chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness, warm to touch at injection site (left arm) Patient has taken Tylenol and applied ice packs to relieve symptoms with some effect 4/13-Spoke with pt today and she said that she is feeling much better only having a slight headache that goes away with Tylenol. She also complains that her arm is itchy now. She has a doctor's appt this Thurs and would like if we call back on Friday. 4/16- PharmD Rcvd follow up called on 4/16/2021 at 2:06pm: Pt reports that she is feeling much better today, and all the symptoms she reported having on the follow up call on 4/13/2021 has resolved. Pt reports feeling fatigue, lightheadedness, and a headache that comes and goes. Pt stated that she took Tylenol on 4/15/2021 for the headache.   ***NOTE*** Recommend pt to monitor her symptoms of lightheadedness and headache. Recommend to continue to stay hydrated and consume adequate meal, and take Tylenol PRN. Also rec pt to get up from sitting and bending position slowly, and to see if the lightheadedness occurs during resting positions. If her symptoms has not gotten better over the weekend, rec for pt to contact MD.
Her arm of course was aching, Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient reported   A 78-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in upper left arm on 01Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced her arm was aching. The patient reported that she received the first dose of the Pfizer vaccine on 01Feb2021, but patient was questioning how many don't have any issues and no symptoms. Reporter stated, she thinks it was normal. It's not going to be effective, she was expecting something, That's kind a good. The patient had a sore arm on the first day, and it subsided, it went away. it's a tiny sore. The patient was a little concerned because she did not have a reaction, that tend to worry. she was not experienced any symptoms except for her arm of course was aching, it was gone away now, is it still effective if there are no symptoms. The patient clarified her arm aching is very slight now. The outcome of the event was resolving.  Information about Lot and Batch has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
The patient experienced dizziness, change in GCS, tachycardia and hypotension. IV access established and EMS activated. Upon arrival of EMS the patients condition improved. The patient refused transport the hospital by EMS.  The patient stated he had an appointment with his PCP the following day.
had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Information has been received from a consumer, concerning her/his cousin, a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for routine vaccination (prophylaxis). It was stated that the patien treacted really badly to M-M-R II. At the time of the report, the outcome of the adverse events was not reported. The consumer considered the reacting really badly to be related to M-M-R II. This is one of three reports received from the same reporter. Additional information is not expected since there reporter did not consent for further follow up. Sender's Comments: US-009507513-1706USA003434: US-009507513-1706USA004399.
This is a spontaneous report from a Study Program received from a contactable nurse practitioner. A 9 months old male patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on unspecified date, at single dose. Relevant medical history and concomitant medications were unknown. On unspecified date the patient had cast on legs. Outcome of the reported event was unknown at the time of report. The nurse practitioner mentioned that the event was due to the PREVNAR 13 injection. Follow-up (29AUG2014): Follow-up attempts completed. No further information expected.
Headache, weakness, decreased concentration, writing illegible, chills, stiffness lower extremities, muscle aching, fever 101 (although this was taken after client took hot bath for chills), eyes aching, nausea.
HIGH FEVER WITH COVID VACCINATION; CHILLS WITH COVID VACCINATION; ACHINESS WITH COVID VACCINATION; OUTBREAKS LOCATED ON SHINS AND FOREARM; This spontaneous case was reported by a consumer and describes the occurrence of RASH (OUTBREAKS LOCATED ON SHINS AND FOREARM), PYREXIA (HIGH FEVER WITH COVID VACCINATION), CHILLS (CHILLS WITH COVID VACCINATION) and VACCINATION SITE PAIN (ACHINESS WITH COVID VACCINATION) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In November 2021, the patient experienced RASH (OUTBREAKS LOCATED ON SHINS AND FOREARM). On an unknown date, the patient experienced PYREXIA (HIGH FEVER WITH COVID VACCINATION), CHILLS (CHILLS WITH COVID VACCINATION) and VACCINATION SITE PAIN (ACHINESS WITH COVID VACCINATION). At the time of the report, RASH (OUTBREAKS LOCATED ON SHINS AND FOREARM) was resolving and PYREXIA (HIGH FEVER WITH COVID VACCINATION), CHILLS (CHILLS WITH COVID VACCINATION) and VACCINATION SITE PAIN (ACHINESS WITH COVID VACCINATION) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of OUTBREAKS LOCATED ON SHINS AND FOREARM with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of HIGH FEVER WITH COVID VACCINATION, CHILLS WITH COVID VACCINATION and ACHINESS WITH COVID VACCINATION with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
swollen arm; body aches; a temp of 103; nausea; This spontaneous report was received from an 80-year-old female patient referring to herself. Her drug reactions/allergies included aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), sulfa, morphine, codeine, vancomycin and penicillin. Her concomitant therapies included blood thinner (unspecified), unspecified medication for blood pressure, zolpidem tartrate (AMBIEN) and diuretic (unspecified). No information regarding her pertinent medical history was provided.  On 30-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), single dose, intramuscularly (lot # T020639, expiration date not reported but upon internal validation established as 13-MAR-2022), for prophylaxis. On the same day, she was vaccinated with influenza virus vaccine (unspecified).  On 30-SEP-2020, the patient experienced a temperature of 103 (unit not provided) which at the reporting time (reported as now), was coming down due to her taking medication. On 30-SEP-2020, she started experiencing a swollen arm, body aches, and nausea. She reached out to her physician who was at the time out of town and she was advised to go to an urgent care but she was not going to. At the time of the report, she stated she had not recovered but was doing a little better. The outcome of body temperature increased was considered to be recovering. The outcome of the rest of the event was considered to be not recovered.  The reporter considered the events to be possibly related (reported as possible side effect) to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the events and influenza virus vaccine (unspecified) was not provided.
Fever, fatigue, blood in nose, nausea, head ache, body pains especially in arm all lasting 2 days (30 hours) took Tylenol otc to relieve
This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-NOV-2016, an expired dose of ZOSTAVAX (lot number: L028285; expiry date: 28-OCT-2016) was administered to the patient. No adverse effects reported. Additional information has been requested.
The patient develop acute onset tinnitus in the immediate period of the second dose of the Moderna Covid vaccine. He had no prior ENT issues. He was having no ENT issues at the preceding the vaccine. The tinnitus has not resolved now going on 5 months since the vaccine.
pt recv vax;fever of 103 approx 48 hrs p/ vax;
Headache, chills, fever from 9:00am - 2:00pm day after vaccine.  Extreme migraine from 2:00pm - 4:00pm.  Symptoms stopped very rapidly and did not come back.
Fever, diarrhea, fussy, excessive crying. Given TYLENOL, like warm baths, and ice packs to neck and under arms.
CONFUSION, WEAKNESS, FEVER, SEPSIS RULED OUT, EXTREME HEARTBEAT FLUCTUATIONS UP TO 160 BEATS PER MINUTE, LIVER & KIDNEY FUNCTION DECREASED.
Patient presented to the pharmacy at 9am, day of vaccination with swelling, redness and warmth, some decreased mobility of deltoid (right) muscle due to amount of swelling. Got steroid shot 6/27/14. Doing better now.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On 12th July 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In July 2018, the patient experienced chills. The patient was treated with Aspirin With Vitamin C. On an unknown date, the outcome of the injection site pain and chills were recovering/resolving. It was unknown if the reporter considered the injection site pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that adverse reactions to a SHINGRIX that he experienced injection site soreness immediately, but later in the middle of the night around 2 PM (on 13th July 2018), the patient developed chills. The patient denied any fever. On the day of reporting, the patient took an aspirin with Vitamin C for the injection site soreness and was inquiring if this would affect the efficacy of the vaccine and the patient also inquired that how long the side effects would be last. Unable to obtain the physician's name and phone number due to call flow. As the patient asked, reviewed PI information regarding timeframe for the adverse reactions according to the PI and the clinical trials and found that advised taking an anti-inflammatory would not affect the efficacy of the vaccine. The patient was offered a copy of the PI (product information), but declined.
Client received the COVID vaccine Janssen booster (Lot# 1855191 exp. 04/11/2022) on 12/14/21 at 4:33 PM administered. While reviewing the participant forms, RN noted the vaccine was administered 33 minutes after beyond use date (time) of 4:00 PM. RN  verified with the vaccine preparer that the vial was punctured at 10:00AM and the beyond use date (time) was 4:00PM. RN  elevated the information to Vaccine Operations Leads. Vaccine Operations Leads elevated the information to the manufacturer Janssen and consulted with our medical team. The medical consult team's recommendation was not to proceed with a repeat dose. RN educated client on possible adverse reactions, signs and symptoms of Guillain-Barre syndrome, signs and symptoms of thrombosis with thrombocytopenia syndrome, and when to seek medical care. The client voiced understanding of this education.
pt recvd vax;  pt was crying & screaming all night after vax; APAP given to pt;
shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (subsequent to inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. By the time of this report, the patient had not recovered from shingles.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Child was in swing sitting and was afebrile and noted to be grey in color. Dad had to stimulate baby and it was 6.5 minutes before child was fully awake. 911 called and paramedics transported child to hospital. Follow up on 03/31/2005:  Leukocytosis, Acute Apnetic Episode
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Oct2021 at 14:00 as dose 1, single (Lot number: FF8841), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Paxlovid was taken as therapeutic measure as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154565 same patient, different drug/event;
I have decreased heat tolerance. During exercise outside after the vaccination I sweat much more and have nearly gotten heat exhaustion on 3 occasions when doing exercise that I had no problem doing immediately prion to the vaccinations,  I have had decreased exercise tolerance, both in duration and intensity.  Both of these have been sustained since and have not gone back to baseline.  My VO2 Max has decreased from 48 to 45.  The exercise load decreased 34.3%. Aerobic Capacity decreased 15.8%.  Duration of exercise tolerated decreased 10.8%.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 18-OCT-2014 the patient was vaccinated with an expired dose of M-M-R II, lot # H018947, expiry date: 18-OCT-2014/reported: 17-OCT-2014, dose/frequency: 0.5 ml (dose number, route not reported). No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Patient describes immediate pain and weakness in the left arm, flulike illness for two weeks, followed by profound fatigue, "brain fog", muscle aches and pelvic pain, now for 3 months since her second dose on 6/2/21.
From faxed correspondence on 11/1/02, it was reported that a 70 year old elderly female received Fluzone (lot # 40888AA) IM in the deltoid on 10/10/02. She felt normal the next day except soreness at injection site. But then she experienced progressive loss of motor control of her left shoulder. Reportedly she recovered.
Delayed menstrual cycle - delayed by 5 days for 2 months, and 3 days for 3rd month.
Patient started to show signs of hives 30 mins after vaccination. Her symptomps started as mild hive and persist and worsen. Advise patient to call PCP for treatment guidance and also advise to go to urgent care if her sympstoms keeps escalating.
I have severe pain and swelling in my armpit and breast area on the side of the injection along with pain, itching and severe swelling at and around the injection site. I have taken does of 800mg ibuprofen with little relief.
Seizure lasting less than 2 minutes, suspected to be febrile seizure. Had a low fever the previous evening but not at time of seizure.  Seizure resolved and she was taken by ambulance to an ER. Tested negative for all respiratory illnesses checked for and negative for UTI. No return of fever after the seizure, full return to normal.
redness on left arm; warm on left arm; Symptoms reemerged with sore right arm again; sore arm right; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on left arm), FEELING HOT (warm on left arm), SYMPTOM RECURRENCE (Symptoms reemerged with sore right arm again) and VACCINATION SITE PAIN (sore arm right) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm right). On 07-May-2021, the patient experienced SYMPTOM RECURRENCE (Symptoms reemerged with sore right arm again). On 08-May-2021, the patient experienced ERYTHEMA (redness on left arm) and FEELING HOT (warm on left arm). On 01-May-2021, VACCINATION SITE PAIN (sore arm right) had resolved. On 08-May-2021, SYMPTOM RECURRENCE (Symptoms reemerged with sore right arm again) had resolved. At the time of the report, ERYTHEMA (redness on left arm) and FEELING HOT (warm on left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-JUL-2021 contains updated contact information - email address and phone number.
Raised red rash weit on upper right thigh near injection site. Four inches in diameter 12/09/2008. grew to about 4 1/4 inches on 12/10/2008
Patient called stating she started having reaction upon minutes of receiving vaccine at pharmacy, stating when she got in her car, her throat started "itching" and that her face felt hot. When she got home, she states she had red rash on face and neck and felt rash on chest and back and felt she had some shortness of breath. Patient states she used her "rescue inhaler" (albuterol) and called primary care provider's office. This RN triaged patient, asking her to dial 911. Patient chose to seek care at Urgent Care. Patient was treated at Urgent Care with SOLU-MEDROL and kept for observation. Macular rash observed on patient on face, neck and back, per treating provider.
It started about May or June of 2021. It hasn't gone away. I have insomnia, so some nights I can't fall asleep. My doctor prescribed Trazadone. At first it 50mg tablets and now its been increased to 100 mg.
MIXED SLEEP APNEA NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE
Rash on upper chest and back. oral antihistamine and topical steroid ointment