chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throbbing a little bit; a little sore on arm by the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing a little bit) and VACCINATION SITE PAIN (a little sore on arm by the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included Indigestion. Concomitant products included FAMOTIDINE for Acid indigestion.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (throbbing a little bit) and VACCINATION SITE PAIN (a little sore on arm by the injection site). At the time of the report, PAIN (throbbing a little bit) and VACCINATION SITE PAIN (a little sore on arm by the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment details included ibuprofen and icepack.
Hot, redness and itchy at injection site. (Unknown vaccine information due to shots not administered by this facility; given at local veteran's hall.)
Patients daughter called and said the patient was in the hospital with pneumonia that the doctor said was caused by the Covid booster. Daughter also mentioned that the patient had blood clots
Oval area under skin noted (approx 3 inches by 2 inches)-very hard and hot with a rash-like appearance. Took 3 days to come on. Self treated with hydrocortisone cream and OTC antihistamine.
Severe arm pain for 3 days and then next day after getting it I woke up with cold like symptoms
sore arm; sore throat; low grade temperature; felt like she was having the flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat), PYREXIA (low grade temperature) and INFLUENZA LIKE ILLNESS (felt like she was having the flu) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat), PYREXIA (low grade temperature) and INFLUENZA LIKE ILLNESS (felt like she was having the flu). On 09-Mar-2021, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat), PYREXIA (low grade temperature) and INFLUENZA LIKE ILLNESS (felt like she was having the flu) had resolved.            Action taken with the mRNA-1273 in response to the events was considered as not applicable.
On 07-29-2021; I had low grade fever but it continued for ten days and at the beginning I felt very tired. I would say ice cream tasted sweeter than normal. I went to see a different doctor on 09-14-2021 and he said it was probably virous. On 08-05-2021; I took a covid test and it was negative. I was also in for a routine physical exam, blood test indicated that my fetal hemoglobin.  I went to see a new doctor on 08-26-2021 because my doctor left.  I experienced tiredness, no appetite, low energy.  I did have a flare up of gout this happened on 08-14-2021 and I was given medication for the gout.  My symptoms eventually went away, I have recovered from the virus.  I do not know if the virus was caused by the vaccine.
A few days after receiving the first dose, I noticed a rash that was red and splotchy. It didn't cover my armpit, it kind of circled my armpit. As it progressed it became uncomfortable. Before I got the medication, deodorant irritated it. I went to see PA, and she prescribed me fluconazole 200mg (2 tablets) and nystatin and triamcinolone acetonide ointment. The ointment cleared up the rash, but it came back again after I received my second dose. My wife had a similar reaction, but hers was under one arm and around her stomach. She received a cream for her rash as well. As of today, the rash is not completely gone, but it has gotten smaller.
fever 103 w/in 24hr lasting 3 days; t104, fuss/irritable, won't walk, gen malaise, arthralgia;rash 5 dasy p/inj;unable to move the leg in which shot given lt w/resistance in lt hip;improved by day 3 & 4;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2014, a physician at an office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2014, the patient was treated by the same physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
This spontaneous medically confirmed report (initial receipt 26-Nov-2014) concerns a 57 year-old male patient. On 24-Nov-2014, the patient received intramuscular AFLURIA (batch number T51808) after it reached 32.5F for 6-7 hours on 22-Nov-2014. The vaccine did not freeze during the excursion. The pharmacist was not aware of any harm to the patient. There were no adverse events reported. The outcome was not reported. Reporter comments: The reporter assessed the events as non-serious. It was reported that it was ok for vaccine to be at 32 degrees F for up to 24 hours based on the bioCSL stability studies. Per company, it was okay for pharmacy to continue using it.
Extreme headache, weakness, tired, bones, joint and muscular pain, injection site swelling. Treatment: Motrin, ice pack.  Over 24 hours after injection still feel the same.
PATIENT CALLED AND REPORTED THAT SHE HAS HAD ARM PAIN SURROUNDING THE INJECTION SITE SINCE THE INJECTION.  SHE SAID IT GOES IN AND OUT AND SHE DOESN'T NOTICE IT ALL OF THE TIME.  IT'S PRIMARILY NEAR THE INJECTION SITE AND NOT AS MUCH HIGH INTO THE SHOULDER AREA.  SHE SAID AFTER DOING ACTIVITIES, SHE NOTICES IT MORE AND IT FEELS ALMOST LIKE THE TENDON GOING FROM HER ARM AND CONNECTING TO HER CHEST IS AFFECTED.
Severe pain in left arm and shoulder approx four hours after the vaccine, with lingering pain as of two weeks later. Primary care MD ordered physical therapy and referred to orthopedic specialist.
Redness, swelling, warm to the touch approx 2.25 in in diameter. As of 06/14/2011 site was still swollen with a noticiable lump and bruising above and bellow the site.
like a blood clot; All around eye is real swollen and puffy and in corner/don't know if it looks like a bruise or it's like a blood clot or something; like a bruise; a red, dark red spot/not on the eye but up on the eyelid it looks like; all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like; This is a spontaneous report from a contactable consumer. An 85-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number like EL1283), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included slightly elevated blood pressure from an unknown date. Concomitant medication included clopidogrel besylate (CLOPIDOGREL) for blood pressure; hydrochlorothiazide, losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) as blood thinner and several of drugs. The patient had the Covid vaccine on the 12Jan2021 and yesterday (14Jan2021) as they noticed his eye, all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like, the reporter didn't know if it looks like a bruise or it's like a blood clot or something and it's still there, it hasn't gone away and they didn't know if this was from the vaccine, the reporter didn't know if it's bruise or if it's a clot the reporter didn't know, it's a red, dark red spot. after we had the vaccine they gave us a paper that had some information on it and it said on there they should advise them if on blood thinners, they did not told beforehand and the patient was on blood thinners. No treatment was received. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
ADMINISTERED AN EXPIRED VACCINE THAT WAS OUTSIDE IT'S 6 HOUR WINDOW OF BEING KEPT AT 36 TO 46 DEGREES; WRONG DOSE WAS ADMINISTERED 0.3 ML INSTEAD OF 0.5 ML; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) .3 ml, administered on 09-JUN-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced administered an expired vaccine that was outside it's 6 hour window of being kept at 36 to 46 degrees. On 09-JUN-2021, the subject experienced wrong dose was administered 0.3 ml instead of 0.5 ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered an expired vaccine that was outside it's 6 hour window of being kept at 36 to 46 degrees and wrong dose was administered 0.3 ml instead of 0.5 ml was not reported. This report was non-serious.
patient received vaccine on 4/7 and developed N/V on 4/9. Presented to hospital on 4/15 with portal vein thrombosis.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported).  There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 had two temperature excursions; one of 24 hours and other one of 32 hours. The lowest recorded temperature of 34 F (1.111111111 Celsius) and the highest recorded temperature of 48 F (8.888888889 Celsius). The vaccine status was reported as "in excursion". The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
The patient became faint a few minutes after his vaccine. I had him lie down on the floor and elevate his feet. When he started doing better he drank some water and ate a snack.
patient reported to hospital with headache for 2 days, and was told she had  a blood clot in her liver last week.  she reports thatshe got the Johnson and Johnson vaccine last month.  exact date not known.
Hardness in the neck area; swelling in the shoulder; General soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Hardness in the neck area), SWELLING (swelling in the shoulder) and VACCINATION SITE PAIN (General soreness at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NECK MASS (Hardness in the neck area), SWELLING (swelling in the shoulder) and VACCINATION SITE PAIN (General soreness at the injection site). At the time of the report, NECK MASS (Hardness in the neck area), SWELLING (swelling in the shoulder) and VACCINATION SITE PAIN (General soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided
sore arm; tiredness; not felling well for 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (not felling well for 24 hours) and FATIGUE (tiredness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to bee sting, Allergy to antibiotic, Allergic reaction and Osteopenia. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not felling well for 24 hours) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown and MALAISE (not felling well for 24 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was a retired registered nurse.  The patient never had COVID positive test or diagnosis. The patient did not have any past medical history and both acute and chronic illnesses at the time of vaccination.   This case was linked to MOD-2022-527083, MOD-2022-527372 (Patient Link).
This report was received from manufacturer for Engerix B and was assigned manufacturer report number A0375941A. It concerns an 18 year old male pt with allergies to chocolate and nuts and celiac sprue who on 7/22/02 was vaccinated with MMR II (637985/0154L) SC into the right deltoid. The pt experienced no adverse events following previous immunizations. No concurrent medications were noted. Concomitant therapy included his first injection of hep B vaccine recombinant (Engerix 5272A2) IM into the right deltoid and diphtheria toxoid/tetanus toxoid IM. Later that evening, the pt developed diarrhea. The pt's mother called the doctor's office and reported that he was also dehydrated and that she was giving him fluids. It was noted that additional info indicated that on 7/29/02 the pt was evaluated by an unspecified specialist and was treated with steroids. As of 8/6/02, the mother reported that the pt was "doing much better." The reporting nurse stated that there were no complications. The nurse reported that the diarrhea and dehydration were possibly related to hep B vaccine recombinant (Engerix B) and celiac disease. Therefore the hep B vaccine recombinant (Engerix B) is secondary suspect. The hep B vaccine recombinant (Engerix B) immunization series was discontinued. As of 12/17/02, the events had resolved. It was noted that the reporting nurse indicated the pt's experience to be important medical events (OMIC). This was originally reported by a registered nurse. Additional info has been requested.  A 15-day follow up report received 03/24/2003 added no new info.
Fever, 3-4 days; Tx: Infant TYLENOL and Ibuprofen. Ranging from 99 degrees F to 103 degrees F over 3-4 days tx regimen rec. by ED Dr. on call; offered relief when followed consistently.
A report was received from a health care professional on 16Oct02, concerning a 22 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662.
Administered vaccine to seated client. Five minutes later, he reports "feeling a little dizzy", given juice box to drink. He remained seated, responsive, then two minutes later he grunted as he tilted his head back, fainted and stiffened entire body, shaking slightly. He urinated on self. Nurse held onto his arm while Amonia inhalant crushed under nose. Client then responsive but still dizzy and complaining of stiff neck, arms and legs. Lying down x 30 min, then sitting up, sipping water. Released home, driven by father at 2:30 5/31/13 - left 2 phone messages checking on client.
Generalized blotchy maculopapular rash within a few minutes of injection, no other systemic reaction or findings.
Felt similar to getting a Novacaine injection, started to hurt very badly about 4 hours later, but it got worse. Got up to go to the bathroom at 5 am and fell, said could not manage the pain, passed out. Ambulance was called- denied ER visit. EMS checked her vital signs but patient was bruised and drenched in sweat, nothing found on exam. Slept all day the next day.
Approx 6 h after vaccines, patient had 20 minute episode of grunting, gray color and lethargy w/o LOC or seizure like activity. On eval in office after event, found to have T 100.2 R, resolved with TYLENOL but per parent still not back to normal self. Admitted for O/N obs for ?ALTE. Progressively more alert, active, only w/o recurrence of event. Discharged 24 hours after event. Seen am 8/2 in office still back to normal baby self.
lower back pain; nausea; vomiting; appetite loss; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 12 years old female patient who experienced lower back pain (back pain), nausea (nausea), vomiting (vomiting) and appetite loss (decreased appetite), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a 0.5mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious vomiting (vomiting), lower back pain (back pain), nausea (nausea) and appetite loss (decreased appetite) (Unknown latency) 48 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient reported that she was fine for 3 days and the it happened again.  Detail of laboratory data were not reported.  Final diagnosis was decreased appetite, nausea, back pain and vomiting.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Had HPV shot in Rt deltoid 10-15-10 and about 20 min later she began having pain in Rt. thumb. About 30 min. later she began having joint pain in Rt wrist. She took Ibuprofen & went to bed but it hurt through the night. The wrist was swollen the next am. It was swollen 2 days. Still has pain 3 days later. Has mild rash area of varicella shot. Had severe headache nt. of vaccine. Also had fever. 10-25-10 Pt. in school with no s/s re mother.
This spontaneous report as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On 01-MAY-2015, 05-MAY-2015, 11-MAY-2015, 19-MAY-2015, 22-MAY-2015, 26-MAY-2015, 03-JUN-2015, 08-JUN-2015, 09-JUN-2015, 12-JUN-2015, 16-JUN-2015, 17-JUN-2015, 22-JUN-2015, 25-JUN-2015 and 01-JUL-2015, the patients were vaccinated with improperly stored doses of GARDASIL (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients' concomitant medication was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Pediatric patient received an adult dose; 20 month old patient received an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 20-month-old male patient who received HAV (Havrix adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   Previously administered products included Havrix (1st dose received on 17th October 2022).   On 21-APR-2023, the patient received Havrix adult (left thigh). On 21-APR-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Pediatric patient received an adult dose) and adult product administered to child (Verbatim: 20 month old patient received an adult dose). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter consented to follow up. A pediatric patient received an adult dose of Havrix which led to overdose and adult product administered.
No symptoms noted per patient: Clinic recognized count of MMR and MMRV was off. Reviewed chart and determined that even through MMR was documented to lot # was for MMRV.
Patient had rec'd one dose of Monovalent Moderna. Patient was then given Pfizer Bivalent dose.  Did not complete primary series.
Client reported 4" X 11/2" area of induration that started near the injection site and spread distal the site.  Reported area was red.  Denied itching.  Took Hydrochloride 10mg tables.  Area was observed by Medical Director and he recommended Benadryl per client.
face itches; face burns; face tingles; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number and Expiration Date not reported), via an unspecified route of administration on an unspecified date, as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient thought he was fine and then when he was driving, he noticed the right side, the same side as the shot, of his face started to tingle and felt like the medication given for tooth extracted. Adds it itches and burns, too. The patient was wondering if this was something that will wear off. The outcome of all the events was not reported.  Information about lot/batch number requested.  Follow-up (16Apr2021): 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.
pt recv vax; eyes were swollen & lt side swollen; T 102.8; to MD; lt leg was extremely sore to touch;