a result of migraine.  Additional information: Migraines now about every 2 months. The patient did not receive any other vaccines within 4 weeks  prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient did not had covid prior vaccination or tested post vaccination. There were no known allergies or other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Malaise, Product administered at inappropriate site, Pyrexia
Clinical narrative: Malaise; lethargy; fever of 101.5; Anatomical Location: Leg Left; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 02Dec2021 15:30 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: 20Oct2021, stop date: 20Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Leg Right, Vaccine Administration Time: 11:30 AM), administration date: 11Nov2021, when the patient was 6 years old, for COVID-19 Immunization, reaction(s): "Anatomical Location: Right leg". The following information was reported: MALAISE (non-serious) with onset 05Dec2021 18:00, outcome "recovering", described as "Malaise"; LETHARGY (non-serious) with onset 05Dec2021 18:00, outcome "recovering", described as "lethargy"; PYREXIA (non-serious) with onset 05Dec2021 18:00, outcome "recovering", described as "fever of 101.5"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 02Dec2021 15:30, outcome "unknown", described as "Anatomical Location: Leg Left". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, lethargy, pyrexia.  Additional Information: Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: with the first shot, she got desperately ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EN6198) at the age of 67 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: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "with the first shot, she got desperately ill".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: my lymph node are swollen; My arm still hurt like hell/I do have pain there all down my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FJ8762) at the age of 46 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: Verbatim: Asthmatic; "knee replacement" (unspecified if ongoing), notes: I take a Motrin or Tylenol for my knee; "Allergy" (unspecified if ongoing); "heart" (unspecified if ongoing); "knee is hurt" (unspecified if ongoing); "nerve pain" (unspecified if ongoing). Concomitant medication(s) included: ASPIRINE taken for cardiac disorder; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; TYLENOL taken for arthralgia; MOTRIN [IBUPROFEN] taken for arthralgia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "My arm still hurt like hell/I do have pain there all down my arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "my lymph node are swollen". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: This report is not related to a study or programme. The patient did not receive any other vaccines prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Feeling abnormal, Pain in extremity
Clinical narrative: cognitive dysfunction; a little funny in the head for a short period of time; sore arms; diminished strength for 10-12 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Lot number: EN6206) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (LOT: EN6200, after their first vaccine dose they both had a little dizziness that was not bad, they were fine.), administration date: 11Mar2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "little dizziness that was not bad". The following information was reported: COGNITIVE DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "cognitive dysfunction"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "a little funny in the head for a short period of time"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "sore arms"; ASTHENIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "diminished strength for 10-12 days". Therapeutic measures were not taken as a result of cognitive disorder, feeling abnormal, pain in extremity, asthenia. Additional information: They had some cognitive dysfunction with the second dose but not as much. After their second vaccine dose they both felt a little funny in the head for a short period of time, and random stuff they don't care about like sore arms which doesn't concern him, and diminished strength for 10-12 days which didn't concern him.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: little dizziness that was not bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Mar2021 (Lot number: EN6200) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "little dizziness that was not bad". Additional information: The patient took Pfizer COVID-19 vaccine as a protection from the various strains of COVID-19. The patient was not taking Other Products and with No Patient History. The patient states that, he never had fit BMI index,  very muscular and very fit and he lifts 4 times at least a week. He get on a trail and hike 15 miles and be fine, he was in the upper percentages of health for his age. No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Nausea; vomitting; Unwell feeling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 03:15 (Lot number: Fk5618) at the age of 11 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: NAUSEA (non-serious) with onset 06Dec2021 07:00, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 06Dec2021 07:00, outcome "unknown", described as "vomitting"; MALAISE (non-serious) with onset 06Dec2021 07:00, outcome "unknown", described as "Unwell feeling". Therapeutic measures were not taken as a result of nausea, vomiting, malaise.  Additional Information: There was no Seriousness criteria for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, and Congenital anomaly/birth defect. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. There was no Prolonged hospitalization. No Relevant past drug history. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Dyspnoea, Full blood count, Heart rate, Heart rate irregular
Clinical narrative: Shortness of breath and I kept getting shorter breath everyday, little tighter; My arm was sore; Irregular heart rates; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 10:00 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus syndrome" (unspecified if ongoing), notes: Verbatim: Lupus syndrome; "Arthritis" (unspecified if ongoing), notes: Verbatim: Inflammatory arthritis; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Tracheomalacia" (unspecified if ongoing), notes: Verbatim: Tracheobronchial malacia; "Low Immunoglobulin" (unspecified if ongoing), notes: Verbatim: Low immunoglobulins/I have low immunoglobulins so I get IV IG; "Rare Lung Pain" (unspecified if ongoing), notes: Verbatim: Rare lung pain; "Hypogammaglobulinaemia" (unspecified if ongoing), notes: Verbatim: Hypogammaglobulinemia; "Anaemia" (unspecified if ongoing), notes: Verbatim: Anemia; "Inflammatory arthritis" (unspecified if ongoing); "lung surgery" (unspecified if ongoing), notes: I have had lung surgery, it didn't feel like any of that it was just shortness of breath. Concomitant medication(s) included: CIMZIA taken for arthritis; IVIGLOB-EX; PLAQUENIL S; NAPROXEN; SYMBICORT; ALBUTEROL HFA; TRAZODONE; ZOLOFT; POTASSIUM; MAGNESIUM; VALTREX. Vaccination history included: Bnt162b2 (Dose:1, Anatomical Location: Left arm, Time of administration:10:00am), administration date: 12Feb2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath and I kept getting shorter breath everyday, little tighter"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was sore"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Irregular heart rates". The patient underwent the following laboratory tests and procedures: cytomegalovirus test: they were fine; full blood count: they were fine; heart rate: irregular; investigation: they were fine. Therapeutic measures were taken as a result of dyspnoea.  Addittional information: Additional information: Patient took steroid Medrol (Methylprednisolone) as a treatment received. Time of vaccination: Nurse Practitioner stated, It was like 10 o'clock in the morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity
Clinical narrative: Shortness of breath and I kept getting shorter breath everyday, little tighter; My arm was sore; Irregular heart rates; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 10:00 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus syndrome" (unspecified if ongoing), notes: Verbatim: Lupus syndrome; "Arthritis" (unspecified if ongoing), notes: Verbatim: Inflammatory arthritis; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Tracheomalacia" (unspecified if ongoing), notes: Verbatim: Tracheobronchial malacia; "Low Immunoglobulin" (unspecified if ongoing), notes: Verbatim: Low immunoglobulins/I have low immunoglobulins so I get IV IG; "Rare Lung Pain" (unspecified if ongoing), notes: Verbatim: Rare lung pain; "Hypogammaglobulinaemia" (unspecified if ongoing), notes: Verbatim: Hypogammaglobulinemia; "Anaemia" (unspecified if ongoing), notes: Verbatim: Anemia; "Inflammatory arthritis" (unspecified if ongoing); "lung surgery" (unspecified if ongoing), notes: I have had lung surgery, it didn't feel like any of that it was just shortness of breath. Concomitant medication(s) included: CIMZIA taken for arthritis; IVIGLOB-EX; PLAQUENIL S; NAPROXEN; SYMBICORT; ALBUTEROL HFA; TRAZODONE; ZOLOFT; POTASSIUM; MAGNESIUM; VALTREX. Vaccination history included: Bnt162b2 (Dose:1, Anatomical Location: Left arm, Time of administration:10:00am), administration date: 12Feb2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath and I kept getting shorter breath everyday, little tighter"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was sore"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Irregular heart rates". The patient underwent the following laboratory tests and procedures: cytomegalovirus test: they were fine; full blood count: they were fine; heart rate: irregular; investigation: they were fine. Therapeutic measures were taken as a result of dyspnoea.  Addittional information: Additional information: Patient took steroid Medrol (Methylprednisolone) as a treatment received. Time of vaccination: Nurse Practitioner stated, It was like 10 o'clock in the morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Muscle twitching, Nasopharyngitis, Tremor
Clinical narrative: I felt I have cold, like colder; I was shaking and twitching kind of like, I mean big twitches, my arms were just twitching, my torsal was twitching, my head was going back and forth and I could not stop any of it; we could not get the arms to stop moving, I couldn''t warm up; I was shaking and twitching kind of like, I mean big twitches, my arms were just twitching, my torsal was twitching, my head was going back and forth and I could not stop any of it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL3248) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Neuropathy peripheral" (unspecified if ongoing), notes: Verbatim: Neuropathy; "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia. Concomitant medication(s) included: GABAPENTIN; CELECOXIB; TIZANIDINE. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovering", described as "I felt I have cold, like colder"; MUSCLE TWITCHING (non-serious), TREMOR (non-serious), outcome "recovering" and all described as "I was shaking and twitching kind of like, I mean big twitches, my arms were just twitching, my torsal was twitching, my head was going back and forth and I could not stop any of it"; BODY TEMPERATURE DECREASED (non-serious), outcome "recovering", described as "we could not get the arms to stop moving, I couldn''t warm up".  Additional information: The patient after the second one, she got up about 4 in the afternoon about 12 hours later about 4 in the morning she woke up and felt that she had cold, like colder than ever had in her life but she did not had a fever and patient husband took her temperature twice. Patient stated that she was shaking and twitching kind of like, she mean big twitches, her arms were just twitching, her torsal was twitching, her head was going back and forth and she could not stop any of it. Patient stated it was just uncontrollable and she was breathing like she did not feel like she wasn't getting breath but that was just everything was uncontrollable they could not get the arms to stop moving, she couldn't warm up. Patient put heat blankets on and put 10 blankets on top but she couldn't get warm and it lasted about 4 hours. Patient thought she was going to die but her husband kept saying he had to take to you to the hospital but it was in winter and she said that she can't go outside, cannot go out from under of these blankets she just cannot. Patient stated that her husband sat up watching her for about 4 hours and this kind of ran away and she fell asleep.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "still experiencing pain" in the arm; 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 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Jun2021 (Lot number: EW0181) at the age of 57 years as dose 1, single and administered in arm left, administration date 16Jul2021 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Verbatim: Blood pressure high; "High cholesterol" (ongoing), notes: High cholesterol; "heart attack" (unspecified if ongoing), notes: Had a heart attack before and felt like it was thing to do. The patient took concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as ""still experiencing pain" in the arm".  Additional information: Patient received his first dose of the vaccine in Jun2021 and his second dose in Jul2021. He reported "still experiencing pain" in the arm where he received his injection and asked if it is "common and typical" to still experience this symptom. He added that his HCPs said they would be worried if the pain continued for a year but at "six months, not worried". When he got the first one his arm started hurting and never quit hurting. It does not hurt constantly, but when relaxes arm it hurts. It's not super painful but hurts. He was calling to determine if this is common or a typical thing that happens. He did not go to the doctor, but he called the doctor. The doctor said would not be worried about it unless it last longer than a year. He initially provided he started hurting the day after the shot. He provided the date as it looks like it could be 16Jun2021. Right where he got the shot in each arm there is a knot in each arm where it hurts. Confirmed happened with both arms, same thing, both arms hurt. The pain occurs sometimes, it's not constant. It's about the same. It's not unbearable, but just there. He had a heart attack before and felt like it was thing to do. He later provided he noticed this hurting pain about an hour afterwards. He was told his arm would get sore and to keep moving it and it never went away. The AE did not require to visit emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Blood uric acid, Blood uric acid increased
Clinical narrative: Uric acid increased; creatinine was elevated; 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 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 11:00 (Lot number: EW0153) at the age of 63 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: 01, Lot Number: FR8730, Anatomical location: Arm left), administration date: 04Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: BLOOD CREATININE INCREASED (non-serious) with onset 10May2021, outcome "not recovered", described as "creatinine was elevated"; BLOOD URIC ACID INCREASED (non-serious) with onset 08Jun2021, outcome "unknown", described as "Uric acid increased". The events "creatinine was elevated" and "uric acid increased" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood uric acid increased. Additional information- It was reported that patient did not have any AE prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: His first dose he experienced "feeling off"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (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: FEELING ABNORMAL (non-serious) with onset May2021, outcome "recovered" (2021), described as "His first dose he experienced "feeling off"".  Additional information: Patient is a male consumer who would like to know if the first two doses and the booster dose that he has received were the Pfizer Bio-N-Tech or the Comirnaty vaccines. He is going to be traveling and stated he got vaccinated for this reason. Patient relayed that his lot numbers for his vaccine doses were EN6207, ER8724, and FY1620. He also stated that with his first dose he experienced feeling off for the month of May2021 but that went away. He had no questions regarding side effects.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Constipation, Headache, Insomnia
Clinical narrative: my hair has been falling out in handfuls; I have had horrible headaches; constipation; insomnia; 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 right, administration date 30Nov2021 11:00 (Lot number: FJ1620) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: other medical history: Celiac disease; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; ZOLOFT; ALEVE. Past drug history included: Known allergies: gluten, reaction(s): "Drug allergy". The following information was reported: ALOPECIA (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "my hair has been falling out in handfuls"; HEADACHE (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "I have had horrible headaches"; CONSTIPATION (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "constipation"; INSOMNIA (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "insomnia". Therapeutic measures were not taken as a result of alopecia, headache, constipation, insomnia.  Additional Information: Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Left testicular dull pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0182) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild gastritis" (unspecified if ongoing). Concomitant medication(s) included: HYOSCYAMINE; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (prev dose administration date=21Apr2021, prev dose dose number=1,, prev dose vaccine location=Left arm, prev dose lot number=EW0161,), administration date: 21Apr2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: TESTICULAR PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Left testicular dull pain". Therapeutic measures were not taken as a result of testicular pain. Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sored; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm sored".  Additional information:Description of Event: Arm soared after Cominarity booster shot. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Bad Headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "slightly achy"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore left arm". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastric pH, Gastritis
Clinical narrative: Upper abdomen inflammation; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: 330308D) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: GASTRITIS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Upper abdomen inflammation". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of gastritis.  Additional information: Upper abdomen inflammation; Gastric inflammation increased acid Related. When probed for vaccine expiration date, Nurse stated, It's "11302021" (further not clarified), she don't know if it's expiration, she don't know, what was that. She don't know because it doesn't have expiration date on here. No Prior Vaccination. No Family Medical History related to event.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased
Clinical narrative: Blood sugar rise; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: BLOOD GLUCOSE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Blood sugar rise". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A ID was not provided by the transfer agent. Reporter stated that her and her mom and someone else had their blood sugar rise after they've had the shots each time. Clarified product as the Covid 19 vaccine and the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101742407 same vaccine, AE and different patient;US-PFIZER INC-202101741528 same vaccine, AE and different patient;US-PFIZER INC-202101741528 same vaccine, AE and different patient;US-PFIZER INC-202101742765 same vaccine, AE and different patient
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days.  Patient cannot remember if this occurred after the 1st, 2nd, or both doses.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172250). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (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: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days.  Patient cannot remember if this occurred after the 1st, 2nd, or both doses.". Additional information: Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week/approx. 3-5 days. Patient cannot remember if this occurred after 1st, 2nd, or both doses. Reporter consider that event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101748710 same patient, different dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days.  Patient cannot remember if this occurred after the 1st, 2nd, or both doses.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172250). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days. Patient cannot remember if this occurred after the 1st, 2nd, or both doses.), administration date: 14Apr2021, for covid 19 immunization, reaction(s): "Patient experienced a sore arm at injection". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days. The patient cannot remember if this occurred after the 1st, 2nd, or both doses." Additional information: [COVID-19 Pfizer Vaccine/approx. May2021 (approx. 4-5 weeks after 1st dose)] Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week/approx. 3-5 days. Patient cannot remember if this occurred after 1st, 2nd, or both doses. Reporter consider that event was caused by suspect product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101748709 same patient, different dose.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain in extremity, Peripheral coldness
Clinical narrative: by evening had chills; felt very freezing cold; legs hurt very bad; legs felt like ice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 14:00 (Lot number: EN6208) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "hair growth" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTINE taken for blood cholesterol increased (ongoing); METOPROLOL taken for hypertension (ongoing); CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN (ongoing); BIOTIN (ongoing); KRILL OIL (ongoing); VITAMIN D3 (ongoing); BABY ASPIRIN (ongoing); TYLENOL (ongoing); IBUPROFEN (ongoing); VIVISCAL [SILICON DIOXIDE] taken for hair growth rate abnormal (ongoing); MOVE FREE ADVANCED (ongoing); VIT C (ongoing). Vaccination history included: BNT162B2 (Dose Number: 1, Lot No: EN6200, left arm, time: 2pm), administration date: 22Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 17Mar2021, outcome "unknown", described as "by evening had chills"; FEELING COLD (non-serious) with onset 17Mar2021, outcome "unknown", described as "felt very freezing cold"; PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "unknown", described as "legs hurt very bad"; PERIPHERAL COLDNESS (non-serious) with onset 17Mar2021, outcome "unknown", described as "legs felt like ice".  Additional Information: Patient had no prior vaccinations within 4 weeks. She had no medical history: None. No relevant tests were done. No specific relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Tinnitus
Clinical narrative: high pitch ringing in my left ear; I felt extreme burning go up my arm and into my face and chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:00 (Lot number: ER8737) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetic" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG. The following information was reported: TINNITUS (non-serious) with onset 13Apr2021, outcome "not recovered", described as "high pitch ringing in my left ear"; BURNING SENSATION (non-serious) with onset 13Apr2021, outcome "not recovered", described as "I felt extreme burning go up my arm and into my face and chest". Therapeutic measures were not taken as a result of tinnitus, burning sensation.  Additional information: The patient was not diagnosed with prior and since the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Neuralgia
Clinical narrative: nerve pain; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 (Lot number: 301458a) 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 (Dose Number: 1, Lot Number: 301458a), administration date: 20Oct2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: NEURALGIA (non-serious) with onset 22Nov2021, outcome "not recovered", described as "nerve pain"; ASTHENIA (non-serious) with onset 22Nov2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of neuralgia, asthenia. No follow-up attempts are possible. No further information is expected.