chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via out of hour services and described the occurrence of stiffness in a female patient who received SHINGRIX. On 20th January 2018, the patient received SHINGRIX. In January 2018, 1 day 3 hrs after receiving SHINGRIX, the patient experienced stiffness, shivering and headache. On an unknown date, the outcome of the stiffness, shivering and headache were unknown. It was unknown if the reporter considered the stiffness, shivering and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At time of reporting, the reporter stated that approximately 27 hours ago she had SHINGRIX vaccine and the same morning the patient woke up feeling stiff and had been progressing throughout the day, had shivers, and slight headache. The aching the patient had a question on how long it would last. The reporter did not know what to expect and had gone on different websites.
PT PRESENTED FOR SECOND COVID VACCINE, STATED HAD "RASH/WELTS" ON RIGHT ARM AFTER FIRST DOSE (RECEIVED IMMUNIZATION IN RIGHT ARM), SHE DISCUSSED WITH MD AND ENCOURAGED TO PROCEED WITH SECOND DOSE, AFTER ADMINISTERING 2ND DOSE IN LEFT ARM, PT REPORTED SWELLING IN FACE NEAR THE LEFT LIP, REPORTER OBSERVED THAT SHE DID HAVE SLIGHT SWELLING OVER HER LEFT LIP.
Received Hepatitis B vaccine about 1:30 pm. At about 7 pm she had severe cramping in left hand, could not make a fist. Went to hospital. Both hands by then were swollen and her left palm and little finger  turned black and blue, was given steroids. Both hands still swollen and tingly this am. Bottom of feet and upper lip tingly, hand still black and blue 24 hours later, was also given Benadryl.
Lethargy, intense migraines, low grade fever, soreness at the injection site preventing use of the arm, body aches, generalized malaise
Pt. began to feel dizzy 10 min after vaccination. He had intermittent syncope, no AMS, symptoms resolved and pt. went home at 1801. BP: 102/67, HR 68, O2 95%
Patient received the 2nd moderna dose at 2 weeks instead of the recommended 3 weeks. Patient denies any adverse reaction from the vaccine besides a sore arm
I was also diagnosed with diabetes; started getting additional & chronic illnesses that I didn't have before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "I was also diagnosed with diabetes"; ILL-DEFINED DISORDER (non-serious), outcome "unknown", described as "started getting additional & chronic illnesses that I didn't have before".  Clinical course: The patient was fully vaccinated (fully vaccinated means one shot of Johnson & Johnson vaccine or two shots of Pfizer/Moderna vaccine). The patient started getting additional & chronic illnesses that she didn't have before. Since she was also diagnosed with diabetes around when this pandemic started, it was just too risky for her health to not use any sources against a serious illness to compromise her already poor health. The patient's age/age range was provided as 65+ and other physical / comorbid information was provided as none  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a Registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAR-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
This spontaneous report was received from a pharmacist referring to a 61 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies and was not taking any concomitant medication. On 08-NOV-2016, the patient was vaccinated with ZOSTAVAX 19400 "PFU" (lot # M033335, expiration date 11-OCT-2017), subcutaneously, for immunization (dose and frequency were not reported). On 14-DEC-2016, the patient experienced rash on arms and torso and, on an unspecified date in December 2016, he experienced itching (pruritus) and, due to it, he went to the hospital on 18-DEC-2016 (reported as yesterday). Treatment was given for the adverse events and no laboratory tests were performed. It was informed that the patient had influenza virus vaccine inactivated (unspecified) within four weeks of administration of ZOSTAVAX. No product quality complaint was involved. The outcome of pruritus and rash was unknown at the time of this report. Causality relationship between the events and ZOSTAVAX administration was not reported. Additional information has been requested.
Stress; a bunch of sores in the mouth, they bleed a lot/bleeding ulcers; a bunch of sores in the mouth, they bleed a lot/bleeding ulcers; The initial case was missing the following minimum criteria: specific number of patients. Upon receipt of follow-up information on 28Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This 27-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 22May2021 09:15 (at the age of 27 years) (Batch/Lot Number: EW0173) as a single dose for COVID-19 immunization. Concomitant medication included unspecified multivitamins. No additional vaccines were administered on the same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 01May2021 09:15 (Batch/Lot Number: EW0172). Historical vaccine information also included tetanus shot a year ago because he had cut a tendon in his hand. Hand got better, it was really intense. He thought he was going to lose his thumb, but he was quick with the medical tape. He had a miraculous recovery in 5 months. No AEs following prior vaccinations. He's never had any medical reactions or allergic reactions or anything before. Patient did have any side effects on 23May2021. On 24May2021 at 22:00, 48 hours after vaccination, patient had a massive out break of bleeding ulcers that lasted for 18 days. At first, patient was spitting out mouth and had falls of blood. Patient never had anything like this before. The doctor said that the patient would be fine and he healed. Patient had a bunch of sores in the mouth and they were "attached where the gum meets the tooth". He reported that these sore did not sting or burn but they bled a lot, and that they could be from stress. He had no sexual contact with anyone or shared drinks for a longtime with anyone. He did not know what it is, but it doesn't look like canker sores or herpes. He is not sure if this was a side effect. He took photos and sent them to a medical professional who said not to worry about it and that it would go away. The patient thinks it came from the vaccine. It is the only thing he has done differently. He has not had any tests. He talked to a person who said it didn't look like it needed to be tested and don't worry about it. Patient underwent tests which included STD Test in "Apr" with result negative (had to get tested for future wife), HIV test in "Jun" with result negative (had to get tested for future wife). Event bleeding ulcers was reported as serious with seriousness criteria: important medical event, required call to physician, but did not require the initiation of new medication/other treatment/procedure. The outcome of the event stress was unknown and of the other events was recovered on an unspecified date in Jun2021.  Follow-up attempts are completed. No further information is expected.
Screamed solid x 3 days et night; Would not take bottle, would not sleep; Mom described cry as high pitched scream-sounded scary; When stopped screaming slept x 16 hrs straight; Parents called ER advised to given APAP, wasn't seen by MD;
very intense reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (very intense reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (First dose), Johnson and Johnson vaccine (first booster dose) and Johnson and Johnson vaccine (second dose). Past adverse reactions to the above products included Vaccination adverse reaction with Johnson and Johnson vaccine, Johnson and Johnson vaccine and Johnson and Johnson vaccine.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (very intense reactions). At the time of the report, IMMUNISATION REACTION (very intense reactions) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported that patient received fifth vaccine from Pfizer COVID-19 Vaccine Bivalent as booster with batch number as CJ2524. It was reported that patient had two regular Johnson and Johnson, one booster Johnson and Johnson, one booster Moderna and then yesterday the Pfizer booster.   No treatment medications were provided by the reporter.   This case was linked to MOD-2022-646083 (Patient Link).
Welt on left thigh with swelling-right thigh with swelling and rash.
Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; No adverse event; Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 6:14 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 6:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Concomitant medication information was not provided.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment information was provided.
Injection site felt hard; Injection site felt bruised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site felt hard) and VACCINATION SITE BRUISING (Injection site felt bruised) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Injection site felt hard) and VACCINATION SITE BRUISING (Injection site felt bruised). At the time of the report, VACCINATION SITE INDURATION (Injection site felt hard) and VACCINATION SITE BRUISING (Injection site felt bruised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided.  No treatment medication were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Follow up received and contained non-significant information: reported denied to make further follow up.
Pain, Tenderness, Swelling, Hardness, Redness, Fatigue, Muscle Pain, Joint Pain, Nausea, The biggest problem is I have severe swelling of the lymph nodes in the same arm of the injection for several days. I want to know when this pain will go away.
Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezing, and nausea after 8-10 minutes of COVID-19 vaccine administration. Vital signs were stable RR 22 and SpO2 96% on RA. She was speaking in full sentence, no acute distress, with expiratory wheezing. No central cyanosis or new rash. After 15 minutes, she reports improvement on her symptoms. She was given Benadryl po and Albuterol 2 puffs in the clinic with improvement on her symptoms. Lungs have more air movement and less wheezing after the albuterol treatment. She was send home and educated in ED precautions.
This spontaneous report as received from a registered nurse refers to a 46 year old female patient who on 24-OCT-2012 at 1:27 pm, was vaccinated intramuscularly in the deltoid with the first dose of LIQUID PEDVAXHIB (lot#H012570, dose and expiration date not reported). The patient received LIQUID PEDVAXHIB in error when she was supposed to get an unspecified Hepatitis B Vaccine. There was no adverse event. This is one of several reports received from the same source (other patients are captured under MARRS # 1211USA004476, 1302USA004704 and 1302USA004705). Additional information is not expected.
My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged lymph nodes and the lymph nodes under my arm has been very, very sore. I've had fevers, chills and fatigue. My stomach has been upset since the vaccine and my appetite has been decreased.
Nauseous for about a week; two days later I started getting nauseated; Light-headed feeling; Upset stomach; Loose stools; It seems to have either caused or brought back some anxiety issues; This is a spontaneous report from a contactable consumer (patient, reported herself) or other Non-health care professional.  A 59-years-old female patient received BNT162B2(CONMINTARY, Solution for injection, Lot No: EW0185), via an unspecified route of administration, administered in left arm (It was in the left upper forearm) on 26May2021 12:15 (pretty sure it was like early part of afternoon) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks patient had not received any other vaccines not event for flu or anything. On 27May2021 patient experienced light-headed feeling, and on 28May2021 she was nauseous for about a week; two days later i started getting nauseated, on unspecified date in May2021 patient experienced upset stomach everyday since and loose stools, it seems to have either caused or brought back some anxiety issues. Patient was scheduled for second dose on 16Jun2021. Patient had not received any treatment for the events reported. Outcome of the events were not recovered (It just persists everyday).  Information about batch/lot number has been requested.
15 MINUTES AFTER LEAVING THE CLINIC, APPROX 25 MINUTES AFTER RECEIVING VACCINATIONS PT VOMITED AND FELT FAINT.  DEVELOPED 1" REDNESS IN LEFT ARM - DELTOID REGION.  REDNESS LASTED APPROX 24 HOURS.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced incorrect product storage. On 02-SEP-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Field of vision too bright and very light-sensitive, complete eye exam revealed nothing abnormal, dr. suggested optic nerve inflammation due to vaccination
Body aches, severe chills/body shakes, fever 101.5, headache, severe fatigue, poor sleep, disturbing dreams, very sore arm, bruise at injection site for a week and a half.  Symptoms  Lasted 36 hours.
Red rectangular area near vaccination spot appeared on 3rd day after 2nd vaccination. Area was itchy and swollen for three days.  Area is about 4x5  inches. Today is 8th day after vaccination and itching and redness seem to be going away.
Red raised rash over torso, about 30 lesions.  No open areas, no s/s infection, no crusting.
Pt died of SIDS 12JAN94; autopsy done 12JAN94;
12/20/22 presents to ED for "weakness". PMHx of "Hypothyroidism, HLD, Parkinson's, and Myasthenia Gravis"
Initial case was received on 01 December 2010 from a healthcare professional. A 54 year old female patient received on 29 October 2010, a left deltoid intramuscular injection of ADACEL (lot number C3539AA) and a right deltoid intramuscular injection of FLUZONE SV (lot number U3734AA). On 10 November 2010 she experienced an onset of mastitis in the right breast. She was seen in the physician's office on 17 November with the mastitis in the right breast and was treated with Clindamycin. The patient had a history of a lumpectomy three years prior. Her allergies included Codeine, adhesive tape, suture, ZETIA, AUGMENTIN and BACTRIM. No other pre-existing medical conditions and no concomitant medications were reported. The patient was not ill at the time of the vaccination. As of this report the patient had not recovered. Documents held by sender: None.
This spontaneous report as received from a consumer (patient's mother) refers to an 8 year old male patient with no drug reactions or allergies. No concurrent conditions or medical history were provided. It was reported that, on an unspecified dates, the patient had received 2 doses of RECOMBIVAX HB injections (doses, routes of administration, indication, lot# and expiry date unspecified for both shots). No concomitant medications were reported. The reporter stated, that after receiving RECOMBIVAX HB (specific dates unknown), the patient had complained of anal and stomach pains and eczema flare ups. The mother reported she had to change patient's diet and "he just doesn't seem to be the same child." The patient sought medical attention and was treated with nystatin (dosage/frequency unknown). The outcome of the events was reported as not recovered. The relatedness between the events and RECOMBIVAX HB was not reported. During the call, the reporter became unable to confirm if the patient received RECOMBIVAX HB. Additional information is not expected as there is no patient and physician's contact information and we could not do follow up with them.
Got fever or got infected somewhere; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (husband) of unknown age that who received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Mar2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Mar2021 the patient started running fever, it has been a week patient got the vaccine and the concern was if the fever was related to the vaccine or maybe he got infected somewhere in between. The event outcome was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Body/Joint aches,  headache, sinus pain, fever. Started about 6 hours after vaccination, took ibuprofen about 12 hours after vaccination
Pt received PREVNAR 13 in left upper arm on the afternoon of 3/27/15. Patient developed 2 1/2-3 inch diameter red-raised rash around injection site. Was warm to touch and swollen.
About three minutes after administering the 1st dose of the Pfizer vaccine the patient fainted to the floor, no head injury was reported.  The patient was still alert and oriented, so we placed her in a chair.  While in the chair the patient was in and out of consciousness.  Since the pharmacy is in a hospital building a Rapid Response code was initiated.  Patient became unresponsive for a moment so a Code Blue was initiated.   Oximeter was utilized and showed normal readings, patient was still alert.  After the physician onsite evaluation was done, patient was taken to the Emergency Room for observation and further testing etc.  Patient was in the ER for about an 1.5 hour and was discharged home with a Syncope diagnosis.
Injection site is the size of a golf ball and there is a poison oak like itchy rash. It is also slightly red and tender.
On 3-9-2021, a recipient of Covid-19 vaccine came requesting to receive her 1st dose of Moderna. Patient was 17 years old at this visit, and she was administered  the vaccine, which was contraindicated due to her age. No adverse reaction noted or reported.