chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no other AE; Caller is a state vaccine coordinator who reports a vaccines were administered following a temperature excursion. Nine patients were reported to have received this product following the temperature excursion; other AEs are reported in cases 02256465,; This spontaneous report was received from state vaccine coordinator, concerning to 4-month-old patient of unknown gender. The patient's medical history, previous allergies reaction, concomitant medications and concurrent conditions were not reported.   On 27-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral, (lot # W004501, has been verified to be a valid lot to ROTATEQ, expiration date: 20-APR-2023) for prophylaxis (strength and dose regimen were not provided). The administered vaccine, live, oral, pentavalent (ROTATEQ) underwent to temperature excursion of  8.6 degree Celsius for 18 minutes (product storage error). Additionally, it was informed that there were a previous temperature excursion on unknown dates of 11.5 degree Celsius for 1 hours 6 minutes, 8.8 degree Celsius for 21 minutes and 9.6 degree Celsius for 6 hours 41 minutes. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010908: US-009507513-2209USA010872: US-009507513-2209USA010921: US-009507513-2209USA010983: US-009507513-2209USA010940: US-009507513-2209USA010884: US-009507513-2209USA010833: US-009507513-2209USA010910:
Patient states that he felt light headed and near syncopal. Onset immediately after having received vaccination to LT deltoid. Vital signs were assessed by medics on site standby. Patient appeared diaphoretic, pale and warm . Patient states he does not have medical HX,  NKA, last oral intake was yesterday, unknown time. Patient denies use of paraphernalia, no medication taken prior to vaccination. Vital signs Pulse 56, SPO2 97%, BP 86/palp. No interventions performed. Fire/rescue was called to site to further assess patient. After approximately 10 minutes, patient states he started to feel better and refused assistance/transportation by EMS. Last set of vital signs BP 110/78, P 58, SPO2 100%. Patient regained normal color, skin warm and dry. Patient was kept an additional 15 minutes for observation.
I was in a Covid trial 2021 blinded test. I went twice. After I had the 2nd shot I was in the ER for heart/bp (ER 2-10-21). They won't unblind the test for a while and I'll hear back which vaccine was used. 1st/2nd Pfizer vaccine gave me a lil trouble regarding my heart/bp, but I never went to the ER for it mainly high bp for days afterwards. Rec'd Moderna booster 9?21 & in ER 12-11-21. That one was bad. They called the crash cart but then the BP started to drop.
Boostrix went down to 29.67 F and was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21-JUN-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix went down to 29.67 F and was administered to a patient). 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: 21-JUN-2023 The reporter stated that Boostrix went down to 29.67-degree Fahrenheit and was administered to a patient this morning (on the day of reporting). The vaccine administration facility was the same as primary reporter. The healthcare professional declined to provide patient details and did not have the vaccine details (lot, expiration date) at the time of the call.  The reporter consented to follow up via postal.  The patient received a dose of Boostrix went down to temperature 29.67-degree Fahrenheit, which led to incorrect storage of drug.
received 4 doses of Shingrix /second dose given 14Apr2021; received 4 doses of Shingrix / first dose in second series was given 14Nov2020; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th August 2019) and Shingrix (2n dose received on 24th January 2020).   On 14th April 2021, the patient received the 4th dose of Shingrix. On 14th November 2020, the patient received the 3rd dose of Shingrix. On 14th November 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 14th April 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were reported as follows: The patient received 3rd and 4th dose of Shingrix, which led to extra dose administered. The reporter consented to follow up via email. No other information provided.
(L) arm deltoid area where immunizations DTAP/IPV given - red approximately 2-3 cm area of redness/papules in center - rash comes/goes - last few hrs - pain - q 1-2 weeks.
64-year-old male who presented to ER with complaints of dehydration and shortness of breath.  States he has had nausea, vomiting, diarrhea, nonproductive cough, decreased appetite, and decreased urine output since Monday.  Has not had much intake and has not been able to take his med since Monday.  He did not experience shortness of breath until today and reports receiving his Johnson & Johnson COVID vaccine in April.  He denies fever, chest pain, sick contacts, or change in taste or smell.  On my arrival, patient was noted to be on 6 L/NC of O2, with an SaO2 of 88-89%, then would temporarily go up above 90%.  As we were talking further, SaO2 dipped to 77% and he had significant respiratory distress.
While abroad, patient received his AVA (1) vaccine. He received no other vaccines on that day. Within 15 minutes of vaccine receipt, patient experienced feeling "clammy" and noted tightness in his chest. He broke out in a pruritic rash in his anticubital areas, behind his knees and across his abdomen. He was given BENADRYL and monitored in the immunization clinic for 1 hour. When he was released, his symptoms had resolved except for the rash on his abdomen, which has changed in appearance, but persists to date. Skin symptoms - Within 2 weeks of receiving his anthrax vaccine in 1999, patient began noting rashes or "splotches" on his back, his face and along his hairline, behind his ears and on his buttocks. Because of mission priorities, evaluation and treatment were often delayed. He was initially treated with a variety of topicals, none of which were effective. He has seen at least 2 Dermatologists and has had at least 2 biopsies. Recently started on MTX.
mom reports pt crying, vomiting, fever 105, rec'd tylenol/benadryl per call to md. mom did not know if site swollen, pt rec'd tylenol prior to adm of vax
Lt arm ached for a couple of days then started with rash-later had a welt itchy-MD suggested using Benadryl.
Expired vaccine used; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PAIN IN EXTREMITY (sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021 at 3:39 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. On 27-Oct-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
swelling, redness pain and warmth at site.   Fever (101) body aches, fatigue
ACT-HIB at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; ACT-HIB at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2022SA370866, 2022SA372086, 2022SA372080, 2022SA372584, 2022SA373534, 2022SA371564, 2022SA371948, 2022SA372095, 2022SA372123, 2022SA372180, 2022SA372199, 2022SA372581, 2022SA373167 and 2022SA372581.  This case involves a 1 years old female patient who was administrated HIB (PRP/T) VACCINE [ACT-HIB] post excursion at a low of negative 5.1 C (Celsius) out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient received 0.5 ml, total, dose 4 of suspect HIB (PRP/T) VACCINE, unknown formulation (lot UJ665AA, exp date: 11-Mar-2023) via intramuscular route in the right thigh as Immunization.  On an unknown date the HIB (PRP/T) VACCINE [ACT-HIB] at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes (product storage error) and was administrated post excursion on 31-Aug-2022 with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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.; Sender's Comments:  US-SA-2022SA372080:
pt recvd vax & 2-3 days post vax exp generalized hives which were raised & the size of a thumbnail
I do not believe this was related to the vaccine in any way, but based on my answers to my most recent V-Safe check-in, I was called and asked to submit a report here. I was vaccinated in April with my second Covid shot and then in August, I tested positive for Covid. I was sick and had to stay in bed for a week and a half and then I continued to fatigue very quickly and have my heart race whenever I did any physical activity at all, even minor things like walking up stairs or across my home.
COVID vaccination  #1 side effects:  My left arm felt sore and limited range of motion above my head the following day for about a day and a half.   Also, general moderate malaise for about a day and a half.  COVID vaccination  #2 side effects:  Approximately four hours after injection, I started to feel  Left arm soreness which increased over four hours and achy lymph nodes in my arm pit and along the left side of my chest. During the next 36-40 hours, I had a temp of 100. 3-8 degrees F. The entire time my joints were moderately achy and sore with general moderate malaise and loss of appetite.
approx 3 mins following administration of vax pt briefly lost consciousness, fell backwards, arched slightly, eyes rolled in head, hadns clenched, inc heart rate, skin pale; episode lasted 20-30 seconds; no treatment necessary;
Patient was given PNEUMOVAX 23 vaccine. After 5 minutes, patient started to complain of throat narrowing and difficulty breathing. Patient also developed urticarial rash on face. Oxygen sat was 93% with HR 113/min. Patient was given 7.5 ml Diphenhydramine HCl 12.5 mg/5 ml suspension. Patient's O2 sat improved to 98% on room air a few minutes after, but feeling drowsy. Patient was tachycardiac with good air entry and mild wheezing. EMS arrived thereafter.
approx 3 minutes p/vax pt became sick @ stomach, lost all color in face lips, broke out w/sweat, & fainted for about 2 seconds, but for about 2 minutes could not keep child awake; pt did not have problems breathing & no reactions @ sites;
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st received more than 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2023 A pharmacist called to ask for information about patient who received the first dose of Shingrix more than 6 months ago. The Healthcare professional asked if the patient need to restart the series. The reporter did not provide information about the patient. The reporter consented to follow up. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023124590:Same reporter, patient 1 of 3 US-GSK-US2023AMR127218:same reporter, patient 2 of 3
No adverse events noted. Pediatric formulation of COVID-19 vaccine inadvertently administered to 15 year old. In consultation with clinical director, a subsequent dose of the age appropriate formulation was administered 20 minutes later.
Mom reports that patient..."was up all night with a 103 degree fever, vomiting and terrible body tremors". Vomiting stopped, but continued with fever and some muscle aches in legs by 24 hours later. By 02/08/2018 at 9:00 am had a temperature spike in the night, but better this morning.
Hep A, Influenza   Complaints of increased temps over 11 days afer vaccines.  Persistent headaches starting 2 days after vaccine to her reporting to us on 2/19/2008.  Bilateral arm pain as 2 vaccines received.
Headache, chills, joint pain for 48 hrs. Completely incapacitating Injection site pain and swelling
killed himself; tinnitus; contracted the virus; contracted the virus; This is a spontaneous report from a non-contactable nurse. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization.  Medical history included COVID-19 on an unknown date. The patient's concomitant medications were not reported. It was reported that the patient, contracted the virus and developed tinnitus after receiving the vaccine and killed himself. The outcome of the event tinnitus and contracted the virus was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a causal association between the reported event tinnitus and BNT162B2 cannot be excluded. Drug ineffective depends on many fators including pharmacokinetics, patient general health condition and immunity system function. However on conservative basis, the possible causality cannot be excluded. The event "killed himself" is not related to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: killed himself
Itch has gotten worse; Redness that is spread all the way up to shoulder, up to 6-8 inches; Arm started itching, itching is not stopping; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Itch has gotten worse), ERYTHEMA (Redness that is spread all the way up to shoulder, up to 6-8 inches) and PRURITUS (Arm started itching, itching is not stopping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Itch has gotten worse), ERYTHEMA (Redness that is spread all the way up to shoulder, up to 6-8 inches) and PRURITUS (Arm started itching, itching is not stopping). At the time of the report, CONDITION AGGRAVATED (Itch has gotten worse), ERYTHEMA (Redness that is spread all the way up to shoulder, up to 6-8 inches) and PRURITUS (Arm started itching, itching is not stopping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Patient called  doctor's office and had telemedicine appointment with the physician's assistant who offered topical antihistamine prescription but patient denied as it has never helped the patient in the past.
Information has been received from a health professional concerning a 24 month old, who's infant sibling was vaccinated with a dose of Rotavirus vaccine (lot 652964/0145F) on 7/28/06. There was no concomitant medication. It was reported that the pt developed diarrhea. Follow up information from a health professional indicated that the vaccainted child was perfectly fine and had no symptoms of diarrhea. The reporter thought that it would be strange for the pt to have developed diarrhea in such a short period of time of 24  hours after the infant receiving the vaccine and that most adults would be immune to Rotavirus vaccine. the reporter noted that no family member were immunocompromised. The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the time that the child was vaccinated with Rotavirus vaccine. the pts brother experienced diarrhea following vaccination of his infant sibling with Rotavirus vaccine (WAES0610USA05119). Additional information has been requested. Follow-up information from a health professional indicated that the vaccinated child was perfectly fine and had no symptoms of diarrhea.  The reporter thought that it would be strange for the patient to have developed diarrhea in such a period of time of 24 hours after the infant receiving the vaccine and that most adults would be immune to ROTATEQ.  The reporter noted that no family member were immunocompromised.  The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the same time that the child was vaccinated with ROTATEQ.  The patient's brother experienced diarrhea following vaccination of his infant sibling with ROTATEQ (WAES# 0610USA05119).  Additional information has been requested.
The pt became febrile with a temp of 102 lasting over 24 hours after vax. The pt was also quite irritable and uncomfortable. No other symptoms were noted.
This spontaneous report has been received from a registered pharmacist refers to unspecified patients of an unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot No: J013137; expiration date: 17-Jan-2015 (dose and route were not provided). The registered pharmacist stated that on an unknown date, the doses of ZOSTAVAX were previously exposed to 31.5F for a cumulative time of 71 hours, were not exposed to the more recent temperature excursions. Additional information has been requested.
pt recv vax; c/o soreness few days p/ vax; now w/ redness, inc soreness & tenderness;
The arm around the area where the shot was red; very warm; there was a bump; It was a rash 6 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The arm around the area where the shot was red), VACCINATION SITE WARMTH (very warm), VACCINATION SITE SWELLING (there was a bump) and VACCINATION SITE RASH (It was a rash 6 inches in diameter) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L204) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (The arm around the area where the shot was red), VACCINATION SITE WARMTH (very warm), VACCINATION SITE SWELLING (there was a bump) and VACCINATION SITE RASH (It was a rash 6 inches in diameter). At the time of the report, VACCINATION SITE ERYTHEMA (The arm around the area where the shot was red), VACCINATION SITE WARMTH (very warm), VACCINATION SITE SWELLING (there was a bump) and VACCINATION SITE RASH (It was a rash 6 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Broke out in hives all over my body.  Also had headache, nausea, dizziness, sore arm, tired
temporal lobe seizure (focal impaired awareness seizure) Patient had one of her typical temporal lobe seizures.  She had been seizure free on medication for years prior to this episode.
Redness and swelling on upper left arm, slight bruising. Minimal pain. Areas of firmness.