chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Presyncope, Syncope, Thirst
Clinical narrative: Pt had a Vasovagal response to vaccine. Pt sat down and passed out, came to about 2-3 minutes after. Looked very pale and was very thirsty. Gave pt water and ice pack to cool body. Mom was present, 911 was called. No breathing issues, asked pt name and dob. and she was able to successfully answer. 911 came and They took vitals and after about 20 more minutes patient walked out.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Seizure
Clinical narrative: patient had a partial seizure and hard time breathing approximately 20 minutes after receiving Moderna vaccine booster (2nd booster shot). We called 911 and took care of the patient until paramedics arrived. patient was still having seizures when paramedics took him away. I am not sure if he forgot to take his anti-epileptic drug for today or if partial seizures were caused by 2nd Moderna vaccine. His mom/grandma did mention to tech who was taking care of the patient at the time of the seizure that she neglected to mention or write on the patient consent form that he has a history of seizures. She just wanted him to receive his 2nd dose.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Mental disorder, Product use issue, Suicidal behaviour
Clinical narrative: I believe the COVID Pfizer shot has made my mental issues worse to the point of being suicidal and thoughts of hurting people whom hurt me. I have terrible OCD, heightened pain, anxiety, poor anger management skills. Nothing has been said that this is a possible side effect and if there was I'd never get the shot. I'm not getting my 2nd dose because I don't want things compounded.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anger, Anxiety, Condition aggravated, Mental disorder, Obsessive-compulsive disorder
Clinical narrative: I believe the COVID Pfizer shot has made my mental issues worse to the point of being suicidal and thoughts of hurting people whom hurt me. I have terrible OCD, heightened pain, anxiety, poor anger management skills. Nothing has been said that this is a possible side effect and if there was I'd never get the shot. I'm not getting my 2nd dose because I don't want things compounded.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Suicidal ideation, Violence-related symptom
Clinical narrative: I believe the COVID Pfizer shot has made my mental issues worse to the point of being suicidal and thoughts of hurting people whom hurt me. I have terrible OCD, heightened pain, anxiety, poor anger management skills. Nothing has been said that this is a possible side effect and if there was I'd never get the shot. I'm not getting my 2nd dose because I don't want things compounded.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Fatigue, Visual impairment
Clinical narrative: Bexsero given 9/15/21. Since he recieved vaccine he complains of chronic fatigue, shortness of breath, dizziness, seeing spots (started a few days later). To F/U with hematology, increase fluid intake and salt.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Electromyogram, Magnetic resonance imaging neck, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Rash on arm, shoulder within 24-48 hrs post PPSV 23 administration, was prescribed prednisone,  Pepcid, however, rash resolved spontaneously without medications.  Subsequently developed left upper extremity burning sensation, pain, being evaluated by ortho  CT ortho Dr, given diagnosis of left brachial plexitis. Evaluated by Physiatrist, Dr, scheduled for EMG.  Also scheduled for f/u w/Dr, neurologist.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash on arm, shoulder within 24-48 hrs post PPSV 23 administration, was prescribed prednisone,  Pepcid, however, rash resolved spontaneously without medications.  Subsequently developed left upper extremity burning sensation, pain, being evaluated by ortho  CT ortho Dr, given diagnosis of left brachial plexitis. Evaluated by Physiatrist, Dr, scheduled for EMG.  Also scheduled for f/u w/Dr, neurologist.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Dyspnoea, Laboratory test, Pulmonary embolism
Clinical narrative: Large pulmonary embolism -admitted to hospital shortness of breath heparin drip
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Productive cough, Rhinorrhoea, Wheezing
Clinical narrative: Muscle aches, wheezes, clear phlegm, nose d/c - clear, weakNess
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Full blood count, Haemoptysis
Clinical narrative: Coughing up Blood Chest tightness
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Red blood cell sedimentation rate
Clinical narrative: Coughing up Blood Chest tightness
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 4th doses of Moderna Vaccine
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 4th doses of Moderna Vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: body aches, fever - 5 days after shot. Patient seen on 9/29/21 and still with body aches, headache
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 4th doses of Moderna Vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9-29-21 injection (L) Deltoid 9-30-21 seems sl red over site 10-1-21 Red, warm, swollen, + enlarging ro systemic symptoms
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Diarrhoea, Gastrointestinal pain, Haematochezia
Clinical narrative: 10-days after vaccine injection - nausea, vommiting, diarrhea, instesinal cramps, blood in stool.  Went to the Emergency Room then admitted to the hospital for 2.5 days.  Blood tests, stool tests and CT scan of GI tract all came back negative.  Fully recovered after 5 days.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Stool analysis normal, Vomiting
Clinical narrative: 10-days after vaccine injection - nausea, vommiting, diarrhea, instesinal cramps, blood in stool.  Went to the Emergency Room then admitted to the hospital for 2.5 days.  Blood tests, stool tests and CT scan of GI tract all came back negative.  Fully recovered after 5 days.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dry throat, Electrocardiogram normal
Clinical narrative: 1546 vaccine Pfizer second dose given, @ 1552 pt c/o chest pain and coughing (dry) tickle in throat EKG done-normal BP- 199/86 P-84 R-18 O2 sat 99% 1645-Solumedrol 125 mp IM given and Benadryl 50 mg po given and Zyrtec 10 mg po given 1720 - cough @ chest pain resolved
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Product preparation error
Clinical narrative: Patient needed 3rd dose of Pfizer COVID vaccine. Medical assistant drew up full vial without diluting. Double checked with another medical assistant who did not realize that only one syringe was drawn up instead of 6 (as it would be had it been diluted). Medical assistant administered this syringe and realized shortly after she had not diluted it, so patient received the equivalent of 6 vaccines. Immediately clinical supervisor and NP present in clinic. Clinical supervisor called Pfizer, which did not recommend hospitalization if no symptoms. NP called patient to come to clinic for q15m vitals until next steps decided. Patient was stable, only symptom was "feeling clammy." NP advised patient to be seen in ER and he declined, preferring to be home and calling family if symptoms occurred. Clinic will reach out daily for the next 3 days.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Vertigo positional
Clinical narrative: 48 hrs after 3rd Pfizer vaccine, I had positional vertigo for 4+ days. Eyes are still a little disoriented, but symptoms are mostly resolved
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Computerised tomogram head, Confusional state, Fatigue, Full blood count
Clinical narrative: seizures; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient just wanted to make sure that severe side effect was reported to you. Patient knew it was reported to VAERS but could not seem to find it anywhere. Patient had seizures since the day after second dose on an unspecified date. The patient underwent lab tests and procedures which included electroencephalogram (EEG): ruled out brain tumors, spots, etc., magnetic resonance imaging (MRI): ruled out brain tumors, spots, etc. The neurologists had ruled out brain tumors, spots, etc. with MRI's, EEG's, and a stay in the emergency multidisciplinary units (EMU) at a hospital. The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Metabolic function test, Urine analysis
Clinical narrative: seizures; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient just wanted to make sure that severe side effect was reported to you. Patient knew it was reported to VAERS but could not seem to find it anywhere. Patient had seizures since the day after second dose on an unspecified date. The patient underwent lab tests and procedures which included electroencephalogram (EEG): ruled out brain tumors, spots, etc., magnetic resonance imaging (MRI): ruled out brain tumors, spots, etc. The neurologists had ruled out brain tumors, spots, etc. with MRI's, EEG's, and a stay in the emergency multidisciplinary units (EMU) at a hospital. The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Magnetic resonance imaging, Seizure
Clinical narrative: seizures; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient just wanted to make sure that severe side effect was reported to you. Patient knew it was reported to VAERS but could not seem to find it anywhere. Patient had seizures since the day after second dose on an unspecified date. The patient underwent lab tests and procedures which included electroencephalogram (EEG): ruled out brain tumors, spots, etc., magnetic resonance imaging (MRI): ruled out brain tumors, spots, etc. The neurologists had ruled out brain tumors, spots, etc. with MRI's, EEG's, and a stay in the emergency multidisciplinary units (EMU) at a hospital. The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Somnolence
Clinical narrative: rash on chest; blood blister on nose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (Lot Number: EN6202) as dose 1, single for covid-19 immunisation. Medical history included pollen allergies and had antigen test for 25 years, 25 years ago, cataract surgery, hip replacements. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL); fluticasone propionate nasal spray; ibuprofen (ADVIL); loratadine (CLARITIN); all 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. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had been tested for COVID-19. On 28Feb2021, 12hrs after 1st dose, patient had blood blister on nose and after 36 hours on 01Mar2021, she had rash on chest. The rash went away about 12hrs later. The nose blister flattened and the came back on day 2. The patient received Eucerin as treatment on nose and rash. The outcome of rash was recovered on 01Mar2021 12:00; and outcome of blood blister was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Rash
Clinical narrative: rash on chest; blood blister on nose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (Lot Number: EN6202) as dose 1, single for covid-19 immunisation. Medical history included pollen allergies and had antigen test for 25 years, 25 years ago, cataract surgery, hip replacements. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL); fluticasone propionate nasal spray; ibuprofen (ADVIL); loratadine (CLARITIN); all 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. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had been tested for COVID-19. On 28Feb2021, 12hrs after 1st dose, patient had blood blister on nose and after 36 hours on 01Mar2021, she had rash on chest. The rash went away about 12hrs later. The nose blister flattened and the came back on day 2. The patient received Eucerin as treatment on nose and rash. The outcome of rash was recovered on 01Mar2021 12:00; and outcome of blood blister was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle ache; This is a spontaneous report from contactable consumer (patient) reported for herself from a Pfizer-sponsored program. A female patient of an unknown age received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on an unknown date in Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19 on an unknown date in Dec2020 and unknown if ongoing. Concomitant medication was not reported. Caller has been seeing information online and on tv questioning if you should get the second dose of the vaccine if you have got covid and had a reaction after the first dose. She got first dose of vaccine in Mar2021. Day after she got first dose she got fever, chills and muscle ache. Reporter's contact information was available. The outcome of events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle ache; This is a spontaneous report from contactable consumer (patient) reported for herself from a Pfizer-sponsored program. A female patient of an unknown age received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on an unknown date in Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19 on an unknown date in Dec2020 and unknown if ongoing. Concomitant medication was not reported. Caller has been seeing information online and on tv questioning if you should get the second dose of the vaccine if you have got covid and had a reaction after the first dose. She got first dose of vaccine in Mar2021. Day after she got first dose she got fever, chills and muscle ache. Reporter's contact information was available. The outcome of events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Hypersomnia, Pain
Clinical narrative: feels like she was hit by a truck; Two days after receiving the second vaccine, her pain doctor's assistant gave her 80mL of corticosteroids.; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP6955), via an unspecified route of administration on 29Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included pain two days after receiving the second vaccine, her pain doctor's assistant  gave her 80mL of corticosteroids. Concomitant medication(s) included corticosteroid taken for pain from 01Apr2021. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. On 04Apr2021, the patient feels like she was hit by a truck, two days after receiving the second vaccine, her pain doctor's assistant gave her 80ml of corticosteroids. She declines doing a safety report because she doesn't think it has anything to do with vaccine. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: feels like she was hit by a truck; Two days after receiving the second vaccine, her pain doctor's assistant gave her 80mL of corticosteroids.; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP6955), via an unspecified route of administration on 29Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included pain two days after receiving the second vaccine, her pain doctor's assistant  gave her 80mL of corticosteroids. Concomitant medication(s) included corticosteroid taken for pain from 01Apr2021. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. On 04Apr2021, the patient feels like she was hit by a truck, two days after receiving the second vaccine, her pain doctor's assistant gave her 80ml of corticosteroids. She declines doing a safety report because she doesn't think it has anything to do with vaccine. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aggression, Irritability, Mood swings, Pollakiuria
Clinical narrative: aggressive behaviors; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 11:45 (at the age of 19-years-old) as DOSE 1 , SINGLE for covid-19 immunisation. The patient's medical history included autism and blind. The patient had known allergies to apricots. Concomitant medication(s) included aripiprazole and unspecified three eye drops. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not Covid tested post vaccination. The patient previously took Risperdal and experienced known allergies. The patient has autism and the next day 25Apr2021, after taking the shot he has displaying very aggressive behaviours. The patient had to take to crisis on Sunday because he was out of control. He has never had a reaction after getting any type of shot before. The adverse event resulted in Emergency room/department or urgent care. The patient received the treatment for the event. The patient was given two medication to calm down. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aggression
Clinical narrative: aggressive behaviors; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 11:45 (at the age of 19-years-old) as DOSE 1 , SINGLE for covid-19 immunisation. The patient's medical history included autism and blind. The patient had known allergies to apricots. Concomitant medication(s) included aripiprazole and unspecified three eye drops. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not Covid tested post vaccination. The patient previously took Risperdal and experienced known allergies. The patient has autism and the next day 25Apr2021, after taking the shot he has displaying very aggressive behaviours. The patient had to take to crisis on Sunday because he was out of control. He has never had a reaction after getting any type of shot before. The adverse event resulted in Emergency room/department or urgent care. The patient received the treatment for the event. The patient was given two medication to calm down. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: fever; headache; hives; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.She received the 2nd dose of the Pfizer covid vaccine on 20Mar2021. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and she noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before.on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: fever; headache; hives; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.She received the 2nd dose of the Pfizer covid vaccine on 20Mar2021. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and she noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before.on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Headache, Insomnia, Pruritus, Pyrexia
Clinical narrative: fever; headache; hives; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.She received the 2nd dose of the Pfizer covid vaccine on 20Mar2021. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and she noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before.on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: fever; headache; hives; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.She received the 2nd dose of the Pfizer covid vaccine on 20Mar2021. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and she noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before.on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: fever; headache; flat hives; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route on 20Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were 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 on unspecified date as dose 1, single for covid-19 immunisation and experienced fever and headache. On 21Mar2021, the patient experienced fever and headache for a few hours. She noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before. The outcome of the events fever and headache was resolved on 21Mar2021 and other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: fever; headache; flat hives; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route on 20Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were 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 on unspecified date as dose 1, single for covid-19 immunisation and experienced fever and headache. On 21Mar2021, the patient experienced fever and headache for a few hours. She noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before. The outcome of the events fever and headache was resolved on 21Mar2021 and other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Headache, Insomnia, Pruritus, Pyrexia
Clinical narrative: fever; headache; flat hives; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route on 20Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were 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 on unspecified date as dose 1, single for covid-19 immunisation and experienced fever and headache. On 21Mar2021, the patient experienced fever and headache for a few hours. She noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before. The outcome of the events fever and headache was resolved on 21Mar2021 and other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: fever; headache; flat hives; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route on 20Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were 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 on unspecified date as dose 1, single for covid-19 immunisation and experienced fever and headache. On 21Mar2021, the patient experienced fever and headache for a few hours. She noticed the flat hives that had developed started to spread to the back of thighs, upper thigs and spread to the front upper inside. She did not have this after the 1st dose, and has never had it before. The outcome of the events fever and headache was resolved on 21Mar2021 and other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient reported being diagnosed with SIRVA on 9/15/21. She sought medical attention five months following her second dose of the COVID-19 Pfizer vaccination. She stated she is still experiencing limited range of motion, mobility, and pain in her right arm. She has been treated with a course of anti-inflammatory medication (unknown drug/dose) with no improvement.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient reported being diagnosed with SIRVA on 9/15/21. She sought medical attention five months following her second dose of the COVID-19 Pfizer vaccination. She stated she is still experiencing limited range of motion, mobility, and pain in her right arm. She has been treated with a course of anti-inflammatory medication (unknown drug/dose) with no improvement.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Injection site vesicles, Rash
Clinical narrative: She got Covid Arm and a severe rash with blisters that covered her whole body; She got Covid Arm and a severe rash with blisters that covered her whole body. hands and feet where more affected.; She got Covid Arm and a severe rash with blisters that covered her whole body. hands and feet where more affected.; Two weeks later she still has dots that look like purpura on her body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 13-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jul2021 14:00 (at the age of 13 years) (Batch/Lot Number: EW0181) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jul2021 09:00 the patient stated she got covid arm and a severe rash with blisters that covered her whole body, hands, and feet where more affected, two weeks later she still has dots that look like purpura on her body. We need to know if she can get shot #2. Please somebody contact me (mom). The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 08Jul2021 Nasal Swab. The patient received the treatment for events as Benadryl and rash cream applied for several days. The clinical outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Purpura, Rash vesicular, SARS-CoV-2 test, Vaccination site reaction
Clinical narrative: She got Covid Arm and a severe rash with blisters that covered her whole body; She got Covid Arm and a severe rash with blisters that covered her whole body. hands and feet where more affected.; She got Covid Arm and a severe rash with blisters that covered her whole body. hands and feet where more affected.; Two weeks later she still has dots that look like purpura on her body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 13-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jul2021 14:00 (at the age of 13 years) (Batch/Lot Number: EW0181) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jul2021 09:00 the patient stated she got covid arm and a severe rash with blisters that covered her whole body, hands, and feet where more affected, two weeks later she still has dots that look like purpura on her body. We need to know if she can get shot #2. Please somebody contact me (mom). The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 08Jul2021 Nasal Swab. The patient received the treatment for events as Benadryl and rash cream applied for several days. The clinical outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Hyperhidrosis, Injection site pain, Lymphadenopathy
Clinical narrative: first 2 days -sore arm; first 2 days nauseous; stomach cramp; first 2 days - minor swollen glands; first 2 days tired; first 2 days - chemical taste fist few minutesday 2.5; first 2 days- intense itching scalp; 3 days excessive sweating; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 65-year) in right arm on 03Jul2021 at 02:30 PM as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported facility where the most recent COVID-19 vaccine was administered was 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. Since the vaccination, the patient has not been tested for COVID-19. The patient not tested COVID post vaccination. On 05Jul2021 at 07:30 PM the patient experienced first 2 days -sore arm, nauseous, stomach cramp, minor swollen glands, tired, chemical taste fist few minutes day 2.5, intense itching scalp and back, 3 days excessive sweating. It was reported that the patient had 10 days intense itching, 3 days perfuse sweating. The seriousness of the events was reported as non-serious. As reported seriousness criteria of the events not resulted in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. The clinical outcome of the events was resolving.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Pruritus
Clinical narrative: first 2 days -sore arm; first 2 days nauseous; stomach cramp; first 2 days - minor swollen glands; first 2 days tired; first 2 days - chemical taste fist few minutesday 2.5; first 2 days- intense itching scalp; 3 days excessive sweating; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 65-year) in right arm on 03Jul2021 at 02:30 PM as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported facility where the most recent COVID-19 vaccine was administered was 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. Since the vaccination, the patient has not been tested for COVID-19. The patient not tested COVID post vaccination. On 05Jul2021 at 07:30 PM the patient experienced first 2 days -sore arm, nauseous, stomach cramp, minor swollen glands, tired, chemical taste fist few minutes day 2.5, intense itching scalp and back, 3 days excessive sweating. It was reported that the patient had 10 days intense itching, 3 days perfuse sweating. The seriousness of the events was reported as non-serious. As reported seriousness criteria of the events not resulted in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. The clinical outcome of the events was resolving.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dysgeusia, Fatigue, Hyperhidrosis, Limb discomfort
Clinical narrative: first 2 days -sore arm; first 2 days nauseous; stomach cramp; first 2 days - minor swollen glands; first 2 days tired; first 2 days - chemical taste fist few minutesday 2.5; first 2 days- intense itching scalp; 3 days excessive sweating; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 65-year) in right arm on 03Jul2021 at 02:30 PM as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported facility where the most recent COVID-19 vaccine was administered was 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. Since the vaccination, the patient has not been tested for COVID-19. The patient not tested COVID post vaccination. On 05Jul2021 at 07:30 PM the patient experienced first 2 days -sore arm, nauseous, stomach cramp, minor swollen glands, tired, chemical taste fist few minutes day 2.5, intense itching scalp and back, 3 days excessive sweating. It was reported that the patient had 10 days intense itching, 3 days perfuse sweating. The seriousness of the events was reported as non-serious. As reported seriousness criteria of the events not resulted in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. The clinical outcome of the events was resolving.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nausea, Pruritus
Clinical narrative: first 2 days -sore arm; first 2 days nauseous; stomach cramp; first 2 days - minor swollen glands; first 2 days tired; first 2 days - chemical taste fist few minutesday 2.5; first 2 days- intense itching scalp; 3 days excessive sweating; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 65-year) in right arm on 03Jul2021 at 02:30 PM as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported facility where the most recent COVID-19 vaccine was administered was 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. Since the vaccination, the patient has not been tested for COVID-19. The patient not tested COVID post vaccination. On 05Jul2021 at 07:30 PM the patient experienced first 2 days -sore arm, nauseous, stomach cramp, minor swollen glands, tired, chemical taste fist few minutes day 2.5, intense itching scalp and back, 3 days excessive sweating. It was reported that the patient had 10 days intense itching, 3 days perfuse sweating. The seriousness of the events was reported as non-serious. As reported seriousness criteria of the events not resulted in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. The clinical outcome of the events was resolving.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dyspnoea, Hyperhidrosis, Movement disorder, Paraesthesia
Clinical narrative: HOT AND COLD FLASHES LIKE FEVER; SORE AT THE INJECTION SITE SORE THAT WON'T HEAL; MUSCLE AND JOINT PAIN; TINGLING; SWOLLEN ARMPITS; EXTREMELY OR SEVERE RIGHT SHOULDER PAIN; DIFFICULT TO MOVE; This spontaneous report received from a health care professional concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the patient experienced difficult to move. On 02-JUN-2021, the patient experienced extremely or severe right shoulder pain. On 09-JUN-2021, the patient experienced swollen armpits. On an unspecified date, the patient experienced hot and cold flashes like fever, sore at the injection site sore that won't heal, muscle and joint pain, and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes like fever, had not recovered from extremely or severe right shoulder pain, sore at the injection site sore that won't heal, muscle and joint pain, difficult to move, and tingling, and the outcome of swollen armpits was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Feeling of body temperature change, Injection site pain, Movement disorder, Musculoskeletal pain
Clinical narrative: HOT AND COLD FLASHES LIKE FEVER; SORE AT THE INJECTION SITE SORE THAT WON'T HEAL; MUSCLE AND JOINT PAIN; TINGLING; SWOLLEN ARMPITS; EXTREMELY OR SEVERE RIGHT SHOULDER PAIN; DIFFICULT TO MOVE; This spontaneous report received from a health care professional concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the patient experienced difficult to move. On 02-JUN-2021, the patient experienced extremely or severe right shoulder pain. On 09-JUN-2021, the patient experienced swollen armpits. On an unspecified date, the patient experienced hot and cold flashes like fever, sore at the injection site sore that won't heal, muscle and joint pain, and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes like fever, had not recovered from extremely or severe right shoulder pain, sore at the injection site sore that won't heal, muscle and joint pain, difficult to move, and tingling, and the outcome of swollen armpits was not reported. This report was non-serious.