chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 19-year-old male who received his 2nd COVID-19 vaccination 2 days ago.  Patient received vaccine in the left shoulder.  Patient the next day (1 day ago)  began to have body aches fever and chills and some right-sided chest discomfort.  Patient states he has some soreness with touching the right chest wall.  Patient states he has no known medical problems.  Patient denies any surgery denies any history of blood clot to the lung or leg.  Patient states he feels mildly short of breath and has some mild chest soreness. 9/21 Hospital Course Patient was admitted to the telemetry floor where he was continued on ibuprofen therapy for suspected acute pericarditis.  Treated with Ibuprofen 800 TID , treatment dose Lovenox , (initially)  Assessment Problem List (1) Acute pericarditis:        Status: Acute (2) Myocarditis:        Status: Acute  Plan (Overall):   Patient with perimyocarditis secondary to COVID vaccination.  Symptoms have improved with ibuprofen.  Awaiting echocardiogram results.  Agree with ibuprofen.  Will make further recommendations after speaking with the rounding physician.  Suspect symptoms will improve with time.  Spoke with Dr. who also had face to face contact with the patient. Continue anti-inflammatory regimen. Continue to trend troponins. No heavy lifting/strenuous physical activity x 2 weeks. Therefore, no work x 2 weeks. If symptoms improve, may return to work at that time.
approximately 15 minutes after the vaccine was administered I developed numbness in my tongue, metallic taste in mouth, and headache and a fullness feeling in ears.  1 and 1/2 hours later I developed neck pain and numbness in the left side of my face that lasted for 48 hours.  Benadryl was taking for 2 days to help with the reaction.  Day 3 after the vaccine symptoms seemed to resolve except for a slight feeling of numbness in left cheek but much better than first 2 days and almost gone completely.
This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced neck pain, pain in arm and erythema. On an unknown date, the outcome of the neck pain, pain in arm and erythema were unknown. It was unknown if the reporter considered the neck pain, pain in arm and erythema to be related to SHINGRIX. Additional details were provided as follows: Pharmacist reported that the patient was having a reaction to SHINGRIX. It was travelling up her neck, and then also below her deltoid, away from the injection site more towards her elbow. The reporter thought the reaction involved both pain and redness, though she was not sure the extent of the redness, if it was travelling all the way up the patient's neck, or if it was just occurring around the injection site, or below the injection site. The patient was concerned that the injection was not given in the deltoid.
Information has been received from a registered nurse concerning a 12 month old patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #656262/1497F). Two weeks after vaccination the patient developed redness and a papule at the injection site. The papule was confirmed to be chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Pt c/o having fever, chills and not feeling well. Pt has red edema on right arm deltoid area.
30min p/vax pt devel inc temp-t104-105 was noted as the highest elevation;elevated temp lasted 5 days then pt taken to ER;no other problems dx;mom noted episode of paleness & listlessness during initial 5 days;by day 7 or 8 pt better
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A,) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants and treatment medications reported.   This case was linked to MOD-2021-363223 (Patient Link).   Reporter did not allow further contact
I got out the shower and was getting ready for work and my smart watch went off and stated my heart was at a dangerously high rate. I sat down and drank water to see if it will go down, it did a little bit. But when I got up and walked it would go back up. Through the day it would fluctuate 121/100 so I called the doctor. I was also exposed to someone with covid-19 within the past week, I took a covid-19 test at the doctor and it was negative. At the doctor they checked my heart rate and it was 80 something while sitting down. When my heart rate went up initially I immediately got a headache and I have a history of migraines. I spoke to the nurse at my cardiologist office. Mid morning I was awaken to a headache and took my heartrate and it was 121. I called my Cardiologist who sent me for an EKG and when they did it yesterday they said I was also running a fever. They also did a COVID-19 test and it was negative and they told me I could have a virus that mimics Covid-19 but is not. They said hopefully it will clear up in a few days.
Muscle spasms in left hand 7-10 times a day; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 10Mar2021 at 15:45 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient did not have any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole magnesium(MANUFACTURER UNKNOWN) 20mg; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 12Mar2021 at 00:00, the patient experienced muscle spasms in left hand 7-10 times a day. Onset occurred directly after second vaccination and has not gone away. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event muscle spasms in left hand 7-10 times a day was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Numbness and pain in left arm from injection site (left deltoid) to fingers. Left fingers locked in place momentarily. Recommended Dr follow-up and OTC pain meds.
Nausea and diarrhea, a little fever, headache, shivering. I am taking acetaminophen
This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown demographics. The patients current conditions or medical history were not reported. On 26-JUN-2013, the patients were vaccinated with the first dose of GARDASIL 120 y 0.5 ml intramuscular (lot and expiration date were not reported). On 04-SEP-2013, the patients were vaccinated with the second dose of GARDASIL 120 y, 0.5 ml intramuscular (lot and expiration date were not reported). On 27-NOV-2013, patients were administered third doses of GARDASIL 120 y, 0.5 ml intramuscular (lot and expiration date were not reported), less than 24 weeks after the first dose of GARDASIL 120 y 0.5 ml intramuscular, was administered. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to an adult patient of unknown age. On 23-FEB-2013, the adult patient was vaccinated with second pediatric dose of RECOMBIVAX HB 5 microgram. It was reported that the date and manufacturer of first dose of Hepatitis B vaccine was unknown. No adverse event reported, No product confusion discovered, just medication error. Additional information has been requested.
Suspected Clinical Vaccination Failure; COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, with frequency as 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-SEP-2021, the patient tested positive for Covid (covid-19 infection). Physician would not order antibody as far as patient knew. Patient had green which was nasty and was congested all day (suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine  was not applicable. The outcome of the suspected clinical vaccination failure and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0. 20210950996-COVID-19 VACCINE - Suspected clinical vaccination failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Painful swelling and lump under left axilla; Painful swelling and lump under left axilla; This is a spontaneous report from a contactable consumer (patient) reported himself that a 43-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: G269), via an unknown route of administration in left arm on 14Feb2021 at 10:00 (at the age of 43-year-old) as single for COVID-19 immunization. Second dose scheduled for 07Mar2021. He will still get the second dose unless he was recommended not to by a healthcare professional. The patient's medical history included about 2 years ago borderline diabetes and was ongoing. She was diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities and obesity; all were from an unknown date and unknown if ongoing. Her father died of lung cancer. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer was none. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL/ HYDROCHLOROTHIAZIDE) for blood pressure from an unknown date (more than 2 years ago) to ongoing. Prior vaccinations (within 4 weeks) were none. On 16Feb2021, the patient developed painful swelling and lump under left axilla. The patient stated that in the morning when he got up this area was a little tender, not severely painful; This morning the lump really became obvious. Patient did not visit to emergency room/ physician office. Testing/investigations/bloodwork/lab work/cultures/scans/x-rays was none. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient admitted 1/17/10 for possible GUILLAIN BARRE syndrome. Who complains of ascending weakness that began in his feet 1/14/10 and progressed to his upper extremities through 1/16/10. Symptoms: 1. ascending weakness Suspect Drug # 1 Dosing: IM once. Treatment Drugs Used: 1. GLOBULIN IMMUNE Dose : 0.4 Units: GM Freq: EVERY DAY route: IV.
There were NO adverse patient reactions. Continually refrigerated Moderna vaccine was given past, recommended 12 hours of opening multi dose vial. Moderna manufacturer contacted regarding issue.
I lost taste and smell of some things. It has not gotten any better with time. It has now been almost a year and the loss continues.
Patient developed fever, runny nose for 1 week. Was seen and put on Augmentin 200 5/cc 3/4tsp BID for 10 days. Patient then returned with left ear red, swollen. Patient was then referred to ENT. Diagnosed with mastoiditis.
First Day: Swelling and redness and soreness at injection site. Second and Third days:  Large amount or swelling and knot (size of an egg) popped out at injection site and felt hot and bright red and unable to sleep for two nights due to the pain (like a tooth ache) in my arm.  The symptoms improved over the next week, but I began to itch all over and at the injection site (felt like a wasp sting healing) and then the symptoms began to improve, but on day 10, I woke up with a bright red circle, hot to the touch and about the size of a baseball at the injection site and itching. On day 11, the size of the redness increased to the size of a softball and still very hot to touch. I contacted the health dept. where I received the vaccine and they said it was probably my bodies reaction to the vaccine and I should be ok since I wasn't having trouble breathing and no itching in my throat and to contact my primary doctor which I am doing tomorrow.  I was also told it was fine to get the second dose, however, I'm very nervous about it.
Swelling, slight tenderness on left upper arm starting with 10 hours DTaP. No treatment.
shingles; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced shingles on an unspecified date. Therapeutic measures were taken as a result of shingles which included treatment with acyclovir. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Within the first 6 days after taking the vaccine a bump appeared on the right thumb. Chronic pain increased, right shoulder, wrist and elbow sore. Has a cough currently.
Shorty after second dose of vac. Started to have dizziness, severe joint pain, extremity pain, visual disturbances.
Severe swollen right legs; Another swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING and SWELLING in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included Peripheral swelling in October 2020 and Osteoarthritis flare up (Treatment provided was prednisone) in January 2021. Previously administered products included for an unreported indication: CORTISONE (Patient received Cortisone injection in the knee) on 01-Feb-2021. Concurrent medical conditions included Baker's cyst, Pseudogout and Chondrocalcinosis.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING and SWELLING. The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING and SWELLING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment for the event included prednisone. The patient was concerned whether the rheumatologist prescribe her prednisone for the for her swollen legs. The patient reported that the swollen right leg had nothing to do with the Moderna vaccine. The patient had this problem back in October November December of 2020.The patient have osteoarthritis, bakers cyst, pseudogout, chondrocalcinosis. The patient reported that her leg swells up and gets inflamed. The patient was on prednisone at the time of report because of another swelling.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Live follow up received on 18-May-2021: Added relevant medical history. On an unknown date, patient took 2nd dose of vaccine.
Did not report to primary care. Face is red and burns, dries out, flaky skin, itches the whole time and repeats several times a month.
Irregular period (twice in one month) Diagnosed with shingles two days ago. Never had shingles before.
Acute Pancreatitis, unknown cause.  Hospitalized 5 days.  Lipase enzyme levels beyond recordable amount.  No food, no water taken orally for 5 days.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
One day after receiving the 2nd dose of the covid vaccine I developed chest tightness/pressure/pain that lasted for 3 days. The pain would come and go. No treatment was received.
patient's arm was red and painful; patient's arm was red and painful; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was red and painful. The outcome of the events was unknown.
Patient  received the Pfizer shot at a vaccination clinic set up at his workplace.  He was shockingly gray and visibly weakened  for two and a half days.  Patient gradually regained his strength. No other reaction was observed or mentioned.
This spontaneous case reported by a patient (subsequently medically confirmed), describes the occurrence of pyrexia (fever) and chills in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. No medical history reported. On Feb 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, patient experienced pyrexia (fever) and chills. Patient treated with Benadryl (diphenhydramine hydrochloride) ongoing since an unknown date; at unknown dosage form; every day. At the time of the report, pyrexia (fever) and chills: not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: not applicable. No concomitant medications reported. This case linked to MOD-2021-023270 (patient link). Reporter did not allow further contact.
No additional AE reported; a dose of PNEUMOVAX 23 was administered after the labeled expiration date.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 13-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, at a dose of 0.5 milliliter, product quantity: 1, lot #U021995, expiration date: 13-JAN-2023 (route of administration and anatomical location were not provided), administered for prophylaxis (expired product administered).  No additional adverse event was reported.
Patient said he got a headache after receiving the vaccine. He eventually sought medical care and was diagnosed with a brain bleed(patient's words)
Patient reported a miscarriage with an onset of 12/16/09. The patient was 9 weeks pregnant when the miscarriage occurred. Reporter is unable to contact patient.
Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; Slight, dull headache; son sprayed her back with a fragranced alcohol and and it started burning; she thought it was a mosquito bite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), intramuscularly on 06Jan2021 at about 13:00 at single dose in Left arm for COVID-19. There were no medical history and no concomitant medications. She was not allergic to anything. The patient previously took shingles vaccine  for immunization before. The patient reported that in the middle of the week (in Jan2021) she started feeling itchy. She said that she did not take anything and never took the flu shot. She was itching so bad last night (on 17Jan2021) she was going nuts. Her doctor told her get BENADRYL. She looked at her shoulder and it was red and it looked like a hive. She said that 5 minutes later and it went away without her taking her BENADRYL. She took the BENADRYL  dose that she picked up from  and that put her out. She stated that she took 10ml. She was a little itchy. She stated that if you look at the area on her shoulder, it was like pinpoint little dots now and you can barely see it. She said that this happened in the same shoulder where she received the vaccine. She said that she w supposed to get the next one next Wednesday. The patient asked if this was a side effect or just a coincidence. She stated that her symptoms started about a week after the shot sometime, but she did not know the exact day. It was around 13Jan2021 or 14Jan2021. It happened in a matter of seconds and she thought she was seeing things, then it went away. It was red and raised and was gone within 5 minutes at the most. It was weird. She said that she thought it was a mosquito bite. The patient stated that her back was itching like crazy. She stated that she put alcohol on it and it went away. Her son sprayed her back with a fragranced alcohol and it started burning. She also had a slight dull headache in Jan2021 and she had never had that in her life. The outcome of events her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine was recovered in Jan2021. The outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.