chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was my first booster shot (Pfizer) following my first John&Johnson shot 6 months ago.  The day of shot: just soreness on the injected area Day 2: none Day 3: from the evening, I felt tiredness with pain in the lower neck and upper chest area. This pain persisted for about 2 hours and I started to have pain around my jaw. The jaw pain was very uncomfortable and it prevented me from sleep throughout the night. I took 1 ibuprofen pill. The next morning when I woke up, the pain was gone.
Aggravation of pre-existing peripheral neuropathy - states dx of Charcot-Marie-Tooth - but had taken influenza shots previously without problems - did not inform staff of diagnosis - not seen in clinic. Reports 1-4 days of leg achiness, T degrees to 102.5.
Erythema and edema at site. BENADRYL given- decreased RXN.
pt exp flu like sx consisting of fever, chills, cough & runny nose 2 days p/vax;
Patient received both doses about 5 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart) had resolved.            No Concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Patient presented with red patches on her forehead neck and chin that were itchy and swollen. Her earlobes were also itchy and swollen 3 days after she received the vaccine. She also had a large area of dark bruising on her arm where the vaccine was administered.
I came down with Covid, I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday; I came down with Covid, I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. Concomitant medication(s) included: LEXAPRO; SINGULAIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "I came down with Covid, I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday. Therapeutic measures were taken as a result of covid-19. COVID is treated with Paxlovid. Report is not related to a study or programme.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tingling (like pin pricks) throughout body; pain throughout body; This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3527M, expiry date 3rd June 2023) for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th March 2022, immediately after receiving Shingrix, the patient experienced pins and needles and general body pain. On an unknown date, the outcome of the pins and needles and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pins and needles and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix intramuscularly into her right arm and began immediately experiencing tingling and pain (like pin pricks) throughout her body after the injection which had still not resolved. The patient did not want GlaxoSmithKline to contact her current PCP (primary care physician) but she will call back with the phone number of her neurologist. No further information reported. The reporter consented to follow-up.
First shot: low energy and irregular heart beat for 3 weeks 2nd shot: Severe chills on 2nd day.  Low energy and irregular heart beat for a couple months.
Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group and a sales representative. The reporter is the patient.  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: PFI E19264), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 85 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Heart failure" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "recovering" and all described as "Contracted COVID-19". The event "contracted covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (21Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: It was unknown if patient received any other vaccine in four weeks. The patient took other medication in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
patient states that he was dizzy and had chills for 4 hours after administration of the vaccines
aching/he is feeling a little achy/ he feels achy; he has not slept well; he is just tired; His arm did hurt for 2 days after; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old male patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: 31Mar2021), via an unspecified route of administration in left arm, on 16Dec2020, at single dose, for COVID-19 immunization. There were no medical history and  concomitant medications. The patient reported he got the COVID Vaccine on 16Dec2020 (Wednesday) and now he is feeling a little achy. He is wondering if that is a side effect. He said it is not a big deal and that maybe he is just tired. He also reported he has not slept well so maybe he could just be tired. Although it could be a side effect. He clarified he did not start feeling achy until 21Dec2020 (today). He reported his arm did hurt after for 2 days. The outcome of the event vaccination site pain was recovered on an unspecified date in Dec2020, pain was not recovered, and the remaining events was unknown.
Patient stated that around 6 pm the same day of vaccination, she started experiencing shivering, teeth chattering, and a migraine-like headache. The symptoms had resolved when she woke up the following morning.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 05-SEP-2017, through 20-SEP-2017, the patients were vaccinated with improperly stored GARDASIL 9 lot # N007931 and expiration date on 17-NOV-2019 (dose and route of administration were not reported) for prophylaxis. The doses of GARDASIL 9 were exposed to a temperature excursion of 10.4 degrees Celsius (°C) during a time frame of 50 minutes which was detected by the data logger. Previous temperature excursion was reported as 13.9°C for 173 minutes. There was no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1709USA010722: US-009507513-1709USA010570:
Pt recvd vax on 21AUG92 & approx 30 mins later devel itching on neck & arms, & urticaria; tx DPH & recovered;
Initial report received on 20 March 2007, from a healthcare professional. A 5 year old male patient received on 16 March 2007 (at morning time) the fourth dose of Daptacel (lot# C2521AA), intra-muscular, into the left arm; third dose of IPOL (lot# Z0456-2), into the left arm; and a dose of MMR (lot# 1025F-9308), into the right arm. On 17 March 2007 (at morning time), a day post vaccination, the left arm was swollen and painful with a rash. The patient returned into the (doctor's) office, unspecified time after vaccination with "cellulitis". The patient was treated with an unknown injection. The patient's outcome was unknown. The patient had no illness and medical condition at the time of vaccination and was not taking other medications. Follow-up information received on 23 April 2007. The patient had no known allergies, did not have any illness at the time of the vaccinations and did not have any additional vaccines within 4 weeks. It was reported the patient recovered.
Patient states that very early the next morning she had extreme chills.  When she woke up the next AM she had aches everywhere.  She said after taking Tylenol, the aches were tolerable.  What she was most concerned about was that early Monday AM ( 1 and 1/2 days post vaccination)  she had lots of itchy red spots on her chest and arm.  She also said her lips felt very rough and a little bit tingly. She said that they were not swollen and that her tongue was not involved.  She presented at the pharmacy 9/23/19 at 6PM and had multiple red, blotchy spots on her left arm about 3 inches below the injection site. She asked if she could take Benadryl and I said yes that she should take.   Patient did not want to run to urgent care and said thought not getting worse but I did tell her if her tongue or any part of her face was to start to swell to seek immediate help./
kidneys are hurting; lower back pain in the area of her kidney; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1. Manufacturer unknown), for COVID-19 immunisation. The following information was reported: RENAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "kidneys are hurting"; BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "lower back pain in the area of her kidney".  Additional information: Report from a Pfizer sponsored program Support. Calling about Pfizer vaccine for COVID 19. Caller had her second dose this weekend and had all the side effects that are listed and it has been almost two full days. Now her kidneys are hurting and not sure if this is a reported side effect and normal. Reporter stated she waited an hour and a half on hold to speak with someone that is supposed to be the medical information department. Verbatim and Event Description: Caller (Name withheld) called in today and said after she got her second dose she experienced lower back pain in the area of her kidney. She wanted to know if that is dangerous and reportable as a side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes after injection which has extended into hand 48 hours after injection
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 31-MAR-2014, the patient was vaccinated with an unspecified improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 960 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
DIED; TROUBLE IN FOCUSING AND CONCENTRATING; WAS FEELING WRONG IN HER WORDS; This spontaneous report received from a consumer via social media via company representative concerned a 61-year-old female of an unspecified race and ethnicity. 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, expiry: Unknown) dose and start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. Age at time of vaccination 7 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 13 hours post vaccination, the patient died in her recliner. That night, at 08:00 pm, it was reported that the patient had trouble in focusing and concentrating and was feeling wrong in her words. Patient was told to take rest by family members, but patient could not talk the next day as she was found dead. On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed or not. The consumer reported as, "My 61-year-old cousin died in her recliner, approximately 13 hours after being bullied into receiving the shot by her doctor on a well visit. I, now, realize that while I was speaking with her at 8:00 pm, that night, she was having trouble focusing and concentrating and was feeling, ("Wrong", her words), so I told her to get some rest and we would talk, tomorrow. Tomorrow never came, for her." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of trouble in focusing and concentrating and was feeling wrong in her words was not reported. This report was serious (Death).; Sender's Comments: V0- 20221156409-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Started with nausea and dizziness, progressed over the next few days (all still active 4 days later): arm pit on arm were injection happened hurt, temp back and forth between 97.1 and 100, stuffed up nose, extremely tired and unable to do anything (sleeping abut 12-14 hours peer day), coughing up chucks of mucous, lungs tight, fingernails and toenails hurt.
Nurse called to report temperature excursion for MMR-II, PROQUAD, and VARIVAX, given vaccine during improperly stored; This spontaneous report was received from a nurse referring to a 13-month-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (route of administration was not reported), lot# T000344, expiration date 05-JAN-2022 for prophylaxis (product storage error).         The vaccine was exposed to the following temperature excursions: -13.9 degrees Celsius (C) to -14.7 C; -14 to -10 C, with an average of -13.9 C for 30 minutes; -14 C to -10 C, with an average of -14.2 C for 15 minutes; -14 C to -10 C, with an average of -14.7 C for 20 minutes and -14 C to -10 C, with an average of -14.6 C for 5 minutes. There were no previous temperature excursions. The call was due to digital data logger.
Received vaccine on (1/29/13, 1 pm). The evening of 1/29 I vomited twice. Wed morning (1/30) when getting up I still felt like my stomach was at a stage where I felt like not eating. At this point my legs were very weak to the point I had to be very careful going up and down stairs. As of now 3:50 pm 2/1 the strength is returning to the legs.
PATIENT STATED THAT HE GOT DIARRHEA,  DROP IN BLOOD PRESSURE, ITCHING IN THE WHOLE BODY, AND WEAKENESS.  IT STARTED 2 DAYS AFTER GETTING THE VACCINE.  HE NEEDED TO GO TO THE ER,  AND GET IV FLUIDS.  AS TO YESTERDAY (13 DAYS AFTER THE SHOT) HE STATES HE IS STILL FEELING WEAK AND HAS ITCHING IN HANDS AND FEET.
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 a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:06 AM, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.33. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021 and 16-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 50, 10 AM: 36, 42, 11 AM: 38, 44, 12 AM: 39, 44, 1PM: 43, 44, 2 PM: 44, 44, 3 PM: 44, 44, 4 PM: 42, 44 and 5 PM: 42, 44. 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 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. It was reported that the patient was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
small amount of hives noted in groin area approx 5 hours after vaccination, rash next day much more extensive involving entire trunk -hives with target lesions, no fever no mucous membrane lesions--treated wtih benadryl 1 tsp q6hrs (parents originally were only giving 1/2 tsp-to fu immediately if mucous memebrane involvement or much worse--otherwise by phone 2 days
Patient started to feel faintness almost immediately upon receiving the vaccine. She then continued to experience a light headed feeling, vertigo, and then had a seizure.  Sought medical advice from PCP, but doctor did not indicate that the seizure was caused by immunization.  Patient has experienced seizures before.  Patient also experienced bruising at the site of the injection that has lasted over 14 days now.
Information has been received from a physician concerning a 20 year old female who on 09-Aug-2007 was vaccinated intramuscularly with the first dose of Gardasil (658222/0927U).  Concomitant therapy included dicyclomine HC1 (BENTYL), citalopram hydrobromide (CELEXA) and lansoprazole (PREVACID).  In September 2007, the patient experienced diarrhea, nausea, pain on the left side of her abdomen, weight loss of 10 pounds within a week and general loss of appetite.  The patient went to the emergency room but was not admitted.  The patient's diarrhea and nausea and pain on the left side of her abdomen and weight loss of 10 pounds within a week and general loss of appetite persisted.  The diarrhea, nausea, pain on the left side of her abdomen, weight loss of 10 pounds within a week and general loss of appetite were considered to be disabling since the patient had to come home from college.  Additional information has been requested.
Chest pain started 7/11 in evening and worsened by morning of 7/12, patient went to ED was admitted to Pediatric ICU, chest pain treated with tylenol, resolved on its own  Discharged to follow up with cardiologist in 2 weeks