chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Her eyes being itchy; Eye tearing; Her eyes being red; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021, as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication taken 2 weeks after the first dose included varicella zoster vaccine rge (cho) (SHINGRIX) from Jan2021, taken for an unspecified indication, stop date was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021, as single dose for COVID-19 immunization. On an unspecified date in Feb2021, the patient's eyes were being itchy and red; and had eye tearing since the second shot. The patient was prescribed with eye drops. The clinical outcome of the events was reported as not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pain in extremity
Clinical narrative: nausea/completely nauseous; bad headache; felt really sick; arm was also sore; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration on 13Jul2021 at 12:30 in the afternoon as dose 2, single dose for covid-19 immunisation. Patient history he had COVID in December, but she just feels really sick. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. She stated that she got her 2nd dose of the Pfizer BioNTech Covid-19 vaccine yesterday 12:30 in the afternoon and on 14Jul2021, she felt really sick around 2 or 3 in the morning of the following day, her arm was also sore, it started out as a bad headache and had progressed to nausea. She took some Advil to relieve the headache, but she is still feeling the side effects of the vaccine. She states that she's just feeling really sick after the second dose. She states she's completely nauseous, she has a bad headache, she just feels really sick. She states she doesn't know what to do. She asked, is it normal to feel nauseous after? she just wanted to know if what she's feeling is normal, she just hates feeling like this. She wanted to know if feeling nausea, bad headache, and feeling unwell are among the commonly reported adverse events after getting the Pfizer BioNTech Covid-19 Vaccine. She confirmed that the product she received and is speaking of was the Pfizer Covid 19 Vaccine. She stated that it was the Pfizer 19, Covid Vaccine number two, she got it done. Reporter seriousness for nauseous, bad headache and just feels really sick was unspecified. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose for a few hours; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 49-year-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Apr2021 09:15 as dose 1, single for covid-19 immunization. patient received 2nd vaccination shot on 19May2021 at approximately 9:30 AM. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021 patient experienced runny nose for a few hours. Reportedly, I am writing this letter to request financial assistance with my medical bills. Consumer request was 2 fold, first to get financial assistance that will cost me thousands in out of pocket expenses due to these tests to see what is going on. I shouldn't have to spend the next few years paying off medical expenses because of a vaccination shot, and second to make Pfizer aware of this situation. The outcome of event was recovered on an unspecified date in Apr2021.   Information about Lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Loss of personal independence in daily activities, SARS-CoV-2 test, Tremor
Clinical narrative: received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after; Vomited; got really shaky; not able to drive; bad headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 (17-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) 40 mg once daily taken for an unspecified indication, start and stop date were not reported. On 30Jun2021, the patient experienced Vomited, got really shaky, not able to drive and bad headache. The patient received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after sars-cov-2 test positive on 05Jul2021. The reporter stated her daughter received the first dose and then ended up testing COVID positive. She received her first Pfizer Vaccine and she ended up with Covid positive, 5 days later. So, my question is with her second vaccine, do they recommend any way or not, should we, because she had the first one and became infected. She also had side effects from the first vaccine. Side effects: Pharmacist stated," I know she vomited, she got really shaky, really bad headache and she was not able to drive." Laboratory test: Pharmacist stated, "No lab but she tested COVID positive e on 05Jul2021 from 'PCR' (Not spelled) COVID test. The outcome of the events were unknown. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 05Jul2021.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after; Vomited; got really shaky; not able to drive; bad headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 (17-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) 40 mg once daily taken for an unspecified indication, start and stop date were not reported. On 30Jun2021, the patient experienced Vomited, got really shaky, not able to drive and bad headache. The patient received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after sars-cov-2 test positive on 05Jul2021. The reporter stated her daughter received the first dose and then ended up testing COVID positive. She received her first Pfizer Vaccine and she ended up with Covid positive, 5 days later. So, my question is with her second vaccine, do they recommend any way or not, should we, because she had the first one and became infected. She also had side effects from the first vaccine. Side effects: Pharmacist stated," I know she vomited, she got really shaky, really bad headache and she was not able to drive." Laboratory test: Pharmacist stated, "No lab but she tested COVID positive e on 05Jul2021 from 'PCR' (Not spelled) COVID test. The outcome of the events were unknown. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 05Jul2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: daughter has had serious hives all over her body; This is a spontaneous report from a contactable consumer. A 35-years-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), 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. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 35-year-old at the time of vaccination), on an unspecified date as single dose for covid-19 immunisation and no adverse reaction experienced. It was reported that patient was perfectly healthy and has had serious hives all over her body after the she got the second Pfizer vaccine for COVID and this has gone on for three months. Nothing she has tried has worked and it's really a terrible situation. I think this is a more common occurrence than we know and wonder if you recommend anything. On an unspecified date, the patient experienced daughter has had serious hives all over her body. Patient received treatment for event. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Gait inability, Mobility decreased, Pain, Urinary tract infection
Clinical narrative: Urinary tract infection; Pain; unable to walk; lack of mobility and that it take 1 and sometimes 2 people to assist her; becoming more depressed and hopeless; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) (at the age of 70-year-old) as dose number unknown, single for covid-19 immunisation; alglucosidase alfa (ALGLUCOSIDASE ALFA), intravenous from 16May2006 (Batch/Lot number was not reported) and ongoing, at 2200 mg every other week, then from 04Jun2021 at unspecified dose for Pompe's disease. Medical history included Pompe's disease. The patient's concomitant medications were not reported. On 19Mar2021, patient was admitted for a urinary tract infection and pain (both assessed as serious due to hospitalization) and the medical team was concerned about her lack of mobility and that it take 1 and sometimes 2 people to assist her (serious: disability) and because of that, the medical team was recommending patient go to a skilled nursing facility. Therapy with alglucosidase alfa was ongoing. On 09Mar2021 the patient received Pfizer biontech covid-19 vaccine, unknown formulation, dose, route and frequency (with an unknown batch number). On 10Mar2021 after a latency of 14 years 9 months 22 days, the patient could not walk for which patient was hospitalized and was sent to a nursing home and was now living in assisted living. The patient will not restart the treatment as she cannot walk and was in assisted living. And patient is increasingly becoming more depressed and hopeless. The action taken in response to the events for alglucosidase alfa was unknown. The outcome of events was unknown. Reporter causality: unassessable for depression and couldnt walk, not reported for rest events. Company causality: not reportable for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Eczema, Fatigue, Illness
Clinical narrative: feel sick; agitated; I had red  swollen spots eczema on my arms then lower legs after two days; I also  am having more fatigue with physical effort -after very simple tasks such as climbing stairs; This is a spontaneous report from a contactable consumer (Patient herself). A 51-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 07Jun2021 at 16:30 (at the age of 51-year-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included depression, anxiety and sleep issues from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 before vaccination. Patient had no known allergies but very sensitive to any medications. Concomitant medication(s) included zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); ubidecarenone (Q10); st john's wort (ST JOHN'S WORT) and panax ginseng (GINSENG [PANAX GINSENG]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received zinc, vitamin D, Q10, saint John's wort and Ginseng within 2 weeks of vaccination. Patent reported I started to feel sick and agitated, not being able to do anything after 3 days of having the second dose not really being aware from what it is from. I had it on Monday at 4 pm and on Sunday I was at the urgent care in another state where I was travelling because starting on Saturday, I had red swollen spots of eczema on my arms then lower legs after two days I called again to my virtual doctor and had a virtual visit. had a pack of methylprednisolone and after it I tried prednisone few days and went back for another few days on methylprednisolone ll this time I took Claritin orally at the end I started using Hydrocortisone cream and zinc cream and hypnosis those last worked so I improved after 2 weeks minimum I want refund for all my urgent care visit and copy for my virtual visit and all over the counter creams I had to purchased I also I am having more fatigue with physical effort after very simple tasks such as climbing stairs I plan to see a cardiologist. Since vaccination patient not tested for covid-19. This case assessed as non-serious by the reporter. Events resulted to visit Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events with methylprednisolone, prednisone, Claritin orally, Hydrocortisone cream and zinc cream and hypnosis. The outcome of the events was reported as recovering.  Information on the Batch/lot number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: Swollen lymph nodes, checked 3 months later with ultrasound and seems resolved; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in left arm on 06Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. Medical history included dystonia and migraines. The patient concomitant medications were not reported. The patient previously took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was yes. Prior to vaccination was the patient diagnosed with covid-19 was no. Since the vaccination, the patient did not test for covid-19. Patient is not pregnant at time of vaccination. On 16Mar2021, the patient experienced swollen lymph nodes, checked 3 months later with ultrasound and seems resolved. The patient underwent lab tests and procedures which included ultrasound scan with results resolved. No treatment received for the adverse events. The outcome of the event was resolved on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Ear pain, Fatigue, Hyperhidrosis
Clinical narrative: My right arm was sore; Rubbery legs; Sinus drainage; Sore ears; Stuffy nose; Slight stomach ache; Chills; Tiredness / I was tired for about a week afterwards; Sweats; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration on 24Jun2021 08:15 (age at vaccination was 43 years) as DOSE 2, SINGLE for COVID-19 immunization at Doctor's office/urgent care. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL), nicotine  taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Jun2021, by early afternoon patient's right arm was sore. At 5:00PM (by evening) the patient experienced rubbery legs, sinus drainage, sore ears, stuffy nose, slight stomachache, chills, tiredness, and sweats. Patient was tired for about a week afterwards. The events were reported as non-serious and patient was not hospitalized. The outcome of the events was recovered on an unspecified date in 2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nasal congestion, Pain in extremity, Rhinorrhoea
Clinical narrative: My right arm was sore; Rubbery legs; Sinus drainage; Sore ears; Stuffy nose; Slight stomach ache; Chills; Tiredness / I was tired for about a week afterwards; Sweats; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration on 24Jun2021 08:15 (age at vaccination was 43 years) as DOSE 2, SINGLE for COVID-19 immunization at Doctor's office/urgent care. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL), nicotine  taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Jun2021, by early afternoon patient's right arm was sore. At 5:00PM (by evening) the patient experienced rubbery legs, sinus drainage, sore ears, stuffy nose, slight stomachache, chills, tiredness, and sweats. Patient was tired for about a week afterwards. The events were reported as non-serious and patient was not hospitalized. The outcome of the events was recovered on an unspecified date in 2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Lymphadenopathy, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore and pin in arm of vaccination site for 7 days; Swollen  lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days; Sore throat; tired; Inappropriate schedule of vaccine administration; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 03Jul2021 at 23:30 as dose 1 single and second dose (Lot number- Pfizer Evvo198 RX5449) via an unspecified route of administration in upper left arm on 03Jul2021 as dose 2 single for COVID-19 immunization. Patient's age at vaccination was 52-year-old). Medical history included Graves' disease, allergic to peanuts, Clidomiocin. Patient previously took Tapazol, Aspartame and experienced allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), amitriptyline. COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 05Jul2021, patient experienced sore and pin in arm of vaccination site for 7 days, swollen lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days, sore throat and tired for a week. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: bloating and feels swollen; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. It was reported that the caller received second shot and was experienced bloating and feels swollen. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I want to know Is my arm still suppose to be sore; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that . A  patient of unspecified age had received unknown dose of bnt162b2 (BioNTech COVID-19 Vaccine RNATY, Solution for injection, Batch/Lot Number: unknown), via intramuscular on unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported.I just got the covid shot Monday. I want to know Is my arm still suppose to be sore. On unspecified date, the patient had experienced Pain in extremity.The following information was not provided during the call: Patient gender. Information about batch/ lot number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Rash, Swelling face, Tonsillar hypertrophy
Clinical narrative: Rash and swelling on face, feet/toes, arms, fingers, and a little on back; Tonsils slightly swollen; Rash and swelling on face, feet/toes, arms, fingers, and a little on back; swelling on face, feet/toes, arms, fingers, and a little on back; swelling on arms, fingers; This is a spontaneous report received from a contactable consumer (patient) or other non hcp.   A 15-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jul2021 13:30 (at the age of 15-years-old) as dose 1, single for covid-19 immunization.Medical history included urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included cefalexin taken for urinary tract infection, start and stop date were not reported.The patient previously took azithromycin for drug hypersensitivity and experienced rash, azithromycin for drug hypersensitivity and experienced swelling. On 13Jul2021 at 06:00 the patient experienced rash and swelling on face, feet/toes, arms, fingers, and a little on back, tonsils slightly swollen, joint swelling, swelling on arms, fingers. Adverse event resulted in patient visited Emergency room, department or urgent care. patient received treatment with Zyrtec.The patient did not tested for covid before and prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date: 14Jul2021.The outcome of the events was recovering.   Information about lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, JC polyomavirus test, Memory impairment, Pain
Clinical narrative: fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a contactable consumer (male patient reported for himself). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included allergies, migraines, nerve pain, acid reflux, JC levels getting too high, ongoing pneumonia, ongoing COVID-19. The patient concomitant medications included teriflunomide (AUBAGIO), hydrocodone bitartrate, paracetamol (NORCO), gabapentin, omeprazole (PROTONIX), azelastine, fluticasone propionate (FLONASE ALLERGY RELIEF), montelukast sodium (SINGULAIR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), allergy shots. The patient experienced fever, chills, headache, body aches, forgetting stuff worsening on 18Mar2021. The patient underwent lab tests and procedures which included JC levels getting too high. Outcome of the events was recovered on an unspecified date in 2021.  No further information was reported. Information on lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a contactable consumer (male patient reported for himself). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included allergies, migraines, nerve pain, acid reflux, JC levels getting too high, ongoing pneumonia, ongoing COVID-19. The patient concomitant medications included teriflunomide (AUBAGIO), hydrocodone bitartrate, paracetamol (NORCO), gabapentin, omeprazole (PROTONIX), azelastine, fluticasone propionate (FLONASE ALLERGY RELIEF), montelukast sodium (SINGULAIR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), allergy shots. The patient experienced fever, chills, headache, body aches, forgetting stuff worsening on 18Mar2021. The patient underwent lab tests and procedures which included JC levels getting too high. Outcome of the events was recovered on an unspecified date in 2021.  No further information was reported. Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin exfoliation, Sunburn
Clinical narrative: Was out in the sun for 45 minutes burned extensively and after 3 weeks still red.; Was out in the sun for 45 minutes burned extensively and after 3 weeks still red.; Skin was scaley; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that when she was out in the sun for 45 minutes burned extensively and after 3 weeks she was still red. she peeled but her skin was scaley, it was not the usual sunburn she get. The outcome of all events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021894278 same reporter, drug and event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: very sick from both, 3 or 4 days he ran fevers and all; very sick from both, 3 or 4 days he ran fevers and all; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that about her son's experience with Pfizer COVID 19 vaccination, her husband got it, and had both shots, he got very sick from both, 3 or 4 days he ran fevers and all. Report declined; states he is fine. The outcome of event was Unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: he has these spots on his body/showed her a red spot; circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body; This is a spontaneous report from a contactable pharmacist.  A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on 09Jul2021 (at the age of 26 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Jul2021 14:00, the patient has these spots on his body. The patient came in and it looks like he has these spots on his body. He got the vaccine 09Jul2021. He showed her a red spot near where it would have been given, that looks like it is likely from it. But then there are bullet spots on the other arm and down on his foot. They almost look like targets and are pretty circular. The patient is there now. The reporter clarified the spot that she thought was where it was given was actually on his other arm. It looks like circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body. The spots first occurred not shortly after lunch time, yesterday, around 2:00PM. He had gotten the vaccine last Thursday and a few days had passed since then. Patient clarifies they were all on the arm, in both arms. The reporter considered the events as non-serious. The outcome of the events was unknown.  Information regarding the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccinated in Apr2021. As of now I have test positive for COVID-19 as of 11Jul2021; Vaccinated in Apr2021. As of now I have test positive for COVID-19 as of 11Jul2021; This is s spontaneous report from a contactable consumer. This consumer (patient) reported that the 27-year-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, Covid-19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced vaccinated in apr2021. as of now i have test positive for covid-19 as of 11jul2021 on an unspecified date with outcome of unknown , vaccinated in apr2021. as of now i have test positive for covid-19 as of 11jul2021 on 11Jul2021 with outcome of unknown.  Seriousness criteria of the events was medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Jul2021. The clinical course was reported as follows: I am 27 years old and was fully vaccinated in Apr2021. As of now I have test positive for COVID-19 as of  11Jul2021.I'm interested in participating for the Pfizer Booster shot.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: One of his friends had same side effects and all over his arms and legs.; This is a spontaneous report from a contactable consumer (patients friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER0161, Expiry date: unknown), dose number unknown via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. Medical history and concomitant medications were not reported. Caller stated that, one of his friends had same side effects and rash all over his arms and legs, all over his body for the last three months and nothing is curing it and it started off on their (friends) legs as well. Reporter stated that, he will tell him about reporting, but that is up to him. Reporter declined to complete report on behalf of his friend. No further details provided. The outcome of the event of rash was not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: has no immunity after his Pfizer COVID vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no immunity after his pfizer covid vaccine on an unspecified date. The outcome of event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Faeces discoloured, Lip swelling, Malaise
Clinical narrative: had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; This is a spontaneous report from a contactable consumer (friend's wife). This consumer reported similar event for 2 patients. This is the second report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had more or less the same reaction that the caller had, her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible. The outcome for the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021894470 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; This is a spontaneous report from a contactable consumer (friend's wife). This consumer reported similar event for 2 patients. This is the second report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had more or less the same reaction that the caller had, her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible. The outcome for the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021894470 same reporter/drug, different patient/AE
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: tired; fever; bodyaches; headaches; tingling and burning on both feet, knees, on the arms, elbows and hands (for both arms); tingling and burning on both feet, knees, on the arms, elbows and hands (for both arms); This is a spontaneous report from a contactable consumer or other non hcp(patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in arm left on 08Jul2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Medical history included, fibromyalgia, arthritis, irritable bowel syndrome, intervertebral disc degeneration, spinal stenosis, intervertebral disc protrusion, pain does not take anything for it, just drinks a lot of water, and tries to walk around and stretch. Concomitant medications included latanoprost (0.005% ophthalmic solution, instill one drop into both eyes at bedtime; Bottle says 125mcg/2.5ml) taken for glaucoma; ascorbic acid (VITAMIN C ACID) 500 mg; ascorbic acid, bioflavonoids NOS (ESTER C + BIOFLAVONOIDS) 1x/day (500mg vegetarian capsule, usually takes one a day); colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 17Jun2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced tired. On 11Jul2021, the patient experienced tingling and burning on both feet, knees, on the arms, elbows and hands. On 12Jul2021 11:00, the patient experienced fever, bodyaches, headaches, tingling and burning on both feet, knees, on the arms, elbows and hands. Reporter is a 62-year-old, female who had both doses of the PFIZER-BIONTECH COVID-19 VACCINE. She has no significant side effect after getting her 1st dose. However, after getting her 2nd dose on 08Jul2021, the Reporter experienced fever, bodyaches, headaches and on 12Jul2021 had experienced tingling and burning on both feet, knees, on the arms, elbows and hands (for both arms). She mentioned that it is tolerable but still keeps her up at night. Caller added that she has autoimmune response and had some inflammatory diseases. Caller also mentioned that she took Tylenol 500 mg for her fever, bodyaches and headaches and was resolved immediately on Saturday/Sunday. In line with this, caller would like to know if she can take ibuprofen for the tingling and burning sensations. The patient underwent lab tests and procedures which included body temperature: 100. Therapeutic measures were taken as result of fever (pyrexia), bodyaches (pain), headaches (headache). The outcome of the events fever, bodyaches, headaches was recovered on unknown date in 2021. The outcome of the events tingling and burning on both feet, knees, on the arms, elbows and hands was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo since receiving both doses of the vaccine; This is a spontaneous report from a contactable consumer (reporter's friend). A 76-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date, as dose 1 and dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced vertigo since receiving both doses of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on skin, face, mouth, legs; This is a spontaneous report from a contactable consumer (patient) or other non health care professional. A 21-years-old male patient received bnt162b2 (Covid-19 vaccine, Formulation: Solution for injection), via an unspecified route of administration on 12Jul2021 as dose 2, single for covid-19 immunisation The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 for Covid-19 immunization (Dose 1). On an unspecified date, the patient experienced rash on skin, face, mouth, legs. Treatment received for the adverse events. The outcome of the event was unknown.   Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma; This is a spontaneous report from a contactable consumer (mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 14Jul2021 (also reported as in this morning) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma. Concomitant medication included salbutamol (SALBUTAMOL) taken for asthma. The patient experienced asthma on 14Jul2021. The reporter was asking if the patient can use her Ventolin inhaler as she experienced asthma. The outcome for the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Right and left feet had went numb; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: An unspecified age of female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date reported, Solution for injection), via an unspecified route of administration, administered on an unspecified date, as an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a right and left feet had went numb. Within the original report the caller mentioned that when her daughter was sitting in the chair after the COVID vaccine that her right and left feet had went numb. She said that this same side effect also happened to her friend (withheld). The event accessed as a non serious. The outcome of event is unknown.  Probed if caller wanted to complete a safety report for the individual mentioned and she declined and said that she cannot speak on their behalf.   Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: Hers are hot and painful; Hers are hot and painful; her feet and ankles down were bright red they got hotter and redder; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's friend) of unspecified age that received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: UNKNOWN) via an unspecified route as a single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient developed 'COVID toes' on unspecified date. Hers (toes) were hot and painful, so hot that you could fry an egg on them. She sat in the sun for maybe 15 minutes and her feet and ankles down were bright red. They got hotter and redder and it was so uncomfortable that she had to go to her doctor who had called it COVID toes phenomenon. She had to get a topical steroid and go back to the doctor's again for her feet. The outcome of the events was unknown.