chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 2 hours of administering the vaccine SQ in the left deltoid, had developed local redness, induration and pain with warmth.  Within 8 hours, had a subjective fever, chills malaise.  Over the next 24 hours, the redness, swelling warmth and pain spread down the arm to involve the entire deltoid region, down to the mid forearm.
1-8-15: fever 101, vomiting, increased HR, WBC-62K, decreased BP 80/60 (per ER) ICU. RA very sore after vaccines, red and hot to touch. Vaccines in question: right arm.
Information has been received from a nurse practitioner concerning a 23 year old female with no pertinent medical history and no drug allergies, who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # 662529/1317Y). There was no concomitant medication. "6 hours after vaccination" the patient experienced nausea, fever and joint pain. There were no labs or diagnostic tests performed. The patient did not seek medical attention. The patient recovered 24 hours after vaccination. Follow up information has been received from a nurse practitioner concerning a 23 year old female patient with no illness at time of vaccination, who on 14-JAN-2010 at 10:00 a.m. was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # 662529/1317Y) in the left deltoid. Approximately 6 hour after vaccination, at 4:00 p.m. on 14-JAN-2010 the patient experienced nausea, fever and joint pain. There were no labs or diagnostic tests performed. No OTC medication nor "thermomet" to continue the fever. The patient recovered on 15-JAN-2010. No further information is available.
BELL'S PALSY. PATIENT WENT TO ER ON 2/13/21 AND WAS DIAGNOSED.  FOLLOWED UP WITH PRIMARY CARE DOCTOR 2/15/2021. 2/13/21 PREDNISONE 10MG TAPER: 50MGX4DAY,  40MGX2 DAY, 30MGX2DAY, 20MGX2DAY, 10MGX2DAY 2/15/21 ACYCLOVIR 800MG  1 FIVE TIMES A DAY FOR 7 DAYS,   BACITRACIN OPTHAMIC OINT AT BEDTIME.
Vertigo; Nausea; Dizziness; Headache; Hives all over his body; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In August 2020, the patient received the 2nd dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced vertigo, nausea, dizziness, headache and hives. The patient was treated with meclozine hydrochloride (Meclizine) and prednisone. On an unknown date, the outcome of the vertigo, nausea, dizziness and hives were not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the vertigo, nausea, dizziness, headache and hives to be related to Shingrix.  Additional details were provided as follows: The patient reported that he had received both doses of the Shingrix vaccine but he was not sure of the amount of time in between the doses. He stated it had only been a month, but then said he did not remember. The patient recieved 2nd dose of Shingrix approximately 2 weeks before the date of reporting and shortly after receiving the injection, he began to have hives all over his body, intermittent dizziness while sitting and lying down, intermittent vertigo when standing, and random times of where he experienced nausea. The patient scheduled an appointment with his HCP and was given Prednisone for the hives and Meclizine for nausea. The reporter consent to follow up.
Hypotension resulting in ICU admission with vasopressors (Levophed and Dopamine) for approximately 24 hours, 3 day overall hospital course with no obvious source of infection as the cause.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored ROTATEQ (oral, dose and dose number were unspecified, lot# K011947/exp 07-JUN-2016, lot# L002048/exp 09-JUL-2016, lot# was reported as K023527/exp 22-JUN-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Horrible stiffness in my joints, especially my hands, I could barely bend my pinky fingers Constipation.  Although I have been able to move my bowels and it seems normal I have felt constipated, bloated, gas pain at times and had a constant feeling like I have to poop but can't since I got the shot.
27 patients were scheduled for the day and provider did not have a nurse or medical assistant, to help with any tasks or check-in. several patients were siblings needing different vials of Pfizer, which required different dilution amounts. Small (1ml) syringes were on the counter, and provider accidentally drew up the wrong dilution amount and diluted the vials with 0.13 mL of NS instead of 1.3 mL. the does given was still 0.2mL  Patient has a sore arm as the only side effect
Flu symptoms - headache, body aches, congestion, dizziness, fatigue started 6 days after vaccine lasted 5+ days. Treatment - OTC cad medicine, acetaminophen.
CHILLS; HEADACHE; MUSCLE ACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included Covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on APR-2021, had not recovered from fatigue, and the outcome of muscle ache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421333.
Swelling at injection site/redness whelpy rash red spots all over body eyes watery.
This spontaneous report as received from a pharmacist, via a company representative, refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose and route were not provided) 19400 PFU. Concomitant medications were not reported. Pharmacist reported that a patient noted an unspecified rash on his opposite arm at an unspecified time after receiving ZOSTAVAX. Reporter stated that the patient went to the pharmacy and showed the rash to the pharmacist on an unspecified date. The patient told the pharmacist that the rash could have been on his arm prior to receiving the ZOSTAVAX but he did not notice the rash till after receiving the ZOSTAVAX. The outcome of rash on his opposite arm was not reported. The relationship between the ZOSTAVAX and the events was not reported. Additional information has been requested.
This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. This healthcare professional reported similar events for three patients. This is the second of three reports. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient complained of significant reactions in the area of the vaccine. It was described as large, pink, hard, wheal like lesions that lasted about 10 days. The patient did not complain about the pain or itching in the area; it was more about the size of the rash. The outcome of the events was recovered on an unspecified date. Sender's Comments: Linked Report(s): US-PFIZER INC-2017340629 same reporter/drug/event, different patient; US-PFIZER INC-2017340747 same reporter/drug/event, different patient.
Information has been received from a physician concerning a 14 year old female who on 25-JAN-2008 was vaccinated with GARDASIL (lot number: 656371/0181U).  On 31-JAN-2008 the patient experienced rash all over body, including back, chest, and legs.  The patient was treated by physician with Benadryl.  No further information is available.
left lower extremety swelling, redness, pain within one week of second COVID vaccine. DVT confirmed at ED visit.
One week of headache that was not changed by tylenol or ibuprophen. Fatigue still three weeks later.
Patient is limping. Left thigh is effected. (Crying and extreme pain on administration. Limping afterwards immediately.) Limping is not getting better with time, as would be expected; instead limping is increasing. Also high fever within a few hours of administration..
Information has been received from a consumer concerning her approximately 15 month old daughter with no known allergies and no past medical history, who on 10/27/99 and 09/10/01 was vaccinated with the first and second doses of MMRII, respectively, administered SC. Within less than a month, in approximately 11/99, the patient developed diarrhea, for a few days along with projectile vomiting. This was followed by a period of wellness. However, the diarrhea and vomiting returned. It was reported that  "this went on for nine months" and the child lost "a lot " of weight. The pediatrician said it was a virus, according to the child's mother. It is eventually subsided.  On 09/10/01, the patient received the second dose of MMRII, administered SC. Within a week, on  approximately 09/17/01, the patient developed diarrhea and vomiting. It was reported that she "is ok" for a couple of weeks and then she is sick again". The patient sought unspecified medical attention. The staff at the pediatrician's office was not sure how much weight the child lost and reported that she has not been seen in that office, recently, possibly due to insurance reasons. Information received on 10/22/01 indicated that the child was vaccinated at a health department and that the child was not seen at the pediatrician's office following vaccination. Vomiting and diarrhea were "verbally" reported by the child's mother. Upon internal review, the patient's episodes of diarrhea, vomiting and virus were determined to be other important medical event.
Developed papules on chest, neck and legs. Began 6/28/10. Also has sore throat. Positive strep test.
Pt inadvertently received 4th dose of GARDASIL vaccine by mistake on 8/4/16. 12 hrs after injection felt feverish, chills, headache, weak, myalgias and fatigue. By 8/6 felt better and was back to baseline by 8/8.
Reporting a medication error - not an ADR   Patient arrived to vaccine clinic for scheduled appointment.  In the documentation system, patient does not appear to have any previous appointments.  Nurse gave vaccine, Pfizer.  After administration, patient informed nurse that his first dose was Moderna, not Pfizer.  His first vaccine was given at a retail pharmacy, which does not use the same documentation system.  Patient did provide vaccine card, but unsure at this time if this was before or after the vaccine was given.  Following up with the administering nurse for further details.   Per suggestion of staff, signs have been made for the front registration to alert clients that this is a Pfizer only location.  Will continue to look at dashboard to monitor for Moderna on the schedule, and will alert staff to be aware of retail pharmacy not being on our documentation system and the potential risks.   Pfizer lot # EN6198 Exp date 6/30/21
Returned to office on 5/4/06 w/ elevated temperature.  Marked erythema and swelling of thigh, tense tissue, very tender.
Varicella vaccine #1 given IM instead of SQ as recommended.  Was under observation at our clinic for 30  minutes following administration of vaccine without incident
White blood cell count high; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and PYREXIA (Fever). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High and diagnosed with fever. On an unknown date, White blood cell count: High.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Patient had high white blood count. She had fever after third vaccine. The reported events were related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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.
This spontaneous report was received from a nurse via company representative regarding an elderly female patient over the age of 65 years. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, route of administration and dosing details were not reported) for prophylaxis. On an unknown date the patient experienced an unspecified severe reaction to PNEUMOVAX 23 (adverse event). The outcome of adverse event was unknown. Causality assessment was not provided by the reporter. This is one of the report received from the same reporter.
Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: A 63yo  female with PMH of Allergic Rhinitis,  Low Back Pain, Hypothyroidism, Hyperlipidemia and HTN.  On February 8, 2023, RN @1303 reported the patient had a historical ADR of Moderna Covid - 19 vaccine induced anaphylaxis.  In the COVID screening note by the nurse,  it was further clarified as
PATIENT FALSIFIED FORM AND SAID SHE WAS 18.  ACCORDING TO PATIENT'S INSURANCE, SHE IS ONLY 17, WITH REAL DOB 11/9/02
Patient got a bruise under her arm that tracked up from injection site from her elbow. Did not bruise at site - stated it looked like track marks. Also had headache and was tired that evening of vaccine.
painful burning in her mouth and tongue, known as burning mouth syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING MOUTH SYNDROME (non-serious) with onset 06Feb2021, outcome "not recovered", described as "painful burning in her mouth and tongue, known as burning mouth syndrome". The events "painful burning in her mouth and tongue, known as burning mouth syndrome" required physician office visit. Therapeutic measures were taken as a result of burning mouth syndrome. Additional information: The patient is active, working, keeping up with grandkids, and very healthy. The next morning following vaccination, the patient awoke to painful burning in her mouth and tongue, known as burning mouth syndrome. The patient had seen 3 neurologists, 3 ENT, 2 dentists with no relief, also gabapentin 900mg/day does nothing, she is in pain 24/7. Lidocaine does not help; the only relief was chewing with Trident sugarless gum all day and sleep with a wad of gum in her mouth at night. She mentioned that she might have it the rest of her life, the patient is asking for help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 22-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (25 microgram (MCG)/0.5 milliliter (ML) 1 standard package vial of 2.5) intramuscularly. Concomitant medications were not reported. The patient was inadvertently given PNEUMOVAX 23 which was expired on 15-FEB-2014 and lot number was unspecified. No adverse effects noted. The outcome of gave PNEUMOVAX 23 which was expired and no adverse effects noted was unknown. Additional information has been requested.
left clinic & came back in about 30min;arm red w/approx dollar-sized red area/blue raised center w/darker red center;hot to touch;sent to MD @ ER for checkup;gave inj in ER;MD stated it was local rxn
pain in arm; This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient stated that her arm was extremely sore after the Shingrix vaccination. The patient did not want a follow up with the health care professional as she believes this would be a hassle and unnecessary.  No further information was provided.
Discharge Provider: DO Primary Care Provider: MD Admission Date: 4/23/2023 Discharge Date: Apr 24, 2023 PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE:  59 y.o. female with past medical history significant for Ehlers-Danlos, OSA, mast cell activation syndrome, T2DM, HTN , Narcolepsy and Morbid obesity presents to ED with complaint of cough, fever, chills, nausea, episode of vomiting x1, diarrhea with last episode 4/22, generalized body aches and weakness, and headache since 4/17 with positive home COVID test 4/21. Pt also endorsing increased shortness of breath from baseline and aching chest pain across her chest between her clavicles. Patients husband who cares for her at home also has COVID. Pt states when she talked to her doctor over the phone on Friday, she was offered Paxlovid but declined as she thought she would get better soon but symptoms have worsened. Pt has had 4 COVID vaccinations in total with the last one being in 04/2022. Pt also has hx of COVID pneumonia in 5/2022. Denies hx of stroke, blood clots, COPD, cardiac hx.   In ED, cardiac workup performed due to complaint of chest pain and shortness of breath. Troponin 17->17. EKG with NSR and LBBB. CMP and CBC unremarkable. CXR with mild pulmonary congestion. Probable mild left-sided pleural effusion with adjacent lung atelectasis. Pt given tylenol 1000mg and 1L fluid bolus in ED. Pt placed in observation to general medicine for further management.   She was afebrile after admission. Her fatigue improved. She continued to be on room air through out stay. CM met with patient and after discussion it was noted that patient is current with home health PTA. She will continue home care services. She will continue isolation per CDC guidelines and discuss with PCP when cleared to come out of isolation.
Jan 1st, woke with an itchy lesion on lower left arm on the exact spot that I had a previous PPD test done years ago. (Can't have PPD done anymore due to allergic reaction). This new lesion appeared to look just like the PPD reaction with raised swelling, redness and itch. Applied Benadryl cream and swelling and itch went away within 4 hours leaving a red spot.  I have photos documenting it from start to end.
Bluish color in urine; Bluish color toilet bowl after bowel movement; This spontaneous case was reported by a physician and describes the occurrence of CHROMATURIA (Bluish color in urine) and URINE ABNORMALITY (Bluish color toilet bowl after bowel movement) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included LISINOPRIL, LEVOTHYROXINE, METOPROLOL, SIMVASTATIN, TAMSULOSIN and CLONAZEPAM for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CHROMATURIA (Bluish color in urine) and URINE ABNORMALITY (Bluish color toilet bowl after bowel movement). At the time of the report, CHROMATURIA (Bluish color in urine) and URINE ABNORMALITY (Bluish color toilet bowl after bowel movement) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment provided.
Since the injection, I have been experiencing a metallic taste in my mouth when I eat.  It lingers for some time after I eat, but eventually goes away.  It started either immediately or within a day of the vaccine.  Initially, it was a very strong taste and was quite bothersome; now, several weeks later, it has become less prominent and more tolerable.
Fatigue, headache, fever, chills, brain fog, loss of appetite, nausea, altered taste of certain foods . Duration as of April 13, 2021 is 17 days. Prednisone prescribed April 8,  for 15 days 20 mg daily.
Expired vaccine was placed in refrigerator; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was placed in refrigerator) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was placed in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was placed in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient received the booster dose. It was reported that Vaccine was placed in refrigerator on 26-Oct-2021, patient had no adverse events and it was also reported that there were no temperature excursion.  No Treatments were reported.