chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administerd dose from vials punctured and refirgerated for more than 6 hours; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine, and  who experienced 3 or 4 employees have received doses from vials that have been open and refrigerated for more than 6 hours.   The patient's medical history was not provided  Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (LOT# unknown) on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist reported that he was taking some days off and while he was off, three or four employees received the Moderna vaccine from vials that had been open and refrigerated longer than six hours. The pharmacist wanted to know if the six hour window was becuase of possible infection, lack of efficacy or some other reason.  He also questioned whether or not he needed to vaccinate his employees again. No adverse events were reported.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, 3 or 4 employees have received doses from vials that have been open and refrigerated for more than 6 hours, was not provided.   The event, 3 or 4 employees have received doses from vials that have been open and refrigerated for more than 6 hours, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of out of specification product use.
Major chills, shivering before bed. Woke up still having chills, extremely tired (unable to get up for work). I woke up later with a headache. When I did get up (midday) I had trouble walking straight so I went back to bed after taking some ibuprofin. Got up about 8pm feeling better but not quite right. Felt ok next morning (29th)
This spontaneous report was received from a medical assistant refers to a male patient (her son) of unknown age. On an unknown date the patient was vaccinated with a dose of PEDVAXHIB (lot#, expiration date and route not reported). On an unknown date there was a possibility that her son had been administered sterile diluent instead of PEDVAXHB on an unspecified date. Cannot rule out PEDVAXHIB. No adverse effect reported. Additional information has been requested.
Fever 102.1, body chills, body aches, nausea, vomiting, could not keep food or liquids down, headaches. All symptoms started on 5/08/21 and continued until 5/12/21.
Administered after the vaccine had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the vaccine had expired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the vaccine had expired). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered after the vaccine had expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medications was reported. Reporter reported that none of the patients experienced any reported symptoms.   This case was linked to MOD-2021-413581, MOD-2021-413560, MOD-2021-413545, MOD-2021-413568, MOD-2021-413587, MOD-2021-413590, MOD-2021-413591, MOD-2021-413593, MOD-2021-413594, MOD-2021-413597, MOD-2021-413598, MOD-2021-413599, MOD-2021-413600, MOD-2021-413434 (Patient Link).
Flublok was administered to a 15 year old patient, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: unknown, expiry date: unknown) via unknown route, on 02-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  Information on the batch number was requested.  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 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.
"The first night I went home and my shoulder was sore, all the way to my joint. The next day it was like my shoulder and my neck. and then it moved on to my other shoulder." Clarifies that it started in the left shoulder and moved to include the right shower within 3 days of the injection. Describes the pain as an internal aching soreness. Reports that it improved briefly last week, over the this past weekend is worsened. Denies strenuous activity over the weekend. Denies treatment - OTC meds or seeking medical advice.
pt admitted to hosp with severe COVID pneumonia, AHRF; on high flow O2; DNR; placed on comfort care; encephalopathy and her condition continued to worsen; no response to verbal or tactile stimuli for 2 days prior to her death in the hospital
pt recv vax 1995 & 6FEB98 pt devel chickenpox;pt recovered;
Patient is dizzy, sweaty, headaches, after getting the vaccine. The patient was given water and saltine crackers and was feeling better. She went home with her parents which drover her there.
I have had tinnitus for 24 years in both ears; however, for a year (around the vaccination), my left ear had a much louder and different sound of tinnitus. I also received a flu vaccine for the first time in December 2020.
Rash on inside elbow of right arm for 10 days; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 16Apr2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, polycystic ovarian syndrome (PCOS) and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 19Mar2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced rash on inside elbow of right arm for 10 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. On 17Apr2021, the patient underwent  SARS-CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event rash on inside elbow of right arm for 10 days was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 20JUL70 & pt alleges that currently exp Epstein-Barr virus synd, chronic fatigue, hypothyroidism, facial tenderness, swollen lymph nodes & chronic arthritis; No further details were provided;
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    This case was for 16th patient out of 19 reported.  No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 16 of 19
Headache, Myalgia, Diarrhea, fatigue, chills Narrative:  Other Relevant History:
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
Injection site itchy; Injection site rash; Injection site red; Injection site soreness from needle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site soreness from needle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site soreness from needle). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site soreness from needle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
Narrative: "I have a intense burning sensation from my elbow to just before my underarm daily, also there is feeling of a cold and hot drip under my skin. This are is very tender and feels raw. Symptoms started one or two days after injection."
No adverse event Covid 19 vaccine expired 10/27/2022 Given 11-16-2022.
Sunday morning I woke up  5:30am with a mild headache.  I had a cup of coffee & toast and 5:45 took 1 500mg Tylenol.  Felt sleepy, so went back to sleep. I took Tylenol 6 hours later, but this time added 2 tablets of cold calm.  Then did drink water throughout  the day.  Slept afternoon and felt a bit better by 5pm. Took an other Tylenol at  8pm and did not take cold calm. Woke up  5:10 Monday morning, feeling much rested and no headache. I see my Primary Doctor on Thursday and will tell her  my reaction.
fever; chills; rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. On 10th April 2022, less than 2 weeks after receiving Shingrix, the patient experienced fever, chills and rash. On an unknown date, the outcome of the fever, chills and rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: This case was reported by patient. The patient reported that she received her first dose of Shingrix last week and yesterday before the day of reporting she experienced fever, chills and rash. The reporter did not consented to follow up.
Bell's Palsy. Entire right side of face paralyzed. Prescribed prednisone and valacyclovir. Face still paralyzed at time of this report.
major lip swelling; sore throat; muscle pain; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31May2021, one week after the vaccination, the patient experienced a delayed reaction of major lip swelling (the patient had lip filler), sore throat, muscle pain and slight fever. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events major lip swelling, sore throat, muscle pain and slight fever were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Narrative: COVID infection following COVID vaccine series 02/08, Moderna , dose #1 03/08, Moderna , dose #2 10/25 pt/inr: 11.13/1.01 10/25 COVID swab, result: not detected 10/29 CRP: 1.948 10/29 ESR: 3 11/05 COVID swab, result: detected 11/05 pt cc: HEADACHE exposure: unknown
fevers, breathing became worse , post nasal drip and nose blowing all day. cough, sore throat, poor appetite, night sweats
This spontaneous report was received from a nurse (immunization official) concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates (from 01-MAR-2016 to an unspecified date), the patients were vaccinated with improperly stored doses (incorrect product storage ) of ROTATEQ orally, lot L020859 and lot L023870, (the expiration dates and dose were not reported) for prophylaxis. No adverse events reported at this time. The call was made by the data logger with a registered temperature of 10.3 °C during 107 hours and 30 minutes and there was no previous temperature excursion registered. This is one of three reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA004691: US-009507513-1701USA004692:
Patient started feeling light-headed and dizzy within a minute after vaccine, started feeling sweaty with nauseous.  Lasted about 15 minutes til felt back to normal.  Used 2 ice packs applied to front and back of neck area, had some cold water and orange juice during this time.  Offered area for her to lie down with feet up but patient didn't want to.  Patient stayed in pharmacy area for observation an additional 30 minutes after this.  Left pharmacy feeling back to normal.
Patient developed a warm red and swollen local reaction within one day of vaccination - at vaccination site. No respiratory symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 28Mar2023 to 01Apr2023.  Based on investigation result conclusion: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940; lot FF8839, fill lot FF8833, and the bulk formulated drug product FA9148; lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319; lot EM9810, fill lot EM9806, and the formulated drug product lot EM9808 and lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency [Name] concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148519 Same patient/reporter, Different drug/adverse event;
LOST 6-8 POUNDS; BAD TICKLE IN THE BACK OF THROAT THAT WON'T GO AWAY; LEGS CRAMPED UP; COULD NOT MOVE FINGERS OR MOVE BETWEEN HER ARMS TO HER ELBOW FOR 5 MINUTES; BAD ITCHING; COVID SYMPTOM; BODY FELT SO BAD; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 174 pounds, and height was 63 inches. The patient's concurrent conditions included: fibromyalgia, graves' disease, endometriosis, hypertension, penicillin allergy, celery allergy, bees allergy, dust allergy, mold allergy, pollen allergy, drinks alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage and also had not been sick in 10 years before getting vaccine despite having 3 autoimmune diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. Concomitant medications included fexofenadine/pseudoephedrine hydrochloride for allergy. On 29-SEP-2021, the patient experienced bad itching. On 29-SEP-2021, the patient experienced covid symptom. On 29-SEP-2021, the patient experienced body felt so bad. On 14-OCT-2021, the patient experienced legs cramped up. On 14-OCT-2021, the patient experienced could not move fingers or move between her arms to her elbow for 5 minutes. On an unspecified date, the patient experienced lost 6-8 pounds, and bad tickle in the back of throat that won't go away. Laboratory data (dates unspecified) included: Weight (NR: not provided) 6-8 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid symptom on OCT-2021, and legs cramped up, and could not move fingers or move between her arms to her elbow for 5 minutes on 14-OCT-2021, had not recovered from lost 6-8 pounds, and bad tickle in the back of throat that won't go away, and the outcome of bad itching and body felt so bad was not reported. This report was non-serious. This case, from the same reporter is linked to 20211039718.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JUN-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient presented to ER with R back pain paresthesia.  CTA performed:Segmental and subsegmental pulmonary emboli involving the left upper lobe.
Immediate: arm numbness and tachycardia Day 1: injection site swelling swollen, tender, red, and warm; myalgias; occipital headache; general malaise Day 2 & 3: injection site swelling swollen, tender, red, and warm (still ongoing)
Diarrhea, SEVERE  abdominal pain,  from 2/23/21 to 2/27/21. Did not go to a Dr. as I thought it would go away, then by the time it didn?t, it was the weekend. It subsided by Monday so I thought it might be food poisoning, although no one else was sick who ate the same thing I did.