chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Condition aggravated, Erythema, Pruritus, SARS-CoV-2 test negative
Clinical narrative: Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; lump in throat; 2 asthma flare-ups; face swollen; itching on face, head and around eyes; itching on face, head and around eyes; Occasional waves of feeling very warm; burning feeling around elbows; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 07Mar2021 13:30, at 62 years of age, (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included contrast media allergy, asthma, hypertension, hypothyroidism, glucose tolerance impaired (pre-diabetic) and allergy to erythromycin, cefaclor (CECLOR), penicillin, cefalexin (KEFLEX), neosporine, polysporin, sulfa drugs, eggs, tree nuts, peanuts, fish, shellfish, mushrooms, mustard, chocolate, some melons, raw apples (rashes of hives reactions). The patient didn't receive any other vaccine in the four weeks previous to COVID-19 vaccine. The patient received unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested from COVID-19 post vaccination. On 07Mar2021 at 13:45 the patient experienced itching of tongue, mouth and throat, sometimes lump in throat, 2 asthma flare-ups, face swollen, itching on face, head and around eyes, occasional waves of feeling very warm and burning feeling around elbows. The patient began treatment with famotidine (PEPCID) and diphenydramine hydrochloride (BENADRYL), contacted Doctor's office, then went to ER the day before this report. The physician assistant in ER prescribed 20 mg prednisone daily for 5 days. At the time of the report the reported events had not resolved yet.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus - ringing in her head and swooshing; This is a spontaneous report from contactable consumer, the patient from a Pfizer sponsored program  A female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified date as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient thinks she had tinnitus, had ringing in her head and swooshing. The case was non-serious. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Abdomen scan, Body temperature, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: reaction at the injection site; temperature variation up to 102F/having fever 12 days after; no appetite; very sick like he had flu symptoms; tired and wanted to lay down; This is a spontaneous report from a contactable consumer(caregiver). A male patient of unspecified age and gender received bnt162b2 (PRIZER BIONTECH COVID-19, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had an acute reaction to the Pfizer vaccine. wondering about taking the 2nd dose. first and second day had normal reaction at the injection site, then started to have temperature variation up to 102 F, no appetite and very sick like he had flu symptoms, tired and wanted to lay down. He was having fever 12 days after. Went to the ER, took scan of abdomen and samples of urine to find out what was wrong. Seems to think person had a reaction. Reporter did not confirm if it's an allergic reaction. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis, Vaccination site reaction
Clinical narrative: reaction at the injection site; temperature variation up to 102F/having fever 12 days after; no appetite; very sick like he had flu symptoms; tired and wanted to lay down; This is a spontaneous report from a contactable consumer(caregiver). A male patient of unspecified age and gender received bnt162b2 (PRIZER BIONTECH COVID-19, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had an acute reaction to the Pfizer vaccine. wondering about taking the 2nd dose. first and second day had normal reaction at the injection site, then started to have temperature variation up to 102 F, no appetite and very sick like he had flu symptoms, tired and wanted to lay down. He was having fever 12 days after. Went to the ER, took scan of abdomen and samples of urine to find out what was wrong. Seems to think person had a reaction. Reporter did not confirm if it's an allergic reaction. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site warmth
Clinical narrative: Some soreness in arm; heat around injection; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration in left arm on 08Mar2021 at 07:45 as single dose for COVID-19 immunisation. Medical history included pre-COPD (chronic obstructive pulmonary disease), allergy to penicillin, dairy and seasonal pollen. Concomitant medication included allopurinol, tiotropium bromide (SPIRIVA), rosuvastatin. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive any other medications in two weeks of vaccination. On 08Mar2021 at 11:00 patient experienced some soreness in arm and heat around injection site. No treatment received for adverse events. Patient was not diagnosed with COVID, prior vaccination. Patient had not been tested for COVID, post vaccination. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching on both legs below knees to ankles. Mild to moderate itching on forearms; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 68-year-old) in Left Arm on 04Mar2021 09:15 as single dose for COVID-19 immunization. Historical vaccine includes the first dose of BNT162B2 (Lot number: EM9809 or EN9809) administered on 12Feb2021 09:15 AM in Left arm for COVID-19 immunization. The patient was having known allergies. The patient was not tested COVID prior and post vaccination. Medical history was not reported. Concomitant medications included omeprazole (PRILOSEC), paracetamol (TYLENOL), simvastatin (ZOCOR), cetirizine hydrochloride (ZYRTEC) and Multivitamin taken for an unspecified indication. On 04Mar2021 18:00 the patient experienced severe itching on both legs below knees to ankles, mild to moderate itching on forearms. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: incidence of arm pain (pain at the injection site); This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot numbers and expiry dates were unknown), first dose administered in right arm on 29Jan2021 and second dose administered in left arm on 19Feb2021; both via unspecified route of administration as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had incidence of arm pain (pain at the injection site) after the 1st and 2nd vaccination. The consumer asked if arm pain (right arm, where the 1st dose was administered) is an adverse event associated to the Pfizer BioNTech COVID-19 vaccine, even if it was administered several weeks ago. When she first got it (first dose), the kind of pain she experienced was like having a stroke or something, is like (feeling) out of whack, it felt like when she exercised it was strange. After receiving the 2nd COVID-19 vaccine (left arm), the pain was gone for 1.5 days. The outcome of the event was recovered on unspecified date.  No follow-up attempts are possible; information about lot numbers of both doses cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Skin odour abnormal
Clinical narrative: her heart was racing (170 bpm); fuzzy headed; peculiar musty scent coming off from her and her clothes; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 28Feb2021 as 1st single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. The patient experienced her heart was racing (170 bpm), fuzzy headed and peculiar musty scent coming off from her and her clothes on 28Feb2021. After vaccination, within moments, patient heart was racing (170 bpm). Patient said that, pulse was fine but heart was racing. It made patient fuzzy headed. Because of this, patient had to call patient's son and give the medication for racing heart. Within 5 minutes, patient heart calmed down. This event made patient very much afraid about taking second dose of the vaccine. Patient was afraid that worse things may happen to patient with the second dose. Patient also said that the night after vaccination and also on the next several days, patient started to had a peculiar musty scent coming off from patient and patient's clothes. It had taken several days of bathing to wash of the scent on patient. The scent had already gone away. Patient had already talked with doctor who advised patient not to take the second dose of the vaccine. Patient's doctor also told that, if patient was pushed to take the second dose of the vaccine, then patient should have to take it in a hospital that would better assist in case worse reactions would occur. Patient wanted to know if Pfizer has recommendations about the second dose of the vaccine considering patient's situation. Therapeutic measures were taken as a result of her heart was racing. The patient underwent lab tests and procedures which included heart rate: 170 on 28Feb2021 Her heart was racing (170 bpm) , heart rate: heart was racing on 28Feb2021 Her heart was racing (170 bpm) , heart rate: calmed down on 28Feb2021 Within 5 minutes, her heart calmed down. The outcome of the event heart was racing (170 bpm) was resolving, fuzzy headed was unknown and peculiar musty scent coming off from patient and patient's clothes was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; mild headache; This is a spontaneous report from a contactable consumer reporting for himself. A 39-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202 (EN6200: as reported in field)), via an unspecified route of administration, administered in Left Arm on 05Mar2021 at 11:45 as single dose for COVID-19 immunization. The patient's Medical history included High blood pressure, and overweight. The patient did not have COVID prior to vaccination. The patient did was not tested for COVID post vaccination. The patient did not take any other vaccine 4 weeks prior to COVID vaccination. The patient's concomitant medications included paracetamol (TYLENOL), ibuprofen, tadalafil (CIALIS), probiotics, and lisinopril. On 05Mar2021 at 13:00, the patient experienced sore arm, and mild headache. Therapeutic measures were taken as a result of events: treatment included Tylenol and Ibuprofen. The outcome for the events was resolved approximately on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Flushing, Nausea
Clinical narrative: flush feeling; chest pain to L lower chest; Vaccine-Related Anxiety (include misc mental health); SOB; NVD; Visual/Neuro concerns; Visual/Neuro concerns; This is a spontaneous report received from a non-contactable Other HCP.  A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and Expiration date was not reported) via an unspecified route of administration, on an unknown date (at the age of 37 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported.On an unknown date, during his 15 minutes waiting period after the injection, the patient began to experience flush feeling with chest pain to L lower chest. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. Differential Diagnosis was reported as Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Monitored for approx. 15 minutes. Pt greatly improved. CP resolved within 1 minute of being in the bay after drinking. VS stable/improved. Pt ambulated out of the medical bay w/o assistance. Recommended protein based food and hydration 30 minutes prior to next vaccination. Follow up with pcp as needed. Pt voiced understanding and is appreciative of today's evaluation. Treatment included: water and snacks. Outcome of the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder, Visual impairment
Clinical narrative: flush feeling; chest pain to L lower chest; Vaccine-Related Anxiety (include misc mental health); SOB; NVD; Visual/Neuro concerns; Visual/Neuro concerns; This is a spontaneous report received from a non-contactable Other HCP.  A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and Expiration date was not reported) via an unspecified route of administration, on an unknown date (at the age of 37 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported.On an unknown date, during his 15 minutes waiting period after the injection, the patient began to experience flush feeling with chest pain to L lower chest. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. Differential Diagnosis was reported as Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Monitored for approx. 15 minutes. Pt greatly improved. CP resolved within 1 minute of being in the bay after drinking. VS stable/improved. Pt ambulated out of the medical bay w/o assistance. Recommended protein based food and hydration 30 minutes prior to next vaccination. Follow up with pcp as needed. Pt voiced understanding and is appreciative of today's evaluation. Treatment included: water and snacks. Outcome of the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My left arm has been sore for the last 5 weeks since the shot; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Em 9808) via an unspecified route of administration administered in arm left on 07Feb2021 09:00 AM as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Facility type vaccine was reported as other. The patient was not tested with Covid infection prior to Covid vaccination. The patient was not on any other vaccine four weeks prior to Covid vaccine. The patient was not on any other medications two weeks prior to Covid vaccine. On 07Feb2021 at 10:00 AM, the patient experienced left arm had been sore and was there for the last 5 weeks since the shot. The patient had not received any treatment medication for the resulted events. The patient received Pfizer other vaccine (unspecified) on 26Feb2021 on left arm. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival recession, Pain
Clinical narrative: receding gums; pain; This is a spontaneous report from a contactable consumer (patient herself). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunisation. Age at vaccination was 82 years. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced receding gums and pain. Enquired that, the patient got the first dose of the Pfizer COVID 19 vaccine today. The patient have receding gums, can she take Tylenol or aspirin for the pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: headache; nausea; vomiting; dizziness; body aches; tiredness; stomach cramps; diarrhea; sleeping long; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: bn6198, Expiration date: unknown) dose 1 via an unspecified route of administration administered in left arm on 03Mar2021 12:30 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus from an unknown date, high blood pressure from an unknown date, bell's palsy from an unknown date, brain tumor from an unknown date. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR), rosuvastatin (ROSUVASTATIN) pioglitazone hydrochloride (ACTOS) taken for an unspecified indication, start and stop date were not reported. patient experienced allergies to sulfur. No covid prior vaccination and no covid tested post vaccination. No other vaccine in four weeks. On 05Mar2021 the patient experienced headache, nausea, vomiting, dizziness, body aches, tiredness, stomach cramps, diarrhea, sleeping long. No treatment taken for adverse events. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nausea, Pain, Vomiting
Clinical narrative: headache; nausea; vomiting; dizziness; body aches; tiredness; stomach cramps; diarrhea; sleeping long; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: bn6198, Expiration date: unknown) dose 1 via an unspecified route of administration administered in left arm on 03Mar2021 12:30 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus from an unknown date, high blood pressure from an unknown date, bell's palsy from an unknown date, brain tumor from an unknown date. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR), rosuvastatin (ROSUVASTATIN) pioglitazone hydrochloride (ACTOS) taken for an unspecified indication, start and stop date were not reported. patient experienced allergies to sulfur. No covid prior vaccination and no covid tested post vaccination. No other vaccine in four weeks. On 05Mar2021 the patient experienced headache, nausea, vomiting, dizziness, body aches, tiredness, stomach cramps, diarrhea, sleeping long. No treatment taken for adverse events. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: he got a rash on both of his arms on day 2 and it lasted until day 5 after that first COVID vaccine; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reporting for a 72-year-old male patient received a dose of vaccine BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205) via an unspecified route of administration on an unspecified date (at the age of 72 years) as an 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported at his second COVID vaccine appointment that after his first COVID vaccine, he got a rash on both of his arms on day 2 (on unknown date) and it lasted until day 5 after that first COVID vaccine. Outcome of the event was resolved.  No follow up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Paraesthesia, Rosacea
Clinical narrative: Tingling in arms and legs; red, swollen ear lobe; rosacea; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN620U), dose 1 via an unspecified route of administration, in left arm on 04Mar2021 11:30 (at the age of 78-year-old) as 1st dose, single dose for covid-19 immunisation. Facility type reported hospital. Medical history included breast cancer. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies reported to dairy, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), monascus purpureus (RED YEAST RICE), probiotics, vitamin D [vitamin D nos]. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04Mar2021 at 15:00, the patient experienced tingling in arms and legs, red, swollen ear lobe and rosacea. The patient received treatment of benadryl for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: a warm and thirsty throat; a warm and thirsty throat; dizziness; nausea; pain around spleen; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EN6206) via an unspecified route of administration administered in Arm Left on 10Mar2021 09:30 (at the age of 53-years-old) as single dose for covid-19 immunization. The patient's medical history included thyroid cancer, chronic back pain, thoracic carcinoid and known allergy to green vegetables and some type of MRI or CT Contrast. The patient's concomitant medications included levothyroxine at 100 mg. On 10Mar2021 at 09:45, after been vaccinated patient started having a warm and thirsty throat. Within next hour, started feeling severe dizziness, nausea and pain around spleen. Next, the patient started feeling tiredness and weakness. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Thirst
Clinical narrative: a warm and thirsty throat; a warm and thirsty throat; dizziness; nausea; pain around spleen; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EN6206) via an unspecified route of administration administered in Arm Left on 10Mar2021 09:30 (at the age of 53-years-old) as single dose for covid-19 immunization. The patient's medical history included thyroid cancer, chronic back pain, thoracic carcinoid and known allergy to green vegetables and some type of MRI or CT Contrast. The patient's concomitant medications included levothyroxine at 100 mg. On 10Mar2021 at 09:45, after been vaccinated patient started having a warm and thirsty throat. Within next hour, started feeling severe dizziness, nausea and pain around spleen. Next, the patient started feeling tiredness and weakness. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: racing heart; This is a spontaneous report from a contactable consumer. A 51-years-old non-pregnant female patient received (BNT162B2, solution for injection,Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 10Mar2021 09:15 as UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history was not reported. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies and other medical history. Post vaccination Patient was not diagnosed or tested for COVID-19 at the time of vaccination. Patient didn't receive any other vaccinations with in 4weeks time of vaccination.Patient received levothyroxine in two weeks of vaccination. On 10Mar2021 12:00 the patient experienced racing heart.The outcome of the event was not recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: headache; high temperature; fatigue; tremors; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age (as reported: Age:52; Unit: Unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 07Mar2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Previously the patient took MMR vaccine on an unknown date in Jul2020, for immunization. Approximately on an unknown date in Mar2021, within 10 hours of receiving the vaccine, the patient experienced headache, high temperature, fatigue and tremors. The caller wanted to know if the MMR vaccination she received in July of 2020 may have caused the reaction. The outcome of all the events was unknown. There was no product quality complaint (PQC) found.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Constipation
Clinical narrative: constipation; Bloating; This is a spontaneous report from a contactable Nurse (patient). A 58-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN-6205 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 13:30 as SINGLE DOSE for covid-19 immunisation(Age at Vaccination was 58years). Medical history included hypothyroid, depression, migraine and known allergies: Sulfa. Concomitant medications included levothyroxine, liothyronine (NP THYROID), escitalopram oxalate (LEXAPRO), montelukast sodium (SINGULAIR) and ergocalciferol (VIT D). The patient received historical vaccine of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM-9809 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 01:00 PM as SINGLE DOSE for covid-19 immunisation. The patient experienced constipation and bloating on 05Mar2021 07:00AM (Six days later (one BM, day 4 with help of stool softer / laxative) and still trying to get through it). No treatment received for the events. Outcome of the events was not recovered..  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Sinus disorder
Clinical narrative: not feeling well; sinus issues; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting) from a Pfizer sponsored program Support. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number and expiration date was not reported), via an unspecified route of administration on 20Feb2021 at a 1st dose, single for COVID-19 immunization. Medical history included COVID-19 from 18Jan2021 (the caller stated she tested positive for COVID on the 18Jan2021 or 19Jan2021). The patient's concomitant medications were not reported. On 20Feb2021 the patient experienced the reporter stated she tested positive for COVID on the 18Jan2021 or 19Jan2021. Her husband scheduled her to get the vaccine and when patient got there, they said she should wait 90 days to get the vaccine but since patient was there they said she could go ahead and get it. Patient received this dose, the first dose, on 20Feb2021. She was not feeling well then when she got the vaccine and then she had a little downturn after the vaccine and was not sure if it was from the vaccine or from getting over COVID . She did not have a fever, just some sinus issues. Patient called to ask, if you had COVID and get the first dose and the second dose necessary. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Muscle spasms, Muscle tightness
Clinical narrative: Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lumbar region); Tightness in upper back; Hamstrings; This is a spontaneous report from a contactable (Patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6203 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:45 PM as single dose for COVID-19 immunisation. The patient medical history included suspected allergy of penicillin and allergic to wasps. The patient not received other vaccine in four weeks. The patient concomitant medications included loratadine (CLARITIN) and omeprazole. The patient did not have COVID prior vaccination. On 06Mar2021 at 08:00 AM (18-hours after the vaccination), patient had severe back spasms (lumbar region) along with tightness in upper back and hamstrings, followed by extreme fatigue after 48 hour (morning of 07Mar2021) lasting until Tuesday (09Mar2021). Lower back pain was now moderate but currently ongoing. The patient visited doctor or other healthcare professional office/clinic as a result of events. The patient received treatment with Ibuprofen and Acetaminophen and electrolytes. The patient not tested for COVID post vaccination. On 09Mar2021, the extreme fatigue was resolved. The outcome of all other events was recovering.   No follow-up attempts are possible. information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: temp of 99.2; feeling unwell; cold like symptoms; This is a spontaneous report from a contactable consumer(patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 05Mar2021 as 1 ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she has been feeling unwell, cold like symptoms and a temperature of 99.2. The outcome of the events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Electrocardiogram
Clinical narrative: bad pain in her heart area/it was so severe, she was "afraid to move". She "felt like her chest was going to split".; felt too weak to do anything else; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (71; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Mar2021 20:00, it was reported that, patient stated, received the first dose of the vaccine on 26Feb2021. She was expected to receive the second dose on 19Mar2021. She experienced a reaction after the first dose. Should she receive the second dose. The patient stated, the third night after receiving the first dose, at around 08:00PM, she started experiencing bad pain in her heart area. She says it was so severe, she was "afraid to move". She "felt like her chest was going to split". She felt too weak to do anything else. She added that it seemed like her heart was off beat. The patient underwent lab tests and procedures which included EKG: heart was in good shape on 2021. Outcome of all the events was an unknown.    No follow up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Tenderness
Clinical narrative: Chills; malaise; tenderness; This is a spontaneous report from a contactable Nurse (patient). A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: el9269) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient received the first vaccine dose and was supposed to get the second dose this past Monday, but she reports that when she told the doctor that she was sore in her arm from getting her Tetanus vaccine the doctor told her she needed to wait 14 days before getting the second dose. Patient stated that following her first dose of the covid vaccine she experienced Chills, a general malaise and tenderness to her left hand for 2 days. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild sore arm; This is a spontaneous report received from a contactable consumer reporting for herself. A 69-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6200), via an unspecified route of administration in Arm Left on 04Mar2021 15:45 (age at vaccination 69years old) as single dose for covid-19 immunization. The patient had known allergies to Penicillin and Codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 and 2 weeks prior to the COVID vaccine. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced mild sore arm on 05Mar2021 09:00. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was resolved approximately on unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swollen face; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 09Mar2021, as first dose, single dose for COVID-19 immunization. The patient medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. One day later, on 10Mar2021 the patient woke up with a swollen face. She explained her face was getting better, but it started to swell again. She mentioned that she has thyroid issues and sometimes wakes up with a swollen face, but her sister recommended for her to report the event. She also mentioned she spoke with her endocrinologist who has her on Benadryl every 8 hours and recommended her to monitor her symptoms, and to go to the emergency room if needed. She asked if her symptom was reported as a side effect to the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Muscle pain in both legs in the upper legs and butt/getting bad muscle pain in back of my legs up to buttocks muscle; Had leg pains and could not walk; could not walk; Muscle pain in both legs in the upper legs and butt; This is a spontaneous report from a contactable consumer (the patient). A 65-years-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: El3302) via an unspecified route of administration in Arm Left on 09Feb2021 at 12:00 PM (65-years-old age at vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included Copd, both knees replaced and both hips replaced from an unknown date and unknown if ongoing. Concomitant medications included theophylline, prednisone, losartan, pravastatin and allop. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not had allergies to medications, food or other products. On 20Feb2021 at 16:00, a week or so after the first shot patient started getting bad muscle pain in back of his legs up to buttocks muscle and could not walk. It was stated that now it was only the right side now (so it seemed). Previously the pain was on both sides. The doctor prescribed him 800mg of Tylenol and he also had diclofenac. Therapeutic measures were taken as a result of the events. The outcome of the events were reported as not recovered. The events were reported as non  serious.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance
Clinical narrative: Muscle pain in both legs in the upper legs and butt/getting bad muscle pain in back of my legs up to buttocks muscle; Had leg pains and could not walk; could not walk; Muscle pain in both legs in the upper legs and butt; This is a spontaneous report from a contactable consumer (the patient). A 65-years-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: El3302) via an unspecified route of administration in Arm Left on 09Feb2021 at 12:00 PM (65-years-old age at vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included Copd, both knees replaced and both hips replaced from an unknown date and unknown if ongoing. Concomitant medications included theophylline, prednisone, losartan, pravastatin and allop. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not had allergies to medications, food or other products. On 20Feb2021 at 16:00, a week or so after the first shot patient started getting bad muscle pain in back of his legs up to buttocks muscle and could not walk. It was stated that now it was only the right side now (so it seemed). Previously the pain was on both sides. The doctor prescribed him 800mg of Tylenol and he also had diclofenac. Therapeutic measures were taken as a result of the events. The outcome of the events were reported as not recovered. The events were reported as non  serious.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: fever; chills; extreme weakness; extreme exhaustion; dizziness; sore muscles and joints; sore muscles and joints; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:30 (at the age of 74-years-old) as single dose for COVID-19 immunisation. Medical history included CLL Leukemia, Chronic Pancreatitis, Lymphocytic Colitis. There were no known allergies. Concomitant medication included Horizant, Progesterone, Estrogen, Levothyroxin. The patient did not receive any other vaccines within four weeks of COVID vaccine. The patient did not have COVID prior to vaccination. On 05Mar2021 at 05:00 (next day of vaccination), patient experienced fever, chills, extreme weakness, extreme exhaustion, dizziness, sore muscles and joints. No treatment was received for events. The patient was not tested for COVID post vaccination. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; chills; extreme weakness; extreme exhaustion; dizziness; sore muscles and joints; sore muscles and joints; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:30 (at the age of 74-years-old) as single dose for COVID-19 immunisation. Medical history included CLL Leukemia, Chronic Pancreatitis, Lymphocytic Colitis. There were no known allergies. Concomitant medication included Horizant, Progesterone, Estrogen, Levothyroxin. The patient did not receive any other vaccines within four weeks of COVID vaccine. The patient did not have COVID prior to vaccination. On 05Mar2021 at 05:00 (next day of vaccination), patient experienced fever, chills, extreme weakness, extreme exhaustion, dizziness, sore muscles and joints. No treatment was received for events. The patient was not tested for COVID post vaccination. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in her arm; This is a spontaneous report received from a contactable consumer or other non hcp. A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was calling for her daughter who is 18 years old. She has gotten the first dose of the Pfizer COVID-19 vaccine and after that, she developed swollen lymph nodes in her arm on unknown date. A week ago, she received the second dose of the vaccine and she had developed swollen lymph node near her throat. Caller wanted to know if this adverse event could be from the Pfizer COVID-19 vaccine. Caller said that her daughter hasn't noticed it until today and it may had occurred earlier than today. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Experienced pins and needles throughout her whole body; Experienced burning in her 4th finger of her left hand; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 08Feb2021 09:15 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced experienced pins and needles throughout her whole body, experienced burning in her 4th finger of her left hand. Patient stated that she did not take the second shot because she experienced burning in her 4th finger of her left hand, which went away the next day. She then experienced pins and needles throughout her whole body which lasted three weeks and is now resolved and wanted to know if it is ok to take the second dose, long she could wait before getting the second dose. The outcome of events was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.