chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain in extremity, Rhinorrhoea
Clinical narrative: She also has runny nose; her left neck is also achy since monday; Patient left arm has been achy since the vaccine on monday; This is a spontaneous report from a contactable consumer reported for a patient. A 30-year-old female patient (no pregnant) received her dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EH9899), via an unspecified route of administration in Left arm on 21Dec2020 11:45 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left arm had been achy since the vaccine on Monday and her left neck was also achy since Monday on 21Dec2020 11:45 AM. She also had runny nose on 21Dec2020 11:45 AM. No treatment received for the events. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Left arm soreness x36 h.; This is a spontaneous report from a contactable pharmacist (patient).  A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) at single dose on 17Dec2020 16:45 the first dose for COVID-19 immunization in left arm. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Cervical intraepithelial neoplasia II (Cin2), iron deficiency anaemia (IDA), diagnosed with covid-19 prior to vaccination and no known drug allergy.  Concomitant medication included ferrous sulfate, cyanocobalamin (B12).  Patient reported that on 18Dec2020, left arm soreness x36 h. No movement 0/10 pain, movement 8h after vaccine was uncomfortable to move, 16h -32h when moving 1/10 pain with some soreness. Did not impede any ADLs or work. Event was reported as non-serious. Since the vaccination, patient had not been tested for COVID-19. The outcome of event resolved in Dec2020 without treatment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Oral mucosal eruption, Pruritus, Rash
Clinical narrative: small rash on left wrist and around lips and mouth/ extremely itchy; small rash on left wrist and around lips and mouth/ extremely itchy; small rash on left wrist and around lips and mouth/ extremely itchy; small rash on left wrist and around lips and mouth/ extremely itchy; small rash on left wrist and around lips and mouth/ extremely itchy; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm on 21Dec2020 12:30 PM, single dose for COVID-19 immunization at 36-year-old. Medical history included: allergies: penicillins. Prior to vaccination, the patient did not diagnose with COVID-19. Concomitant medications in two weeks of vaccination included: fluoxetine 20mg from Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Dec2020 05:00 AM, after the injection, the patient developed a small rash on her left wrist and around her lips and mouth. It was extremely itchy and remained after three days. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was not resolved. It was reported as non-serious.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster
Clinical narrative: Moderate Left upper mid back pain started less than 24 hours after injection. 7 days after injection pt had fully developed shingles in this area; This is a spontaneous report from a contactable Physician. A 39-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular route of administration on 16Dec2020 17:00 at single dose on left arm for COVID-19 immunization. Medical history was none. Concomitant medication included omeprazole. The patient had no other vaccine in four weeks. The patient experienced moderate Left upper mid back pain started less than 24 hours after injection on 17Dec2020 15:00. 7 days after injection (23Dec2020) the patient had fully developed shingles in this area. Treatment received included Valacyclovir tid (Three times a day) for 7 days. The outcome of the events was not resolved.   Information on the lot/batch number has been requested
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: no sense of taste and smell; no sense of taste and smell; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 19Dec2020 8:15 pm intramuscularly to left deltoid at single dose for COVID-19 immunization. Patient medical history included diabetes diagnosed 02Nov2020. Family medical history was none. Concomitant medications included Metformin. The patient previously took PPD many years ago and had a rash. She received the COVID 19 vaccine on 19Dec2020. On Sunday (20Dec2020) 07:00, she had no sense of taste or smell and still has that as of today. She has not seen anything that says that is a normal side effect. There was no prescriber. She received it at the hospital where she works. She stated she just takes Metformin but did not believe it was relevant to this report. NO ER or physician's office required. No test. Vaccination facility type was Hospital. Not a military facility Vaccination. No previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). None Additional Vaccines Administered on Same Date of the Pfizer Suspect. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugar shooting up between 200-250; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received his dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730, Expiry Date: Unknown), via an unspecified route of administration in Left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history included type 2 diabetes/diabetic which was diagnosed more than 10 years ago. There was no family medical history. There were no concomitant medications. The patient previously had influenza vaccine (FLU VACCINE VII, reported as flu vaccination) for vaccination and had no reaction. The patient received COVID-19 vaccine on 16Dec2020 between 10:00 and 10:15. His blood sugar was usually between 100 and 150. Now his blood sugar was shooting up between 200-250 in Dec2020. He took his blood sugar every day and realized it was going up. He was taking medication every day. He wanted to know if any other diabetic patients reported and increase in blood sugar after receiving COVID-19 vaccine. There were no additional vaccines administered on same date of COVID-19 vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Vaccination facility was hospital. The outcome of the event was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysgeusia, Headache, Malaise
Clinical narrative: Malaise; body aches; headaches; stuffy nose; pain in neck; Felling ill; pain in neck, joints; fever; chills; sore throat; stuffy head; Metallic taste in mouth; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the 18Dec2020 14:00 intramuscularly right arm at single dose for Care for COVID patients. Patient medical history included Recently diagnosed with fibromyalgia and is taking medication. Family medical history was unknown; Both of her parents are deceased. Mother died from heart disease and father died from alcoholism. Concomitant medications included medication for fibromyalgia. Patient previously had flu shot probably in Sep2020. After she got the Covid vaccine she started to feel ill with fever, chills, sore throat and stuffy head. Patient received COVID-19 Vaccine on Friday (18Dec2020) from hospital. Began feeling ill last night (23Dec2020) with fever, chills, sore throat, and stuffy head. Wants to know if she needs to go get tested. Received COVID-19 Vaccine on 18Dec2020 at 14:00. Began to fill ill last night 23Dec2020. Had a metallic taste starting 19Dec2020 around 18:00 for a couple of hours. On 23Dec2020 around 18:00 started to feel malaise, body aches, and headache. Got home from work, went to bed, and had a full blown pounding headache with pain in the neck, her joints, and malaise. Had a stuffy nose and sore throat yesterday, 23Dec2020 around the time she went to bed. Prior vaccinations within 4 weeks was No. Vaccination facility type was hospital. vaccine administered at military site was no. The outcome of events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Neck pain, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Malaise; body aches; headaches; stuffy nose; pain in neck; Felling ill; pain in neck, joints; fever; chills; sore throat; stuffy head; Metallic taste in mouth; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the 18Dec2020 14:00 intramuscularly right arm at single dose for Care for COVID patients. Patient medical history included Recently diagnosed with fibromyalgia and is taking medication. Family medical history was unknown; Both of her parents are deceased. Mother died from heart disease and father died from alcoholism. Concomitant medications included medication for fibromyalgia. Patient previously had flu shot probably in Sep2020. After she got the Covid vaccine she started to feel ill with fever, chills, sore throat and stuffy head. Patient received COVID-19 Vaccine on Friday (18Dec2020) from hospital. Began feeling ill last night (23Dec2020) with fever, chills, sore throat, and stuffy head. Wants to know if she needs to go get tested. Received COVID-19 Vaccine on 18Dec2020 at 14:00. Began to fill ill last night 23Dec2020. Had a metallic taste starting 19Dec2020 around 18:00 for a couple of hours. On 23Dec2020 around 18:00 started to feel malaise, body aches, and headache. Got home from work, went to bed, and had a full blown pounding headache with pain in the neck, her joints, and malaise. Had a stuffy nose and sore throat yesterday, 23Dec2020 around the time she went to bed. Prior vaccinations within 4 weeks was No. Vaccination facility type was hospital. vaccine administered at military site was no. The outcome of events was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Palpitations
Clinical narrative: Headache; fatigue; palpitations; elevated heart rate; fever; chills; This is a spontaneous report from a non-contactable physician reporting for a patient.  A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot # EH9899, intramuscularly on 22Dec2020, as a single dose in right arm (age at vaccination: 28 years old) for COVID-19 immunization (dose 1). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced headache, fatigue, palpitations/elevated heart rate, fever, and chills. The events were reported as non-serious. The patient received treated for the events with acetaminophen (TYLENOL). She recovered from the events headache, fatigue, palpitations/elevated heart rate, fever, and chills on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; fatigue; palpitations; elevated heart rate; fever; chills; This is a spontaneous report from a non-contactable physician reporting for a patient.  A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot # EH9899, intramuscularly on 22Dec2020, as a single dose in right arm (age at vaccination: 28 years old) for COVID-19 immunization (dose 1). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced headache, fatigue, palpitations/elevated heart rate, fever, and chills. The events were reported as non-serious. The patient received treated for the events with acetaminophen (TYLENOL). She recovered from the events headache, fatigue, palpitations/elevated heart rate, fever, and chills on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus on her R ear; dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), intramuscularly on the left arm on 23Dec2020 at 13:30 at a single dose for COVID-19 immunization administered at the hospital facility. Relevant medical history included rheumatoid arthritis, bipolar disorder, anxiety, and depression; all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included unspecified anti-depressants. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 at 07:00, about 18 hours after the vaccine was administered, the patient experienced tinnitus on her right (R) ear and dizziness, which were assessed as non-serious. She had never experienced these combinations of symptoms before even when she was taking her anti-depressants. The patient had a Covid test post vaccination (test type: Other, Rapid) with unknown results on an unspecified date in Dec2020. The patient also had a Covid test on 18Dec2020 with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via rapid test. Unspecified therapeutic measures were taken as a result of tinnitus on her R ear and dizziness. The patient was recovering from both the events.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: his thighs are getting tossed to the right; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: unknown), via an unspecified route of administration at the right deltoid on 22Dec2020 18:40 at 0.3 mL, single for covid-19 immunization. Medical history included mini strokes and master strokes, connective tissue disorder from 2018 (diagnosed 2 years ago), seizure and brain issues.  The patient experienced "his thighs are getting tossed to the right" on 24Dec2020 05:00. The morning of 24Dec2020, patient woke up and he felt like everything was getting switched to the right on his thighs. Below his calf and his torso are fine. He feels fine though, it was just his hips and thighs. His sister reminded him that this is how he felt when he had mini strokes and master strokes in the past. She reminded him that his left leg would go to the right. He was not falling or anything though. He feels fine, it just has that feeling. He would like to know if he should be seen for this. He was just asking because his sister is freaking out and asked if he should be seen. Patient takes epilepsy medication, blood thinners and thyroid medication. He will receive 2nd dose on 08Jan2020. Outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: he is feeling aches/feel body aches; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 23Dec2020 08:00 at a single dose as COVID-19 vaccine. The patient's medical history and concomitant medications were not reported. Patient would like to know if it's okay to visit with his family tonight since he was feeling aches after receiving the vaccine. Patient further reported that he received the COVID-19 vaccine yesterday, 23Dec2020 at 8:00AM. He stated he worked the graveyard shift (clarified as overnight shift) and came home and slept with no problem. He said he came home from work this morning, 24Dec2020, and he was starting to feel body aches. He said he read the information about the COVID-19 Vaccine side effects, and he knew that feeling body aches after receiving the vaccine is normal. He said he has a question, clarifying that he forgot to ask the question before receiving the COVID-19 vaccine. He asked if it is OK for him to have dinner with his parents after receiving the COVID-19 vaccine. He stated there would be 4 people total, clarifying he would be gathering with 3 people plus himself. The outcome of the event body aches was not recovered.   Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Patient received the covid vaccine on 12/22/2020.   On 12/23/2020  at 3:00 am, she was awakened in the middle of night with a "bad" headache and feeling "chills". No fever. Felt better the next day, 12/24/20 but noted left neck lymph node swelling. No sore throat or cough.  No problem swallowing.  On 12/28/2020 chills recur, L neck lymph node is enlarged. Sxs persist until today. Had covid testing on 12/28/2020 with PCP. Waiting result.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Confusional state, Dysstasia, Electrocardiogram, Hypertension
Clinical narrative: Approx 5 minutes after injection, injection site arm shoulder began to have a burning sensation, progressed to neck back of head burning sensation and pain. Then progressed to all over body shakiness, confusion, high blood pressure 220/120 , tachycardia , unable to stand without falling.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Tachycardia, Tremor
Clinical narrative: Approx 5 minutes after injection, injection site arm shoulder began to have a burning sensation, progressed to neck back of head burning sensation and pain. Then progressed to all over body shakiness, confusion, high blood pressure 220/120 , tachycardia , unable to stand without falling.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Heart rate increased, Hypertension, Injection site pain
Clinical narrative: Approx 5 minutes after injection, injection site arm shoulder began to have a burning sensation, progressed to neck back of head burning sensation and pain. Then progressed to all over body shakiness, confusion, high blood pressure 220/120 , tachycardia , unable to stand without falling.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site paraesthesia, Nausea, Palpitations, Tremor
Clinical narrative: Approx 5 minutes after injection, injection site arm shoulder began to have a burning sensation, progressed to neck back of head burning sensation and pain. Then progressed to all over body shakiness, confusion, high blood pressure 220/120 , tachycardia , unable to stand without falling.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Confusional state, Dysstasia, Electrocardiogram, Hypertension
Clinical narrative: reported tingling sensation and soreness of deltoid at injection site.  Tingling traveled up her shoulder to back of her heck.  Felt nauseous with dry mouth and shaky.  Felt dizzy and like heart was racing.  No difficulty swallowing or SOB.  BP 200/100, HR 100, RR 16.   Stood to transfer from chair to stretcher.  Transported to ED via stretcher.   In ED 179/102 HR 116, RR18.  Felt better after 10 minutes.  Patient shared previous history of vaso-vagal reaction after severe cut of finger.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Tachycardia, Tremor
Clinical narrative: reported tingling sensation and soreness of deltoid at injection site.  Tingling traveled up her shoulder to back of her heck.  Felt nauseous with dry mouth and shaky.  Felt dizzy and like heart was racing.  No difficulty swallowing or SOB.  BP 200/100, HR 100, RR 16.   Stood to transfer from chair to stretcher.  Transported to ED via stretcher.   In ED 179/102 HR 116, RR18.  Felt better after 10 minutes.  Patient shared previous history of vaso-vagal reaction after severe cut of finger.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Heart rate increased, Hypertension, Injection site pain
Clinical narrative: reported tingling sensation and soreness of deltoid at injection site.  Tingling traveled up her shoulder to back of her heck.  Felt nauseous with dry mouth and shaky.  Felt dizzy and like heart was racing.  No difficulty swallowing or SOB.  BP 200/100, HR 100, RR 16.   Stood to transfer from chair to stretcher.  Transported to ED via stretcher.   In ED 179/102 HR 116, RR18.  Felt better after 10 minutes.  Patient shared previous history of vaso-vagal reaction after severe cut of finger.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site paraesthesia, Nausea, Palpitations, Tremor
Clinical narrative: reported tingling sensation and soreness of deltoid at injection site.  Tingling traveled up her shoulder to back of her heck.  Felt nauseous with dry mouth and shaky.  Felt dizzy and like heart was racing.  No difficulty swallowing or SOB.  BP 200/100, HR 100, RR 16.   Stood to transfer from chair to stretcher.  Transported to ED via stretcher.   In ED 179/102 HR 116, RR18.  Felt better after 10 minutes.  Patient shared previous history of vaso-vagal reaction after severe cut of finger.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Fatigue, Headache, Myalgia
Clinical narrative: Muscle soreness; Profound fatigue/exhaustion; Mild headache; Agitation; This is a spontaneous report from a contactable pharmacist. A 23-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284 , intramuscularly on 22Dec2020 14:45 (at the age of 23-years-old) as a single dose in the left for COVID-19 immunization. Medical history included anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), irritable bowel syndrome (IBS). The patient had allergies to medications doxycycline, mupirocin, and intolerant to garlic and onion  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) 20 mg, sertraline 150 mg, clonazepam 1 mg everyday at bedtime (QHS), melatonin "ER" 10mg QHS (every bedtime), montelukast 10mg HS (at bedtime), famotidine 20 mg twice a day(BID), pantoprazole (PANTOPRAZOLE) 20mg once  day (QD), ondansetron 8 mg three times a day(TID) as needed (PRN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital.  On 23Dec2020, the patient experienced muscle soreness, profound fatigue/exhaustion, mild headache and agitation.  The events muscle soreness, Profound fatigue/exhaustion, mild headache and agitation  did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events muscle soreness, profound fatigue/exhaustion, mild headache and agitation was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Resident developed an all over body, raised, itchy red rash. Treatment with Benadryl, Vistaril, Hydrocortisone cream, Solumedrol and Medrol dose pack. Rash has improved but not completely resolved.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Pyrexia
Clinical narrative: temp of 101.7-102.9; chest tightness; stabbing chest pain; pulse was 118; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 15:45 (at the age of 44-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. It was reported that the patient had no known allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. The patient was tested for COVID-19 on 21Dec2020, the day prior to vaccination, and received a positive test result on 23Dec2020, the day after vaccination. The COVID test name was reported. Concomitant medications included celecoxib (CELEXA), trazodone, potassium citrate and hydrochlorothiazid, all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 15:00, the patient experienced temp of 101.7-102.9, pulse was 118, chest tightness and stabbing chest pain. The clinical course was reported as follows: "I was tested (mandatory) on Monday. I got the 1st vaccine on Tuesday. I found out my test was positive on Wednesday morning. I had no symptoms until 24 hrs. after my vaccine. I had a temp of 101.7-102.9, O2- 94-95, pulse was 118. I also had chest tightness and stabbing chest pain. My fever broke Wednesday at 11:00pm. I woke up today, Thursday, feeling a lot better. O2 is 97, pulse is 85. No chest issues today." It was reported that the events were non-serious and did not require hospitalization. The patient did not receive any treatment for the events. The clinical outcome of the event temp of 101.7-102.9 was recovered/resolved on 23Dec2020 at 23:00 and the clinical outcomes of the events chest tightness, stabbing chest pain and pulse was 118 were recovered/resolved on 24Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pain
Clinical narrative: Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; This is a spontaneous report from a contactable healthcare professional.  This 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL1284, via an unspecified route of administration, in the left arm on 23Dec2020 at 15:00 ( at the age of 30 years-old) as a single dose for COVID-19 immunization. The COVID-19 vaccine was administered at a facility. Medical history included an allergy to bee venom. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On 24Dec2020 at 0100, the patient had muscle pain, chills, nausea and a general body ache. He was not hospitalized nor treated for the events. The clinical outcome of the events of muscle pain, chills, nausea and a general body ache was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash macular, Skin warm, Tenderness
Clinical narrative: some tenderness in right leg; a rash on both thighs and both legs to my ankles. Front and back of both legs; Just red and blotchy; Just red and blotchy; Leg feels warm to touch; This is a spontaneous report from a contactable consumer (patient). A (age:56, unit not provide) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 22Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She got the vaccine on 22Dec2020 and this morning (24Dec2020) she noticed some tenderness in right leg. She didn't notice at work. Until she got home from work at 9:00 PM ET. Then she noticed a rash on both thighs and both legs to her ankles. Front and back of both legs. No pain. Just red and blotchy. Leg feels warm to touch. It's red it is kind of splotchy. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: Moderate muscle soreness to the right affected arm and lymphadenopathy to right underarm; Moderate muscle soreness to the right affected arm and lymphadenopathy to right underarm; This is a spontaneous report from a contactable Nurse, the patient. This 36-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the right arm on 22Dec2020 at 14:45 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included raynaud's phenomenon from an unknown date and unknown if ongoing and latex allergy from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. Concomitant medication included acetaminophen (ACETAMINOPHEN) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 23Dec2020 at 07:00, the patient experienced moderate muscle soreness to the right affected arm and lymphadenopathy to the right underarm. No therapeutic measures were taken as a result of the events. The clinical outcome of muscle soreness and lymphadenopathy was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Defaecation urgency, Faeces soft, Feeling cold, Piloerection
Clinical narrative: 3 or 4 of soft stools( diarrhea), 5 soft stools; a couple of chills; got cold; goose bumps easily; This is a spontaneous report from a contactable Other Health Professional (patient). A 20-year-old female patient, not pregnant at the time of vaccination, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration in right arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication the patient received within 2 weeks of vaccination included cetirizine hydrochloride (CETRIZINE, 10 mg), 10mg, per day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Allergies to medications, food, or other products: No. The patient experienced 3 or 4 of soft stools( diarrhea), 5 soft stools, a couple of chills, got cold and goose bumps easily on 23Dec2020 11:00 AM with outcome of not recovered. The patient had about 3 or 4 of soft stools (diarrhea) on 23Dec2020. Had a couple of chills and sense of urgency going to the restroom and have had 5 soft stools(diarrhea) on 24Dec2020. The patient felt and got cold, chills, and goose bumps easily. AE resulted in none. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Identification of the case safety report: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: runny nose; some post nasal drip; ache; headache; dry occ. cough; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 58-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly at site of left arm at 08:15 on 19Dec2020 at single dose for COVID-19 immunization. Medical history included breast cancer from 2017. Concomitant medication included atorvastatin and exemestane. The patient previously took aspirin and experienced allergies: aspirin. The patient started with dry occ. Cough at 9:00 on 23Dec2020, with aches and headache, no fever on 24Dec2020, with some postnasal drip, runny nose and aches, no fever on 25Dec2020. The patient received paracetamol (TYLENOL) for treatment. The event still here but slightly improved. Reporter would assume they were related to the vaccine but she wanted to be sure because if they started like three days later and she had the aches and things, that could be COVID related, the aches and the headache but also could be vaccine related. The outcome of event was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration (right arm) on 23Dec2020 12:00 at a single dose for Covid-19 immunisation. Medical history included hypothyroidism, crest syndrome, and celiac disease. The patient's concomitant medications were not reported. The patient previously took gluten and experienced allergies. The patient had her first dose and experienced soreness at injection site on 23Dec2020 12:00. The event was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested. Patient was not pregnant. Outcome of the event was recovered in Dec2020.  Information on Lot/Batch has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Small joint pain. Bilateral hands, starting 24 hours after administration, worsened at 36 hours after administration. Bilateral SI joints, starting 36 hours after administration.; Small joint pain. Bilateral hands, starting 24 hours after administration, worsened at 36 hours after administration. Bilateral SI joints, starting 36 hours after administration.; This is a spontaneous report from a contactable physician (the patient).  A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number  Ej1685) via an unspecified route of administration on 23Dec2020 at 13:45 (at the age of 31-years-old) at an unspecified dose in the right arm for COVID-19 Vaccination. Medical history included Crohn's Disease (currently in remission) and Phenylketonuria from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was administered the vaccine in the hospital. Concomitant medication included mesalamine (MESALAMINE),pegvaliase pqpz (PALYNZIQ), vedolizumab (ENTYVIO), budesonide (UCERIS) and omeprazole (OMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. Starting twenty-four hours after administration, the patient experienced small joint pain in his hands bilaterally on 24Dec2020; this worsened at thirty-six hours after administration. The patient also experienced bilateral pain in sacroiliac joints (reported as "SI joints"), starting thirty-six  hours after administration. Treatment was received and included the administration of celecoxib (CELEBREX). The clinical outcome was reported as not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable physician.  A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231), intramuscularly, on 24Dec2020 at 13:30 (at the age of 27 years old) at an unspecified dose in the left arm for COVID-19 Vaccination. Medical history included obesity, migraine and bipolar disorder from unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19 (date not specified).The patient's known allergies included shellfish products and chocolate.The patient was administered the vaccine in the hospital. It was unknown if the patient was pregnant at the time of the vaccination. Concomitant medication included ergocalciferol (ERGOCALCIFEROL), rizatriptan (RIZATRIPTAN), tretinoin (TRETINOIN). It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. On 25Dec2020, the patient experienced fever (no value reported). The patient did not receive any treatment for the event. The clinical outcome of fever was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Erythema, Pruritus, Throat irritation
Clinical narrative: After administration of the COVID-19 vaccine, patient began to have redness, itching of arm/chest/neck at 0910.  At 0930, patient  had tightness of chest and throat was scratchy.  At 1015, patient administered benadryl 25 mg.  At 1115, patient stated all symptoms resolved.  Patient instructed to follow up with physician in regards to 2nd dose of COVID-19 vaccine due in 17-21 days.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Malaise, Pain
Clinical narrative: still felt rather weak; body ache; felt malaise throughout the day that lasted until night time; headache; fatigue; drowsiness; This is a spontaneous report from a contactable nurse reporting for herself.  A 31-year-old male patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) intramuscular in left arm on 22Dec2020 16:15 at single dose for COVID-19 immunization.  Medical history was none. Concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient reported that after the vaccine was administered at 4:15 pm on 22Dec2020, she experienced headache and fatigue about 4 hours after. She also experienced drowsiness and had to sleep 2 hours earlier than usual. The following day 23Dec2020, she experienced more fatigue, body ache and felt malaise throughout the day that lasted until night time. on 24Dec2020, the body aches went away but still felt rather weak and got tired easily 25Dec2020 she felt almost back to her normal sel. No treatment was received. The outcome of all the events was reported as recovered on 25Dec2020.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: still felt rather weak; body ache; felt malaise throughout the day that lasted until night time; headache; fatigue; drowsiness; This is a spontaneous report from a contactable nurse reporting for herself.  A 31-year-old male patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) intramuscular in left arm on 22Dec2020 16:15 at single dose for COVID-19 immunization.  Medical history was none. Concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient reported that after the vaccine was administered at 4:15 pm on 22Dec2020, she experienced headache and fatigue about 4 hours after. She also experienced drowsiness and had to sleep 2 hours earlier than usual. The following day 23Dec2020, she experienced more fatigue, body ache and felt malaise throughout the day that lasted until night time. on 24Dec2020, the body aches went away but still felt rather weak and got tired easily 25Dec2020 she felt almost back to her normal sel. No treatment was received. The outcome of all the events was reported as recovered on 25Dec2020.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lymphadenopathy, Nausea
Clinical narrative: Headache; soreness in the injection site; chills; soreness on the right side of neck; swollen lymph nodes on right side of neck; nausea; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 33-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left arm on 16Dec2020 16:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included paracetamol (TYLENOL) and birth control pills, multivitamins taken within 2 weeks of vaccination. The patient experienced headache, soreness in the injection site, chills, soreness on the right side of neck, swollen lymph nodes on right side of neck, nausea all on 17Dec2020 08:00 with outcome of not recovered. The patient did not receive treatment.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Headache; soreness in the injection site; chills; soreness on the right side of neck; swollen lymph nodes on right side of neck; nausea; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 33-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left arm on 16Dec2020 16:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included paracetamol (TYLENOL) and birth control pills, multivitamins taken within 2 weeks of vaccination. The patient experienced headache, soreness in the injection site, chills, soreness on the right side of neck, swollen lymph nodes on right side of neck, nausea all on 17Dec2020 08:00 with outcome of not recovered. The patient did not receive treatment.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Two days following injection: Right (non-injection side) forearm and hand soreness/sensit; Upper left arm (injection site) slight soreness day of injection.; This is a spontaneous report from a contactable other healthcare professional (hcp) (patient). A 30-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included severe neutropenia, arthritis in neck, osteophyte in neck. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). No other vaccine in four weeks provided. On 23Dec2020 12:15, the patient experienced upper left arm (injection site) slight soreness day of injection, slight increase in soreness here and in left back area near left underarm the following day, two days following injection in 25Dec2020: right (non-injection side) forearm and hand soreness/sensit. None of the aforementioned events have been more than mild in severity. This is non-serious report. The patient had no COVID prior vaccination and no COVID tested post vaccination. No treatment received for this AE. The outcome of events was not resolved.  Information on the batch/lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Somnolence, Swollen tongue, Throat tightness
Clinical narrative: per patient, 10 minutes after immunization, patient felt tongue swelling, throat tightness, and difficulty swallowing.  pt also felt dizzy.  No rash/ no itchiness.   Medical staff at fire department where patient received vaccine, did not notice tongue/lip swelling, but gave Benadryl 50 mg IV and transported to Ed.   At ED, patient felt better, except complained of dizziness and sleepiness.