chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Pain in extremity
Clinical narrative: tenderness in the arm; high blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 66 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), outcome "unknown", described as "tenderness in the arm"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high blood sugar". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that the patient got her first vaccine shot and the next day, she had a funny thing happen "but it was not the shot". She is experiencing a high blood sugar and tenderness in the arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Joint lock, Pain in extremity, Trigger finger
Clinical narrative: Trigger finger; tender and sore in one finger and leads to all of the fingers on the same arm; middle finger was locked; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 02Mar2021 (Lot number: EN6201) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TRIGGER FINGER (non-serious) with onset Mar2021, outcome "not recovered", described as "Trigger finger"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "tender and sore in one finger and leads to all of the fingers on the same arm"; JOINT LOCK (non-serious) with onset Mar2021, outcome "not recovered", described as "middle finger was locked". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of trigger finger, pain in extremity, joint lock. Additional information: Treatment included paracetamol (TYLENOL) 650 mg capsule as pain relief, taken only twice from 02Mar2021 and ongoing.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little ache in her arm next day; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administration date 10Mar2021 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 62 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypertension", start date: Mar2020 (ongoing). Concomitant medication included: LOSARTAN POTASSIUM taken for hypertension, start date: Mar2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "little ache in her arm next day".  Additional information: The patient had a little ache in her arm next day. She stated that it was quite a bit actually, that was the second day and in the evening but after that she had no problem at all; it was fine. The patient also stated that she was supposed to get the second dose after 3 weeks, it was on the back of her card they have write the 31Mar2021 but they were postponing shots and stretching that to 4 weeks (07Apr2021).   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Fatigue
Clinical narrative: incredibly tired; not even able to get out of bed; started having trouble with his blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 IMMUNISATION, reaction(s): "fast asleep with drool coming out of his mouth shortly", "was sleepy for a couple days after receiving his first COVID-19 Vaccine". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "incredibly tired; not even able to get out of bed"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "started having trouble with his blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated that when her husband received his second COVID-19 Vaccine, he was incredibly tired. She said her husband was not even able to get out of bed, and he started having trouble with his blood pressure. She said she was wondering if anyone else had reported being severely tired for over 2 weeks after getting the COVID-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administration error, Reading disorder
Clinical narrative: Has difficulty making out the writing on the card.  Also has difficulty reading LOT number; the girl gave her the shot and then took it out and stated that it did not have a seal on it; she received 2 shots yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 10:15 (Lot number: EN6198) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing), notes: Verbatim: COPD. Family history included: "Heart Disease" (unspecified if ongoing), notes: Heart disease; "Cancer" (unspecified if ongoing), notes: Cancer. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for blood pressure abnormal (ongoing); DILTIAZEM taken for cardiac disorder (ongoing); RANOLAZINE EXTENDED RELEASE (ongoing). Vaccination history included: Bnt162b2 (Provides Information for First Dose that she received on 22Feb2021:  LOT EM9810, Route: Injection, Anatomical Location: Right Arm), administration date: 22Feb2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 15Mar2021, outcome "unknown", described as "the girl gave her the shot and then took it out and stated that it did not have a seal on it"; OFF LABEL USE (non-serious) with onset 15Mar2021, outcome "unknown", described as "she received 2 shots yesterday"; READING DISORDER (non-serious), outcome "unknown", described as "Has difficulty making out the writing on the card.  Also has difficulty reading LOT number".  Additional information:  Vaccination Facility Type was Drive Through, Hospital Facilitated, Mass Vaccination Event. There was no emergency room visit or physician's office visit due to the adverse events. Concomitant products Ranolazine extended release started about 2 years ago.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired a lot / fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 (Lot number: EL9262) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Restless legs syndrome", start date: 2001 (ongoing); "high blood pressure", start date: 2006 (unspecified if ongoing); "High cholesterol" (ongoing), notes: High cholesterol; "Factor V Leiden" (ongoing); "Weak bones" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for factor v leiden carrier (ongoing); CLONAZEPAM taken for restless legs syndrome, start date: 2001 (ongoing); GABAPENTIN taken for restless legs syndrome, start date: 2001 (ongoing); STALEVO [CARBIDOPA MONOHYDRATE;ENTACAPONE;LEVODOPA] taken for restless legs syndrome, start date: 2001 (ongoing); TRAMADOL taken for restless legs syndrome, start date: 2016 (ongoing); PRAVASTATIN taken for blood cholesterol increased, start date: 2006 (ongoing); AMLODIPINE taken for hypertension, start date: 2006 (ongoing); VITAMIN D [COLECALCIFEROL] taken for bone disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset 04Feb2021, outcome "recovered" (11Feb2021), described as "Tired a lot / fatigue". Additional information: It was reported that the patient was typically tired a lot because she doesn't do anything after the first dose; patient slept better. It was reported that the patient experienced fatigue from 04Feb2021 to 11Feb2021; however, it was also reported that the event lasted for 6 days (possibly discrepant). The patient has been diagnosed 22-23 years ago for other conditions. The patient has been taking Aspirin for 22-23 years and Vitamin D for 5-6 years. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: My arm, where the injection was, it just started hurting; Body ache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 15Mar2021 (Batch/Lot number: unknown) 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: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021, outcome "recovered" (15Mar2021), described as "My arm, where the injection was, it just started hurting"; PAIN (non-serious) with onset 15Mar2021, outcome "unknown", described as "Body ache"; CHILLS (non-serious) with onset 15Mar2021, outcome "unknown", described as "Chills".  Additional Information: The patient was asking if it was okay for her/him to feed her/his grandchildren.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 13Feb2021 10:00 (Lot number: EN6201) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart attack in 2019", start date: 2019 (unspecified if ongoing); "asthma" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "obese" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; CLOPIDOGREL; MELOXICAM; METFORMIN ER; PANTOPRAZOLE; SPIRONOLACTONE; LOSARTAN; MONTELUKAST; ATORVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Mild pain at place of administration; General mild tiredness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection), administered in arm left, administration date 16Mar2021 at 10:30 (Lot number: EL3247) at the age of 36 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, administration time: 10:00 AM, vaccine location: Left arm), administration date: 23Feb2021, when the patient was 36 years old, for COVID-19 immunisation, reaction(s): "Mild/moderate pain at the site of injection".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Mar2021 17:00, outcome "recovering", described as "Mild pain at place of administration"; FATIGUE (non-serious) with onset 16Mar2021 17:00, outcome "recovering", described as "General mild tiredness.". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient had not been tested for COVID post-vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: soreness on the arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "brain issue" (unspecified if ongoing), notes: He keeps asking me every day, because he has a brain issue,. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness on the arm"; HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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: FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Muscle spasms
Clinical narrative: Cramping; Swollen lymph node in right armpit/swollen lymph node in left armpit; can't close her arm pit without pain/The right is not as painful and a little bigger than when it started; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 12:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: went to her oncologist for her chemotherapy on 10Mar2021, gets 2 medications for chemotherapy. The patient took concomitant medications. Past drug history included: Steroid. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Swollen lymph node in right armpit/swollen lymph node in left armpit"; LYMPH NODE PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as " can't close her arm pit without pain/The right is not as painful and a little bigger than when it started"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Cramping". Therapeutic measures were taken as a result of muscle spasms.  Additional information: Patient had no prior vaccinations within 4 weeks. On Friday, 12Mar2021 she developed a swollen lymph node in her left armpit. Then the next day on Saturday, 13Mar2021 she had a swollen lymph node in the right armpit. The one in the left armpit has gotten so big that she can't close her arm pit without pain. She doesn't know if that's the shot because it's been a week and a half. The right armpit lymph node is much smaller than the one on the left. The right is not as painful and a little bigger than when it started. The right side is not as big as the one on the left. The left used to be bean size it's almost now the size of a large grape. The patient also went to her oncologist for her chemotherapy on Wednesday, 10Mar2021. The chemotherapy gets hooked up on Wednesdays then they unhook it on Friday. She was told at the oncologist that the patients have been getting swollen lymph nodes with the Covid 19 vaccine and it's normal. The patient gets 2 medications for chemotherapy, she does not recall the names. She also gets a steroid, and another medication to help with cramping, she does not remember the names of the medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold like symptoms; This is a spontaneous report received from a contactable consumer.  A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 15Mar2021 (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: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Alopecia, Fatigue, Malaise, Nausea
Clinical narrative: 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 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: EN6208, Expiration Date: Jun2021) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "throat" (unspecified if ongoing), notes: on pantoprazole; "cancer" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; FINASTERIDE taken for neoplasm malignant; PANTOPRAZOLE 40 taken for pharyngeal disorder. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 17Feb2021, when the patient was 80 years old, for COVID-19 immunisation.The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "feeling unwell/ doesn't feel good"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Mar2021, outcome "unknown", described as "his stomach is upset, states this started about four days after the vaccine"; VACCINATION SITE ERYTHEMA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "arm where he got the vaccine is still red, that it was not red but now yesterday and today it was red"; NAUSEA (non-serious), outcome "not recovered", described as "feels like he is very nauseated"; ALOPECIA (non-serious), outcome "not recovered", described as "he is losing too much hair; when he takes a shower and wipes his hair, more than normal is coming out"; FATIGUE (non-serious), outcome "not recovered", described as "he is also very tired, and this is not normal for him". Additional Information: Additional information for concomitant products included 4-5 years for Losartan, 1 year for finasteride and 16 years for pantoprazole. The reporter wanted to know how long will these symptoms persist and asked what to do about the symptoms, if they can take paracetamol (TYLENOL).No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: 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 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: EN6208, Expiration Date: Jun2021) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "throat" (unspecified if ongoing), notes: on pantoprazole; "cancer" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; FINASTERIDE taken for neoplasm malignant; PANTOPRAZOLE 40 taken for pharyngeal disorder. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 17Feb2021, when the patient was 80 years old, for COVID-19 immunisation.The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "feeling unwell/ doesn't feel good"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Mar2021, outcome "unknown", described as "his stomach is upset, states this started about four days after the vaccine"; VACCINATION SITE ERYTHEMA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "arm where he got the vaccine is still red, that it was not red but now yesterday and today it was red"; NAUSEA (non-serious), outcome "not recovered", described as "feels like he is very nauseated"; ALOPECIA (non-serious), outcome "not recovered", described as "he is losing too much hair; when he takes a shower and wipes his hair, more than normal is coming out"; FATIGUE (non-serious), outcome "not recovered", described as "he is also very tired, and this is not normal for him". Additional Information: Additional information for concomitant products included 4-5 years for Losartan, 1 year for finasteride and 16 years for pantoprazole. The reporter wanted to know how long will these symptoms persist and asked what to do about the symptoms, if they can take paracetamol (TYLENOL).No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: loose stools; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 17Mar2021 15:30 (Lot number: en6203) at the age of 54 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 1, lot number: EL3247, location: rt arm), administration date: 24Feb2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 18Mar2021 09:00, outcome "recovered", described as "loose stools"; FATIGUE (non-serious) with onset 18Mar2021 09:00, outcome "recovered", described as "Fatigue". Therapeutic measures were not taken as a result of diarrhoea, fatigue. Additional information: The patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. No allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache and aches for about 24 hours; headache and aches for about 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 11:00 (Lot number: EN6203) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO; AMLODIPINE. Vaccination history included: Bnt162b2 (lot number=EL3247, administration date=24Feb2021,, administration time=11:00 AM,, vaccine location=Left arm,, dose number=1), administration date: 24Feb2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Covid-19 immunization". The following information was reported: PAIN (non-serious), HEADACHE (non-serious) all with onset 18Mar2021 07:00, outcome "recovered" (Mar2021) and all described as "headache and aches for about 24 hours". Therapeutic measures were not taken as a result of pain, headache. Additional information: the patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Fatigue
Clinical narrative: Still tired; Slurring his words; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 08:30 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "unknown", described as "Still tired"; DYSARTHRIA (non-serious) with onset 17Mar2021, outcome "unknown", described as "Slurring his words".  Additional Information: The patient mentioned that he did not see slurring of words in reported side effects, that's the reason he called, to ask about if event was relative to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 14:45 (Lot number: EN6203) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose 1, single; Lot number: EN6203; on 25Feb2021 at 02:45 PM administered in the left arm), administration date: 25Feb2021, when the patient was 45 years old, for covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "Body ache"; HEADACHE (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "chill". Therapeutic measures were not taken as a result of pain, headache, chills. Additional information: The vaccine was administered in the workplace clinic. No other vaccine in four weeks. No covid prior vaccination and not covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 37 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 (1st shot of covid vaccine, Lot unknown : false), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Headache"; NAUSEA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Nausea". Therapeutic measures were not taken as a result of headache, nausea. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "covid-19", start date: 10Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Headache"; CHILLS (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Chills"; FATIGUE (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Tired". Additional information: The patient felt uncomfortable for about 3 hours due to headache and chills, but had no fever. She started having problems about 8-10 hours after vaccination. She also added that she had headache, tired, and chills for about 14 hours. The patient was scheduled for her next shot on 01Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Nausea
Clinical narrative: Nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Feb2021 (Lot number: EL9266) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "over weight" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "heart trouble" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 20Feb2021, outcome "recovered" (Mar2021), described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not have any problems with the first dose except nausea. She was feeling nausea the whole time until the week before she went to get the second shot. The week prior to getting the second shot, it seemed to end so she felt like he had nausea for about 2 weeks.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303335 same patient and product, different dose and events
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain, Vaccination site warmth
Clinical narrative: right arm was a little sore; his right arm was warm at the site of the shot; felt kind of blah; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Feb2021 12:30 (Lot number: EN6198) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol" (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Feb2021, outcome "recovered" (17Mar2021), described as "right arm was a little sore"; VACCINATION SITE WARMTH (non-serious) with onset 21Feb2021, outcome "recovered" (22Feb2021), described as "his right arm was warm at the site of the shot"; FEELING ABNORMAL (non-serious) with onset 21Feb2021, outcome "unknown", described as "felt kind of blah". No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: some swelling going on under both of his arms; glands are swollen on both sides, but it is mostly on the side he got the shot on, which is his right side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Mar2021 12:30 (Lot number: EN6207) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Lot number: EN6198 intramuscularly in right arm at 12:30 as dose 1, single), administration date: 20Feb2021, when the patient was 65 years old, for COVID-19 immunisation, reaction(s): "right arm was a little sore", "his right arm was warm at the site of the shot", "felt kind of blah". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 14Mar2021, outcome "recovering", described as "some swelling going on under both of his arms"; LYMPHADENOPATHY (non-serious) with onset 14Mar2021, outcome "recovering", described as "glands are swollen on both sides, but it is mostly on the side he got the shot on, which is his right side". The events "some swelling going on under both of his arms" and "glands are swollen on both sides, but it is mostly on the side he got the shot on, which is his right side" were evaluated at the physician office visit.  Additional information: It was reported that events has improved since Sunday and he was hoping it goes away.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after the end of the date of use.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiomyopathy
Clinical narrative: Arrhythmia signs and symptoms, Cardiomyopathy
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Lymphadenopathy, Tinnitus
Clinical narrative: Fullness and ringing in right ear. Loss of hearing. Onset about six hours after injection, lasted 24+ hours.   Left lymph node (arm pit) swelling to size of baseball
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: A couple minutes after administration, patient felt light headed, dizzy, and reported vision changes. Advised patient to lay down or but patient declined, took his blood pressure and it was 174/80 with a pulse of 148.  Called EMS and monitored patient while waiting for EMS, during which time patient remained conscious but still appeared pale, clammy, and felt extremely light headed.  EMS arrived and assessed patient blood pressure eventually normalized to 128/70 after about 30 minutes.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia, Tremor, Visual impairment
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: A couple minutes after administration, patient felt light headed, dizzy, and reported vision changes. Advised patient to lay down or but patient declined, took his blood pressure and it was 174/80 with a pulse of 148.  Called EMS and monitored patient while waiting for EMS, during which time patient remained conscious but still appeared pale, clammy, and felt extremely light headed.  EMS arrived and assessed patient blood pressure eventually normalized to 128/70 after about 30 minutes.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Electrocardiogram, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient got the vaccine in left deltoid and seemed fine.  She stayed in waiting area and suddenly developed symptoms of light headedness difficulty breathing and sweating.  Benadryl was given and symptoms monitored.  Blood pressure, heartrate were monitored.   Husband took her to ER where blood panel and EKG were done.  EpiPen was not admistered.  She recovered and went home.  ER told her not to get 2nd shot and to contact her PCP for followup.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersensitivity
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient got the vaccine in left deltoid and seemed fine.  She stayed in waiting area and suddenly developed symptoms of light headedness difficulty breathing and sweating.  Benadryl was given and symptoms monitored.  Blood pressure, heartrate were monitored.   Husband took her to ER where blood panel and EKG were done.  EpiPen was not admistered.  She recovered and went home.  ER told her not to get 2nd shot and to contact her PCP for followup.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Additional Details: just pain in shoulder with limited range of motion
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: Reactivation of herpes simplex - ongoing
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong vaccine formulation  (ex. different manufacturer initial and booster).
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Seizure, Vision blurred
Clinical narrative: Systemic: Seizure-Mild, Additional Details: pt was given child pfizer vaccine. vial and syringe verified by pt's mom. pt was nervous at time of injection.  proceeded to give brother child pfizer vaccine. came out of room and pt states she had blurred vision. i asked if she felt dizzy and her eyes rolled back and she starting to convulse. place patient on floor laying down with mom and by that time she came back to and went to sit on chair. states she doesn't remember anything besides sitting on chair and waking up on floor.  fed h20/food
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Laboratory test
Clinical narrative: Joint pain in both shoukders
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: back ache pulsing back ache-Severe
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Additional Details: Approximately five minutes after administering vaccines patient reported sweating, dizziness and faintenss. emergency was called to the pharmacy and patient was taken for further evaluation by EMS personnel
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Additional Details: Approximately five minutes after administering vaccines patient reported sweating, dizziness and faintenss. emergency was called to the pharmacy and patient was taken for further evaluation by EMS personnel
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temperature).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Pain, Pain in extremity, Restlessness
Clinical narrative: Arm soreness above a server for vaccination.  Next day increased X2, increase tenderness at shot site. Body aches, uneasy sleeping, restless. Arm still sore and body aches to this day (48hrs+) after injection.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Anticoagulant therapy, Asthenia, COVID-19, Chest X-ray abnormal
Clinical narrative: Patient is fully vaccinated.  COVID + on 11/15/2021.  Hospitalized from 12/10/2021.  Admitted with COVID 19 infection. Presented to the hospital from  Nursing Home/Rehab.  Over there, the patient was tested for COVID-19 and recently patient reported that fatigue, weakness, cough, and she has started suffering from shortness of breath recently.  Active problems:  hypertension, acquired hypothyroidism, hyperlipidemia, kidney stone, AKI.  COVID-19, diagnosed more than 10 days ago.  The patient presented to thehospital with shortness of breath. Had a chest x-ray, which was multifocal bilateral pneumonia.   Continue with dexamethasone.  Shortness of breath/respiratory distress. Continue oxygen supplementation, breathing treatment if needed. Elevated Ddimer .The patient was started on heparin drip due to elevated D-dimer.   Need to do a CT to rule out PE. CT: no acute pulmonary embolism present.  Anemia - likely the Hb drop from 11 - 8. Acute kidney injury.. Avoid nephrotoxic medication.  Encourage the patient to use oral intake and follow up with the CBC and chem 7.  Hypertension.  Blood pressure stable and under control.  Discharged
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax normal, Cough, Dyspnoea, Fatigue, Fibrin D dimer increased
Clinical narrative: Patient is fully vaccinated.  COVID + on 11/15/2021.  Hospitalized from 12/10/2021.  Admitted with COVID 19 infection. Presented to the hospital from  Nursing Home/Rehab.  Over there, the patient was tested for COVID-19 and recently patient reported that fatigue, weakness, cough, and she has started suffering from shortness of breath recently.  Active problems:  hypertension, acquired hypothyroidism, hyperlipidemia, kidney stone, AKI.  COVID-19, diagnosed more than 10 days ago.  The patient presented to thehospital with shortness of breath. Had a chest x-ray, which was multifocal bilateral pneumonia.   Continue with dexamethasone.  Shortness of breath/respiratory distress. Continue oxygen supplementation, breathing treatment if needed. Elevated Ddimer .The patient was started on heparin drip due to elevated D-dimer.   Need to do a CT to rule out PE. CT: no acute pulmonary embolism present.  Anemia - likely the Hb drop from 11 - 8. Acute kidney injury.. Avoid nephrotoxic medication.  Encourage the patient to use oral intake and follow up with the CBC and chem 7.  Hypertension.  Blood pressure stable and under control.  Discharged
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Pneumonia, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Patient is fully vaccinated.  COVID + on 11/15/2021.  Hospitalized from 12/10/2021.  Admitted with COVID 19 infection. Presented to the hospital from  Nursing Home/Rehab.  Over there, the patient was tested for COVID-19 and recently patient reported that fatigue, weakness, cough, and she has started suffering from shortness of breath recently.  Active problems:  hypertension, acquired hypothyroidism, hyperlipidemia, kidney stone, AKI.  COVID-19, diagnosed more than 10 days ago.  The patient presented to thehospital with shortness of breath. Had a chest x-ray, which was multifocal bilateral pneumonia.   Continue with dexamethasone.  Shortness of breath/respiratory distress. Continue oxygen supplementation, breathing treatment if needed. Elevated Ddimer .The patient was started on heparin drip due to elevated D-dimer.   Need to do a CT to rule out PE. CT: no acute pulmonary embolism present.  Anemia - likely the Hb drop from 11 - 8. Acute kidney injury.. Avoid nephrotoxic medication.  Encourage the patient to use oral intake and follow up with the CBC and chem 7.  Hypertension.  Blood pressure stable and under control.  Discharged
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: I have covid arm on the injection area on my left arm. Redness and soreness on arm even though it?s been 4 days.I?m also feeling fatigued.