chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Got very ill with that first one when I got it, I got flu like symptoms; I got very ill; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25May2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer stated, the first vaccination was 25May2021, who was very ill with that first one when got it and also got flu like symptoms. The outcome of both events was unknown.  Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Neck pain, Pain
Clinical narrative: the muscle in my neck on the site where I got my shot was extremely tight, it was just this tight and painful as to be; the muscle in my neck on the site where I got my shot was extremely tight, it was just this tight and painful as to be; It was like a little shot or something kind of going through the muscle or within it goes from where I got my injection up to my shoulder and like over my clavicle at my neck into the earlobe; This is a spontaneous report from a contactable other hcp. A  patient received bnt162b2 (CONMINTARY, Solution for injection, Lot No# EW0172), via intramuscular, administered in Arm Left on 05May2021 as 2nd dose, single for covid-19 immunisation. Medical history included hypertension since patient was  (ongoing), sinus node dysfunction from an unknown date and unknown if ongoing. The patient stated she did have a pacemaker and had then checked the pacemaker because she wanted to make sure this wasn't anything related to pacemaker. Concomitant medications included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On 06May2021, the patient experienced event which she described as "the muscle in my neck on the site where I got my shot was extremely tight, it was just this tight and painful as to be" and "It was like a little shot or something kind of going through the muscle or within it goes from where I got my injection up to my shoulder and like over my clavicle at my neck into the earlobe". Outcome of the events was reported as not recovered.    Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: we do heart palpitations in; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. He and her wife both had the shots about a month ago, it's kind of interesting that we do heart palpitations in. The outcome of the event was unknown.  Follow-up attempts are needed. Information on Lot/Batch number was available, additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Oropharyngeal pain, Speech disorder
Clinical narrative: Two days later got really sick; Had flu like symptoms; She could barely talk; Her throat hurt; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was Unknown) via an unspecified route of administration on 12Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She took the Pfizer shot for the 1st dose on 12Jun2021, two days later on 15Jun2021, the patient got really sick, her throat was hurt, she could barely talk and had flu like symptoms and was asking if this is normal and will it go away or should she go to her HCP. She was aware that Pfizer cannot give medical advice or treatment recommendations and was referred to her HCP. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Condition aggravated, Influenza like illness, Malaise
Clinical narrative: All of a sudden the caller's arm was not getting better, the caller's arm was getting worse; Felt sick for a few days; That arm was a little sore; The caller woke up and felt like really bad like the flu; Everything on the caller ached the callers little finger nails and joints; The caller wanted to do things and tried to get up and do something but had no energy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: EW0202), via intramuscular in left arm on 01Jun2021 at 11:00 as 1st dose, single for COVID-19 immunization (75 years at the time of vaccination). Medical history included ongoing lyme disease for a bout 20 years now. The patient was tested positive for COVID-19 on an unknown date in Dec2020 to an unknown date. The patient had double pneumonia from an unknown date and the patient recovered from this. The patient had flu shot and never had any problems with the flu shot. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01Jun2021, post vaccination the patient experienced arm was a little sore, all of a sudden the patient's arm was not getting better, the patient's arm was getting worse. The patient was not able to put her arm behind her back. The patient stated the arm soreness woke the patient up in the night. On 02Jun2021, patient felt sick for a few days. On an unspecified date in Jun2021, the patient woke up and felt like really bad like the flu. Everything on the patient ached, little fingernails and joints. Everything was aching, the patient felt blah like the flu. The patient wanted to do things and tried to get up and do something but had no energy. The patient had to lay back down. The patient stated that this lasted 4 days. The patient tried to do something and had no energy, was weak and just wiped out like the patient had the flu. When the patient had Covid (back in Dec2020) and was in the hospital with Covid, the doctor told the patient to remember that the Covid symptoms can linger for quite a few months. The patient stated that she could still have effects. Patient thought maybe because she had Covid, is she was still having effects after. The patient had to visit the doctor due to the events. The doctor checked the patient and said the arm wasn't red and the arm looked a little swollen and told the patient to keep a check on the arm. The patient had reported that the second dose for the vaccination has been scheduled on 22Jun2021 and the patient was concerned about if she should take it or not. Outcome of felt sick for a few days was recovered on 06Jun2021, arm was a little sore was not recovered while for the other events was unknown.   Information on lot/batch number was available. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: All of a sudden the caller's arm was not getting better, the caller's arm was getting worse; Felt sick for a few days; That arm was a little sore; The caller woke up and felt like really bad like the flu; Everything on the caller ached the callers little finger nails and joints; The caller wanted to do things and tried to get up and do something but had no energy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: EW0202), via intramuscular in left arm on 01Jun2021 at 11:00 as 1st dose, single for COVID-19 immunization (75 years at the time of vaccination). Medical history included ongoing lyme disease for a bout 20 years now. The patient was tested positive for COVID-19 on an unknown date in Dec2020 to an unknown date. The patient had double pneumonia from an unknown date and the patient recovered from this. The patient had flu shot and never had any problems with the flu shot. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01Jun2021, post vaccination the patient experienced arm was a little sore, all of a sudden the patient's arm was not getting better, the patient's arm was getting worse. The patient was not able to put her arm behind her back. The patient stated the arm soreness woke the patient up in the night. On 02Jun2021, patient felt sick for a few days. On an unspecified date in Jun2021, the patient woke up and felt like really bad like the flu. Everything on the patient ached, little fingernails and joints. Everything was aching, the patient felt blah like the flu. The patient wanted to do things and tried to get up and do something but had no energy. The patient had to lay back down. The patient stated that this lasted 4 days. The patient tried to do something and had no energy, was weak and just wiped out like the patient had the flu. When the patient had Covid (back in Dec2020) and was in the hospital with Covid, the doctor told the patient to remember that the Covid symptoms can linger for quite a few months. The patient stated that she could still have effects. Patient thought maybe because she had Covid, is she was still having effects after. The patient had to visit the doctor due to the events. The doctor checked the patient and said the arm wasn't red and the arm looked a little swollen and told the patient to keep a check on the arm. The patient had reported that the second dose for the vaccination has been scheduled on 22Jun2021 and the patient was concerned about if she should take it or not. Outcome of felt sick for a few days was recovered on 06Jun2021, arm was a little sore was not recovered while for the other events was unknown.   Information on lot/batch number was available. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Hives was reported as worsened; Hives; This is a spontaneous report from a contactable consumer or other non hcp. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose1, single for COVID-19 immunisation. The patient medical history includes allergy to Erythromycin. Concomitant medications were not reported. The patient sisters all seem to have an allergy to Erythromycin. On 16Jun2021, the patient experienced hives, Hives was reported as worsened. The consumer who is calling regarding her daughter who received her first dose of the Pfizer COVID Vaccine and is experience hives would like to inquire if the hives are due to the vaccine. Caller states she is trying to figure out if Pfizer has seen this before. She states her daughter's hives showed up a couple days later after she received the vaccine on Monday. Caller states the hives are good sized hives and merging into each. The caller states her concern is if this is a systemic thing, forbearing to an anaphylactic reaction. She states she knows her daughter probably needs to see and HCP for that. No other vaccines were administered on Same Date of the Pfizer Suspect nor within 4 weeks prior to the vaccination. The events did not require visit to emergency room nor physician office. The outcome of the events was not recovered.  Follow-up attempts are needed; Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product storage error, Somnolence
Clinical narrative: Vaccine(Covid-19) was not frozen when I got it.; Vaccine(Covid-19) was not frozen when I got it.; Arm got sore; Very sleepy; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW01191(reporter not sure); Expiration Date: 30Sep2021) via an unspecified route of administration in left arm (left shoulder) on 08Jun2021(at the age of 63-year-old) as unknown, single for COVID-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included potassium, hormones, blood pressure, thyroid medicine and horseshoe supplement. The patient did not received any other vaccine within 4 weeks of COVID vaccine. The reporter stated that, this is the only vaccine which she should have got in years. About a year vaccine, she got couple of vaccination. she don't know what they were for, her knees have had premature by me and rest to be around for. On an unspecified date, the patient experienced very sleepy and her Arm got sore. The reporter stated that, "The Pfizer vaccine, that is supposed to be shift and keep frozen until I go to take it correct. The Pfizer vaccine that is supposed to be frozen until I go to take the shot." The reporter confirmed It's Pfizer Covid-19 Vaccine. The reporter stated, " If she go to get the vaccine at and they said that they get it in from you frozen. They put it in a refrigerator and don't keep it frozen anymore in the refrigerator then go, get a shot. They take it out and get it to room temperature and they give it to you. The reporter wanted to know if it is going to do, good to get it. They didn't gave her one shot and they didn't put a date to come back to get the other shot on her card. This is supposed to be kept frozen and to be fad when someone comes to get a shot. I ask him having fault. She said, if it was not frozen it might not given from your side frozen, when she turned around and put it in a refrigerator and when comes to get the shots they take out of the refrigerator and to let it come to room temperature to give it to but she want to know if it do not me any good to go get it if I didn't keep in freezer and take it after and then keep in refrigerator." The patient reported that, Just arm got sore. All that, What she noticed. She had been really sleepy a lot since but not sure getting thing with it to do or not. She just turned a year older too. Not that much worst." The patient had blood work the day, she got the vaccination. Before she went, got the vaccination. Referred for Pfizer Medical Information Department for further guidance. The outcome of the events were unknown.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Having pain in the other side of his arm; This is a spontaneous report from a contactable Pharmacist. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration, administered in an unspecified arm on 24May2021 (at the age of 55-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she has a patient there that came for his second dose of the Pfizer and he complained about having pain in the other side of his arm from the first dose. The reporter stated that she knew the sore arm goes away after a week or so and it should be on the same side of the arm that you were poked at. The patient said he "feels like" there was a bee sting on the other side of his armpit. The reporter stated that she knew that was not a part of the listed side effects for not giving a second dose, like an anaphylaxis reaction. The reporter wants to know if this would be something that was an issue for giving the patient his second dose and the patient has an appointment with his doctor on 01Jul2021. The reporter seriousness and investigation assessment were not provided. The outcome of the event was reported as unknown.  Communication:"Specific product name was not provided by the caller and was only referred to as "The Pfizer" and by First and Second dose. DSU agent was unable to verify a specific product name, as caller declined to complete report".  No further details were obtained or provided.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain
Clinical narrative: Having pain in the other side of his arm; This is a spontaneous report from a contactable Pharmacist. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration, administered in an unspecified arm on 24May2021 (at the age of 55-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she has a patient there that came for his second dose of the Pfizer and he complained about having pain in the other side of his arm from the first dose. The reporter stated that she knew the sore arm goes away after a week or so and it should be on the same side of the arm that you were poked at. The patient said he "feels like" there was a bee sting on the other side of his armpit. The reporter stated that she knew that was not a part of the listed side effects for not giving a second dose, like an anaphylaxis reaction. The reporter wants to know if this would be something that was an issue for giving the patient his second dose and the patient has an appointment with his doctor on 01Jul2021. The reporter seriousness and investigation assessment were not provided. The outcome of the event was reported as unknown.  Communication:"Specific product name was not provided by the caller and was only referred to as "The Pfizer" and by First and Second dose. DSU agent was unable to verify a specific product name, as caller declined to complete report".  No further details were obtained or provided.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: started feeling arm pain in his right arm near armpit; This is a spontaneous report received from a contactable pharmacist via information team. A 55-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: unknown, expiration date: unknown), via an unspecified route of administration, administered in arm left on 24May2021 (at the age of 55-years) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first dose of Covid vaccine on 24May2021 in his left arm and he started feeling arm pain in his right arm near his armpit starting that day and has had it since then. She wanted to know if it was ok for him to get the second dose of the vaccine today. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain
Clinical narrative: started feeling arm pain in his right arm near armpit; This is a spontaneous report received from a contactable pharmacist via information team. A 55-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: unknown, expiration date: unknown), via an unspecified route of administration, administered in arm left on 24May2021 (at the age of 55-years) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first dose of Covid vaccine on 24May2021 in his left arm and he started feeling arm pain in his right arm near his armpit starting that day and has had it since then. She wanted to know if it was ok for him to get the second dose of the vaccine today. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Inappropriate schedule of product administration, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: First dose 07Mar2021, second dose 12May2021; Arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Right on 12May2021 (at the age of 65-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included allergies to penicillin, sulfa, skin tissue adhesive, grass, and pollen (environmental) from an unknown date and unknown if ongoing. Concomitant medications included Estradiol, Simvastatin, Ramipril and Famotidine (medications prior to the event being reported) taken for an unspecified indication, start and stop date were not reported. The patient previously received Ampicillin, and Ciprofloxacin and experienced allergies.Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot Number: EN6199, Route: Injection) administered in Left upper arm on 07Mar2021 (morning) for Covid-19 immunization and experienced tachycardia, bounding heart beats, shortness of breath, dizziness, numb lips, tachypnoea, dry cough and hoarse voice. Patient previously had history of allergies and used Fluticasone proprionate and Fexofenadine as a specific medication for it. Prior to the event patient did not receive any recent vaccines for any other conditions. Prior to the event, patient did not receive any recent vaccines for SRAS-CoV2 other than Pfizer-Biotech COVID-19 Vaccine and not receive any other vaccines around the time of Pfizer-Biotech COVID-19 Vaccine Vaccination. Patient received first dose 07Mar2021 and second dose on 12May2021 (inappropriate schedule of vaccine administered). On an unspecified date in 2021, patient experianced arm soreness and reported that she had no other adverse reaction. The patient underwent lab tests and procedures which included on 12May2021, allergy testing for PEG allergy: negative and Sars Cov 2 AB (166) spike semi QN: zero and greater than 20 on 01Jun2021. The outcome of events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Gingival swelling
Clinical narrative: swollen gums; bad taste in her mouth; This is a spontaneous report from a contactable consumer or other non-health professional (patient) received from a Pfizer sponsored Marketing program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 17May2021 as a 2nd dose, 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 and expiration date were not reported), via an unspecified route of administration on an unspecified date as a 1st dose, single for COVID-19 immunisation. It was reported that, patient experienced swollen gums later that night and a bad taste in her mouth after the patient received the second dose of the Pfizer covid vaccine. Patient went to the dentist and was going to have some sort of periodontal work done. The patient been given an anti-inflammatory medication, but she had not taken it yet. Stated that, she did not know whether it was a side effect or not. The patient was going to have a deep cleaning done on her teeth. Patient questioned was this part of the vaccine and had anyone else reported this reaction. The reporter seriousness for the events was unspecified. The report was related to a study or program. The outcome of the events was unknown.  Information about Lot/Batch number are requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles two weeks after second vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old 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 on 21May2021 at 12:00 pm at the age of 43-years-old) as single dose for covid-19 immunization. Medical history included autoimmune disease-RA (rheumatoid arthritis), hashimoto's and UCTD (undifferentiated connective tissue disease) but was stable and doing well and ongoing hypothyroidism. Concomitant medications included Acela natural thyroid for hypothyroid (received within two weeks vaccination). Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization and had no reaction. On 05Jun2021, 2 weeks after second vaccine, patient was diagnosed with shingles. Patient received Valetex, and Gabapentin as a treatment for the event. Event was resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Ocular hyperaemia, Oral pruritus, Urticaria
Clinical narrative: broke out in hives; I will just get tired, it seems like I need to go to sleep; mouth starts itching; I get a reaction in my eyes like they turn red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: EW0168) as single dose for COVID-19 immunisation. Medical history included allergic to fish. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14May2021 (Batch/Lot Number: EW0179) for COVID-19 immunisation and patient didn't get any reaction from the first one. The patient stated that patient was just not really, had second shot on Friday, patient think it was the 15Jun2021. The patient was allergic to fish and right now patient had this kind of complicated. The patient was super allergic to fish and fish odor and mouth started itching, patient got a reaction in eyes like they turn red and patient also broke out in hives yesterday (15Jun2021). The hive went away but the hive just return in last 30 minutes. The patient meant, their place today, patient had dinner around, fish or any fish odor (statement incomplete), patient did not know if it's patient sensitivity to things that patient might be allergic to changing because patient ate in a 'barb' with peanuts in it and patient could deal with Covid shots every once in a while. It would just hit patient. The patient would just get tired you know it seems like patient need to go to sleep, it might be hard to determine what it was, this hives would go away but it's still on the backside. Consumer stated that can't rule that one, patient don't think they are, but patient really didn't want to take a chance but patient had the second shot on 11Jun2021. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination. Also, fatigue, the day after the vaccine. The injection site pain decreased but still ong; Injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination. Also, fatigue, the day after the vaccine. The injection site pain decreased but still ong; Injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ew0178), via an unspecified route of administration, in right arm on 15Jun2021 (age at vaccination: 58 years) as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no known drug allergies. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient was now not diagnosed with COVID-19. On 16Jun2021, the patient experienced injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination and fatigue, the day after the vaccine. The injection site pain decreased but still ongoing. Since the vaccination, the patient was not tested for COVID-19. No treatment received for reported adverse events. The outcome of event fatigue was reported as resolved on an unknown date in 2021 and for other events were reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Lumbar puncture, Pyrexia, Vomiting
Clinical narrative: Severe headache which developed into uncontrollable throwing up.; Fever; Severe headache which developed into uncontrollable throwing up.; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot Number: not reported), via an unspecified route of administration on 10Jun2021 as unknown, sin-gle for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reported stated that all their three children were vaccinated and two of them just had fever (in Jun2021) which was normal. One daughter (Patient) had severe headache (in Jun2021) which developed into uncontrollable throwing up. Patient has fever on an unknown date in jun2021. Since then, they were at hospital. She had been tested and had a lumbar punch, CT scan and X-ray were performed, and she was schedule for MRI. She never had migraine or anything before. On 17Jun2021, the patient underwent lab tests and procedures which included CT scan: unknown result, lumbar punch: unknown result and x-ray: unknown result. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Severe headache which developed into uncontrollable throwing up.; Fever; Severe headache which developed into uncontrollable throwing up.; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot Number: not reported), via an unspecified route of administration on 10Jun2021 as unknown, sin-gle for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reported stated that all their three children were vaccinated and two of them just had fever (in Jun2021) which was normal. One daughter (Patient) had severe headache (in Jun2021) which developed into uncontrollable throwing up. Patient has fever on an unknown date in jun2021. Since then, they were at hospital. She had been tested and had a lumbar punch, CT scan and X-ray were performed, and she was schedule for MRI. She never had migraine or anything before. On 17Jun2021, the patient underwent lab tests and procedures which included CT scan: unknown result, lumbar punch: unknown result and x-ray: unknown result. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Lumbar puncture, Pyrexia, Vomiting
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, expiry date was unknown) via an unspecified route of administration on 10Jun2021 as a 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reported stated that all their three children were vaccinated and two of them just had fever which was normal. The event assessed as non-serious. One daughter had severe headache which developed into uncontrollable throwing up. Since then, they were at hospital. She had been tested and had a lumbar punch, CT scan and X-ray were performed, and she was schedule for MRI. She never had migraine or anything before. The outcome of the event was unknown.  Follow-up attempts are needed: Information about batch/ lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, expiry date was unknown) via an unspecified route of administration on 10Jun2021 as a 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reported stated that all their three children were vaccinated and two of them just had fever which was normal. The event assessed as non-serious. One daughter had severe headache which developed into uncontrollable throwing up. Since then, they were at hospital. She had been tested and had a lumbar punch, CT scan and X-ray were performed, and she was schedule for MRI. She never had migraine or anything before. The outcome of the event was unknown.  Follow-up attempts are needed: Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm was itching at the injection site and was really red with heat; arm was itching at the injection site and was really red with heat; Huge knot like the medicine is just right there; arm was itching at the injection site and was really red with heat; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm on 15Jun2021 09:40 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 25May2021 Batch/Lot Number: EW0172) for covid-19 immunisation. The patient experienced arm was itching at the injection site, really red with heat and huge knot like the medicine is just right there on 16Jun2021. The reporter stated she got the vaccine on the 15Jun2021 at 9:40 am and the next day her arm was itching at the injection site and was really red with heat and there is a huge knot like the medicine is just right there. Reporter stated she was not sure if it did not get in the muscle and was just in the tissue. Reporter stated her shot still good and absorbed in her body and she was not sure why the knot is there. The outcome of the events was reported as unknown.   Information about lot/batch number is available. Follow-up attempts are needed.
Sex: F
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: Psychosis; This is a spontaneous report received from a contactable consumer or other non hcp (parent). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22May2021 after receiving of the vaccine patient experienced an episode of psycho-sis, however patient also on an acne medication that could also cause psychosis, so not sure which it could have been from. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Photosensitivity reaction, Pruritus, Vaccination site nodule
Clinical narrative: Day after vaccine woke with small nodule in arm at injection site; Slight itching/tingling; Slight itching/tingling; very photosensitive to the point nearly passed out; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration in left arm on 12May2021 at 10:45 (at the age of 64-year-old) as single for covid-19 immunisation at hospital. The patient medical history included asthma, IBS (irritable bowel syndrome), fibromyalgia, possibly MS (multiple sclerosis) and recent attempted repair of atrial septal defect on 22Jan2021. The patient known allergies: iodine, demerol, phenobarbital, sodium pentathol, dilaudid and vancomycin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) 60mg daily and acetylsalicylic acid (ASPIRINE) 81mg daily (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to covid vaccine. It was reported that after vaccination there was no reaction at first. On 13May2021 at 07:15, day after vaccine patient woke with small nodule in arm at injection site; seemed to burst and release something into arm on rubbing. Slight itching/tingling, no noticeable rash, for about an hour. 3 hours later when went outside was very photosensitive to the point nearly passed out. This occurred for 3 days if patient went out in sunlight. Nurse from hospital said not what they were told was customary or something to look for or note. The patient did not receive any treatment for the events. The outcome of events was reported as resolved on an unspecified date in Jun2021.   Information on lot/batch number was available. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Dysphagia, Ear discomfort
Clinical narrative: Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph nodes enlarged on right neck \extremely painful even without touching; Right leg:  joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Right leg:  joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; difficult swallowing due to the pain; Right ear painful, feeling like too much pressure on it; Right ear painful, feeling like too much pressure on it; Right head painful, excruciating pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0185 and Expiry date: Unknown), via dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin [penicillin nos] for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. On 21May2021, the patient experienced right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; lymph nodes enlarged on right neck (multiple places: under chin, above collar bone, beside right ear), extremely painful even without touching, difficult swallowing due to the pain; right ear painful, feeling like too much pressure on it and right head painful, excruciating pain. The patient was not received any treatment for the events. The outcome of events was not resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lymphadenopathy, Muscular weakness
Clinical narrative: Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph nodes enlarged on right neck \extremely painful even without touching; Right leg:  joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Right leg:  joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; difficult swallowing due to the pain; Right ear painful, feeling like too much pressure on it; Right ear painful, feeling like too much pressure on it; Right head painful, excruciating pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0185 and Expiry date: Unknown), via dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin [penicillin nos] for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. On 21May2021, the patient experienced right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; lymph nodes enlarged on right neck (multiple places: under chin, above collar bone, beside right ear), extremely painful even without touching, difficult swallowing due to the pain; right ear painful, feeling like too much pressure on it and right head painful, excruciating pain. The patient was not received any treatment for the events. The outcome of events was not resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Miosis, Myalgia, Ocular discomfort
Clinical narrative: The patient was not had any history of previous immunization with the Pfizer vaccine. There were no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccines 4 weeks before the Pfizer vaccination, has not had any vaccines within ten years, but is due for a tetanus vaccine. The outcome of myalgia was reported as recovering and all the other events were recovered 28May2021 and unknown for allergies are a little worse. There was product quality complaint (PQC) found.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: The patient was not had any history of previous immunization with the Pfizer vaccine. There were no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccines 4 weeks before the Pfizer vaccination, has not had any vaccines within ten years, but is due for a tetanus vaccine. The outcome of myalgia was reported as recovering and all the other events were recovered 28May2021 and unknown for allergies are a little worse. There was product quality complaint (PQC) found.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; she feels like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle; This is a spontaneous report from a contactable consumer (patient) via US COVAX Support program. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in arm left on 16Jun2021 11:00 as 2nd dose, single dose for covid-19 immunisation. Medical history included, overweight, heart issues, breathing issues, thyroid issues, CPap, gallbladder removal. Concomitant medications included hydrochlorothiazide taken for an unspecified indication and potassium taken for an unspecified indication. No prior vaccinations were done within 4 weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 ), via an unspecified route of administration, administered in arm left on 26May2021 11:00 as 1st dose, single dose for covid-19 immunisation. On 16Jun2021, she felt like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle. On 17Jun2021, her arm was sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck. She mentioned that she had no problems with her 1st dose, she was asking if she should get another dose or what she should do. The girl who did the injection, was a tech at the CVS pharmacy. Stated she did not even get it in her biceps; she squeezed her arm not even near there until it puffed out; and then set the bandaid on the back of her arm not where she gave the shot. She tried to rub it but that did not help. She did take Tylenol and that helped a little. It was persisting on 17Jun2021. No additional vaccines administered on same date of the Pfizer suspect. She did not want her kids to get COVID. She mentioned she also take a plethora of supplements. Therapeutic measures were taken as a result of her arm was sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck with Tylenol. The outcome of the event she felt like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle was unknown and not recovered for other events.