chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23; Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23), WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT) and NO ADVERSE EVENT (No adverse event) in an adolescent female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient had no relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 28-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23) and WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23), WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23) and WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT).    Patient did not received any other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vaccine expiry date was reported as 13-Jun-2023.  Treatment information was not provided.
breakthrough case admission after 3 vaccines Pfizer 3/31/21 Lot# Ew0150;  Pfizer 4/21/21 Lot# Ew0150;  Pfizer 12/17/21 Lot# FJ8757
Pt recvd vax & exp swollen arm, fatigue, lightheadedness & was bruised;
A strange headache with occasional twinges in my head, body aches and fatigue had been gradually developing during the day on Saturday.  I took two Tylenol Saturday afternoon, which seemed to help.   An area in my left armpit became extremely painful to the touch (possibly lymph node?) beginning Saturday night at 8:30 pm.  I went to bed and woke up at 10:30pm with all the same aches and pains and felt slight chills.  I took two more Tylenol and felt good enough to go back to sleep.   Armpit pain persists as of now, Sunday morning, but other side effects are mostly gone.
The night of the vaccine, severe insomnia. Began treatment a month later with Quetiapine. Problem still persists.
Fever 99.1. Severe arm pain and lump at injection site. Pain radiates entire shoulder and arm pit. Hurts to touch. Fatigue, headache, chills, body aches worsening throughout day after injection.
achy; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid vaccine (Covid vaccine received in winters). Concomitant products included acetylsalicylic acid (Aspirin).   On 10th June 2021, the patient received the 1st dose of Shingrix. On 11th June 2021, 1 days after receiving Shingrix, the patient experienced pain and pain in arm. On an unknown date, the outcome of the pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient received the Covid vaccine in winters. The patient received the 1st dose of Shingrix and next day after the vaccination the patient felt achy and had a sore arm. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR170252.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170252:Same reporter
1 of the recipients was redosed at another one of our clinics.; A nurse administered 4 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and EXTRA DOSE ADMINISTERED (1 of the recipients was redosed at another one of our clinics.) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (1 of the recipients was redosed at another one of our clinics.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and EXTRA DOSE ADMINISTERED (1 of the recipients was redosed at another one of our clinics.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  On 18-Feb-2022, the vial was initially stored In refrigerator: . The vial did not undergo any temperature excursions.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Non-significant follow up recieved
Raised, reddened and highly-itchy rash; Raised, reddened and highly-itchy rash; Raised, reddened and highly-itchy rash; Headache; Itching; Spontaneous report received on 28MAY2019 from a face to face interview with an employee who experienced rash and headache following the administration of BioThrax.  On 21MAY2019, a male employee received a dose of BioThrax intramuscularly in the right arm. This was approximately his 14th dose; he had been receiving immunizations since 2008.  He denied prior adverse events following previous doses of BioThrax.  On 24MAY2019, about 72 hours after receiving the dose, the employee noticed that his bilateral forearms and upper legs began to itch. Within 24 hours after beginning to itch, a raised, reddened and highly-itchy rash developed on his extremities. The employee began treating the rash with an available prescription-strength steroid cream, used in the past to treat eczema. Concurrent with the rash, the employee developed a moderate headache, for which he took 600mg of ibuprofen every 6 hours. Throughout the next several days both the rash and headache persisted with despite continued treatment.   On 28MAY2019, the male presented to the Emergent pharmacovigilance department to report the adverse experience. He denied use of any new possible irritants, medications, or foods. The red, raised rash was observed on his bilateral forearms. He reported that his headache had improved at the time of this report with only mild symptoms and treatment with ibuprofen was no longer required. The rash and its associated itching however, continued to persist at the time of the report.  Additional information has been requested.  Company Comment: This is a spontaneous report of an adult male experiencing pruritis; an itchy, raised, erythematous rash; and a headache occurring almost 3 days after receiving Biothrax vaccination.  He denies use of additional medications or contact with irritants prior to vaccination.  Each of these symptoms have been known to occur with AVA injection. Given this patient's history of eczema and prior exposures to Biothrax vaccination, a hypersensitivity reaction can also be considered. In light of the strong temporal association and the nature of the stated events, the causality association is determined to be related.; Sender's Comments: This is a spontaneous report of an adult male experiencing pruritis; an itchy, raised, erythematous rash; and a headache occurring almost 3 days after receiving Biothrax vaccination.  He denies use of additional medications or contact with irritants prior to vaccination.  Each of these symptoms have been known to occur with AVA injection. Given this patient's history of eczema and prior exposures to Biothrax vaccination, a hypersensitivity reaction can also be considered. In light of the strong temporal association and the nature of the stated events, the causality association is determined to be related.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 20-MAY-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided)  for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.          This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
In the evening 01/12/2021 started having bodyache, fatigue, chill 99.8.  Took sick day yesterday and slept most of the time.  Feeling fine today.
Started with chest pain like being kicked in chest about a week/ then severe migraines lasting 6-7 days sometimes couldn?t walk so dizzy/ then severe shaking off and on then sores in my nose by July they still haven?t heeled/ body pain so bad it hurts if you touch me! Too weak to get out of bed a lot of days when I try to talk sometimes I slur my words or they don?t quite come out right I forget things really easy I never used to be like that I worked as a technician and yarn developer on the sAme job for 25 years now I can?t remember to eat sometimes and I can?t drive a car !!! I am only 51 almost 52 years old I have grandchildren I should be playing with I can barely carry on a conversation with! Yes I took the shot but this was not supposed to happen!!!! I want my life back!!!!
Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 21-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 1 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118616:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118572:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118569:Same reporter.
Child had fever, severe irritability and obvious pain at injections sites. This was the second time Hib was administered with an additional vaccines (I believe Prevnar both times) wherein the child had this reaction. When the same child was given Hib and Prevnar injections separately, he had no adverse reactions.
Fatigue, fever 99.7, muscle and joint aches, mild nausea, soreness at injection site.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-JUN-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J00141 and expiry date: 04-JUL-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
exhaustion night of Feb 27 fever 100, chills, dizziness, exhaustion, sore throat upon awakening on Feb    27
Tiredness, Chills, Joint Pain, Mild Nausea.  I started getting the chills during the night (night of receiving my second dose), and was cold most of the next day.  I was very tired, slept most of the day, and felt some joint pain and mild nausea.  I woke up today (second day after second shot) feeling a little tired, but basically fine, without symptoms.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-MAR-2014, the patient's health care provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 02-APR-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, 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 include 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. Additional information has been requested.
Vomiting, diarrhea, abdominal pain, insomnia, severe arm pain.
Gave ROTATEQ, PENTACEL, Hep B, PREVNAR pt. went limp right after Imms. No cyanosis or apnea noted at 3-5 min (HR 129 O2 sat 100%).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-AUG-2015, the patient was vaccinated with the improperly stored M-M-R II (lot # K024035 and expiration date 26-NOV-2016) (dose and route of administration were not reported). On the same day the patient was vaccinated with VAQTA (lot number L009445 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.).    No concomitant information was reported. This case is reported for patient 3 out of 3 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721695 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721695:(Master Document) (Patient no -1)
8/23/23 Pt received Shingrix - 1st dose at 10:50AM. Only sore arm and burning sensation upon administration. Right Deltoid. 8/27/23 Pt woke up @ 8am with welts that began on each side of back along spine and spread to stomach, arms, legs, and back. No change in vision, no significant pain, only pruritus - large visible welts. MD gave pt 40mg loratadine, Benadryl 50mg & hydroxyzine.  No sxn between these dates. 8/28/23 MD sent in high dose Prednisone as per 18 days use.
Initial unsolicited report received from nurse on 19-Apr-2018. This case is non-valid, as the type of reaction was not reported. This case involves two patients (age and gender not reported) who were vaccinated with a dose of PNEUMOVAX 23 (Batch number: N030111, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced significant reaction (unspecified). Lab data and corrective treatment were not reported. The outcome of the event was not reported. This case was considered as serious due to medically significant event. List of documents held by sender: none.
Got my shingles shot, still got shingles/suspected vaccination failure; Shingles; Painful but not as bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.  It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patent for herself or himself. The age at vaccination was not reported. The patient stated that the got the shingles vaccine shot and still got shingles. The patient stated that painful but not as bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting
Severe case of shingles began 9/2/13. Still has neuropathy due to it. Several people in area had vaccine and still got shingles. Is vaccine any good or did he get water instead of medication?
Around 30 hours after vaccine, I experienced vertigo. The room was spinning for a few seconds on two occasions. Though I no longer have spinning sensations, I am still experiencing general dizziness. My second shot was on April 2nd, 2021. I am still feeling general dizziness. Worse on some days, better on other days.
Patient has redness/erythema with swelling beginning a few inches BELOW the actual injection site and spreading around her arm and down to the crease of the elbow. Patient cannot take diphenhydramine due to excessive sedation it causes. Patient will apply cold compress for 20 minutes at a time several times per day. She will mark the borders of the redness so she can monitor for spread/recede and will contact her PCP if she notices spreading beyond current limits.