chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her 1-year-old immunizations today including the MMR for the first time. Paitent went to urgent care on 6/15/05, the day she received her immunizations. "Patient has been fussy all day but has been eating and drinking normally. She has had no fever but her mom and grandma note she seems to have body swelling. Her face isn't effected and she has had no wheezing. No toxic symptoms. She takes Tylenol. NKMA." MD spoke with another MD: "I spoke about this case with MD as I had never seen a reaction such as this before. Mom assures me this child isn't usually "this puffy" just by her normal exam and normal O2 SATs and afebrile nature, the mom was quite concerned. I spoke with MD who reassured me that such an immunization reaction is not usual but is also not terribly concerning. He advised Benadryl 1 tsp q6h. Follow up with PCP in the a.m. Precautions are given to mom."
Pain and swelling at vaccination site. Benadryl 12/5 po 1/2 q tid x 2-3, Tylenol for pain/fever.
On day of vaccine, I was nauseous, body aches all except arm until few days later, muscle pain, hard time walking, headache. As of today 05/24/2021, I declined, I have had a multitude of symptoms, sore throat, cold symptoms, covid like symptoms
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pains) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On an unknown date, the patient experienced ARTHRALGIA (Joint pains). At the time of the report, ARTHRALGIA (Joint pains) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact.
Employee reports prolonged left deltoid muscle pain since receiving the flu vaccination on 10/29/18. She is having difficulty with angular movements (circumduction) of her LUE due to muscle pain. Employee denies any radiating paresthesias down the LUE but does have descending aching pain down through the elbow and forearm. No other symptoms reported. Employee has taken both Ibuprofen and TYLENOL with little effect. PCP evaluated employee's left upper extremity on 11/08/18, employee reports provider feels it is residual nerve irritation s/p vaccination and will take time to go away. Provider advised employee to continue use of ice to the injection site as well as Ibuprofen for pain management. She continues to work full duty since evaluation.
I had a sore arm and just didn't feel good for about six hours after receiving the vaccine. I tested positive for COVID-19 on 02/07/2023. I had a video appointment with my doctor on 02/08/2023 and got a prescription for PAXLOVID. I felt better after taking the medication for five days, but I tested positive for COVID-19 again on 02/16/2023. I felt worse with the rebound than the original and I took over the counter medicine to help with my symptoms. I finally tested negative for COVID-19 on 02/19/2023. Also, on 02/11/2023 I went into AFIB, but I took my medication and by 02/12/2023 I was back into normal rhythm. As of today, I do not, I feel better with no lingering symptoms.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Patient was taking concomitant medications, which were not specified by the reporter.
On 10/21/09 8am noted bumpy facial rash extending down neck - no fever, redness or itching. No soreness. On 10/22/09 am noted rash had migrated to arms, upper chest. No creams or ointments applied. 10/23/09 no spread of rash.
This spontaneous report as received from a medical assistant refers to 113 patients of demographics. Since an unknown date in August 2012, the patients were vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). It was unknown as to how many patients received just GARDASIL and how many received just PEDVAXHIB or how many patients had received both. Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit0 for a total of 135 hours. No adverse effects reported. Additional information has been requested.
Information has been received from a registered nurse concerning a male child of unknown age who was vaccinated with one dose of VARIVAX (Merck). The nurse reported that the patient acquired shingles within a year or two after received the vaccine. The nurse stated that she was trying to figure out whether the child needed two doses of vaccine. She wanted to know if the child needed a second dose of vaccine or whether the child is adequately protected against varicella. Additional information has been requested.
12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away
Initial pruritus, redness, 5 dime sized welts around the injection site; Arm pain, feels swollen.
Vaccine administered after 30 day use by date and manufacturer date of expiry; No adverse event; Vaccine with lot 015B22A was given to patient after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date), PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date), PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date) and PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medications details were not reported by the reporter. They had the date written down as March and they found out it expired in February. Caller wanted to check and make sure there was no extension to the expiration date. Vial was initially stored in the refrigerator on 09-Feb-2023.  Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
100.5 fever lasting most of the day Friday. It was fairly minor and I felt fine on the day of the shot (Thursday) and the day after the fever (Saturday).
After I received  the vaccine I felt normal, sat for 15 minutes, and drove home. Once I got home I sat down and started to get very anxious and my chest felt heavy and my tongue and throat started to swell. I say and tried to relax and was going to call 911 if it got worse. They swelling maintained so I took one benadryl, followed by another one 30 minutes later. When I woke up the swelling was still there but had gotten better. I took another benadryl that night. The swelling continued to go down over the next couple of days. After about 5 days I felt back to normal.
Patient had chest pain 2 days after having the COVID vaccine, was taken to ER and found to have elevated cardiac enzymes, was monitored and remained stable in Cardiac ICU, discharged home to FU with Cardiologist on 1/13/22.Myocarditis thought to be result of COVID vaccine.- Doctor. On 1/13/22 patient had the cardiologist consult in which both EKG and Echo-cardiogram were performed. Both with normal results.  According to the cardiologist his case was very mild and the diagnoses was made based on the chest pain that had resolved by the time he was admitted and troponin leak that was already down-trending by the time he came to the Cardiologist. Patient is to follow up with Cardiologist in 3 months to repeat troponin leak and NT-Pro BNP levels to confirm downtrend. No limitation on activities per Cardiologist.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: unknown) at the age of 23 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, vaccine location=Left arm), administration date: 30Jul2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset 01Sep2021, outcome "recovered with sequelae" (2021), described as "Frequent PVCs needing surgical intervention". The event "frequent PVCS needing surgical intervention". Was evaluated at the physician office visit. Therapeutic measures were taken as a result of ventricular extra systoles. Clinical course: The patient was not pregnant during the vaccination. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient received treatment Cardiac ablation for the adverse events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
When at home unexpectedly developed severe coldness in right hand, especially fingers, followed by numbness.  Since after few minutes and with rubbing it was not  going away,  proceeded with warming up hand under warm water and continued to rub it.  Symptoms resolved 15-20 minutes later
Patient and mother report - after HPV #1 patient skip one period.  After HPV #2 skipped 2 periods and now menstrual cycle irregular.
Pt had rash & itching on both arms within 1 hr. of getting shots.
pt recv vax  21AUG97 & devel about 6 to 8 bloody noses all w/in 24-36hr of vax;
This spontaneous report as received from a 67 year old female patient with allergy to cortizone (manufacturer unknown) and allergy to PREDNISONE refers to herself. No other pertinent medical history was provided. In approximately 2010 (reported as "about 4 years ago"; also reported as "over three years ago") the patient was vaccinated in pharmacy with a dose of ZOSTAVAX injection in the left arm (dose, route, lot#, expiry date unspecified). Concomitant therapies included benzethonium chloride, diphenhydramine hydrochloride, CALAGEL lotion. On 01-APR-2014 (also reported as "3 weeks ago"), the patient developed shingles: she had severe pain in her back, and about four days later she broke out into the rash. She went to the doctor and the doctor diagnosed her with shingles and she received the treatment (also reported as she did not seek the medical attention). The outcome of shingles was reported as recovered on 13-MAY-2014. The relatedness between event and ZOSTAVAX was not reported. This is one of several reports for the same patient (linked report # 1406USA013901 & # 1406USA013902). Additional information has been requested.
reports red rash covering trunk & extremities 2 dasy p/vax; seen by MD who dx pt react to flu shot;
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. From 14-APR-2016 until 02-DEC-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K018986, expiration date: 03-APR-2016; and lot # M001578, expiration date: 21-NOV-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine doses were exposed a temperature of 1 °C for 68 cycles for a time frame of 12 hours each time, data logger was involved . There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007899: US-009507513-1701USA007900.
Within 30 minutes I felt itchy at the injection site. That evening I began feeling pain in my left wrist; I believe it was joint pain. The next day I felt moderate pain, swelling and firmness at the injection site. I was also lethargic and mentally depressed; however, the pain in my left wrist ceased. The third day I had no pain in my wrist or arm, but the muscle around the injection site felt firm and swollen. This is the 7th day and I still have firmness/ swelling at the injection site and experience itchiness.
PER MOM:  REDNESS THE SIZE OF A SMALL ORANGE,TENDER, HOT AT INJECTION SITE
Subsequently post vax, the pt had her first episode of arthritic symptoms. She had a tick bite about six weeks ago and had erythema around the bite. She then had the second episode of arthritic symptoms since taking Lymerix and felt arthritic pain in back and thumbs. Additionally, she was feverish and exhausted. She felt worse than with previous episodes. The pt did not have any lab test to verify dx and did not yet seek treatment.
The patient passed out after leaning over to tie her shoelace; This spontaneous report was received from a physician via company representative, referring to a 11-year-old female patient. The patient's medical history, concurrent condition, drug allergies/reactions and concomitant medications were unknown. On 13-AUG-2019, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, anatomical location, lot# and expiry date was unknown) via intramuscular route for vaccination. On the same day the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (strengths, doses, schedules, anatomical locations, route of administrations, lot#s and expiry dates not reported) for prophylaxis. On the same day (13-AUG-2019), the patient passed out after leaning over to tie her shoelace (loss of consciousness). The patient sought medical attention. The patient did not receive any treatment or undergo any lab diagnostics/studies for the event. The physician observed the patient for about an hour and after the patient recovered completely she was sent home on the same day. There was no associated product quality complaint. Cancer and overdose were not involved. The reporter did not provide the causality assessment between the suspect therapies and the reported events.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Patient had delayed allergic reaction, with itching of both arms from hands to elbows. Given vaccine at 10:50am, returned at 2:45pm. Gave 25mg of diphenhydramine at 2:47pm and another 25mg at 3:07pm. Patient improved and was released at 3:25pm. No itching/swelling of mouth or throat involved. No reaction at vaccination site.
Case number PHEH2013US022764 is an initial spontaneous report from the consumer received on 28 Oct 2013. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 17 Oct 2013. Three days after vaccination she developed a severe form of hives behind her ears, both hands and scalp. The patient was unsure whether the events related to FLUVIRIN vaccine or not. She received methylprednisolone, but it did not do anything with the events. She visited the urgent care center on 27 Oct 2013 and received 8 mg shot of dexamethasone. The patient felt better. Later that night hives reappeared and the severity was unchanged. It was reported that the patient could not even make a fist. The seriousness and causality were not reported.
Fever 40 C; chills, shaking, cold, overall no good feeling. Taken 2 Tylenol pills by 10 PM felt much better. 10/06/2014 8:00 AM symptoms gone however falls very week.
Patient had a delayed red, circular rash on arm at injection site. Received his vaccine almost 2 weeks ago. It is itchy as well.
Aseptic meningitis 12 d after smallpox & anthrax vaccine.
Site: Pain at Injection Site-Medium, Additional Details: PATIENT THINKS VACCINE WAS GIVEN TOO HIGH IN THE ARM
Pt called on 1/31/22 at 10:30am about chest pressure,  she stated that it feels like someone in squeezing her heart.  She said that it started the day after her vaccination.  No rash or other symptoms reported.  I advised her to go to the hospital, that it might be pericarditis.
severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered.  No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 63 years old female patient. The patient was vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (reported lot # 0468AA, is an invalid lot number for ZOSTAVAX; exp date 04-APR-2012) on 17-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient had a local injection site reaction to ZOSTAVAX. The patient developed itchy redness in the upper left arm. The registered nurse stated that the patient called in to report this the day after the vaccination on 18-SEP-2012. The events persisted for 7 days (until approximately 24-SEP-2012). No treatment was given for the events and no lab diagnostic tests were performed. The outcome of local injection site reaction and itchy redness in the upper left arm was reported as recovered. Additional information has been requested.
Approximately the end of August pt had severe Herpes Simplex outbreak on mouth/face/nose was given Zostavax on 6/27/2007. Pt given Valtrex reported to pharmacy on 9/10/2007 pt had been in sun on a long walk
Five severe and sudden Bloody Noses: #1-8/21/2021 7:30 am,  #2-8/22/2021  6 am, #3-8/24/2021 9pm, #4-8/25/2021 1:30 pm, #5-8/26/2021 1:10 pm No history of bloody noses. These came on suddenly, lasted for 15-20 minutes
Pt developed a fever, followed by extreme pain in her knee joint. X-rays were normal but blood tests determined a high sedimentation rate. She was hospitalized 11/12/03 and surgery to aspirate the infection (Staph infection of bone in leg) IV medication of antibiotic (Cefazolin) every 8 hrs for 6 weeks.
Little reaction at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Little reaction at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Thyroid condition for about 40 years ) and Addison's disease (Addison's disease for about 20 years). Concomitant products included PREDNISONE, FLUDROCORTISONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Feb-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 VACCINATION SITE REACTION (Little reaction at the injection site). At the time of the report, VACCINATION SITE REACTION (Little reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-301960 (Patient Link).
Female client indicated that  vaccine would be her 1st dose. Requested Moderna.  When clinic reviewed Client had received 3 additional doses of vaccine. Jassen on 05/21/2021, Pfizer -2 doses on 06/28/2021 and 7/16/2021. Client denied have any other vaccines when presented at the clinic. When approached regarding additional vaccines she indicated that "she wanted to be safe". Client was advised to not receive any additional vaccines. Client had changed spelling of her name on consent form.
At 2230 I experienced severe chills, headache of 7/10 on right temporal lobe, nausea, and a fever that started at 102.3 that elevated to 103.8  At 2415 I went to VA. I had uncontrollable vomiting, dehydration, and fever. I was given 2L of iv saline and iv Zofran and oral ibuprofen. After 4 hours my vitals stabilized. Initial vitals of pulse in 130s, 18 respiration?s, and systolic bp of 130. My normal systolic bp is in the low 110s. Can contact riverside for labs and vitals and other information.