chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LEVOTHYROXINE from 02-Jan-2012 to an unknown date for an unknown indication.    On 04-May-2022 at 11:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound infection) had not resolved.            Patient took other medications or products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 vaccine. On 02-Jun-2022, the patient had rebound infection.  Company Comment: This is a Spontaneous case concerning a 73-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 in an unknown date in the context of the administration of the 4th dose of the mRNA-1273 vaccine (in the covid 19 vaccination series of an unknown schedule of administration). It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) starting on 24-May-2022 for covid 19 treatment for 5 days. Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement; Sender's Comments: This is a Spontaneous case concerning a 73-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 in an unknown date in the context of the administration of the 4th dose of the mRNA-1273 vaccine (in the covid 19 vaccination series of an unknown schedule of administration). It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) starting on 24-May-2022 for covid 19 treatment for 5 days. Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced off label use. On an unspecified date, the subject experienced product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
pt recv vax 29AUG97 & 2SEP97 pt exp a inj site rxn consisting of redness & swelling;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. In October 2015, the patient was vaccinated with an improperly stored dose of VAQTA injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). The medical assistant was unable to provide the temperature and time frame for the improperly stored VAQTA, but she stated that the vaccine was stored outside of the recommended temperature range and it was found to be unsupported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
shingles; Information has been received on 04-MAR-2020 from a lawyer regarding a case in litigation. This case refers to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2015, pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a local pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, pt was treated by a healthcare provider at a medical office for shingles (herpes zoster). As direct and proximate result of use of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue 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 cost 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. At the reporting time, the pt was not recovered from the event and it was related to zoster vaccine live (ZOSTAVAX).
Chills at night and sweating in morning Abnormal lump/nodule in neck that feels like a knot
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received additional dose with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported (approximately around 0.3 mL) (dose number in series 2), 1 total, administered on 01-DEC-2021 on left arm for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported.  As per the report, "the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL."(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the vaccine as a booster dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209976, 20211210058, 20211210160, 20211210588, 20211209775, 20211210159, 20211210610, 20211210409, 20211210733, 20211210408, 20211210555, 20211209880, 20211210133, 20211209816, 20211209782, 20211212082, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210067, 20211212088, 20211210662, 20211209706, 20211210019, 20211210112, 20211209798, 20211209874, 20211209884, 20211210549, 20211210106, 20211210143, 20211210180, 20211210334, 20211210590, 20211210590, 20211210684, 20211210385, 20211210165, 20211209843 and 20211209921.
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The practice lead from a medical facility reported that, the patient received an expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up.
This spontaneous report as received from a registered nurse via a company representative refers to a 20 year old female patient. On 13-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (dose and route not reported) (Lot# H017758 and Expiration Date 11/28/2014 58) for prevention of HPV. On 13-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (dose and route not reported) (lot# reported as H01755 and expirations date: 21-MAR-2015). This patient had had 2 out of the 3 doses of GARDASIL and with each dose experienced numbness in her arm. The numbness occurred in greater severity with the second dose. In 2013, the patient was recovered. The patient had sought medical attention by contacting the office. Lot number H10755 is an invalid lot number for GARDASIL. Additional information has been requested.
On 3-27-2008 client received Tdap vaccine and was hospitalized on 3-30-2008 with possible Guillain-Barre syndrome. She remains in the hospital at this time.  5/2/08 Reviewed hospital medical records of 3/30- 4/8/2008. FINAL DX: Rheumatic fever; questionable viral myositis; LE pain & weakness; questionable Guillain Barre syndrome; elevated ESR & leukocytosis; hypokalemia. Records reveal patient experienced sore throat.  Seen in ER 3/26 & dx w/strep throat.  Tx w/antibiotics & steroids.  Seen by PCP next day & received booster vaccination.  Developed tingling, pain & weakness on 3/28 in both legs which progressed to making it difficult to ambulate.  On admit, reflexes & strength in LEs diminished.  Neuro, ID & rheum consults done.  Spiked fever on 4/2 w/knee swelling.  Developed multiple joint inflammatory synovitis & diastolic murmur.  Tx w/PCN, steroids & antiinflammatory meds.  Improved & d/c to home on antiinflammatory meds & IM PCN to f/u w/rheum.
Headache; Pain like body aches and pains; all meshed up; Chills; Nausea; Diarrhea; A low grade fever like 101 got highest; Eye pain; really got sick; cramping; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after the second dose of vaccine, patient was really sick for couple of days, as like reporter's signs and symptoms (headache, pain, body aches, chills, nausea, a little diarrhea and a low grade fever of 101 and eye pain). She also had cramping, but was worst than reporter had. At the time of report, she is good. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345894 Same reporter/drug/, different patient/similar events
pt said she had hotflashs for few minutes after the vaccine , then shorlty she was ok and every thing feels normal to her .
Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a spontaneous report from a contactable other HCP. This 78-year-old female other HCP (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN6201) via an unspecified route of administration from 08Feb2021 at 1:00 pm to 08Feb2021 at 1:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type vaccine was doctor's office/urgent care. The patient was 78 years old and not pregnant at the time of vaccination. Patient's medical history included hypothyroid, hypertension, elevated cholesterol, possible heart condition, obesity, known allergies: shellfish, MSG (dates unspecified). Concomitant medications included Losartan, hydrochlorothiazide, triamterene (Dyazide), Levothyroxine, Pravastatin via an unspecified route of administration from unspecified date to an unspecified date at unknown dose and frequency for an unknown indication. If other vaccine in four weeks: No. Patient experienced trembling, muscle weakness, palpitations. light-headed, dizziness, slight headache on 08Feb2021 at 01:15 pm. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment AE: no, If covid prior vaccination: no, If covid tested post vaccination: no. The outcome of events was recovered on an unknown date.
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 5-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 23-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Immediately after the injection was given....it was sore, as always in the past, so thought it would take a few days to disappear....not so....Lots of pain on the shoulder, down the arm....three months later finally saw the doctor....here it is now four months later, and still has pain.
Redness, swelling, itchiness, and rigid muscle at vaccination site. Lasting over 7 days.
awoke with Vertigo ...not just dizziness with the room spinning; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 17:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included high (LDL) and allergy to pork and adhesive. The patient did not take any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 the patient awoke with Vertigo ...not just dizziness with the room spinning. Patient had to lay back down 2 times before episode past and in the evening it happened again. Since this time, she had issues with Vertigo, Dizziness and nausea and seen ENT doctor and doctor gave her exercises to help with the dizziness and Vertigo. she still felt like she was always on the edge of having an episode of Vertigo. She had never had Vertigo before and on 29Mar2021, patient had not connected that it could be a side effect of the Pfizer vaccine. Patient friend said that they had heard of this potential side effect. So, patient did an internet search and found several people commenting about having Vertigo and dizziness several days after their first dose of Pfizer versus an immediate reaction and that it had been ongoing. Patient were concerned if they should have second dose due to this continuous side effect. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included exercises to try and correct. The clinical outcome of the events vertigo, dizziness and nausea were not recovered.  No follow-up attempts are needed. No further information is expected.
Narrative: PT WAS VACCINATED AT A NON SITE IN A TIMELY MANNER IN JAN/FEB 2021 WITH PFIZER. PT TESTED POSITIVE FOR COVID 9-3-21 AND WAS ADMITTED FOR HYPOXIA REQUIRING O2 SUPPORT. PT IMPROVED AND WAS DISCHARGED
Narrative:  74yr patient hospitalized who was COVID symptomatic requiring oxygen supplementation in the ED at 2L via NC quickly escalated overnight to 5L NC. Initiated on dexamethasone plus remdesivir upon admission. Oxygen supplementation continued to escalate to HFNC; airvo 40L and 50%, spo2 90% by day 2 in ICU; baricitinib 4mg was started. Oxygen supplementation slowly was de-escalated by day 14 of hospitalization. Completed remdesivir course and received 9 doses of barcitinib before therapy was d'ced due to clinical improvement. Was discharged at day 15 with home oxygen at 2L NC keep o2 >90% along with respiratory therapy follow up. PMH: T2DM on meds (po metformin), OAB, Dyslipidemia COVID Vaccination Status: Pfizer x 2 (Feb 21 and March 21 at facility) Symptoms:   Fever, CoughWheeze & decrease taste, chills, fatigue Treatment:   REMDESIVIR 100 MG EVERY DAY ,DEXAMETHASONE 6 MG EVERY DAY ,BARICITINIB 4 MG EVERY DAY
Vaccine administered on 07/12/02. Mom returned to clinic on 07/15/02. Right thigh showed on injection site hematoma and roseotu infartion.
Itchy rash started to form, looks like a mixture of hives or bug bites. All over torso, shoulders.
Patient reported chills/fever on next day, called her primary physician. Blood pressure was also low, so she landed up in the hospital. They initially thought was cellulitis but infectious disease doctor ruled out this and said it was reaction to the pneumovax
Patient has watery/loose stool 3-4x/day since 8/27/06 vaccination ? Rotavirus adverse effect.
Itching on arm; Transient pain on arm; A spontaneous report was received from a Consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itching on arm (Pruritus), Transient pain on arm (Pain in extremity).  The patient's medical history was not provided.  Relevant concomitant medication was reported ELIQUIS.  On 11 FEB 2021, prior to the onset of the events the patient received their planned dose of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 FEB 2021, the patient experienced Itching on arm (Pruritus), Transient pain on arm (Pain in extremity).  Laboratory details were not provided. Treatment information was provided as antibiotic.  Action taken with mRNA-1273 in response to the events was not reported. At the of this report, the outcome of the event's Itching on arm (Pruritus), Transient pain on arm (Pain in extremity) was considered as unknown.
Info has been received from a physician concerning a 4 1/2 year old black female with an allergy to eggs, dogs, cats, cockroaches, soy, milk, peanuts, fish, strawberries, chocolate and celery who on 6/14/05, at approximately 13:00, was vaccinated, SC, into the left arm with a 2nd dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 6/14/2005, at approximately 13:35, the pt developed persistent vomiting. The pt's mother was advised to give the pt opiraphnephrine (Epi-Pen). It was also noted that the pt's mother called 10 minutes later and stated that the pt's vomiting had stopped and the pt looked much better. It was noted that she was seen in the ER for evaluation and was released. Lab exams revealed a serum tryptase test value of 4.2. That day, the pt recovered. No product quality complaint was involved. It was also noted that on 12/8/03, the pt was vaccinated with a first dose of influenza virus vaccine (unspecified) and developed swelling of the face. Additional info is not expected.
chills; low-grade fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (low-grade fever) and MYALGIA (body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, AMLODIPINE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced CHILLS (chills), PYREXIA (low-grade fever) and MYALGIA (body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 06-Nov-2021, CHILLS (chills), PYREXIA (low-grade fever) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: 99 (Low) low grade fever 99 F.