chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash pruritic
Clinical narrative: Significant spreading rash developed to right side lower flank area, itchy, hot to touch; Significant spreading rash developed to right side lower flank area, itchy, hot to touch; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection; Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in left arm on 19Apr2021 at 09:00 (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient had known allergies for Sulpha meds. Concomitant medications included Occasional vitamin, fish oil, vitamin d3 and probiotic (PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]). Patient previously took first dose of BNT162B2 (at the age of 36-year-old) (lot number: ER8727, vaccine location: Right arm) on 29Mar2021 at 09:00 AM as dose 1 for covid-19 immunisation. On 20Apr2021 at 20:00 the patient experienced significant spreading rash developed to right side lower flank area, itchy, hot to touch. Where the patient stated that it started off as small dot and significantly spread over next 4-5 days. Patient received treatment post onset of the events which includes emergency room visit and physician office visit. The patient was under treatment with oral antihistamines only was ineffective and she saw physician on day 6 and started topical steroid cream, oral steroid, and oral antibiotic. Second physician on started Zyrtec BID on day 8 of rash. Took approximately 3 weeks to fully subside. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. Outcome of all the events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Menstruation delayed, Pruritus, SARS-CoV-2 antibody test
Clinical narrative: Delayed period / yellow drops I never get instead of my eri of and I had been checked for sexual diseases I have none /after 4 days delay I got my period two days ago; last two weeks my hands been itching; small pressure at left side of my chest; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: Ee0161), via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 18:00 (at the age of 44-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. On 01Jun2021, patient experienced delayed period / yellow drops I never get instead of my eri of and I had been checked for sexual diseases I have none /after 4 days delay I got my period two days ago/ also for last two weeks my hands been itching and small pressure at left side of my chest. The patient underwent lab tests and procedures which included sars-cov-2 antibody test which was negative on 26May2021. Therapeutic measures were not taken due to the events. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away.; muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away.; muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away.; This is a spontaneous report from a contactable consumer (patient himself).  A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EP6955, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Age at vaccination 47-years-old) as dose number unknown, single for covid-19 immunisation. The facility Type Vaccine was school or school health clinic. Medical history included High Cholesterol from an unknown date and unknown if ongoing. The patient known allergies was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021, the patient experienced muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Echocardiogram, Electrocardiogram, Heart rate increased
Clinical narrative: Damaged heart muscle and caused a state of non-corrective atrial fibrillation with a persistent elevated resting heart rate and regular episodes of tachycardia.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial injury, Tachycardia
Clinical narrative: Damaged heart muscle and caused a state of non-corrective atrial fibrillation with a persistent elevated resting heart rate and regular episodes of tachycardia.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Shot was in left arm on 10/25/21. Followed by soreness in upper arm for 1 day and numbness in entire left arm  started mid day 2 days after shot on 10/27/21 around 1 pm
Age: 34.0
Sex: F
Vaccine: ADEN_4_7, COVID19
Symptoms: Cardiac monitoring, Chills, Injection site pain, Myalgia, Palpitations
Clinical narrative: Received moderna Covid vaccine booster in left deltoid. Flu shot in right.  Sore muscles began 3 hours post shots as to be expected. But at 2:30 this morning (shots were at 10:30am yesterday) heart began racing  (resting asleep was roughly 60bpm- and woke up at 93bpm went up to 114) and chills/ shivering which has continued for 3 hours. I wear a heart monitor that has been tracking it. Took 2 650mg of 8 hour Tylenol at 2300 10/27 for extreme pain in left arm (Covid site) and just had to take some again at 0500 10/28. Waiting for heart to stop racing and chills, pain to subside.   Flu shot site on right arm is tender but not radiating or extremely painful. Only left arm with moderna.
Age: 34.0
Sex: F
Vaccine: ADEN_4_7, COVID19
Symptoms: Tenderness
Clinical narrative: Received moderna Covid vaccine booster in left deltoid. Flu shot in right.  Sore muscles began 3 hours post shots as to be expected. But at 2:30 this morning (shots were at 10:30am yesterday) heart began racing  (resting asleep was roughly 60bpm- and woke up at 93bpm went up to 114) and chills/ shivering which has continued for 3 hours. I wear a heart monitor that has been tracking it. Took 2 650mg of 8 hour Tylenol at 2300 10/27 for extreme pain in left arm (Covid site) and just had to take some again at 0500 10/28. Waiting for heart to stop racing and chills, pain to subside.   Flu shot site on right arm is tender but not radiating or extremely painful. Only left arm with moderna.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Hypoaesthesia, Influenza like illness, Migraine
Clinical narrative: 2 days  after both shots had flu like symptoms. I week after both shots had all over body and muscle ache, numbness and tingling, nausea, migraine, shortness of breath, diarrhea
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: 2 days  after both shots had flu like symptoms. I week after both shots had all over body and muscle ache, numbness and tingling, nausea, migraine, shortness of breath, diarrhea
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: I am getting my period every two weeks now since the second vaccine shot; I am getting my period every two weeks now since the second vaccine shot; I am getting my period every two weeks now since the second vaccine shot; This is a spontaneous report from a contactable consumer (patient). A adult non pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization at pharmacy or drug store.No other vaccines were received in four weeks. No other medications were received in two weeks. Medical history included migraines from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient previously received bnt162b2 (Batch/Lot number: EW0170), via an unspecified route, administered on arm left on 28Apr2021 at 01:00 PM as DOSE 1, SINGLE for covid-19 immunization and experienced irregular and heavy periods lasting longer than normal up to 8 days (at this point) After the first shot patient's period was 2 weeks early. On an unspecified date in 2021, the patient was getting her period every two weeks since the second vaccine shot. Before that the patient was always regular. The adverse event resulted in visit to doctor or other healthcare professional office/clinic visit. No treatment was received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pyrexia, Swelling, Swelling face
Clinical narrative: Mild fever; Mild Cold; Mild swelling on face; Mild pain on swelling area of pain; Mild pain on swelling area of pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 43-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Ew0175) via an unspecified route of administration in left arm on 06May2021 13:00 as dose 2, single (at the age of 43-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The device timestamp was on 20Jun2021. Medical history included diabetes mellitus. The patient no known allergies. The patient did not have covid prior to vaccination. The concomitant medications included metformin, semaglutide (RYBELSUS), atorvastatin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Er8735) via an unspecified route of administration in left arm on 15Apr2021 18:00 as dose 1, single for COVID-19 immunization. The patient did not take other vaccine in four weeks. On 07Jun2021 at 13:00, the patient experienced mild fever, mild cold, mild swelling on face, mild pain on swelling area of pain. The patient did not test covid post vaccination. The therapeutic measures were not taken as a result of the adverse events. The outcome of the events was not recovered.  Follow-up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Retching, Throat tightness
Clinical narrative: Dry heaving; Very congested; Throat felt tight; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ew0186), via an unspecified route, administered in left arm on 15Jun2021 at 12:00 evening (age at the time of vaccination was 46 years old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroid and food allergy (food allergies and this reaction was frightening); both were from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (CETRIZINE), diphenhydramine hydrochloride (BENADRYL), paracetamol (TYLENOL); all were taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (Batch/Lot Number: Ew0186), via an unspecified route, administered in left arm on 25May2021 at 12:00 evening (age at the time of vaccination was 46 years old) as dose 1, single for COVID-19 immunization and experienced hot, nauseous and heart was racing. The patient had the second dose and the onset was faster and more severe. On 15Jun2021, with 3 minutes, the patient experiencing dry heaving, very congested and throat felt tight. She could still breathe. That all happened even though she took Benadryl and a Tylenol 45 minutes prior to her injection. Again, the pharmacist gave a dose of Benadryl to help with the effects of the vaccine. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included Benadryl and Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis
Clinical narrative: chest tightness; I had difficulty breathing; profusely sweating; This is a spontaneous report from a contactable consumer. A 21-years-old non pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0182), via an unspecified route of administration, administered in Arm Left on 04May2021 at 16:45 (at the age of 21-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 18:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. On 12May2021 12:00, patient experienced an episode where she had difficulty breathing, was profusely sweating, and had chest tightness a few minutes after vaccine was administered for around 30 minutes, but it slowly subsided after that. On the same day, she took a video appointment with a doctor that was available. Therapeutic measures were not taken due to the events. Patient was not tested for covid post vaccination. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Pruritus, Skin irritation, Therapeutic response unexpected
Clinical narrative: tick bite; Caller states he sent an email to the FDA last week and they suggested he contact Pfizer to find out more information since it was a positive side effect; still itches and irritated where tick bite is; still itches and irritated where tick bite is; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 60-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Formulation: Solution For injection, Batch/Lot Number: EW0153, Expiration Date: Unknown) via an unspecified route of administration, administered in left arm on 10Apr2021 (at the age of 60-year-old) as DOSE 2, SINGLE and received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine Formulation: Solution For injection Batch/Lot Number: ER2613 Expiration Date: Unknown) via an unspecified route of administration, administered in left arm on 20Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Patient medical history and family medical history was reported as none. Patient previously received Flu shot on an unspecified date one time but doesn't remember the date and states it was in the 1990s. Concomitant medications were reported as none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced tick bite, Patient states he lives in a rural area and was bit by a tick. He states when he pulled the tick off of him it was dead. Patient states another tick bit him and when he pulled that one off it was dead as well. Patient wanted to know if there something in the vaccines that kills ticks. The first tick bite was in Mar2021 and that he was actually bitten 3 times total with this past Wednesday 15Jun2021 being the last time he was bitten. Patient states the bites still itches and the skin is irritated. Patient states he sent an email to the FDA last week and they suggested he contact Pfizer to find out more information since it was a positive side effect. The events did not result in visit to emergency room or physician office. The outcome of tick bite was not resolved and the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Nausea, Oral herpes, Pain
Clinical narrative: pain all over; temp of 102; fever blister; skin darken/ peeling around mouth/chin; skin darken/ peeling around mouth/chin; injection site sore/ Vaccination site pain; Felt weak/ nauseated; Felt weak/nauseated; thirsty; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 50-years-old non-pregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172, expiry date: unknown) via an unspecified route of administration in left arm on 01Jun2021 at 10:00 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization at pharmacy/drug store. The patient was non-pregnant at the time of vaccination. The patient's medical history included gallbladder removed on 21May2021 (surgery follow-up was on 01Jun2021), gastritis, gastroparesis, chronic fatigue syndrome, type 2 diabetes, venous inefficacy and Penicillin allergy. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took erythromycin, sulfa [sulfanilamide], morphine, demerol and experienced drug hypersensitivity with them. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172, expiry date: unknown) via an unspecified route of administration in left arm on 21Apr2021 at 11:45 (at the age of 50-years-old) as historical vaccine as dose 1, single for COVID-19 immunization and experienced gout. Few days after surgery patient called the nurse to inquire about scheduling second injection. After follow-up appointment, she had a good report but never had gout before but was diagnosis & prescribed Meloxicam. On 01Jun2021 at 15:00, symptoms on the day of second injection, the patient experienced pain all over, temp of 102, fever blister, skin darken/ peeling around mouth/chin, injection site sore, felt weak, nauseated, & thirsty. Symptoms lasted about a week except skin peeling around mouth/chin which was ongoing. Patient did not have COVID prior to vaccination and was not tested for it post vaccination. The patient underwent lab tests and procedures which included body temperature 102 on 01Jun2021. Therapeutic measures were taken as a result of events as home remedy, Tylenol, Hydrocodone and rest. The outcome of the event skin peeling around mouth/chin' was not recovered, while the outcome of remaining events was recovering at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Skin exfoliation, Thirst, Vaccination site pain
Clinical narrative: pain all over; temp of 102; fever blister; skin darken/ peeling around mouth/chin; skin darken/ peeling around mouth/chin; injection site sore/ Vaccination site pain; Felt weak/ nauseated; Felt weak/nauseated; thirsty; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 50-years-old non-pregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172, expiry date: unknown) via an unspecified route of administration in left arm on 01Jun2021 at 10:00 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization at pharmacy/drug store. The patient was non-pregnant at the time of vaccination. The patient's medical history included gallbladder removed on 21May2021 (surgery follow-up was on 01Jun2021), gastritis, gastroparesis, chronic fatigue syndrome, type 2 diabetes, venous inefficacy and Penicillin allergy. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took erythromycin, sulfa [sulfanilamide], morphine, demerol and experienced drug hypersensitivity with them. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172, expiry date: unknown) via an unspecified route of administration in left arm on 21Apr2021 at 11:45 (at the age of 50-years-old) as historical vaccine as dose 1, single for COVID-19 immunization and experienced gout. Few days after surgery patient called the nurse to inquire about scheduling second injection. After follow-up appointment, she had a good report but never had gout before but was diagnosis & prescribed Meloxicam. On 01Jun2021 at 15:00, symptoms on the day of second injection, the patient experienced pain all over, temp of 102, fever blister, skin darken/ peeling around mouth/chin, injection site sore, felt weak, nauseated, & thirsty. Symptoms lasted about a week except skin peeling around mouth/chin which was ongoing. Patient did not have COVID prior to vaccination and was not tested for it post vaccination. The patient underwent lab tests and procedures which included body temperature 102 on 01Jun2021. Therapeutic measures were taken as a result of events as home remedy, Tylenol, Hydrocodone and rest. The outcome of the event skin peeling around mouth/chin' was not recovered, while the outcome of remaining events was recovering at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Body aches; feeling really sick; soreness and pain in injection site; Pain I had it was my arm, it was very sore; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, Expiry date: unknown), via an unspecified route of administration on 17Jun2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received vaccine last Thursday, 17Jun2021 and experienced soreness, and pain in injection site. So, her question was, she got her vaccine on Thursday and the only pain she had it been her arm, it was very sore but all it seems very general and Friday on 18Jun2021, next day she cooked the spaghetti, and she had a glass of wine with her dinner, was alcohol allowed or not allowed with vaccine, She stated that she had lot of pain, her body aches a lot and she was feeling really sick yesterday, even after taking Tylenol does not help. Patient mentioned that someone told her that wine should not be taken with other vaccines. She spoke with the pharmacy, and they had no say about it. She asked if alcohol had any interactions with the Pfizer BioNTech COVID-19 vaccine. Patient hung up the call abruptly. Patient was unwilling to complete the report. Hence, limited information available. Outcome of the events was unknown.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that:  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, lot Number: Ew0183) via intramuscular, administered in Arm Right on 07Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: Ew0177), via intramuscular, administered in arm Right on 15May2021 as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 07Jun2021, the patient experienced fever and fatigue. Therapeutic measures were taken as a result of the events using Ibuprofen. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer, based on information received by Pfizer (control number: US-AMGEN-USASL2021086866). A 64-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date: unknown), via unknown route of administration, on May 18, 2021, single dose, for COVID-19. The patient's current medical condition included rheumatoid arthritis. Patient stated she received the first COVID-19 (Coronavirus) vaccine Moderna (COVID-19 vaccine mRNA 1273) on Apr 20, 2021. Then three days after (Apr 23, 2021), patient took her dose of Enbrel. An hour later her left arm (where she received her COVID vaccine) suddenly developed a large, red circle. Patient stated it was the size of a baseball and looked like a tattoo. It was such a perfect circle. Patient confirmed that she has not had any red area on her arm like this before. This lasted for approximately five days. The patient received her second COVID-19 vaccine on May 18, 2021, followed by her usual dose of Enbrel on May 21, 2021. Patient stated this time, almost immediately after her Enbrel injection, her arm developed a sudden red circle. Patient stated this circle was not as big and lasted approximately four days. No treatment information received. The outcome of the event resolved in 2021. Follow-up requested for batch/lot number.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Fatigue, Hypertension, Pain in extremity
Clinical narrative: tired; hypertension; COVID vaccine / sore arm; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-088905), for BNT162B2.  A non-pregnant female patient (not pregnant at the time of vaccination) of an unspecified age received patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization and lenvatinib mesilate (LENVIMA), oral from 14May2021 (Batch/Lot Number: Unknown) and ongoing, at 4 mg, daily for ovarian cancer; ovarian cancer Lenvima 20 mg once a day with keytruda - of which on hold since 18Mar2021). The patient medical was not reported and concomitant medications included pembrolizumab (KEYTRUDA) via intravenous route for ovarian cancer which on hold since 18Mar2021. On an unspecified date in May2021, the patient experienced tired, hypertension and COVID vaccine / sore arm. It was reported that patient feel "very good" so far, except "sometimes" tired unknown onset; however, she can function with daily activities (shopping). Previously reported blood pressure on 27May2021 blood pressure 150/80 & today 128/82 improving. Missed doses due to receiving the COVID 19 vaccine (2 months ago) symptoms "sore arms" resolved, unknown if MD was aware. Tired from time to time unchanged (onset unknown). MD is pleased with recent blood work. On 27May2021, the patient underwent lab tests and procedures which included blood pressure measurement: 150/80 and on an unspecified date on 2021, blood pressure measurement: 128/82 (improving). Therapeutic measures were taken as a result of hypertension with lisinopril oral. On an unspecified date on 2021, the patient recovered from the event COVID vaccine / sore arm. The outcome of the event hypertension was recovering and for tired was unknown.  No follow-up attempts are needed, information about batch/lot number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Periorbital swelling, Swelling of eyelid
Clinical narrative: Eye puffiness; Minor Headache; Swollen eyelids; This is a spontaneous report from a contactable consumer. This 62-years-old female consumer (patient) reported for herself. A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0217), dose 1 intramuscular, administered in Arm Left on 16Jun2021 04:00 (at the age of 62-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism, drug hypersensitivity. Concomitant medication(s) in two weeks included levothyroxine sodium (SYNTHROID) taken for hypothyroidism; ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). The patient had allergies with tetracycline and avolox antibiotics. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. At day 5 post covid vaccine, the patient experienced minor headache, swollen eyelids on 21Jun2021 06:00 and had eye puffiness on 26Jun2021. No discharge or stuffy nose. The patient received treatment for event eye puffiness. The seriousness of the event was considered as non-serious. Outcome of the event was not recovered and eye puffiness was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Hypoaesthesia, Limb discomfort, Vaccination site swelling
Clinical narrative: allergic reaction; swelling of the injection arm (left); heaviness; change in her skin color (reddish color); numbness in her hand; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: not reported), via an unspecified route of administration administered in Arm Left on 27May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27May2021 after 4 hours, the patient experienced allergic reaction, swelling of the injection arm (left), heaviness, change in her skin colour (reddish color), numbness in her hand. The patient reported that she received the first dose of the Pfizer Covid-19 vaccine on 27May2021 and experienced reactions afterwards. She was receiving the second dose yesterday (28Jun2021) but nurse referred her to Primacy Care Physician (PCP). Where she explained she had symptoms after 4 hours, she is not sure if it was an allergic reaction. She experienced swelling of the injection arm (left), heaviness, change in her skin color (reddish color) and experienced numbness in her hand. She wanted guidance on how to proceed. The patient is asking that If she received the Pfizer Covid-19 vaccine on 27May2021 how much time do she have left to get the second dose. She also asked can she get the Moderna Covid-19 vaccine as a second dose instead of Pfizer's Covid-19 vaccine or not. There is no product complaint to report, no medical information request and no other report. The outcome of all events were unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin burning sensation, Skin induration
Clinical narrative: After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; Rubbed against poison ivy, within a few days severe rash covering every part of my body; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch Number: ER8727;) via an unspecified route of administration, administered in left arm on 26Mar2021 17:00 (age at vaccination 52 years) as dose 2, single for Covid-19 immunization. Medical history and concomitant medication were not reported. The patient had no known allergy. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6205) via an unspecified route of administration, administered in right arm on 05Mar2021 17:00 (age at vaccination 52 years) as dose 1, single for Covid-19 immunization. Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 21Jun2021 at 19:00 the patient had rubbed against poison ivy, within a few days severe rash covering every part of her body. The severity and extent were unusual, much more severe than any previous time. First saw a PA in family medicine, prescribed prednisone, 3 days later saw another PA in dermatology, got antibiotic ointment. After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened. The patient received Prednisone and mupirocin ointment for treatment of events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Skin weeping
Clinical narrative: After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; Rubbed against poison ivy, within a few days severe rash covering every part of my body; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened.; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch Number: ER8727;) via an unspecified route of administration, administered in left arm on 26Mar2021 17:00 (age at vaccination 52 years) as dose 2, single for Covid-19 immunization. Medical history and concomitant medication were not reported. The patient had no known allergy. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6205) via an unspecified route of administration, administered in right arm on 05Mar2021 17:00 (age at vaccination 52 years) as dose 1, single for Covid-19 immunization. Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 21Jun2021 at 19:00 the patient had rubbed against poison ivy, within a few days severe rash covering every part of her body. The severity and extent were unusual, much more severe than any previous time. First saw a PA in family medicine, prescribed prednisone, 3 days later saw another PA in dermatology, got antibiotic ointment. After 10 days there is less oozing but the itching flares up and skin feels on fire, looks red and hardened. The patient received Prednisone and mupirocin ointment for treatment of events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: Chest pains; shortness of breath; dizzyness; heart skips a beat sometimes, heart beats too fast; heat flashes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 46 years old) as a DOSE 2, SINGLE for COVID-19 immunisation. Medical history was none reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient did not have any known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) in left arm on 03Apr2021 (at the age of 46 years old) for covid-19 immunisation. On 04Jun2021 at 17:30 the patient experienced Chest pains, shortness of breath, dizzyness, heart skips a beat sometimes, heart beats too fast sometimes when resting followed by heat flashes. CT scan and blood work all looked healthy. The patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included blood work, CT scan and resulted all looked healthy and heart beats was fast on 04Jun2021 while on 14Jun2021 SARS-CoV-2 (COVID-19) RT-PCR was done and resulted negative. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Hot flush, SARS-CoV-2 test
Clinical narrative: Chest pains; shortness of breath; dizzyness; heart skips a beat sometimes, heart beats too fast; heat flashes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 46 years old) as a DOSE 2, SINGLE for COVID-19 immunisation. Medical history was none reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient did not have any known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) in left arm on 03Apr2021 (at the age of 46 years old) for covid-19 immunisation. On 04Jun2021 at 17:30 the patient experienced Chest pains, shortness of breath, dizzyness, heart skips a beat sometimes, heart beats too fast sometimes when resting followed by heat flashes. CT scan and blood work all looked healthy. The patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included blood work, CT scan and resulted all looked healthy and heart beats was fast on 04Jun2021 while on 14Jun2021 SARS-CoV-2 (COVID-19) RT-PCR was done and resulted negative. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness on my arm; now it started to spread down my arm and it itches pretty bad; Redness on my arm; now it started to spread down my arm and it itches pretty bad; This is a spontaneous report from a contactable consumer (reported for herself). A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179/Batch number was not reported) via an unspecified route of administration, administered in left arm on 27Jun2021 (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. Medical history was not reported. Concomitant medication included unspecified "just birth control". The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jun2021, the patient experienced redness on my arm; now it started to spread down her arm, and it itches pretty bad (erythema, pruritus). It was reported that patient got the shot on 27Jun2021, (Pfizer shot) and maybe a couple of days later, she noticed that the redness on her arm 'right away kind of like where the bandage was' (Further clarification was unknown) but now it started to spread down her arm, and it itches pretty bad. Therapeutic measures were taken as a result of event erythema which included treatment with 1 percent hydrocortisone (yesterday). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle tightness, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot#EW0181), via an unspecified route of administration, on Jun 16, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient stated 2 days before the day of report, he developed a pretty severe arm ache in his left shoulder and in his upper arm that radiates to his hands. He also added he experienced injection pain, two and a half weeks before. He wanted to know if this was a side effect of the vaccine. The patient had a really sore shoulder and it kind of radiated down his arm (pain). This was actually bad enough that he went to the ER that morning. He thought it was just some really tight muscle. They gave him a unspecified muscle relaxant, which just was not working. So, he is just curious if there has been any reported very sore shoulders as much as over 2 weeks after the initial injection. The patient did not think this was a side effect of the vaccine. His second dose due on Jul 7, 2021. Therapeutic measures were taken as a result of the events; with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: Severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7; Severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7; Couldn't lift arm from shoulder, but could from elbow; Fever - low grade (99-100°F) - 7days; Chills; Body Aches - even when fever gone; Severe fatigue even after full nites sleep; Tinnitus - this continued full 3wks; Had to force myself to eat, Bfast & Dinner at least, every day; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 63-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunization. Medical history included Chronic migraines. Concomitant medication(s) included paraffin (MINERAL), start and stop date were not reported. Patient received other medications in two weeks was Mineral and Vitamins supplements. The patient previously took tylenol and experienced drug allergies. On 04Mar2021 at 14:00, patient experienced severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7, couldn't lift arm from shoulder, but could from elbow, fever - low grade (99-100°f) - 7days, chills, body aches - even when fever gone, severe fatigue even after full nites sleep, tinnitus - this continued full 3wks, Had to force myself to eat, Bfast & Dinner at least, every day. Patient did not received any treatment. On 04Mar2021, patient underwent lab tests and procedures which included body temperature: low grade (99-100°f) fahrenheit. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.