chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756493A, A0756495A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: The registered nurse manager reported that the patient was administered with expired dose of Havrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
low grade fever-warm to touch; malaise; pink maculopapular rash, face, forehead & trunk some confluence; duration 4 days; no koplik spots;
Headaches began later in the afternoon after getting vaccine. Loss of sleep that is abnormal and worrisome due to seizure condition. Sore arm at injection site and general body aches present.
redness & swelling (now resolved), blister like rash, mildly itchy, recurring, relieved with Benadryl, also resolves spontaneously after several hours
Visions went completely white. Ringing in ears. Clammy sweaty skin. Partially incoherent for 5-10 seconds.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Rash on his body; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on his body) and RASH PRURITIC (Itchy rash) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2124) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (High blood pressure medication).    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced RASH (Rash on his body) and RASH PRURITIC (Itchy rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on his body) and RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was reported Concomitant medications: High blood pressure medication Treatment drugs: Benadryl for rash but it got worse
Loss of hearing the next day. Always had excellent hearing till second shot. It?s now 30 days after second shot with sufficient loss of hearing. Both ears now ringing. Can?t get into doctor appointment right away. Loss over 30 percent of hearing.
Patient is an otherwise healthy 41-year-old male who presents emergency department for evaluation of reaction after giving the 1st dose of a COVID vaccine.  Patient states he did not eat much for breakfast, drank 2 cups of coffee.  He got the vaccine and 5-10 minutes later began to feel lightheaded, flushed and warm.  He denies any difficulty breathing.  Denies any difficulty swallowing.  Denies any rash or itchiness.  Denies any nausea, vomiting or diarrhea.  Patient was brought to the emergency department for further evaluation.
Pt scheduled for Pfizer (12+) bivalent covid vaccine, but received Pfizer (12+) monovalent covid vaccine. Pt left clinic in stable condition, no distress noted. Called and informed pt about the error and advised to wait at least 2 months before receiving Pfizer bivalent vaccine.  Pt verbalized understanding. Pt states she will speak with her PCP.
pt recv vax 22MAY96 & 9DEC96 pt exp full-blown chickenpox w/greater than 50 lesions;
No adverse event.  I am reporting the error of administering a 3rd dose of Pfizer COVID vaccine.   The pt told us on 5/4 that it was her first dose.  and on 5/25 that it was her second dose.   The intern that administered the vaccine on 5/25 came back after administering the vaccine and told me the pt mentioned getting COVID in December of 2020 right after getting a Moderna vaccine.  He said she had told him that because of getting COVID she was told to wait 90 days then repeat the series.  She told him she called the CDC to ask what to do because of her situation and was told she needed to start the series all over and get 2 doses.  We pulled up database reporting website and was able to see that she had received a Pfizer dose on 12/31/2020 at a pharmacy not a Moderna dose, and that we had administered 2 more doses.  1 on 5/4/21 and another on 5/25/21.
Had vaccine Monday morning around 11 AM. Fever at 103 and muscle pain starting Monday night. Treated with Tylenol Tuesday morning and night.  Moderate diarrhea on Wednesday night for about 1-1.5 hours without treatment.
Pt had episode of syncope in the lobby while leaving the office today. She was able to tell her family she did not feel good and sat herself in a chair. She then was pale and lost consciousness for less than 1 min. She had not injury with the loss of consciousness. VS at that time 109/65 HR 62 She did seem confused after the event. She was given apple juice and observed in the office and return to normal state within 30 min. Discussed with mom and pt that combination of HPV vaccine, no breakfast and baseline low BP probably contributed to the event.
Patient complaining of flu like symptoms (diarrhea, cramps, body aches). States BP is 150/100s despite taking BP meds. States able to tolerate PO. States temperature over 100 but doesn't recall exact number. Doctor phones the patient and discussed the adverse reaction, and advised further evaluation at her PCP or UC, especially to evaluate for signs of dehydration since patient is having diarrhea every 10 minutes. Patient expressed understanding.
Pt devel fever of 104.2 night of inject; site @ lt arm red & swollen; Following morning fever 101.8, arm still swollen, less erythema;
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 29-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004707: US-009507513-2207USA001345: US-009507513-2207USA004698: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004712: US-009507513-2207USA004709: US-009507513-2207USA004691: US-009507513-2207USA004700: US-009507513-2207USA004710: US-009507513-2207USA004715:
2 black dots noted on childs left thigh where Dtap and IPV had been administered on 12/16/11.
Oth complications following immunization, NEC, subs on 2016-11-25.
Anxiety, musculoskeletal pain, disconfort, weakeness and erectile dysfunction and decline in libido. Situation getting worse. Immunization record sent in by pt indicates that the date of 12/7/02 in Box 10 was for his first Anthrax vaccination. It was noted in the comment section of the NRFU that the pt stated on the follow up questionnaire that he was not seen in the ER and was not hospitalized for this event. However, on his web report he checked hospitalization in Box 8. Body aches, low energy, anxiety, low libido. Conditions have remained pretty much the same.
After injecting a dose of afluria into his left deltoid, the patient appears as being unable to breath.  The pt was unresponsive when I asked if he was okay.He leaned back & appeared to have a seizure for a few secs. I located the Epipen.  The other rph administered the Epipen IM to the right thigh of the pt. We called 911 and they transported him to the ER. Later I called the mother, she stated that her son was doing fine and that he is at home now. Per the mother, the doctor indicated the event was due to a ?atypical vaso reaction or seizure.?
This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was administered vaccine which was opened sometime in April and administered on 01May2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 939902, 030L20A and 025J20-2A) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was administered vaccine which was opened sometime in April and administered on 01May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient was administered vaccine which was opened sometime in April and administered on 01May2022) outcome was unknown. No concomitant medications were reported. From the COVID-19 vaccination on 01-May-2022, he had no reaction to it. During administration, he asked when the vaccine was opened. The person who was administering it said sometime in April. He saw online the vial should be discarded after 12 hours once punctured. No treatment medications were reported. This case was linked to MOD-2022-555870, MOD-2022-555960, MOD-2022-555961 (Patient Link).
A slight red area appeared on 12/29/05 on upper L arm.  Area is 2.5 x3.  Not warm to the touch but is tender.  Patient having no problems with movement in the extremity.  Dad of patient not sure if she is receiving Tylenol or Benadryl.  Advised to use Tylenol for the soreness and warm compresses.
In September i was diagnosed with High Blood pressure and a UTI. Have not had high blood pressure prior to vaccine or UTI. Not sure if these are related to Moderna vaccine or not.
Please see below, this is the note from MD: "36 yo M here due to not feeling well after 2nd COVID vaccine. Patient got the J&J vaccine in March. Patient did not get his card and was tired of being on quarantine at other facilities, so patient did not disclose that he was already vaccinated and then requested vaccination here. Received on 6/25 Pfizer #1, 7/16 was given 2nd COVID vaccine. About 2 nights ago woke up with NBNB vomiting x 3 times, headache, chills and body pain, injection site pain. Feels like "strep throat." Now is only congested, body pain, and throat pain. No other issues. Denies any medical history."
Anxiety/extreme amount of anxiety; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced anxiety/extreme amount of anxiety on an unspecified date in Jul2021. Reporter states, she got the COVID vaccine and she had been experiencing  an extreme amount of anxiety.  Product details and pharmacy details could not be probed as the consumer was unwilling to complete the report. Hence limited information available over the call. NDC number and UPC number of COVID-19 vaccine was unknown. The outcome of event was unknown.   Information on lot/batch number has been requested.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
similar reaction hives the whales/the welts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD-2023-710892 (RA).  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: URTICARIA (non-serious), outcome "unknown", described as "similar reaction hives the whales/the welts". Therapeutic measures were taken as a result of urticaria. Additional information: There were a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the whales. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But at the time when they had them they took an antihistamine and it relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300081003 Same reporter, same drug, same event, different patient;US-PFIZER INC-202300081004 Same reporter, same drug, same event, different patient;US-PFIZER INC-202300081005 Same reporter, same drug, same event, different patient;US-PFIZER INC-202300081006 Same reporter, same drug, same event, different patient;US-PFIZER INC-202300081007 Same reporter, same drug, same event, different patient;US-PFIZER INC-202300080315 Same reporter, same drug, same event, different patient;
Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27; Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) and PRODUCT STORAGE ERROR (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 3:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 3:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) and PRODUCT STORAGE ERROR (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reportedly patient ethnicity was given.  Concomitant medications details were not reported by the reporter.   Booster vaccine administration time reported as 15:27:29. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
I called to determine if this would be considered "serious" at 4:19PM, but was unable to speak to a person; got a recording, which is of no help.  After receiving the vaccine, I am experiencing severe arm pain (difficult to sleep because of the pain); exhaustion; horrible muscle aches and pains; chills.  I know this will end in 2 or 3 days, but was wondering if you needed to be aware of it.  I am not returning to the doctor's office or the ER; I am staying in bed until this is over.  I accidently entered two vaccines on the form;  received only one.  I think it was Shindrix-not sure.  It was a Shingles vaccine.
Shortness of breath, similar to asthma attack.  Symptoms began within 5 minutes following vaccination. Child's mother was present and took child home to use inhaler, which did not improve condition.  Child's mother then took child to ER for observation/evaluation.  No nebulizers or other treatments provided, given Benadryl.
vaccine administered with temperature deviation; A spontaneous report was received from a healthcare professional (HCP) concerning a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect product storage/administered with a temperature deviation.  The patient's medical history was not provided. No concomitant product use was reported.  On 26 Jan2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 26-Jan-2021, the vaccine which was initially frozen had a 45 minute excursion when was left out of the freezer, at the room temperature (approximately 65 degrees Fahrenheit) and was put back into the freezer (-23 degrees Fahrenheit). No adverse events were reported.   Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, incorrect product storage was considered recovered/resolved.; Reporter's Comments: This report refers to a case of product storage error for  mRNA-1273 (Lot number: unknown) with no associated AEs.