chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hours after receiving the 2nd injection, I had a fever that would not go away with medication, and lasted for 36 hours strait.  I was extremely tired, very heavy feeling,  and had severe body aches. I had a headache that lasted off and on for about 6 days that was always there.  It would lessen slightly with OTC medication, but was never really fully gone. It would get worse upon standing, or if I laid my head down.  I had an itchy rash that went from the injection site across and under my arm for weeks.  extremely itchy in both arm pits which is still continuing.  having upper arm pain that goes to my elbow at night now, that has not gone away.  makes it very hard to go to sleep due to the sharpness and uncomfortableness of it.
Subacromial bursitis, shoulder pain on active and passive ROM. No warmth redness or erythema.
I have experienced four (4) canker sores in my mouth since getting the second dose of Moderna vaccine.  I typically experience 1-2 canker sores per year.  4 in a 6 week period has never happened before.
first shot around December 2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. The patient received 1st shot around December 2020. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported On 30-JUN-2009, patient received VARIVAX dose 1, from lot # 663709/0193Y expiry date: 06-FEB-2011. On 31-JUL-2009, the patient received second dose of improperly stored VARIVAX from lot # 663709/0193Y expiry date: 06-FEB-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received HD Flu shot in left deltoid in afternoon on 10/6. She noticed some redness and swelling at the injection site and extending down her arm about an inch or two later that evening. On 10/9 she presented to the pharmacy with very little swelling or redness. She will discuss with her PCP at next visit.
patient was inadvertently administered an ADACEL vaccination 11AUG2022 instead of the intended 5th dose of DTaP with no reported adverse event; Initial information received on 11-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old male patient who was inadvertently administered an adacel vaccination 11aug2022 instead of the intended 5th dose of dtap with no reported adverse event while receiving vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On an unknown date, the patient received suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation. On 11-Aug-2022, the patient received suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a suspect at a dose of 0.5 ml once (lot U6923AA, expiry date: 21-Jan-2023) via intramuscular route in the left thigh for immunisation.  On 11-Aug-2022 the patient was inadvertently administered an adacel vaccination instead of the intended 5th dose of dtap with no reported adverse event (wrong product administered) same day latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Action taken: Not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Profound malaise, nausea, vomiting within 24 hours afterward.  Then ongoing cardiac palpitations and a sense of skipped heart beats and vague dyspnea, still ongoing as of 7/23/2021 here in urgent care.
I am 61, received Pfizer-BioNTech Covid Vaccine on 3-19-21, & 4-9-21. On 5-2-21, after doing some gardening, I felt a sharp pain in my right eye resulting in the sclera part of eye becoming red/bloodshot. I saw PCP, then ophthalmologist on 5-5-21, diagnosing it as right sub conjunctival hemorrhage.  I did not lose any vision, but as of today, I still have some residual redness in sclera. My younger sister who had the same above vaccine on same above dates, also experienced right eye redness on 5-11-21, stating no trauma to area.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 15-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVSX (dose and route unknown, lot # L025001, expiration date: 06-OCT-2016). No adverse effects were reported. Additional information has been requested.
COVID BOOSTER SHOT MADE ARM RED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (COVID BOOSTER SHOT MADE ARM RED) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (COVID BOOSTER SHOT MADE ARM RED). At the time of the report, VACCINATION SITE ERYTHEMA (COVID BOOSTER SHOT MADE ARM RED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided. 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.
Cellulitis reaction to vaccine pt received pneumonia and influenza vaccine in right arm on 11/03/06. Pt seen 11/06/06 with about 8"x3" RUA, DX with cellulitis, responded well to Augmentin.
I experienced flu-like symptoms at about 3am on 09/26/2021 which lasted approximately about 6 hours. I felt feverish, chills and fatigued. I took Tylenol which resolved the symptoms. On, 12/27/2021 at approximately 5:30pm I tested for COVID-19.
Temp of 104.9 that dropped to 102 w/in 24 hrs; Chest congestion for 2.5 wks; MD consulted attributed rxn to the HIB;
still itchy; red on my arm where I got the shot; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (still itchy), CHILLS (chills), HEADACHE (bad headache) and VACCINATION SITE ERYTHEMA (red on my arm where I got the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 032L20A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (bad headache). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (still itchy) and VACCINATION SITE ERYTHEMA (red on my arm where I got the shot). At the time of the report, VACCINATION SITE PRURITUS (still itchy), CHILLS (chills), HEADACHE (bad headache) and VACCINATION SITE ERYTHEMA (red on my arm where I got the shot) outcome was unknown. Not Provided    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 unspecified anti-itch cream..   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No new information received, Argus ID number provided.
had the vaccine, have shingles/Suspected vaccination failure; now I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In July 2022, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine 2 years ago and now have had shingles at the moment. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Narrative: COVID infection following COVID vaccine series 01/21, Pfizer, dose #1 02/12, Pfizer, dose #2 08/31 COVID swab, result: detected 08/31 pt cc: exposure: unknown
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 9/11/2021 for unknown duration
generalized body aches; chills; heart rate in 140s; diaphoretic; dizzy; fatigue; This is a spontaneous report from a contactable healthcare professional. A 65-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration from 07Jan2021 13:30 to 07Jan2021 13:30 at a single dose for an unspecified indication. Medical history included covid (COVID prior vaccination: Yes). Concomitant medication included valacyclovir and vitamin d3. The patient previously took ampicillin, Keflex and metronidazole; the patient had allergies with all. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020. It was reported that 9-hours post second vaccine, the patient had generalized body aches, chills, 2 hours later Heart Rate in 140s, diaphoretic, chills and dizzy. HR normalized 6 hours later. Diaphoresis lasted 10 hours. No treatment was received for the events. The patient also reported to have extreme fatigue. The outcome of the event heart rate abnormal and diaphoretic was recovered on 08Jan2021 while recovering for the other events.
Complained of "lump in her throat"; History of "lump in throat feeling"; Took 2 puffs of inhaler and said she felt fine after using inhaler; she used her own inhaler; symptom subsided after 30 minute wait in recovery-observation.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 27-Oct-2021 at 4:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 27-Oct-2021, Excursion time was 10 AM, temp was 32 , total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021, 4 vial was moved to clinic. Vaccine BUD date was 04-Nov-2021. On 27-Oct-2021, Excursion time was 9 AM, temp was 29 , total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021, 2 vial was moved to clinic. Vaccine BUD date was 29-Oct-2021.  Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration at 8 AM:41,  9 AM:29, 10 AM: 32, 11 AM:43, 12 AM:43, 1PM : 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45.  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vials only punctured right before administration  Treatment medications were not reported.
Broke out in a Psoriatic type rash lasted about a month. Permanently lost some sensation in the bottom of my feet.
After RECEIVING vaccines and the Penicillin injection started complaining of throat difficult swallowing and felt like something grabbing at throat. Family member have history of penicillin allergy, but not self. Patient received 50 mg IM of BENADRYL.
After shot, pt complained a lot of "ouch & owy" when walking, putting on her shoes. Lasted 2 wks, until she had the seizure. No fever until time of the seizure w/muscle aches, possibly. She had a seizure, temp of 103 (rectal).
arm pain in muscle at injection site; nausea; headache; body ache; chills; This is a spontaneous report received from a contactable consumer via a Pfizer colleague. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: Mar2021, for COVID-19 immunisation, reaction: "axillary pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "arm pain in muscle at injection site"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body ache"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills".  Additional information: The events took place 10 hours after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired vaccine was administered, expired on 07/27/2021 and was administered on 07/29/2021. Manuafacter and parents were both notified.
Breathlessness; Diarrhea; Feeling very weak; Headache; Running a high fever for 2 nights; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathlessness), DIARRHOEA (Diarrhea), ASTHENIA (Feeling very weak), HEADACHE (Headache) and PYREXIA (Running a high fever for 2 nights) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Breathlessness), DIARRHOEA (Diarrhea), ASTHENIA (Feeling very weak), HEADACHE (Headache) and PYREXIA (Running a high fever for 2 nights). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. In March 2021, PYREXIA (Running a high fever for 2 nights) had resolved. At the time of the report, DYSPNOEA (Breathlessness), DIARRHOEA (Diarrhea), ASTHENIA (Feeling very weak) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperatue: 104.7 f (High) 104.7 F, 103 f (High) 103 F and 100.4 f (High) 100.4 F.         Concomitant products used were not provided by the reporter.
Raised Rash/Diamond Shaped Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Raised Rash/Diamond Shaped Rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced RASH PAPULAR (Raised Rash/Diamond Shaped Rash). On 25-Feb-2021, RASH PAPULAR (Raised Rash/Diamond Shaped Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Brief episode of light headedness 5 minute post vaccination.  O2 sat 97%
Diarrhea and cramps, headache, muscle aches. Tylenol, fluids, rest.
pt recv vax 31OCT98 & NOV98 pt exp elevated liver enzymes w/SGOT 40 & SGPT 59;
Pain above right eye with double vision. Several episodes lasting about 1 minute for several days. Visited family doctor, suspected sinus problem and treated for same. Also gave senior flu shot at time of visit. Next day started having temporary blindness in left eye lasting 1 or 2 minutes. Repeated episodes for about 4 days. Went to emergency room on Sunday, admitted for testing.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On 08-JUN-2017, the patients received doses of improperly stored ROTATEQ, orally, lot # M041184 with expiration date on 31-MAY-2018 (doses were not reported). No adverse effects were reported. Administered doses of vaccines experienced a temperature excursion from 0 degree Celsius to 1 degree Celsius, which lasted for 1 hour 19 minutes. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA005016: US-009507513-1706USA004996.
Information has been received through a pregnancy registry from a 24 year old female healthcare worker with no allergies, no concurrent medical conditions or pertinent medical history, and one previous pregnancy resulting in a miscarriage at six weeks who on 6/23/04 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on 7/15/04 included a dose of tetanus toxoid. There was no other concomitant medication. It was noted that the patient had no local reaction at the vaccination site. She had no symptoms of varicella or herpes zoster post vaccination. The date of her LMP was 6/30/04 and her estimated delivery date is 4/6/05. A pregnancy test in the physician's office was positive (date unspecified). The patient had a blood test on 8/10/04 to confirm pregnancy (results not provided). Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a physician's office which indicated that on 8/12/04, the patient had a spontaneous abortion at five and a half weeks from her LMP. The products of conception were not examined and it was unknown if the fetus was normal. There were no complications during pregnancy and no diagnostic tests during pregnancy were performed. It was was noted that the patient had a yeast infection during pregnancy. No further information is expected.
THIS INDIVIDUAL RECEIVED FLUCELVAX WHILE UNDER THE AGE OF 18 YEARS WITH NOT ADVERSE REACTIONS.
Developed hives 30-60 minutes after injection Benadryl 25mg PO liquid given x 1.