chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potential AE due to doses administered from vials that may have been compromised.; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. That was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 02-Feb-2022. Moderna date ordered was reported as 03-Jan-2022.  No treatment details were reported.
Received shot on Jan 30th.  On Feb 7th I had severe  itching and larger than silver dollar red circle that was warm to touch
The patient started to feel nauseated and warm after his vaccination.  His mother also reported that he looked sweaty.  They report that he has had the same reaction in the past with any sort of needle sticks (typically with blood draws).   His symptoms resolved over a period of 5 minutes.  He had some water and sat down and started to feel better.
Developed COVID-19 infection after being fully vaccinated. Lab confirmed Nasopharyngeal PCR test. Reported household exposure of COVID -19 from children and AuPair.
Diarrhea: green and mucous filled. Mon 9/16/2013:  Blood in stool. Blood in stool and green, mucous in stools lasted throughout week.  Still having issue at time of reporting.
Seen in clinic on 12/17/07 for complaint of "swollen left arm" at site where received Gardasil vaccine with initial sore redness swell after vaccination after 8 hours, but pain continues with limited range of motion.
I started noticing itching a week after the vaccine. I had painful lesions on my armpit, on my back underneath my shoulder blade and on my buttock. The lesions were very painful. I was diagnosed with Shingles two weeks after the first dose of the vaccine. I had to delay the second dose because I was taking the medicine for the Shingles. The Shingles cleared up a week after I started the medication. I was also exposed to Covid-19 during that time but tested negative. I also have a lingering achy feeling in the back of my throat over the last couple of months. It is an uncomfortable feeling.
Weird feeling when he urinated; Went to the bathroom twice; Arm on fire; Body feels cold; Chills; Woke up fatigue; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, and CHILLS in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, CHILLS, FATIGUE, and MYALGIA. At the time of the report, MICTURITION DISORDER, ABNORMAL FAECES, BURNING SENSATION, FEELING COLD, CHILLS, FATIGUE, and MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ice. Concomitant drugs are not provided.
A few days after my first shot I came down with shingles on my buttocks. They were typical shingles blisters that burned and itched unlike any other pain I have ever experienced. It occured on Sunday so I had to do a virtual Doctors visit. I was prescribed 2 different drugs to counter act the shingles. I do not remember what they were but my doctor should have a record of it.
Day of: Hydrated pre-vaccination. Soreness at injection site onset approx. 3 hours after vaccination and has lasted a few days. Refrained from massaging muscle or sleeping on that side. At approx. 5-6 hours post-vaccination, aches and chills onset. No fever throughout the evening. Nausea onset approx. 7-8 hours post-vaccination. Took 1,000mg of NSAID containing acetaminophen and went to bed @9pm to try to sleep it off. Day after: Woke up at 12:15am and 12:45am vomiting. Continued to have aches, chills, and fever (ranging from 99.9? to 101.5?) throughout the day. Took 1,000mg of fast acting Tylenol in the afternoon, drank fluids and rested. Two days after: Woke up @8:30am and felt faint (whistling in ears as well) for approx. 20 minutes. Continued to feel fatigued and weak throughout the day but fever and chills subsided.
Pt mentioned she did not eat dinner previous night and breakfast the morning of vaccination and right after the vaccine shot she fainted a few seconds and we watched her longer than 15mins and she said she was fine and left with her ride.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date, the patient was (route not provided) vaccinated with ZOSTAVAX (lot number and expiry date not provided). On an unknown date, the patient had a "horrible reaction" involving redness and swelling at the injection site. The outcome of "horrible reaction" involving redness and swelling at the injection site was unknown. The action taken with ZOSTAVAX was not provided. The reporter did not assess the relationship between the events and the ZOSTAVAX. Additional information has been requested.
pt recv vax 18APR97 & 28APR97 devel morbilliform rash on trunk;pt taken to hosp for the dx of rash @ which rt OM was found;
pain in extremity; Knee pain; Limbs stiffness; This is a spontaneous report based on the information received by Pfizer from AbbVie Pharmacovigilance (Mfr Report# 21K-163-3741997-00). A contactable 66-year-old female consumer (patient) reported that:  This is a spontaneous report based on the information received by Pfizer from AbbVie Pharmacovigilance (Mfr Report# 21K-163-3741997-00).  A contactable 66-year-old female consumer (patient) received adalimumab (HUMIRA) subcutaneous from unknown date for moderate to severe rheumatoid arthritis and COVID vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. Patient experienced on unknown date events of non-serious arm, hands, fingers hurt and tight/left leg hurts from knee down sometimes and arm was a little sore/hands and fingers hurt and tight with HUMIRA (ADALIMUMAB). There was no reported medical history. Covid vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Outcome of events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Rash at the injection site and arm; Rash in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site and arm) and RASH (Rash in arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site and arm) and RASH (Rash in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash at the injection site and arm) and RASH (Rash in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.
Rash head to toe entire body on 5/27/09. Started with fever 104 @ 2-3 days prior then rash. Received MMR immunization of 5/14/09.
Information has been received from a medical assistant referring to two unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. From 26-APR-2016 through 03-NOV-2016, the patients received improperly stored doses of VAQTA (lot # L009445 with expiration date 01-JUN-2017; dose and route were not reported). The temperature and time frame that the vaccine was improperly stored at were reported as below: On 26-APR-2016, 34 Fahrenheit (F) for 24 hours; On 22-JUL-2016, 34 F for 16 hours 40 minutes; On 27-JUL-2016, 34 F for 16 hours 30 minutes; On 28-JUL-2016, 33 F for 15 hours 33 minutes; On 01-AUG-2016, 33 F for 64 hours 3 minutes; On 02-AUG-2016, 32 F for 14 hours 56 minutes; On 03-AUG-2016., 35 F for 16 hours 37 minutes; On 04-AUG-2016, 33 F for 16 hours 10 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; on 09-AUG-2016, 35 F for 16 hours 1 minutes; On 15-AUG-2016, 35 F for 65 hours 30 minutes; On 08-SEP-2016, 47 F for 17 hours 18 minutes; On 09-SEP-2016, 47 F for 15 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Welts on face, face flushed, redness & pain to site down to almost the elbow. Area warm to touch - lasted 2 wks (all symptoms).
Began with scratchy throat, progressed to mild sore throat by 6PM. At 10PM examined my throat with a large magnifying mirror and found throat, mouth, tongue, lips with moderate signs of yeast infection which had not been there the day/night before.
In October of 2022 I started to cough a little bit to the point that I would need to excuse myself from the room. I thought it was being caused by allergies, I started taking Mucinex DM to help with any drainage that may be occurring and Claritin to combat the allergies. In January I had a chest x-ray that revealed that I had an anomaly in my lungs. I went on vacation, during my vacation in January my coughing was much better. Once I returned, I went to my doctor who ordered a PET scan, and I am awaiting the results.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 09-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
My daughter received Gardisil vaccine today..Number 3, and she fainted about 8 minutes after the shot.  She was okay..nurse kept us a few minutes to be sure, but then walking to the check out desk she said she didn't feel well and fainted onto the floor (I caught her on the way donw)She had no reaction to the first 2 doses, but fainted after this one.
No additional AE reported; Patient is three years and three months old and was not yet due for second dose of PROQUAD.; This spontaneous report was received from a nurse practitioner referring a 3 years and 3 months old patient of unknown gender. The patient's historical vaccines included measles mumps rubella vaccine and varicella vaccine (both manufacturer unknown). Pertinent medical history, drug Drug reactions, allergies and concomitant medications were not reported.  On 06-SEP-2022, the patient was accidentally vaccinated earlier than indicated with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, once, lot number W012739 with expiration date 16-OCT-2023, administered for prophylaxis (strength, dose, anatomical location, and route of administration not provided) (product administered to patient of inappropriate age).  No adverse events were reported.
Swelling, redness, tenderness at site of injection 7 x 10 cm size (left arm-site of DTaP).
Information has been received from a physician concerning a female patient who was vaccinated with 2 doses of GARDASIL, date of doses unknown, lot # was not reported. The patient experienced breakthrough bleeding after getting GARDASIL. Unspecified medical attention had been sought. This is one of several reports received from the same source. Additional information has been requested.
The pt experienced a 5 x 4 inch area around the injection site which became red, swollen, and painful about 9 hours after injection. The pain also involved top of shoulder and side of neck. Pain, redness and swelling lasted 4 days. Slight temp elevation onset 11 hours post vax lasting one day and was relieved by Tylenol.
Onset 2 hours prior to clinic appt: red, hot, swollen upper arm. Complained of pain. Able to move arm. 10cm firm moderately swollen erythamatous hot area left deltoid to shoulder. Some movement of arm. Dr Tx: cold packs, given Tylenol, Rx Benadryl.
RECEIVED EXTRA DOSE OF PFIZER VACCINE. RECEIVED 3 TOTAL DOSES. 02/25/2021 PFIZER DOSE #1 @ PHARMACY 03/16/2021 PFIZER DOSE #2 @ EVENT 04/13/2021 PFIZER DOSE #3 @ EVENT
Injection site redness(very small red bruised dot around site of injection); Fever of 38.8 overnight (12-15 hours after the vaccine); This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever of 38.8 overnight (12-15 hours after the vaccine)) and VACCINATION SITE ERYTHEMA (Injection site redness(very small red bruised dot around site of injection)) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced PYREXIA (Fever of 38.8 overnight (12-15 hours after the vaccine)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness(very small red bruised dot around site of injection)). At the time of the report, PYREXIA (Fever of 38.8 overnight (12-15 hours after the vaccine)) and VACCINATION SITE ERYTHEMA (Injection site redness(very small red bruised dot around site of injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
BURNING SENSATION IN VEIN; FEELING COLD INSIDE; SEVERE PAIN ALL OVER BODY; CHILLS; NAUSEA; HEADACHE; MUSCLE PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced burning sensation in vein, feeling cold inside, severe pain all over body, chills, nausea, headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe pain all over body, had not recovered from nausea, chills, and headache, and the outcome of feeling cold inside, muscle pain and burning sensation in vein was not reported. This report was non-serious.
The patient was administered undiluted vaccine of the Pfizer pediatric covid vaccine. Spoke  with the parent (father) of the patient, informed him about the side effects to watch out for (headache, fever, body aches, chills) and contact doctor if they become concerning.  Per CDC, it is okay to skip the 2nd dose if the side effects are severe with the 1st vaccine.
delayed second dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  Patient got first dose like 4 months ago and that's when patient got second one and was just wondering about the booster. Patient was good no side effects. Patient had covid vaccination report card that has the dates and stuff. The patient had no complaints, was just wondering if there's going to be a booster as the patient had the first two moderna.
After 26 year of no flares of Relapsing Polychondritis I had a major flare involving cartilage inflammation of both ears, knees, ankles and wrists. Also had eye inflammation. Symptoms treated with prednisone and methotrexate.
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of M-M-R II (lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature  excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the reports from the same reporter. Additional information has been requested.
Patient was given a Monovalent Pfizer Covid Vaccine on 04/12/2023 and it was not 60 days which is the recommendation by CDC to give the booster Bivalent Covid Vaccine that he received today.
Fever, vomiting, SOB and fatigue  for 3 days. COVID test negative
I noticed a funny metallic taste almost immediately after the vaccine. I thought it was my imagination until I saw it mentioned on a banner across the news a few nights later. The taste lasted a few hours.
a red circle that was two inches around the site, is puffed out, and is itchy.; knees have been achy; a red circle that was two inches around the site, is puffed out, and is itchy.; injection site had a 1.5 inch red circle around it and was a little elevated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a red circle that was two inches around the site, is puffed out, and is itchy.), ARTHRALGIA (knees have been achy), VACCINATION SITE SWELLING (a red circle that was two inches around the site, is puffed out, and is itchy.) and VACCINATION SITE ERYTHEMA (injection site had a 1.5 inch red circle around it and was a little elevated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Benzocaine).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (injection site had a 1.5 inch red circle around it and was a little elevated). On 05-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (a red circle that was two inches around the site, is puffed out, and is itchy.), ARTHRALGIA (knees have been achy) and VACCINATION SITE SWELLING (a red circle that was two inches around the site, is puffed out, and is itchy.). At the time of the report, VACCINATION SITE PRURITUS (a red circle that was two inches around the site, is puffed out, and is itchy.), ARTHRALGIA (knees have been achy), VACCINATION SITE SWELLING (a red circle that was two inches around the site, is puffed out, and is itchy.) and VACCINATION SITE ERYTHEMA (injection site had a 1.5 inch red circle around it and was a little elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported Treatment for the events included Tylenol and ice.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
16SEP92 mom called to report pt had vax on 15SEP92 had fever of approx 102; rash on face & lt ear; dec appetite x 2 days-crying-inject site looks nl according to mom;