chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Pain in arm; Headache; Chills; Tiredness; Heavy eyes feeling; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 09:45 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety disorder" (unspecified if ongoing), notes: Anxiety Syndrome; "Cardiovascular disease" (unspecified if ongoing), notes: Cardiovascular disease. Concomitant medication(s) included: MELEX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE LOT NUMBER: UNKNOWN ANATOMICAL SITE: ARM LEFT, time of administration: 09:45 AM.), administration date: 29Apr2021, when the patient was 40 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Pain in arm"; HEADACHE (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Chills"; FATIGUE (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Tiredness"; ASTHENOPIA (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Heavy eyes feeling"; MYALGIA (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Muscle pain".  Additional information: Other medication in two weeks included mexazolam (MELEX), anxiety and cardiovascular medications (UNSPECIFIED) from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; Headache; Chills; Tiredness; Heavy eyes feeling; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 09:45 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety disorder" (unspecified if ongoing), notes: Anxiety Syndrome; "Cardiovascular disease" (unspecified if ongoing), notes: Cardiovascular disease. Concomitant medication(s) included: MELEX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE LOT NUMBER: UNKNOWN ANATOMICAL SITE: ARM LEFT, time of administration: 09:45 AM.), administration date: 29Apr2021, when the patient was 40 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Pain in arm"; HEADACHE (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Chills"; FATIGUE (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Tiredness"; ASTHENOPIA (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Heavy eyes feeling"; MYALGIA (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Muscle pain".  Additional information: Other medication in two weeks included mexazolam (MELEX), anxiety and cardiovascular medications (UNSPECIFIED) from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Right arm is sore; Headaches; Body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20May2021 12:30 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "Right arm is sore"; HEADACHE (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "Headaches"; PAIN (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of pain in extremity, headache, pain, chills.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. 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; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: Back pain; Feeling very tired; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) at the age of 47 years as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibrance, start date: 04Dec2020, for Breast Cancer, reaction(s): "Tired", notes: Strength: 100mg, Frequency: Once a day, Route: by mouth, Feeling very tired; Ibrance, start date: 04Dec2020, for Breast Cancer, reaction(s): "Hot flashes", notes: Strength: 100mg, Frequency: Once a day, Route: by mouth; Ibrance, start date: 04Dec2020, for Breast Cancer, reaction(s): "Back pain", notes: Strength: 100mg, Frequency: Once a day, Route: by mouth. The following information was reported: BACK PAIN (non-serious) with onset May2021, outcome "unknown", described as "Back pain"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Feeling very tired".  Additional Information: patient states she had covid vaccine on 17May2021 and since then she has back pain and feeling very tired. Md not aware. advised to contact md. Patient takes for 21 days on and 7 days off.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Muscle spasms
Clinical narrative: stomach cramps; diarrhea; intense cramps; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (BNT162B2), administration date 13Apr2021 (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: ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "stomach cramps"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "intense cramps". Additional Information: She received the first dose of the Pfizer Covid-19 vaccine on 13Apr2021 and she experienced stomach cramps and diarrhea as side side effects. She would like to know if these symptoms have been reported and how long will those last. She missed her second dose due to something with his husband. She added that she was still having stomach cramps and occasional diarrhea. She had diarrhea and intense cramps for two weeks and she was glued to the pot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dry mouth, Dysgeusia
Clinical narrative: stomach cramps; diarrhea; intense cramps; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (BNT162B2), administration date 13Apr2021 (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: ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "stomach cramps"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "intense cramps". Additional Information: She received the first dose of the Pfizer Covid-19 vaccine on 13Apr2021 and she experienced stomach cramps and diarrhea as side side effects. She would like to know if these symptoms have been reported and how long will those last. She missed her second dose due to something with his husband. She added that she was still having stomach cramps and occasional diarrhea. She had diarrhea and intense cramps for two weeks and she was glued to the pot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Muscle spasms
Clinical narrative: cold metallic taste; mouth went dry; Diarrhea; Stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "super allergies to food and medicines" (unspecified if ongoing), notes: Verbatim: super allergies to food and medicines; "super allergies to food and medicines" (unspecified if ongoing), notes: Verbatim: super allergies to food and medicines. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "Super allergies". The following information was reported: DYSGEUSIA (non-serious) with onset 13Apr2021, outcome "recovered" (Apr2021), described as "cold metallic taste"; DRY MOUTH (non-serious) with onset 13Apr2021, outcome "recovered" (Apr2021), described as "mouth went dry"; DIARRHOEA (non-serious) with onset 13Apr2021, outcome "recovered" (Apr2021), described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Stomach cramps".  Additional Information: It was reported that the patient attempt to get her second dose of the vaccine, her first dose was on 13Apr2021, and seconds after getting her first dose, she had a cold metallic taste, and her mouth went dry. Some hours later, she got diarrhea and stomach cramps that lasted for two weeks, and she still has the stomach cramps. Her second dose on 07May2021, but she was unable to go get her second dose that day, as she had something she was doing with her husband that day. She has heard that the second dose is worse than the first, and she does not know how that could be, because she still has the stomach cramps at this time that started after her first dose. She went in today to try and get her second dose, but they would not give it to her, unless she really wanted to do it. She has not yet taken her second dose of the product, as they would not give it to her unless she got medical clearance from her doctor, or the doctor as caller has super allergies to a whole bunch of foods and medicines and the flu vaccine. She was the caregiver of her 91-year-old husband, so she cannot afford too not be able to be vertical.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dry mouth, Dysgeusia
Clinical narrative: cold metallic taste; mouth went dry; Diarrhea; Stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "super allergies to food and medicines" (unspecified if ongoing), notes: Verbatim: super allergies to food and medicines; "super allergies to food and medicines" (unspecified if ongoing), notes: Verbatim: super allergies to food and medicines. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "Super allergies". The following information was reported: DYSGEUSIA (non-serious) with onset 13Apr2021, outcome "recovered" (Apr2021), described as "cold metallic taste"; DRY MOUTH (non-serious) with onset 13Apr2021, outcome "recovered" (Apr2021), described as "mouth went dry"; DIARRHOEA (non-serious) with onset 13Apr2021, outcome "recovered" (Apr2021), described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Stomach cramps".  Additional Information: It was reported that the patient attempt to get her second dose of the vaccine, her first dose was on 13Apr2021, and seconds after getting her first dose, she had a cold metallic taste, and her mouth went dry. Some hours later, she got diarrhea and stomach cramps that lasted for two weeks, and she still has the stomach cramps. Her second dose on 07May2021, but she was unable to go get her second dose that day, as she had something she was doing with her husband that day. She has heard that the second dose is worse than the first, and she does not know how that could be, because she still has the stomach cramps at this time that started after her first dose. She went in today to try and get her second dose, but they would not give it to her, unless she really wanted to do it. She has not yet taken her second dose of the product, as they would not give it to her unless she got medical clearance from her doctor, or the doctor as caller has super allergies to a whole bunch of foods and medicines and the flu vaccine. She was the caregiver of her 91-year-old husband, so she cannot afford too not be able to be vertical.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Insomnia, Swelling
Clinical narrative: Swelled armpits; Painful armpit/swelled armpits, painful; Not able to sleep; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: SWELLING (non-serious) with onset 20May2021, outcome "unknown", described as "Swelled armpits"; AXILLARY PAIN (non-serious) with onset 20May2021, outcome "unknown", described as "Painful armpit/swelled armpits, painful "; INSOMNIA (non-serious) with onset 20May2021, outcome "unknown", described as "Not able to sleep". Therapeutic measures were not taken as a result of swelling, axillary pain, insomnia.  Additional information: The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unknown date. The patient did not have any allergies to medications, food, or other products. Concomitant medications included Pfizer vaccine taken within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Swollen lymph nodes under arm; Sharp Pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 03:00 (Lot number: EW0172) at the age of 12 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Verbatim: ADHD. Concomitant medication(s) included: GUANFACINE; CONCERTA. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 19May2021, outcome "not recovered", described as "Swollen lymph nodes under arm"; PAIN (non-serious) with onset 19May2021, outcome "not recovered", described as "Sharp Pains". The events "swollen lymph nodes under arm" and "sharp pains" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The caller was calling in regard to her 12-year-old son who received his first dose of the vaccine and now has swollen lymph nodes. They visited urgent care today. Patient is having sharp pains and she is assuming it is from swollen lymph nodes under the arm. Caller states the pain and lymph nodes are getting worse. She thought maybe it' worse in the morning, can be sicker in the morning and walking around increases circulation and other stuff. Caller states patient woke up this morning and it was worse.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tooth disorder
Clinical narrative: I am walking around in pain; I want to get my tooth fixed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I am walking around in pain"; TOOTH DISORDER (non-serious), outcome "unknown", described as "I want to get my tooth fixed". Additional information: Caller got a second dose of Product Pfizer-BioNTech Covid-19 Vaccine on Tuesday, scheduled to have a dental procedure on Thursday, stated: when I went to the dentist dental assistant told me that just a previous week a patient came in after having a second vaccine and he had Novocaine and he had two cavities and the dentist fixed it and he left and they said later on it the day he called and he was at the hospital because he had allergic reaction and they said that the doctor said that it was a Novocaine interacting with the vaccine shot. so I asked the dentist how soon after getting the vaccine I can get a dental work done and nobody seems to know so of course they indicated that I should contact the manufacturer and ask that question. He decided to wait. Caller Stated: so I am walking around in pain, I want to get my tooth fixed but at the same time I don't want to have an allergic reaction.  Information on lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo; dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 08:15 (Lot number: EN6199) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MICROGESTIN. The following information was reported: VERTIGO (non-serious) with onset 10Mar2021, outcome "recovering", described as "vertigo"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "dizzy". The events "vertigo" and "dizzy" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, dizziness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Two days following dose 1 I experienced vertigo that after a few days became less severe and have been dizzy ever since After the second dose I had immediate numbness in left hand. Numbness returns frequently in left hand. 6 wks. following 2nd dose tingling in right arm and feet and ankles. the adverse event result in doctor or other healthcare professional office/clinic visit. 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.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: Metallic taste in her mouth; Slight numbness feeling on her tongue; Slight arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 21May2021 12:50 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Arm didn't hurt like it did after the first one". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Slight arm pain"; DYSGEUSIA (non-serious) with onset 21May2021 13:25, outcome "recovering", described as "Metallic taste in her mouth"; HYPOAESTHESIA ORAL (non-serious) with onset 21May2021, outcome "recovering", described as "Slight numbness feeling on her tongue".  Additional information: The patient received second dose of vaccine 2 hours ago that afternoon. She felt fine and her arm didn't hurt like it did after the first one. She stated that then she got a strong metallic taste on her tongue about 35 minutes after the shot. Her tongue felt a little numb. Her whole tongue had a metallic taste and then it faded and 30 minutes later she could taste it on the tip of her tongue and it was very slightly numb on her tongue. She wanted to make sure that this was a normal side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Illness
Clinical narrative: she felt very cold for 10 days; was scheduled to get her second dose on May 11 but she was very sick and missed the appointment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (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 COLD (non-serious) with onset 2021, outcome "recovered" (2021), described as "she felt very cold for 10 days"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "was scheduled to get her second dose on May 11 but she was very sick and missed the appointment.". The events "she felt very cold for 10 days" and "was scheduled to get her second dose on may 11 but she was very sick and missed the appointment." were evaluated at the physician office visit. Therapeutic measures were taken as a result of feeling cold, illness.  Additional information: She felt very cold for 10 days. She had seen her doctor and was prescribed an antibiotic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17May2021 (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: OROPHARYNGEAL PAIN (non-serious) with onset 19May2021, outcome "not recovered", described as "sore throat".  Additional information: Caller states she had the Pfizer covid vaccine on Monday and began having a sore throat on Wednesday, Thursday, and Friday, which is today. Caller is asking if this is a normal side effect of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: a little heat at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 78-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "a little heat at the injection site". 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: Myalgia
Clinical narrative: I have muscle pain right now; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44-year-old female patient received bnt162b2 (BNT162B2), administration date 20May2021 18:30 (Lot number: EW0187) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Takes insulin; "Cholesterol" (unspecified if ongoing), notes: Takes atorvastatin; "Neuropathic pain" (unspecified if ongoing), notes: patient sometimes experience nerve pain because she was neuropathic; "Blood pressure high" (unspecified if ongoing); "Uric acid" (unspecified if ongoing), notes: Takes allopurinol. Concomitant medication(s) included: ALLOPURINOL taken for blood uric acid abnormal; AMLODIPINE taken for hypertension; ATORVASTATIN taken for blood cholesterol abnormal; INSULIN taken for diabetes mellitus; GABAPENTIN. Vaccination history included: Bnt162b2 (First dose, Lot number: EW0167), administration date: 29Apr2021, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 21May2021, outcome "not recovered", described as "I have muscle pain right now". Therapeutic measures were taken as a result of myalgia and included paracetamol (TYLENOL).  Additional information: Caller (patient) received the second dose of the Pfizer COVID-19 vaccine the day before the present report (20May2021) at work. Her time of work was 6:30, at 6:35 PM, and she took vaccine at 6:30 and she work for night shifts. She got to work for night shift when she went home she slept and when she woke up, she saw muscle pain, and all she wanted to know is if she needed was it okay to take her gabapentin or her nerve pain medication. She said she had muscle pain the day of this report (21May2021) which was normal for her because of work. She asked if it was safe to take gabapentin twice per day as ordered. She stated the product information (PI) for the vaccine contains no information regarding the concomitant use of gabapentin with the vaccine. She had found no information in her other resources either. She wanted to ask if it was okay to take nerve pain medicine because she took TYLENOL (treatment) 8 hours before the present report (May2021) but her muscles were still aching at the time of this report, she had prescription from her doctor, it was gabapentin, she thought so it was gabapentin, it was for muscle pain she asked if she could take that. It was also reported that yesterday when   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Headache; Sore throat; Runny nose; Nausea; Muscle pain; Injection site pain; Chills; Feeling unwell; Tiredness; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 19:00 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes; "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Drug allergy", notes: Known allergies: Azithromyicin. The following information was reported: HEADACHE (non-serious) with onset 14May2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 14May2021, outcome "not recovered", described as "Sore throat"; RHINORRHOEA (non-serious) with onset 14May2021, outcome "not recovered", described as "Runny nose"; NAUSEA (non-serious) with onset 14May2021, outcome "not recovered", described as "Nausea"; MYALGIA (non-serious) with onset 14May2021, outcome "not recovered", described as "Muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 14May2021, outcome "not recovered", described as "Injection site pain"; CHILLS (non-serious) with onset 14May2021, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 14May2021, outcome "not recovered", described as "Feeling unwell"; FATIGUE (non-serious) with onset 14May2021, outcome "not recovered", described as "Tiredness". The events "headache", "sore throat", "runny nose", "nausea", "muscle pain", "injection site pain", "chills", "feeling unwell" and "tiredness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of headache, oropharyngeal pain, rhinorrhoea, nausea, myalgia, vaccination site pain, chills, malaise, fatigue.  Additional information: The patient previously took azithromycin on an unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Rhinorrhoea, Vaccination site pain
Clinical narrative: Headache; Sore throat; Runny nose; Nausea; Muscle pain; Injection site pain; Chills; Feeling unwell; Tiredness; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 19:00 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes; "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Drug allergy", notes: Known allergies: Azithromyicin. The following information was reported: HEADACHE (non-serious) with onset 14May2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 14May2021, outcome "not recovered", described as "Sore throat"; RHINORRHOEA (non-serious) with onset 14May2021, outcome "not recovered", described as "Runny nose"; NAUSEA (non-serious) with onset 14May2021, outcome "not recovered", described as "Nausea"; MYALGIA (non-serious) with onset 14May2021, outcome "not recovered", described as "Muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 14May2021, outcome "not recovered", described as "Injection site pain"; CHILLS (non-serious) with onset 14May2021, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 14May2021, outcome "not recovered", described as "Feeling unwell"; FATIGUE (non-serious) with onset 14May2021, outcome "not recovered", described as "Tiredness". The events "headache", "sore throat", "runny nose", "nausea", "muscle pain", "injection site pain", "chills", "feeling unwell" and "tiredness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of headache, oropharyngeal pain, rhinorrhoea, nausea, myalgia, vaccination site pain, chills, malaise, fatigue.  Additional information: The patient previously took azithromycin on an unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: full neck is stiff, hurts on movement; full neck is stiff, hurts on movement; 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, administered in arm right, administration date 10May2021 10:30 (Lot number: EW0151, Expiration Date: Unknown) 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 (Product=COVID 19 , Brand =Pfizer, Lot number= EW0151, Lot unknown= False, Expiration Date: Unknown, Administration date=19Apr2021, Administration time=03:45 PM, Vaccine location=Left arm, Dose number=1), administration date: 19Apr2021, when the patient was 41 years old, for Covid-19 Immunisation, reaction(s): "stiffness in the neck", "painful movement". The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), NECK PAIN (non-serious) all with onset 10May2021, outcome "not recovered" and all described as "full neck is stiff, hurts on movement". Therapeutic measures were taken as a result of musculoskeletal stiffness, neck pain.  Additional Information: Facility type vaccine for vaccination Pharmacy or Drug Store. Patient did not took other vaccine in four weeks. Patient did not took other medications in two weeks. 3 days before second does on 10May, stiffness in the neck, left side. Motion of the next obstructed and painful movement. (Left arm). Second dose on 10May, right arm, it's been 10 days now and full neck is stiff, hurts on movement. Taken pain killers but now does not help. Now both right and left side of the neck is impacted. Adverse event start date: 07May2021 12:00 PM. Patient received treatment as Pain Killer medication self prescribed. No covid prior vaccine administered to the patient. Patient did not tested post vaccination. No Known allergies or other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholinesterase, Blood thyroid stimulating hormone, Full blood count, Hypoaesthesia, Magnetic resonance imaging head abnormal
Clinical narrative: Peripheral neuropathy; numbness in left hand; tingling in right arm and feet and ankles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Mar2021 08:30 (Lot number: ER8737) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MICROGESTIN (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Date: 08Mar2021, Time: 08:30 , Anatomical Site of injection: left Arm, Route of Administration: Intramuscular, Batch/Lot number: EN6199, Illness/AE: Vertigo, Onset date: 09Mar2021, Stop date: 23Mar2021), administration date: 08Mar2021, when the patient was 37 years old, for Covid-19 Immunization, reaction(s): "vertigo"; Bnt162b2 (Dose 1, Date: 08Mar2021, Time: 08:30 , Anatomical Site of injection: left Arm, Route of Administration: Intramuscular, Batch/Lot number: EN6199, Illness/AE: Dizzyness, Onset date: 24Mar2021, Stop date: Ongoing, Pertinent Details: Vertigo improved to general dizziness), administration date: 08Mar2021, when the patient was 37 years old, for Covid-19 immunization, reaction(s): "Dizziness". The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 29Mar2021 08:35, outcome "not recovered", described as "Peripheral neuropathy"; HYPOAESTHESIA (non-serious) with onset 29Mar2021 08:35, outcome "not recovered", described as "numbness in left hand"; PARAESTHESIA (non-serious) with onset 29Mar2021 08:35, outcome "not recovered", described as "tingling in right arm and feet and ankles". The events "peripheral neuropathy", "numbness in left hand" and "tingling in right arm and feet and ankles" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood cholinesterase: (10May2021) negative; blood thyroid stimulating hormone: (02Jun2021) normal; full blood count: (14May2021) normal; magnetic resonance imaging head abnormal: (25May2021) normal; metabolic function test: (10May2021) normal; vitamin b12: (14May2021) normal. Therapeutic measures were taken as a result of neuropathy peripheral, hypoaesthesia, paraesthesia.  Clinical course: Patient had not received other vaccine in four weeks. Patient had received Microgestin medications in two weeks. Patient had not Covid prior vaccination. Patient had not Covid tested post vaccination. Patient had not Known allergies.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021581846 same patient, different dose vaccine and different event
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Neuropathy peripheral, Paraesthesia, Vitamin B12
Clinical narrative: Peripheral neuropathy; numbness in left hand; tingling in right arm and feet and ankles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Mar2021 08:30 (Lot number: ER8737) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MICROGESTIN (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Date: 08Mar2021, Time: 08:30 , Anatomical Site of injection: left Arm, Route of Administration: Intramuscular, Batch/Lot number: EN6199, Illness/AE: Vertigo, Onset date: 09Mar2021, Stop date: 23Mar2021), administration date: 08Mar2021, when the patient was 37 years old, for Covid-19 Immunization, reaction(s): "vertigo"; Bnt162b2 (Dose 1, Date: 08Mar2021, Time: 08:30 , Anatomical Site of injection: left Arm, Route of Administration: Intramuscular, Batch/Lot number: EN6199, Illness/AE: Dizzyness, Onset date: 24Mar2021, Stop date: Ongoing, Pertinent Details: Vertigo improved to general dizziness), administration date: 08Mar2021, when the patient was 37 years old, for Covid-19 immunization, reaction(s): "Dizziness". The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 29Mar2021 08:35, outcome "not recovered", described as "Peripheral neuropathy"; HYPOAESTHESIA (non-serious) with onset 29Mar2021 08:35, outcome "not recovered", described as "numbness in left hand"; PARAESTHESIA (non-serious) with onset 29Mar2021 08:35, outcome "not recovered", described as "tingling in right arm and feet and ankles". The events "peripheral neuropathy", "numbness in left hand" and "tingling in right arm and feet and ankles" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood cholinesterase: (10May2021) negative; blood thyroid stimulating hormone: (02Jun2021) normal; full blood count: (14May2021) normal; magnetic resonance imaging head abnormal: (25May2021) normal; metabolic function test: (10May2021) normal; vitamin b12: (14May2021) normal. Therapeutic measures were taken as a result of neuropathy peripheral, hypoaesthesia, paraesthesia.  Clinical course: Patient had not received other vaccine in four weeks. Patient had received Microgestin medications in two weeks. Patient had not Covid prior vaccination. Patient had not Covid tested post vaccination. Patient had not Known allergies.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021581846 same patient, different dose vaccine and different event
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiac disorder
Clinical narrative: I was just having reaction because it was like anxiety reaction; Heart reaction; 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. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 49 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: ANXIETY (non-serious), outcome "unknown", described as "I was just having reaction because it was like anxiety reaction"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Symptoms like after the flu vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 93 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2021 (Lot number: EN5318, Expiration Date: May2021) at the age of 93 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart issues" (ongoing); "Heart stents placed" (unspecified if ongoing), notes: He had the stents first close to 20 years ago and then another one 10 years ago; "Pacemaker" (unspecified if ongoing), notes: It was put in about 2 years ago; "Sleep" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS (ongoing); FLOMAX RELIEF (ongoing); KLONOPIN (ongoing); LIPITOR ORIFARM (ongoing); TYLENOL; MELATONIN taken for sleep disorder; CANDESARTAN taken for blood pressure measurement (ongoing). Vaccination history included: Pneumonia shot (He gets his flu shot every year and pneumonia shot with no problem); Flu shot (He gets his flu shot every year and pneumonia shot with no problem). The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Symptoms like after the flu vaccine". Therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient taking Eliquis for about 3 years, Flomax for probably 3 years, Klonopin for probably over 10 and Lipitor for might be 10 years. The patient did not visit emergency room or physician office for the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 20's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PITYRIASIS ROSEA (non-serious), outcome "unknown", described as "Pityriasis rosea".  Additional information: One developed pityriasis rosea immediately after the injection. Event took place after use of product. The patient did not think it was the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.