chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Fatigue, Headache, Pain in extremity
Clinical narrative: headache; tired; sore arm; This is a spontaneous report from a contactable consumer (patient, self-reported). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date: Jun2021), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization at hospital. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9261 and expiry date: May2021), via an unspecified route of administration, in Arm Right, on an unknown date at 11:00 AM, as a single dose for COVID-19 immunization at hospital and had pain in esophagus, tightness in throat and joint pain, headache, and tired. The patient received first vaccine at 11 AM, left hospital and picked up lunch and came home. After eating meat ball sandwich soon after her throat was tight and painful. The patient's medical history included oral Lichen planus, chronic dry eyes for long time, and extreme dry mouth. The patient mentioned that she had a difficult intubation, unable to swallow large pills and had EpiPen (for Peanut intolerance). Concomitant medications were not reported. The patient was treated by oral Surgeon and biopsy was done on 13Nov2020 of inside of cheeks, sores on tongue, salivary gland, and lip which resulted in not being Sjogrens, oral lichen planus. The patient reported some mild symptoms like Sjogrens disease, joint pain (took Ex strength Tylenol), and throat felt like it was closing which lasted- 3 to 4 hours (no treatment received). Second vaccine side effects were mild in comparison to first headache, sore arm, tired. On an unknown date, after unspecified time, the patient experienced headache (seriousness: hospitalization), tired (seriousness: hospitalization) and sore arm. The patient received Tylenol for headache and no treatment was received for tiredness. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: tiredness; fever of 101; had the runs; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old male patient received BNT162B2, (COMIRNATY, solution for injection, lot# EN6206) via an unspecified route of administration, administered on left arm on 09Mar2021 as 1ST dose, single dose for covid-19 immunization. The patient medical history including but not limited to these conditions:  diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine ab-normalities (including diabetes) and obesity, COVID virus in October 2020. The concomitant medications were not reported. Symptoms came on right at the same time, he had second Pfizer Covid vaccine at 10:40 in the morning and by 17:00 in the evening had the reactions. The patient experienced headache on 09Mar2021 15:00, on 10 Mar 2021 woke up about 8:30 and he had all the symptoms start right after that. Tiredness on 10Mar2021, fever of 101 on 10Mar2021, had the runs on 10Mar2021. Outcome of headache tiredness, fever (fever of 101) and had the runs recovered on 11Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pruritus, Pyrexia, Urticaria
Clinical narrative: headache; fever of 99.9; itching from belly to knees with hives the size of quarters; itching from belly to knees with hives the size of quarters; This is a spontaneous report received from a contactable consumer reported for himself. A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: unknown), via intramuscularly, on 30Mar2021 (at 10:40) single dose on left arm for COVID-19 immunization. Historical vaccination included the patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, on 09Mar2021 (10:10). The patient medical history and concomitant medications were not reported. The patient had COVID in October 2020 and was hospitalized for 17 days. No vaccines were taken prior 4 weeks. On 30Mar2021, by evening (at 17:00), the patient experienced a fever of 99.9, headache that was the worst, itching from belly to knees with hives the size of quarters. All the events lasted for one day. Allegra tablet was taken as a therapeutic measure fore itching from belly to knees with hives the size of quarters. The reporter assessed all events as non-serious. The outcome of the events was resolved on 31Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: not feeling well; Headache; This is a spontaneous report received from Pfizer sponsored program. A contactable male consumer reported for his wife. This is report 2 of 2.   A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Not Provided), via an unspecified route of administration in Arm Left on 19Mar2021 at 16:30(at the age of 48 years old) as 1st dose, single dose for covid-19 immunisation. Medical history was reported none. Concomitant medication included vitamins (VITAMINS NOS). The patient experienced headache on 08Apr2021 and not feeling well on an unspecified date. Reporter stated as, "him and his wife had their first doses 19 mar 2021 second dose is today 9Apr2021, but they can't make it because both of them are not feeling well. he also said he is experiencing head cold symptoms now. Can they reschedule their second dose today and if not how can they set up their second dose, he also states that everything that they read said they shouldn't go if they are not feeling well. he wants to know if this is a reason not to have the shot and if he can go under these circumstances or not. He states his wife got Pfizer COVID-19 vaccine on 19 Mar 2021 at 1630. She has a headache that started last night. She has not taken anything for it". Outcome of the events headache was not recovered and unknown for malaise.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Headache on same side as shot arm, beginning 36 hours after shot and still continuing 6 days later, can control with tylenol and ibuprofen but has not fully gone away; Low grade fever; Chills; Aching; Pain/heaviness at injection site; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 39-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8729 and Expiry date: not provided), dose 1 via an unspecified route of administration, in the left arm, on 06Apr2021, as single for COVID-19 immunisation in the Doctor's office/urgent care. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks. On 07Apr2021, the patient experienced headache on same side as shot arm, beginning 36 hours after shot and continuing 6 days later, can control with tylenol and ibuprofen but has not fully gone away, low grade fever, chills, aching, heaviness at injection site, pain/heaviness at injection site. The events were assessed as non-serious. The timeframe between vaccination and starting of symptoms is 1 day. Therapeutic measures were taken for all the events with Tylenol, and ibuprofen. The facility where the most recent COVID-19 vaccine was administered in Doctor's office/urgent care. The outcome of the events was reported as not recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: headache; sore throat; fatigue; sore arm; This is a spontaneous report was received from a contactable consumer or other non-Health Care Professional. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 08Apr2021 10:15 at the age of 27-years-old as 2nd dose, single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC); cyanocobalamin (B12-VITAMIIN); loratadine (CLARITIN); guaifenesin (MUCINEX) taken for an unspecified indication. Patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on 18-MAR-2021 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient has not received any treatment and was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. On 08Apr2021, 21:30 the patient experienced headache, sore throat, fatigue, sore arm. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced a headache aftergetting the 1st dose; This is a spontaneous report received from a Pfizer Sponsored Program COVAX US support. A contactable consumer female patient of an unspecified age 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 08Apr2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a headache after getting the 1st dose on 08Apr2021. She wants to know if it is contagious. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bad headache; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program COVAX US Support.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unspecified), via unknown route of administration on 09Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received her 1st shot of COVID-19 vaccine on 09Apr2021, and really had a bad headache. She was asking if she could take Tylenol or Advil or any pain killer. The patient was not sure if her 2nd dose was scheduled on 07May or 09May or when. The events were assessed as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable consumer (Patient). A 72-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: ER87347), via an unspecified route of administration in Arm Left on 08Apr2021(age t vaccination: 72-years-old) as first dose, single dose for covid-19 immunization. (Vaccination Facility Name: Hospital hosted the event). Medical history included cardiac pacemaker insertion from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing. Concomitant medication was not reported. It was reported on 08Apr2021 after first dose of the vaccine she experienced headache for 8 days now, first started half an hour after getting vaccinated and it just has not stopped. patient asked for treatment recommendations. She has a question about her headache. She was asking is there anything she can do to stop the headache. She has had a headache every day for 40 years. But this headache was different. She normally gets migraines, but she has not had any lately. Patient did not require ER and physician office visit. The outcome of the event was Not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, Confusional state, Dizziness, Eye pain
Clinical narrative: I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes.   I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug  Amitriptyline on May 30, and symptoms are not disappearing.   I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid sensory disorder, Fatigue, Hypoaesthesia, Impaired work ability, Magnetic resonance imaging head
Clinical narrative: I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes.   I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug  Amitriptyline on May 30, and symptoms are not disappearing.   I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging normal, Migraine, Visual impairment
Clinical narrative: I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes.   I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug  Amitriptyline on May 30, and symptoms are not disappearing.   I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Thinking abnormal
Clinical narrative: My thoughts and memory became cloudy. I couldn't fully remember what was said to me not long before that and I couldn't think straight.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Ear swelling, Herpes zoster, Neck pain, Swelling
Clinical narrative: Shingles; Diagnosed May 30, 2021, by Dr.  Vesicular eruption on forehead, above left eye. Pain and swelling around left ear and left side of neck.   Treatment: Seven-day course of antiviral medication (Valacyclovir): 600mg ibuprofen tablets as needed for pain; Hydrocodone-acetemin (Norco) for pain at night in order to sleep
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Lipase normal, Lymphocyte count decreased, Lymphocyte percentage increased, Metabolic function test normal
Clinical narrative: Received 2nd covid vaccine on 4/28/2021 Early morning hours on 4/29/2021, she developed nausea and vomiting She went to ER, was given deoperidol,  IV fluids, sent home with zofran ODT Came in to urgent care on 5/1/2021 because she was still having nausea and vomiting She was unable to keep anything down  Attempted to start IV x 3 attempts, but were unsuccessful she refused to go back to ER We administered phenergan 25 mg IM x 1 dose She was able to keep oral fluids down She was sent home with PO phenergan and rectal phenergan in case she couldn't keep PO down  *** she had similar reaction after first vaccine on 3/31/2021 but symptoms were mild*** ***Was + for SARS-CoV-2 in November 2020***
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neutrophil count increased, Sinus tachycardia, Urine analysis abnormal, Urine ketone body present
Clinical narrative: Received 2nd covid vaccine on 4/28/2021 Early morning hours on 4/29/2021, she developed nausea and vomiting She went to ER, was given deoperidol,  IV fluids, sent home with zofran ODT Came in to urgent care on 5/1/2021 because she was still having nausea and vomiting She was unable to keep anything down  Attempted to start IV x 3 attempts, but were unsuccessful she refused to go back to ER We administered phenergan 25 mg IM x 1 dose She was able to keep oral fluids down She was sent home with PO phenergan and rectal phenergan in case she couldn't keep PO down  *** she had similar reaction after first vaccine on 3/31/2021 but symptoms were mild*** ***Was + for SARS-CoV-2 in November 2020***
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Received 2nd covid vaccine on 4/28/2021 Early morning hours on 4/29/2021, she developed nausea and vomiting She went to ER, was given deoperidol,  IV fluids, sent home with zofran ODT Came in to urgent care on 5/1/2021 because she was still having nausea and vomiting She was unable to keep anything down  Attempted to start IV x 3 attempts, but were unsuccessful she refused to go back to ER We administered phenergan 25 mg IM x 1 dose She was able to keep oral fluids down She was sent home with PO phenergan and rectal phenergan in case she couldn't keep PO down  *** she had similar reaction after first vaccine on 3/31/2021 but symptoms were mild*** ***Was + for SARS-CoV-2 in November 2020***
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Covid arm. 2 inch diameter red, itchy, hard spot at injection site.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Received vaccine on 4/29/2021 On 5/2/2021 she developed hives (arms, trunk, legs, back, neck)  She tried using cortisone cream on the hives and Benadryl came in to Urgent care on 5/6/2021 due worsening of hives She was given depomedrol 80 mg IM x 1 Pepcid 40 mg  prednisone 40mg daily x 5 days  Her symptoms improved after injection, she completed the prednisone She returned to Urgent Care on 5/20/21 when hives reappeared on arms she was given depomedrol 80 mg IM x1  started on prednisone again, but longer duration with taper and referred to allergist   ***she tested + for SARS-CoV-2 December 2020***
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Injection site erythema, Injection site swelling, Ocular hyperaemia, Pruritus
Clinical narrative: 8 days after the injection site turned pink and raised and I experienced red itchy eyes and felt itchy all over.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood test, Computerised tomogram, Culture, Fatigue
Clinical narrative: Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory  pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Immediate post-injection reaction, Malaise, Nausea, Pain
Clinical narrative: Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory  pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pneumonia, Pyrexia, Respiratory viral panel, Sepsis
Clinical narrative: Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory  pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome, X-ray
Clinical narrative: Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory  pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: broke my hip; fell; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Apr2021, the patient stated that he couldn't make the 2nd dose scheduled on 20Apr2021 because he just got released from the hospital because of hip replacement surgery and needed to rest for a bit. The patient planned to reschedule the 2nd dose on 26Apr2021 if possible. On 18May2021, the patient stated that the week before his 2nd shot appointment in Apr2021, he fell and broke his hip and had to delay the 2nd shot by one week. The patient had no issues with the shot. The outcome of the event was unknown. The patient reported that there was no relationship to shot.  Information on the lot/batch number has been requested. Further information is expected.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported events fell and broke his hip are not related to BNT162B2, but an accident.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Body temperature decreased, Cold sweat
Clinical narrative: His blood pressure dropped to around 100; His temperature was down to 91°F; His entire left side of his body was numb/left feet/middle 3 toes remain numb currently; Started to break out in a profuse cold sweat; he was cold; Fatigued; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 13Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin from an unknown date. Concomitant medications were not reported. The reporter stated her partner received his first dose of BNT162B2 on 13Mar2021 and immediately after started to break out in a profuse cold sweat, his blood pressure dropped to 100, which was very low for him, and his entire left side of his body was numb. The reporter stated the numbness had mostly improved and only his left foot/middle three toes remained numb "currently." She reported his temperature was down to 91 degrees Fahrenheit when his temperature was checked to go into work. She reported he was cold and fatigued for two weeks after the vaccine. The reporter was concerned his symptoms had lasted that long and was seeking more information on this. She also stated that her partner was allergic to penicillin and she had read that people with this allergy should not receive anything with "PEG," thus he might have had this reported side effect due to his penicillin allergy. The clinical outcomes of his blood pressure dropped to around 100, his temperature was down to 91 degrees Fahrenheit, profuse cold sweat, he was cold, and fatigued were unknown; the outcome of his entire left side of his body was numb/left feet middle three toes remain numb was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Hypoaesthesia
Clinical narrative: His blood pressure dropped to around 100; His temperature was down to 91°F; His entire left side of his body was numb/left feet/middle 3 toes remain numb currently; Started to break out in a profuse cold sweat; he was cold; Fatigued; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 13Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin from an unknown date. Concomitant medications were not reported. The reporter stated her partner received his first dose of BNT162B2 on 13Mar2021 and immediately after started to break out in a profuse cold sweat, his blood pressure dropped to 100, which was very low for him, and his entire left side of his body was numb. The reporter stated the numbness had mostly improved and only his left foot/middle three toes remained numb "currently." She reported his temperature was down to 91 degrees Fahrenheit when his temperature was checked to go into work. She reported he was cold and fatigued for two weeks after the vaccine. The reporter was concerned his symptoms had lasted that long and was seeking more information on this. She also stated that her partner was allergic to penicillin and she had read that people with this allergy should not receive anything with "PEG," thus he might have had this reported side effect due to his penicillin allergy. The clinical outcomes of his blood pressure dropped to around 100, his temperature was down to 91 degrees Fahrenheit, profuse cold sweat, he was cold, and fatigued were unknown; the outcome of his entire left side of his body was numb/left feet middle three toes remain numb was not recovered.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Cough, Erythema multiforme
Clinical narrative: Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. 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. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered.  Information about lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Night sweats
Clinical narrative: Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. 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. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered.  Information about lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. 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. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered.  Information about lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. 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. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered.  Information about lot/batch number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema to lips; generalized hives (legs, arms, back, stomach); This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 17:00 (Lot Number: ER8736) at the age of 18-year-old at a single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history included mitral valve defect, seasonal allergies and allergies to peanuts, nuts, goldfish and cheez it crackers. Concomitant medications received in two weeks included minocycline; loratadine, colecalciferol (D3) and multivitamin gummies once a day, these medications taken for an unspecified indication, start and stop date were not reported. No other vaccine administered in four weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Apr2021 10:30 (Lot Number: EW0150) at a single dose for covid-19 immunisation. The patient experienced angioedema to lips and generalized hives (legs, arms, back, stomach) on 28Apr2021 03:00 and received benadryl 25 mg, then claritin 20mg later in afternoon as treatment. The patient did not get covid prior vaccination and no covid test post vaccination. The outcome of the events was recovered in Apr2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, SARS-CoV-2 test
Clinical narrative: prone to hypoglycemia; This is a spontaneous report received from a contactable consumer (patient).  A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left in Mar2021 12:45 PM (Batch/Lot Number: EN6204) as single dose at the age of 51-year-old for COVID-19 immunisation.  Medical history included cholesteatoma, known allergies: Sulfa drugs, cephalosporins and strawberries. The patient's concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced prone to hypoglycemia on an unspecified date with outcome of unknown. The course of events was as follows: After the first dose of Pfizer vaccine, the patient had almost no side effects, just more prone to hypoglycemia.  The patient subsequently received the 2nd dose on 01Apr2021. Since the vaccination, the patient has been tested for COVID-19: lab tests and procedures included Sars-cov-2 test: negative on: 11Mar2021, 18Mar2021 25Mar2021, 08Apr2021, 19Apr2021, and Sars-cov-2 test: pending on 28Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Nausea, Pyrexia
Clinical narrative: Mild fever; tiredness; nausea; shingles; This is a spontaneous report from a contactable consumer (patient). This is the report regarding first dose. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:30 (Lot Number: 8729) at the age of 55 years, as single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received multivitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Apr2021 19:00 the patient experienced mild fever, tiredness, nausea, shingles appeared on right arm. The events were non-serious with outcome of recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection sit lump; On/off headache; The swelling was a size of a lemon, itchy and rashy; The swelling was a size of a lemon, itchy and rashy; The swelling was a size of a lemon, itchy and rashy; This is a spontaneous report from a contactable consumer reporting for the mother. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 21Apr2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection sit lump (non-serious) on an unspecified date with outcome of unknown, headache (non-serious) on an unspecified date with outcome of recovered, the swelling was a size of a lemon, itchy and rashy (non-serious) on an unspecified date with outcome of unknown. She had a little red lump around the injection site after receiving the vaccine. She basically went for a colonoscopy couple days later. They gave her anesthesia treatment. A day or 2 after she came back from the hospital. The injection sit lump started growing a bit in size. The swelling was a size of a lemon, itchy and rashy. Therapeutic measures were taken as a result of the swelling and included antihistamine. It helped and swelling got smaller. Since the day before report it grew again and its now bigger, rashy and itchy after she took her antihistamine medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she was scheduled to receive the second dose of BNT162B2 "today" (as of 02May2021). She stated she had a headache in the morning, and she took ibuprofen. She inquired if she should still receive the second dose that day or if she should postpone it. The clinical outcome of headache was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Contusion, Pain in extremity, Swelling
Clinical narrative: Swelling in the arm pit of her left arm /swelling feels like a sore water pouch; Swelling in the arm pit of my left arm with small circular bruising; I have swelling in the arm pit of my left arm with small circular bruising. It hurts and aches/swelling felt like a sore water pouch; The ache was also felt through my whole arm; This is a spontaneous report from a contactable consumer (patient) via a sponsored program. This non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 30Apr2021 at 16:30 the patient experienced swelling in the arm pit of her left arm with small circular bruising. She reported it hurt and ached and she had to take ibuprofen to sleep. The ache also was felt through her whole arm. The swelling felt like a sore water pouch. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of swelling in the armpit of her left arm with small circular bruising, it hurt and ached, swelling felt like a sore water pouch, and ache was felt through her whole arm were reported as recovered in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19.    No follow-up attempts are needed; information about lot number cannot be obtained.