chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022; No adverse event; Patient was administered expired bivalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 73-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 18-Oct-2022, 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 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022) 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 EXPIRED PRODUCT ADMINISTERED (Patient was administered expired bivalent dose) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct-2022).    Concomitant product use was not provided by the reporter.  On 13-SEP-2022, the vial was initially stored in the refrigerator.  Vial size was 2.5ml.  The vial did not undergone any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661310 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661310:same reporter
Sore left arm after the second vaccine/Arm was a little less sore after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm after the second vaccine/Arm was a little less sore after the second vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, 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 VACCINATION SITE PAIN (Sore left arm after the second vaccine/Arm was a little less sore after the second vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left arm after the second vaccine/Arm was a little less sore after the second vaccine) outcome was unknown.            No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-408549 (Patient Link).   Reporter did not allow further contact
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 2nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. In March 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX in the left arm and experienced sore arm on next day. Till 15th March 2018 (Monday), it only felt like a minor bee sting. The caller was not aware of it or when this resolved and was unaware of patient's initials or date of birth.
Patient came in 10/26/2013 and said she got sick form shot she said it wasn't until about 4 hours later she got achy and had diarrhea. Patient had rash on both arms and left arm was swollen and had big bump around injection site.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a six-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Information has been received from a registered nurse concerning a child who was vaccianted with a dose of varicella virus vaccine live. Subsequently the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Case number PHEH2014US014007 is an initial spontaneous report received from a nurse on 11 Jul 2014. This report refers to a 12-year-old male patient. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X13030) intramuscularly instead of being reconstituted with Men A lyophilized conjugate component on 03 Jul 2014. No adverse events were reported following this medication error (inappropriate preparation of medication).
Within 2 days of ROTATEQ vaccination, he developed severe diarrhea of 3 weeks duration. No causes found.
Approx 6 days after the shot, experiencing significant pain in left arm that has not gone away.  Unable to use arm due to pain.
From information received on 2/1/02, it was reported that a 6 month old female received a 2nd dose of Prevnar, Infanrix, Pedvax-Hib (MSD) and Polio vaccines on 11/20/01. The child developed a seizure associated with a fever of 104.5F and crying. No additional information was available as of the date of this report. From follow-up correspondence received on 2/14/02, the correct lot numbers were provided for all products.
Enlarged Gallbladder (cholecystitis) and Enlarged Spleen, resulting in sharp abdomen pain & visible mass/lump on the right side of abdomen; symptoms lasted over the course of approximately 3 days.
Patient within 10 minutes experienced nausea, lightheadedness, and dizziness. Patient went to ED. received hydration and ondansetron 4 mg. Discharged from ED.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 30-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995,  1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link).
Around 08/24/2021 evening, I started experiencing joint pain in thumb of my left hand, and it locks into a bent position and it's a little bit painful. They called it trigger thumb. I went to my Doctor on 08/31/2021 and they took X-rays and she has since referred me to an orthopedist but I haven't been to that appointment yet.
bump; itchy; area of the injection got red; swollen; warm to the touch; pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red) and VACCINATION SITE SWELLING (swollen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunosuppression. Concomitant products included PREDNISONE, PANCREATIN (CREON), CYCLOBENZAPRINE, CHLORTHALIDONE, POTASSIUM CHLORIDE, METOPROLOL, ETANERCEPT (ENBREL), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and Gabapentin for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 20-Jan-2021, the patient experienced VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to the touch). On 13-Jan-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Temp 4/5/02 at 3pm 103 rectal temp. Advil and Tylenol given alternately. Diarrhea 1 time. None 4/4. Started diarrhea 1-2 times daily 4/5-4/8. Went to PMD 4/6/02. Dx with stomach virus.
extreme pelvic pain; 101 fever; felt mentally disoriented; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 22Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included shoulder replacement (I'm 70 and I've had shoulder replacement about a year ago and still recovering from that). Concomitant medications were not reported.  It was reported that patient received her first dose of Pfizer's COVID vaccine on 22Mar2021. She was fine until 6 days later on 28Mar2021, she stated she had 101 fever, and felt mentally disoriented but she managed to get in for a COVID test the next day on Monday, and it was negative. By Easter Sunday, she had extreme pelvic pain, so she went into a walk-in clinic and got treated for that. Just today, my symptoms are letting up. She is 70 and she have  had shoulder replacement about a year ago and still recovering from that. Patient is concerned if she should get the second dose. Patient was asking if there may be more symptoms on the second dose. Patient also asking if surgery causes you to be immunocompromised. The patient underwent lab tests and procedures which included fever (body temperature): 101 on an unspecified date, COVID test (sars-cov-2 test): negative on an unspecified date. Therapeutic measures were taken as a result of extreme pelvic pain. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
3/27/23 I made a doctor?s appointment because of a lump in my chest I discovered in the shower.  I had a biopsy on 4/4/23 which was non-cancerous. I had surgery on 5/2/23 and had the lump removed. It was non-cancerous and I was told it would not come back.
Spells of blinking eyes continuously hospitalized for possible seizure EEG normal recovered. Happened 24 H. after MMR and PENTACEL vaccine.
flu-like symptoms; aches; hives; can't move arm; itching; rash throughout body (upper back, left breast, leg); injection site pain; injection site redness; injection site sore red knot; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm) and PRURITUS (itching) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), SALBUTAMOL (ALBUTEROL HFA), NYSTATIN, HCTZ, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FAMOTIDINE (PEPCID AC), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm), PRURITUS (itching), RASH (rash throughout body (upper back, left breast, leg)), INJECTION SITE PAIN (injection site pain), INJECTION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (injection site sore red knot) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm), PRURITUS (itching), RASH (rash throughout body (upper back, left breast, leg)), INJECTION SITE PAIN (injection site pain), INJECTION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (injection site sore red knot) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR received contains no new informations
husband had long term GI issues since the vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "husband had long term GI issues since the vaccine".  Additional information: The patient received her first dose of the Pfizer COVID Vaccine 30MAR2021 and her 2nd dose on 20Apr2021. On 21Apr2021 the caller reports starting to feel sick to her stomach and having sharp epigastric pain. She also experienced change in her bowel habits. She initially thought she has gastritis then questioned possibly her Irritable Bowel starting to flare. She states its been getting worse and worse and she has never felt so "unwell" in her life. She cannot eat and has gone through a lot. She was seen in the ER, Carafate and another medication were given that did not help, she was given Compazine which did not help her "queasy stomach" either. Maalox does not work. She went through an upper and a lower endoscopy procedure and put on antibiotics which did not help either. One of the antibiotics was noted to be Flagyl. She now will have to do the prep over again and have a "pill cam" study done. She states she has never felt like this. She notes having "sonometer size random spots on my thigh, 1 or 2 on each arm and one or 2 on her chest. The caller states nobody knows what they are. They are pink in color per report. Caller reports being "fine until next day following the second shot." She has a friend who shared something that some else had "reposted" where her "husband had long term GI issues since the vaccine." Caller states she wishes agent could "make me feel better." She reports being "scared to take the booster." She states she has medical conditions/health concerns and needs to get the booster, but she is "afraid to get it." She notes being "tired of sitting in the house. I can't plan anything because I don't know how I will feel. I can't wear tight clothes, jeans, bra, because can't stand it because it pushes" on my stomach. She states she has been enduring this for "5 months. Advised caller no information pertaining exactly to her GI symptoms reported, however per the PI/fact sheet does provide some information, however caller was already aware of this. No further request for the request to be escalated since the patient is also HCP. Post Authorization Experience The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Gastrointestinal Disorders: diarrhea, vomiting. LAB  No follow-up attempts are possible. No further information is expected.
first two days-pain at injection site, fatigue-- 2/10 pt has knot in arm where vaccination was given/tender
Patient reported "virtigo" with last pfizer vaccination; but after todays incident occurred, patient and mother agreed seizure-like activity occurred with both doses (today included). Within 20 seconds of administering pfizer vaccine, patient began experiencing seizure-like activity: muscle spasms of head, arms, feet, pale skin, blue lips that lasted about 30 seconds. During seizure, the mother of the patient and myself supported patient to prevent falling out of the chair until seizure was complete. Following the seizure-like movement, patient ate a piece of candy and drank a small amount of soda; patient was disoriented. Patient remained seated for 30 minutes until post-ictal confusion subsided. EMS was not called as this incident has happened in the past, but patient was instructed to seek medical attention.
This case was reported by a pharmacist and described the occurrence of injection site rash in a 12-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline). The subject's medical history included contact dermatitis. On 14 January 2014 the subject received a dose of HAVRIX (unknown details, unknown arm). On the evening of 14 January 2014, within hours of vaccination with HAVRIX, the subject experienced injection site rash. The pharmacist reproted that the rash was from "his shoulder to his elbow and it looks like a mosquito bite rash." It was unknown if the vaccination series was discontinued at the time of reporting. At the time of reporting the event was improved. Per the pharmacist, the rash was "diminishing" and the rash was "now very light" at the time of reporting. The pharmacist considered the event was unrelated to vaccination with HAVRIX.
Very scary hallucinations, unable to speak or stand up. Could not open eyes or get call for help. Very scared. Hallucinated for about 4 hours and they were very scary. was very weak as in could not stand up for 24 hours. Couldn't move body. muscles not working. extreme exhaustion, weakness, loss of muscle control. This was all from the second shot. First shot stiff arm for one week
Twenty minutes post vax afebrile seizure, twitching of arms and legs. No treatment needed. Seen in ER normal findings. Temp 98F.
Expired vaccine administered to 6 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) 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.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) to be possibly related.    No concomitant medications were reported. No treatment medications were reported. Pharmacist was calling to report that 6 patients received the Moderna COVID-19 vaccine from 29SEP2021 to 30SEP2021. The Moderna Covid-19 vials administered to these 6 patients expired on 28SEP2021.   Reporter did not allow further contact