chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate during exercising; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0180) at single dose via an unknown route on 16Jun2021 for Covid-19 immunization. Historical vaccine included 1st of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient experienced elevated heart rate during exercising on 20Jun2021. The clinical course was reported as follows:   just over a week ago (as of 22Jun2021), patient had 1st experience exercising after that and had an extremely elevated heart rate which was very unusual for him/her.  Patient stated, right now (as of 22Jun2021) other than the elevated heart rate during exercising there was no other side effect. No treatment for event. No investigation assessment. Outcome of the event was unknown.   Information about lot/batch number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration, on 20Jun2021, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness at injection site on an unspecified date. It was reported that they expected the event and they knew about the arm tenderness at the injection site. The outcome for the event was unknown.  Information on batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Cardiomegaly, Death, Pericardial effusion
Clinical narrative: died three days after Covid vaccination; Autopsy showed enlarged heart and fluid surrounding the heart; Autopsy showed enlarged heart and fluid surrounding the heart; This is a spontaneous report from a contactable consumer or other non-health care professional in response to mail sent regarding the confirmation of below mentioned query. A 13-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose 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 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient after receiving his second Covid vaccine from Pfizer died three days later. The patient underwent lab tests and procedures which included autopsy: enlarged heart and fluid surrounding the heart caused by the Covid vaccination. The outcome of the events was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: enlarged heart and fluid surrounding the heart
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: muscle body ache; Pain Discomfort; Headache; Fatigue Tiredness; Nausea; This is a spontaneous report from a contactable consumer.  A 80-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 19Feb2021 11:00 (Batch/Lot Number: EL9267; Expiration Date: 31May2021) (age at time of Vaccination: 80 year-old) at single dose for covid-19 immunisation.  The patient received the first dose of vaccine Intramuscular on 28Jan2021 at 10:00 (Batch/Lot number: EL9263; Exp: 31May2021). Medical history included Short of Breath on 12Jan2021, went to ER checked out all normal got breath treatment, negative swab for Covid.  The patient's concomitant medications were not reported.  On 20Feb2021 the patient experienced pain discomfort, muscle/body actress, headache, fatigue/Body actress, Nausea. The outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216583 same patient, same vaccine different dose
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore on her lip; This is a spontaneous report from a contactable consumer.   A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 21Jun2021 as dose unknown, single for (at the age of 51-year-old) covid-19 immunisation. The patient's medical history included herpes virus infection. It was reported that, when patient was 10 years old and her brother was 8 years old, they had the oral herpes virus. Patient stated her brother had a small case of it, but she on the other hand had a very bad case of it. Patient stated it went in her mouth, her throat and into her stomach. Patient stated which she thinks now may have been part of hand foot mouth disease. The patient's concomitant medications were not reported. The patient experienced cold sore on her lip on 23Jun2021. Reporter stated that she woke up this morning with it and it's ongoing. Caller states it doesn't disappear unless you have something to make it disappear with. The outcome of the event was not resolved.  Information about lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This is a spontaneous report from a contactable pharmacist received from a Pfizer sponsored program. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3302), dose 1 via an unspecified route of administration on 09Mar2021 (at the age of 72 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the reporter states that a patient that got their first dose of the Pfizer covid vaccine on 09Mar2021 and after the patient got their first dose, they developed a cough, and did not go get their second dose, and is now at the pharmacy today, wanting to get the second dose and asks if they can do a second dose, states doctor told patient they would have to start the first dose again. The outcome of the events was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Developed Covid Foot; feet were swollen and red and typically for Covid toes; Developed Covid Foot; feet were swollen and red and typically for Covid toes; This is a spontaneous report from a contactable physician. This physician reported for a 76-year-old male patient that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, expiration date: not reported) via an unspecified route of administration on an unspecified date in Jun2021 (Exact date of the first vaccine unknown, it was about 7 days ago) as dose 1, single for COVID-19 immunisation (at the age of 76-year-old). The patient medical history and concomitant medications were not reported. The patient got the PFIZER COVID 19 VACCINE, and after about 24 hours on an unspecified date in Jun2021, developed pink-red feet with swelling, especially toes and especially great toes, very similar to Covid foot- toes that been seen with the actual disease, had improved significantly since then, now the question was he needed the second vaccine and were worried about the above reaction to the first dose of vaccine. The patient's feet were swollen and red and typically for Covid toes (start date: Jun2021). The patient had Covid feet (start date: Jun2021), and the toes were involved. It was reported that slowly it had improved significantly, but the patient was due for his second shot and he was worried about if he will have more issues with the second shot. The patient had significantly improved, about 90% improved and could get the information about the Covid vaccine later if needed. The patient wanted to get some help and information with how to proceed with the second vaccination. Reporter's seriousness for the events was medically significant. The outcome of both the events was resolving.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relationship, the association between the events of swelling of feet and redness and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction, Nervous system disorder
Clinical narrative: stroke; heart attack; neurological problems; This is a spontaneous report from a contactable consumer (patient's neighbor). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after getting the vaccine; the patient experienced stroke, heart attack and neurological problems. The events caused of hospitalization. The clinical outcome of the events was unknown.  Information about lot/Batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Myalgia, Pain, Vaccination site pain
Clinical narrative: Aches; The last 3 weeks it had gotten progressively worse/ progressed to not pleasant; Had minor muscle pain.; The injection site was sore; joint pain throughout his body, especially in his hands and wrists, and that they almost feel arthritic; This is a spontaneous report from a contactable consumer. A 58-years-old male consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182) via an unspecified route of administration on 18May2021 in right arm as dose 2, single for COVID-19 immunization. The patient medical history (including any illness at time of vaccination), prior vaccinations received within 4 weeks, adverse events following prior vaccinations, family medical history relevant to adverse events, additional vaccines administered on same date of the Pfizer suspect and concomitant medications were reported as none. This report was not related to a study or programme. Investigation assessment was not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: ER8735; expiry date and NDC number was unknown) on 27Apr2021 in afternoon around 13:30 or 14:00 in right arm for COVID-19 immunization and experienced myalgia, joint noise, loss of personal independence in daily activities, joint swelling, hand deformity, pain in extremity and peripheral swelling. The patient reported that within a week after the second dose injection site was sore, and he had aches. It progressed worse over the next 2 to 3 weeks. He also had minor muscle pain five weeks ago and had progressed to not pleasant. He experienced joint pain throughout his body, especially in his hands and wrists, it was almost arthritic feeling. He did not require emergency room and physician office visit. He wanted to know how long the effects had lasted with others that reported similar effects. He asked if it's common, and if it was, he might wait a little longer to see his HCP. He stated that he had not gone to the doctor or ER as it would be a waste of time because if there was a .0001 percent chance of a reaction, he doesn't want unneeded tests and procedures. He thought the events would go away. He stated that if events went on for 6 to 8 weeks, he would probably get into his doctor. He did not like running to the doctor. He said that if he cut off his leg, he would probably not go for 3 days, he did not like the process. He had been negligent, and his symptoms were not getting any better, they were getting worse. He reported that all of his family had been vaccinated with no issues at all. Relevant tests were reported as none. The outcome of all the events was not resolved.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: arm is still hurting and he has limited movement with it; arm is still hurting and he has limited movement with it; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the Pfizer COVID-19 vaccine on 01Apr2021 and stated that his arm was still hurting and he had limited movement with it. He states that it is not hurting on the outside of the arm where they gave the shot but deep inside. He states that they must of done something to his arm like hit a nerve or something. He stated that he had been calling and told them about his issue but they keep telling him to call back in two weeks, and referred him to a physical therapist. He stated that he called a gentleman at the university and the gentleman stated he did not need physical therapy. Caller stated that no one in his family will get the shot because of what had happened with his arm. He stated he had called several 800 numbers but he kept getting the run around. Caller wanted to know if the vaccine was suppose to be given at a certain angle and a certain temperature and what Pfizer can suggest to get rid of the pain. The outcome of events was not recovered.   Information on the Lot/Batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: I was diagnosed and hospitalized with ITP - Idiopathic thrombocytopenic purpura or Immune thrombocytopenic purpura.  I have never had this before and have always been in good health.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 am at age of 48-year-old (Batch/Lot Number: EN6207) at single dose for COVID-19 immunisation.  Medical history included known allergies to sulfa drugs, diagnosed with COVID-19 prior vaccination. The patient is not pregnant. Concomitant medications within 2 weeks of vaccination included magnesium sulfate; montelukast sodium (SINGULAIR); fluticasone propionate (FLONASE); cetirizine hydrochloride (ZYRTEC); omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 on 25Feb2021 10:00 am at age of 48-year-old administered in arm left (Batch/lot number EN6202) at single dose for COVID-19 immunisation. The patient experienced ITP (idiopathic thrombocytopenic purpura or immune thrombocytopenic purpura) on 09May2021 22:00. The patient was diagnosed and hospitalized with ITP in 2021 for 7 days.  The patient had never had this before and have always been in good health. The event was serious for hospitalization, life threatening. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse event which included 5 bags of platelets, 5 IVIG (intravenous immunoglobulin) infusions, eltrombopag olamine (PROMACTA), P.  Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not resolved.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Computerised tomogram, Dyspnoea, Haemodynamic instability
Clinical narrative: chest pain/SOB; chest pain/SOB; large pericardial effusion; hemodynamic instability; started exploring Lupus; joint pain; low WBC; This is a spontaneous report from a contactable pharmacist (patient). A 31 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 07Jan2021 (Lot Number: EL1283) at the age of 30 years old, as single dose for covid-19 immunisation. Medical history included sulfa products cause rash, anxiety, migraine. Concomitant medications included sumatriptan succinate (IMITREX); ibuprofen (MOTRIN); paracetamol (TYLENOL), OTC vitamin B complex supplement, OTC iron supplement. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Dec2020 (Lot Number: EK9899) at the age of 30 years old, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient came to the ER on 14Jun2021 for chest pain/SOB, CT scan found large pericardial effusion, had to undergo emergency pericardiocentesis due to hemodynamic instability and hospitalized from 14Jun2021 and until 17Jun2021. Labs on fluid ruled our infectious or cancer origin. The patient had no prior medical history aside from anxiety and migraines, although the patient had recently started exploring Lupus but not confirmed. The patient have biomarkers consistent with Lupus, minor and infrequent joint pain, and chronically low WBC but WBC is unaffected by plaquenil (plaquenil started after vaccine) and no trademark rash. Events started from 06Jun2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment pericardiocentesis, prednisone, ibuprofen, colchicine, Nexium was received. The outcome of the events was Recovered with lasting effects/ Recovered with Sequel.  Follow-up attempts are possible. Further information is expected.; Sender's Comments: Based on known safety profile and lack of close temporal association the reported events are assessed as intercurrent medical conditions and unrelated to  BNT162B2.  Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Systemic lupus erythematosus, White blood cell count, White blood cell count decreased
Clinical narrative: chest pain/SOB; chest pain/SOB; large pericardial effusion; hemodynamic instability; started exploring Lupus; joint pain; low WBC; This is a spontaneous report from a contactable pharmacist (patient). A 31 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 07Jan2021 (Lot Number: EL1283) at the age of 30 years old, as single dose for covid-19 immunisation. Medical history included sulfa products cause rash, anxiety, migraine. Concomitant medications included sumatriptan succinate (IMITREX); ibuprofen (MOTRIN); paracetamol (TYLENOL), OTC vitamin B complex supplement, OTC iron supplement. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Dec2020 (Lot Number: EK9899) at the age of 30 years old, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient came to the ER on 14Jun2021 for chest pain/SOB, CT scan found large pericardial effusion, had to undergo emergency pericardiocentesis due to hemodynamic instability and hospitalized from 14Jun2021 and until 17Jun2021. Labs on fluid ruled our infectious or cancer origin. The patient had no prior medical history aside from anxiety and migraines, although the patient had recently started exploring Lupus but not confirmed. The patient have biomarkers consistent with Lupus, minor and infrequent joint pain, and chronically low WBC but WBC is unaffected by plaquenil (plaquenil started after vaccine) and no trademark rash. Events started from 06Jun2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment pericardiocentesis, prednisone, ibuprofen, colchicine, Nexium was received. The outcome of the events was Recovered with lasting effects/ Recovered with Sequel.  Follow-up attempts are possible. Further information is expected.; Sender's Comments: Based on known safety profile and lack of close temporal association the reported events are assessed as intercurrent medical conditions and unrelated to  BNT162B2.  Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiomegaly, Heart rate, Heart rate increased, X-ray
Clinical narrative: slight enlarged heart; went to ER for heart rate of over 180; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 26May2021 10:30 (Lot Number: Ew0177) as dose 2, single at the age of 55-year-old for covid-19 immunisation. The patient was not pregnant. 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 had not been tested for COVID-19. Medical history included high cholesterol from an unknown date, thyroid removal in 2011. The patient had no known allergies. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in left arm on 06May2021 10:30 (Lot Number: Ew0167) as dose 1, single at the age of 55-year-old for covid-19 immunisation. Concomitant medications included atorvastatin calcium 10 mg, levothyroxine sodium 100, all taken for an unspecified indication, within 2 weeks of vaccination. 9 days after shot (04Jun2021) the patient went to ER for heart rate of over 180, sent home and had to go to ER 3 more than mrs within a 7 day period the last time they admitted her for 2 days. The patient did not have heart issues nor high blood pressure or any heart disease. She ran 110/55 normal pulse 50-60. The patient now had to see a cardiologist and he wanted to do a monitor. The patient had never had to go through this ever until this shot. They took X-rays and it showed an slight enlarged heart (06Jun2021 03:30 as reported). The patient was so upset the shot had done this to her. The patient underwent lab tests and procedures which included 9 days after shot (04Jun2021) heart rate of over 180; blood pressure: 110/55, normal pulse: 50-60 on an unknown date; x-ray: an slight enlarged heart on 06Jun2021. The adverse events resulted in emergency room/department or urgent care and physician office visit. The seriousness of events was hospitalization for 2 days from Jun2021. Therapeutic measures were taken as a result of events which included a pill to regulate to restart her heart. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction
Clinical narrative: PCR test yesterday that came back positive today; This is a spontaneous report from a contactable consumer (patient's friend).  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) solution for injection, via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as dose number unknown, single (at an unknown age) for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The consumer stated the patient received the BNT162B2 (reported as Pfizer BioNtech COVID 19 vaccine) last Friday (18Jun2021) and did a polymerase chain reaction (PCR) test yesterday (22Jun2021) that came back positive today (23Jun2021). The consumer wondered if a positive PCR test after BNT162B2 was normal.  Outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: weird bumps on her face and neck; weird bumps on her face and neck; This is a spontaneous report from a contactable consumer or other non hcp.   A 16-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jun2021 11:00 (Batch/Lot Number: EW0181) as DOSE 2, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: SW0179 ) as DOSE 1, SINGLE for covid-19 immunisation. Patient took the second dose about 4 hours ago and now weird bumped appeared on her face. Caller wants to know if this is normal. At the time of this report event outcome was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain, Vaccination site pain
Clinical narrative: pain under her armpit where her lymph nodes are in the injection arm; radiated from where the shot was given up and around her armpit and it had been super painful; radiated from where the shot was given up and around her armpit and it had been super painful; This is a spontaneous report from a contactable consumer (patient's mother). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 21Jun2021 as dose 1, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's mother stated her daughter received the Pfizer COVID vaccine on 21Jun2021 (on Monday evening of this week). The patient had been experiencing pain under her armpit where her lymph nodes were, in the injection arm (on Jun2021). It radiated from where the shot was given up and around her armpit and it had been super painful for her on 23Jun2021 (today). The reporter would like to know if this will subside or what should she do about it. The patient's mother stated since this was possibly due to a robust immune response, she had heard that the second dose would produce more side effects than the first. The patient's mother would like to know if this was true and should she expect the same type of reaction with the second dose. The patient's mother would like to know if her daughter should receive the second dose of the vaccine. The outcome for all events was not recovered. Information related to batch/Lot no. was requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Respiratory tract congestion, Sinus disorder
Clinical narrative: Sinus problems; Asthma; Congestion in his chest; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in left arm on 24May2021 (at the age of 64-year-old), as dose 1, single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. After first dose, the patient had severe sinus problems. The patient stated this probably began maybe like 2 to 3 days after (in May2021) the patient received the first dose Pfizer COVID 19 shot, maybe later, maybe longer. Could had been the weather change. The patient took some sinus medication and the sinus problems went away. The patient states this went away completely. The patient had asthma. The lady the caller was speaking with that gave the patient the first dose Pfizer COVID 19 shot, said normally some people have sinus problems. The patient stated it started to get in the patient chest, the patient got congestion in his chest. Therapeutic measures were taken as a result of sinus problems and treatment with sinus medication. Outcome of the event sinus problems was resolved on an unknown date in 2021 and rest of the events it was unknown.   Information on the lot/batch was available, Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Headache; injection site is at hurts a little bit.; he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know; arm hurts; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced headache, injection site is at hurts a little bit, he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know and arm hurts on an unspecified date in 2021. Patient asked if it's alright to take Aspirin or place an ice pack on the injection site. Outcome of all the events was unknown.  Information about Lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Experienced odd numbness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced odd numbness. On an unspecified date in 2021, the patient had recovered from the event.  Information on batch/lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021766717 Same Vaccine/event, different  patient
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Psoriasis, Skin fissures, Skin haemorrhage
Clinical narrative: thickening of feet with humira (adalimumab).; psoriasis plaques on elbow and scalp/biggest; Skin fissure/ feet cracking; feet bleeding; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8737), intramuscular on 21Apr2021 as dose 2, single for COVID-19 immunisation; adalimumab (HUMIRA; Solution for injection in pre-filled pen), subcutaneous from 2000 (Batch/Lot number was not reported) at an unspecified dose (Daily dose: 1 in 2 week) for an unspecified indication. Medical history included abstains from alcohol and Non-smoker. The patient had no known allergies. Concomitant medications included pravastatin taken for cholesterol and colecalciferol (VITAMIN D). The patient previously took secukinumab (COSENTYX) and ustekinumab (STELARA). The patient historical vaccine included first dose of BNT162B2 (lot number: ER8729) on 31Mar2021 (at 64-Year-old) for COVID-19 immunisation. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. It was reported that, on an unknown date, the patient experienced thickening of feet with HUMIRA (adalimumab). In 2000, the patient HUMIRA not working. In 2006, the patient experienced hypothyroidism. On 31Mar2021, patient received 1st dose of COVID-19 vaccine. On 21Apr2021, patient received 2nd dose of COVID-19 vaccine. On an unspecified date in Apr2021, the patient experienced psoriasis plaques on elbow and scalp/biggest ones are on the bottom of feet and hands, feet cracking and feet bleeding. The patient was treated with betamethasone dipropionate cream and levothyroxin. The action taken in response to the events with adalimumab was dose not changed. The outcome of the events hypothyroidism, Plaque psoriasis was not recovered, Skin fissure/ feet cracking, feet bleeding was recovered in 2021, whereas unknown for other events. Causality for HUMIRA (adalimumab): The reporter's causality for the event of Humira not working and thickening of feet was not provided. The reporter's causality for the events of psoriasis plaques on elbow and scalp/biggest ones are on the bottom of feet and hands, feet cracking, hypothyroidism and feet bleeding with Humira (adalimumab) was no reasonable possibility.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash, Rash erythematous, Rash vesicular, Vasculitis
Clinical narrative: Her white count is extremely high and she was told to go to the hospital; developed rash all over her body two weeks ago; She is filled with red welt/ rash which has become red ,dark purple and blistery.; The doctor diagnosed her with vasculitis after running some blood work.; She is filled with red welt/ rash which has become red ,dark purple and blistery.; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient (reporter's mother) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06May2021 (at the age of 64-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history reported as Urticaria after the first dose of vaccination and concomitant medications were not reported. The patient previously received first dose received (BNT162B2, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration as DOSE 1, SINGLE for covid-19 immunisation. After the second dose of the vaccine which was 06May2021. She developed rash all over her body two weeks ago (on an unspecified date). She is filled with red welt/ rash which has become red ,dark purple and blistery (on an unspecified date). The doctor diagnosed her with vasculitis after running some blood work (on an unspecified date). Her white count was extremely high and she was told to go to the hospital (on an unspecified date). She had no other issue prior to the vaccine. She sated that she had seen on the internet million of such report related to the vaccine. But she could not think of anything else but the vaccine that might have caused her to feel that way. Caller wants to know if this side effect had been reported with the vaccine. The patient underwent lab tests and procedures which included blood test: unknown on diagnosed her with vasculitis after running some blood work, white blood cell count extremely high on an unspecified date. The outcome of the was unknown.  Information about lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: Her white count is extremely high and she was told to go to the hospital; developed rash all over her body two weeks ago; She is filled with red welt/ rash which has become red ,dark purple and blistery.; The doctor diagnosed her with vasculitis after running some blood work.; She is filled with red welt/ rash which has become red ,dark purple and blistery.; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient (reporter's mother) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06May2021 (at the age of 64-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history reported as Urticaria after the first dose of vaccination and concomitant medications were not reported. The patient previously received first dose received (BNT162B2, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration as DOSE 1, SINGLE for covid-19 immunisation. After the second dose of the vaccine which was 06May2021. She developed rash all over her body two weeks ago (on an unspecified date). She is filled with red welt/ rash which has become red ,dark purple and blistery (on an unspecified date). The doctor diagnosed her with vasculitis after running some blood work (on an unspecified date). Her white count was extremely high and she was told to go to the hospital (on an unspecified date). She had no other issue prior to the vaccine. She sated that she had seen on the internet million of such report related to the vaccine. But she could not think of anything else but the vaccine that might have caused her to feel that way. Caller wants to know if this side effect had been reported with the vaccine. The patient underwent lab tests and procedures which included blood test: unknown on diagnosed her with vasculitis after running some blood work, white blood cell count extremely high on an unspecified date. The outcome of the was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Have swelling of an axillary lymph node; Fatigue; Muscle aches; This is a spontaneous report from a contactable consumer (patient). This report was received from a sales representative. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The patient reported have swelling of an axillary lymph node, fatigue, and muscle aches following her second dose. These side effects lasted for several days and then fully resolved. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Respiratory tract congestion
Clinical narrative: He has a chest congestion; his is a spontaneous report from contactable male consumer via Pfizer sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and guaifenesin (MUCINEX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. he took the vaccine on unspecified date hour and half an hour ago and he has a chest congestion on an unspecified date that's why he was asking if he can take the medication Mucinex. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Inappropriate schedule of product administration, Myalgia, Off label use
Clinical narrative: Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Muscle ache; Joint pain; Extreme cold like fever; Extreme cold like fever; This is a spontaneous report from a contactable consumer reporting for himself. A 20-years-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 22Jun2021 as single dose (at age of 20-years old) for covid-19 immunization which was administered outside of the range 19 - 42 days after the first dose. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 02Apr2021 for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, after getting the second dose on 22Jun2021 (yesterday), he experienced a side effect like muscle ache, joint pain and extreme cold like fever on unspecified date in Jun2021. Consumer added, he was just trying to figure out symptoms were that he was experiencing if he needed to go to the ER or not. The outcome of all events was unknown.  Information regarding the lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Muscle ache; Joint pain; Extreme cold like fever; Extreme cold like fever; This is a spontaneous report from a contactable consumer reporting for himself. A 20-years-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 22Jun2021 as single dose (at age of 20-years old) for covid-19 immunization which was administered outside of the range 19 - 42 days after the first dose. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 02Apr2021 for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, after getting the second dose on 22Jun2021 (yesterday), he experienced a side effect like muscle ache, joint pain and extreme cold like fever on unspecified date in Jun2021. Consumer added, he was just trying to figure out symptoms were that he was experiencing if he needed to go to the ER or not. The outcome of all events was unknown.  Information regarding the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blepharospasm, Dizziness, Head discomfort, Ophthalmological examination
Clinical narrative: vision went blurry; Dizzy/Light-headed; weird sensations in different parts of her head; hands and legs went weak; vision was so bad.; left eye twitching; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, solution for injection, lot number: EW0176) via unknown route of administration on 30Apr2021 at dose 1 single in deltoid left (left shoulder as reported) for COVID-19 immunisation. Medical history included lyme disease (since she was young, weakened immune system), bartonella (since she was young, weakened immune system), anaemia (several years), vitamin D low (several years), interstitial cystitis (10 years) all are ongoing. Concomitant medications were not reported. Then 1-2 min after her vision went blurry. She was dizzy, and light-headed. She felt weird in different parts of her head. She was like having weird sensations in different parts of her head. One second it would be in her forehead and then in the back of her head. It was weird. That occurred on 30Apr2021 but went away that same day. Her hands and legs went weak. That happened on 30Apr2021, just that day and she recovered. All the side effects subsided after several hours except for the blurred vision. Her vision was still blurry. Her left eye was also twitching which has started since the vaccine in 2021. She didn't have eye twitching before, but she thinks that was less frequent now. She went to the Ophthalmologist, and he did an eye exam with unknown results. That was 3 weeks ago in 2021. Her last eye exam was 8 years ago with unknown results. But he said that her vision change since that exam was extremely significant. It was now illegal for her to drive her vision was so bad in 2021. Her doctor was not sure what happened either. Her doctor was now referring her to a Neuro-ophthalmologist.  She has been taking Vitamins to try to help. She has been taking Vitamin D3 and iron. She does have chronic Lyme disease and Bartonella because of that she does have a weakened immune system. She has had both of those since she was little. She was a lot better now. She was not as sick anymore from those. She was not going to get the second dose. She was wondering if she can reverse the blurry vision. she asked her doctor about the Lyme disease, and her vision change. The doctor said she needed to report this to Pfizer. If it was because of the Lyme disease it would have happened before the vaccine. The outcome of event vision blurred was not recovered, vision abnormal was unknown, eyelid twitching was recovering and remaining were recovered on 30Apr2021.   Information on the batch number has been requested.