chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine 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.   The patient age was reported as 83.73   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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   On 11-Jan-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 PM: 35, 1PM: 36, 2 PM: 37 and 3 PM: 37.  On 11-Jan-2021, Excursion time was 2 PM, temp was 35 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vial was moved to clinic. Vaccine BUD date was 07-Feb-2021.  No treatment information was provided.
Hives started next day. Progressively got worse until they were on my eyelids.  Went to urgent care after 6 days. Given a steroid shot and 5 day oral steroids as well as rx antihistamine.  Rash and severe itching continued for 24 days.
BAD RASH ALL OVER HER BODY; This spontaneous report received from a consumer concerned an 86 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2021, the subject experienced bad rash all over her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad rash all over her body. This report was non-serious.
Diarrhea for 10-12 days starting on 7/16/17. Also diaper rash and fussiness. Seen in office 7/18/17 and 7/25/17 for rash and diarrhea.
was sick all winter; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.   This case involves patient (unknown demography) who was sick all winter (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick all winter (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
The patient reported dizziness, upset stomach and headache after immunization. The pt also fell down after getting dizzy. The pt denied hitting her head. Pt asked her PCP and was informed that she can take 2 Tylenol.
Initial information received on 29-Jan-2019 regarding an unsolicited valid non-serious case received from another health professional. This case involves a 17 months old male patient who was vaccinated with a 0.5 ml dose of vaccine QUADRACEL instead of DAPTACEL (lot C5497AA and Exp. Date 17-JUL-2020) via unknown route in the left thigh on 16-Jan-2019. The patients medical history not reported. The patient had three DTaP vaccines in the past. Concomitant vaccinations included ACT-HIB; PREVNAR and FLULAVAL for Immunisation. It was an actual medication error case due to wrong vaccine administered. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Total body numbness, trouble breathing, extreme pain at injection site, GuillainBarré syndrome.
The day after second vaccine I awoke with left underarm and neck lymph nodes swollen, tender, uncomfortable, with slight redness to area.  Over course of next 5 days I felt more tired  than usual as swelling subsided.   After first vaccine I only experienced left arm soreness at injection site,  mild headache and some tiredness for first 24-36 hrs.
got two shots have Shingles/ Suspected vaccination failure; went to er, shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the two Shingles shots a year before the date of reporting and went to the emergency room last Friday and had the Shingles. The patient stated it was horrible. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
No adverse effects reported; patient received expired dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 23-APR-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) lot # N024717, expiration date: 06-APR-2019 (dose, frequency and route not provided)  for prophylaxis (expired product administered). No adverse effects reported.
Extremely swollen lymph nodes in neck and arm pit in left side. Continuing neck soreness and pulsatile tinnitus both of which began in early February after receiving the vaccine.
The patient reported worsening skin reaction to Sanofi Pasteur intradermal vaccine beginning on her drive home from the store.  She states there was a burning sensation at the site of the injection and she developed a few localized hives.  She did not have problems breathing or hives beyond the injection site.  The site reaction worsened and she contacted her physician the following morning. The physician prescribed a course of prednisone to reduce the swelling and injection site reaction.  The patient reports a four inch diameter area of raised, reddish/purple skin which itches and burns.
sx inc swelling, pain, nausea, sweats, & chills;tx off work 1 days, rest arm, heat w/heating pad to site, Naprosyn, return  if any problems;
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 38-month-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 29-Nov-2010. On 07-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. 09-Mar-2011: Follow up call was conducted on 09-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Information has been received from an administrator referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of RECOMBIVAX HB (lot # K010216 with expired date of 17-SEP-2016, lot# K018180 with unspecified expired date, dose and route were unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
On 1/12/21, woke up with area of redness and swelling near injection site. It proceeded to extend down my arm until 1/15/21. Warm to touch, erythematous, raised and indurated. No fever or other signs of illness. Slowly subsided by 1/17/21.
Symptoms started with a stiff neck and a raspy voice shortly after injection. They continued throughout the day and into the evening became more intense. The next morning I had severe pain at the base of my skull that radiated through my head. My eyes hurt and it felt like I had skinny sticks piercing through the roof of my mouth and sinuses. My head felt like it was going to split open. The pain from the base of my skull radiated down my shoulders and down to the middle of my back. It only felt bearable to lay down on a heated mattress pad and flat. I was nauseous about an hour after the shot into the next day. Eventually I sat with a heating pad on my back and took 4 Ibuprofen. It helped slightly, but the pain in the neck (base of skull) lasted all day and into the next. I managed the pain by taking more Ibuprofen.
Patient was given a lower than recommended dosage, mother (legal guardian) denied any adverse effects after vaccine. Advised to return to clinic for administration of vaccine with correct dosage.
PATIEN FAINTED AFTER ABOUT   RECEIVING FIRST DOSE MODERNA COVID-19 VACCINATION. PATIENT REGAINED CONCIOUSNESS FEW MINUTES LATER.
VACCINE IS GIVEN TO A 17 YEARS OLD AND 6 MONTHS PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAR-2021, the vaccine was given to a 17 years old and 6 months patient (coded as off label use and drug administered to patient of inappropriate age). Nurse wanted to know if there was anything she need to do from their end. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine is given to a 17 years old and 6 months patient and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350675-COVID-19 VACCINE AD26.COV2.S -Vaccine Is Given To A 17 Years Old And 6 Months Patient, Off Label Use. This events are considered not related. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Swallowing and voice changes issues that Cardiologyst thought it was due to Hypertension pill, we changed the pills three times and the condition continues. Vocal cords were examined and they were fine.
Patient had no adverse effects or symptoms from this dose; A dose of PROQUAD and VARIVAX were both given to a patient on the same day; This spontaneous report has been received from a medical assistant regarding to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  On an unknown date (also reported as 17-JUN-2022), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant human albumin]) (PROQUAD) (strength and route of administration not reported)  (lot number U029320 with expiration date 19-MAR-2023) administered at a dose of 0.5 mL, once, for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported) (lot number U020238 with expiration date 28-JUN-2023) administered at a dose of 0.5 mL, once, for prophylaxis.  The medical assistant reported that on the day of vaccination, both doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant human albumin]) (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) were administered to the patient (overdose). The patient did not have adverse effects (no adverse event) or symptoms from this dose.
Red blister/boil like mark, increased redness, hard to the touch, no fever, not hot, no body aches that started 24 hours after injection.
Rash on face the evening of 10/30/12. Benadryl was administered orally.  10/31/12 c/o headache and facial edema.
It was reported that a patient (6 of 6) received a Fluzone SV '01-'02 vaccination, Lot number U)590AA administered IM on 09/26/01. Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and the symptoms resolved. Linked cases: U2001-01025, U2001-01195, U2001-01196, U2001-01197 & U2001-01198.
I had some of the expected side effects described on the fact sheet (for my first dose 3 weeks prior I didn't have any side effects besides some slight arm soreness). I didn't notice any significant symptoms for about 11 hours following my 8:45am 2nd dose on the 26th. Then in the evening I started getting a fever, chills, soreness in the legs in addition to existing arm soreness. The fever got up to about 102 F I believe around 10-11pm, at which point I took 200 mg ibuprofen. I slept for most of the next day when possible, and the fever dropped to a bit above 100 F before rising slightly in the evening. Still had chills (shivering, teeth chattering). I took another 200 mg ibuprofen that evening. As of today (28th) the fever is gone and, besides a mild headache, I feel much better.
Headache, Fever, NauseaVomiting, chills, abdominal pain, shortness of breath Narrative:
Pt. received BEXSERO vaccine in (L) deltoid on 2/14/18. She awoke in early morning 2/15/18 C/O sharp pain in upper (L) arm, extending from shoulder to elbow. Pain was decreased with administration of heat and PO ALEVE. No neuro deficits noted on exam 2/15/18.
Pt recvd 3 doses of Engerix-B 30OCT90, 26NOV90 & 24MAY91 & 14OCT91 it was determined that pts titer was neg p/3 doses of Engerix-B;
approx 10-15 minutes post vaccine administration, patient reported tightness in throat, left arm tingling, and right shoulder pain. Epipen was administered, patient was taken by ambulance
On 08 Feb, patient reported burning sensation in RT arm immediately following immunization and a generalized feeling of flushing or "hotness." Patient reported diarrhea approximately 3 hours later. On the morning of 09 Feb, patient reported swelling and tenderness across chest and into the Right Armpit. The patient went to see a physician on the morning of 10 Feb. Redness appeared on the morning of 11 Feb across face and chest area. Patient was given cetirizine to be taken 10 and 11 Feb.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Intense shaking and trembling, weakness and aching of legs. Making sleep difficult. Had similar symptoms when doctor gave him flu AND pneumonia shot on the same day.
Information has been received from a registered nurse referring to three patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with VAQTA (dose, route and lot# were not reported), which were improperly stored. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
erythema and induration at injection site about 4cm*5cm in size. Regional lymphadenopathy
I'm having issues with my heart, my heart races my muscles then hurt then I get extremely dehydrated, heart rate went into the 200s, I'm having diarrhea, stomach pain, water and loose stools, muscle weakness when I walk, I stumble a lot,.
My ear started clogging up, as the day went on it got worse. They said I had sudden sensor neural hearing loss. The noise in my ear are so serious I can't hardly think. Its double echoing, vibration, and whistling.  It feels like I am under water. The noise is 24/7. It feels like someone is in my head talking from the inside out. It is completely debilitating. It is still going on at this time.
Avascular necrosis; COVID-19; COVID-19;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4197207-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10May2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 2 wk)) for rheumatoid arthritis. Relevant medical history included: "Ankle pain", start date: Apr2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 04Dec2021, outcome "recovered" (2021) and all described as "COVID-19"; OSTEONECROSIS (medically significant), outcome "unknown", described as "Avascular necrosis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive. The action taken for adalimumab was dosage permanently withdrawn. It was reported that, the solicited report from the PRIVACY by a consumer of a 55-year-old female patient with events of Avascular necrosis and non-serious COVID-19 Symptoms with HUMIRA (ADALIMUMAB). PFIZER BioNTech COVID-19 Vaccine (TOZINAMERAN) was also considered as suspect. She reported ankle pain which was prior to initiation of Humira and it was diagnosed as Avascular necrosis. It was unknown whether the patient was enrolled in a COVID-19 vaccine trial. Stated that, the primary reporter did not have the lot number information as the packaging was discarded.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Avascular necrosis and COVID-19 symptoms was not reported. opinion was that there was no reasonable possibility that the events of Avascular Necrosis and COVID-19 symptoms are related to HUMIRA(ADALIMUMAB). The reporter's causality of PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) for the event(s) of Avascular necrosis and COVID-19 symptoms was reported as Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events. Case will be reviewed further on receipt of FU information  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Rash at the injection site; A spontaneous report was received from an other health professional concerning patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced a rash at the injection site.  The patient's medical history and concomitant medication were not reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, after administration of vaccine, some of the patients had a rash at the injection site. Treatment information was not reported.  Action taken with the mRNA-1273 in response to the event was unknown.   The outcome of event rash at the injection site was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
9/14 had COVID bivalent 9/28 had shingrix 9/30 developed shingles