chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023; Vial was expired 30 days after being in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023) and PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge).    No concomitant medications were reported.  The vaccine was delivered on 12-Dec-2022 and they have had them in the refrigerator since. The reporter stated that it was their understanding that it expires 30 days after being in the fridge but they were getting notices from the department of health that the expiration date of the said batch were extended, the last one they received said that expiration date was 14-May-2023. The batch was administered to 6 patients after 12-Jan-2023, last dose was given on 13-Apr-2023.  No treatment medications were reported.  This case contains information for the 5 of 6th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:05th patient case
Redness all over lower face and neck and chest 4 hours after injection. At time of injection, swelling after shot. Patient feels fine other than dermatologic reaction. She sent picture to dermatologist-saw nothing to worry. Patient recovered next day.
presented with SOB/ + covid PTA x2 days; started zithromax, vitamins and medrol pack PTA; no improvement so advised by PCP to come to ED; CXR with bilat infiltrates: LABs: D-dimer 1.41, CRP 16.20, Ferritin 484.5; Tx: zithromax, maxipime, decadon, eliquis, vit c, rocephin, vit D3, lovenox, singulair, remdesivir, zinc, tocilizumab, minimal O2 supplementation; back to room air at d/c
7 days after my vaccine. I am experiencing arm pain, slight swelling, and  hardness in the area I received the shot.
Pt started to have restless leg symptoms (which he only feels at night) 15 minutes after vaccination. He also started to have muscle twitching and a visible tremor. He developed some subjective SOB, RR30.  Lung sounds clear. His BP was 179/80. He was given water and monitored for 45 minutes, at which point his RR was 16 and BP dropped to 160 systolic. Tremor cleared up. RLS symptoms resolved. He was sent home with education to go to ED with worsening symptoms.
Received 4 yr old immunizations on 11/14/06. 11/16/06 swelling and redness in left arm came in for appt 1/17/06 DX with left arm cellulitis treated with Omnicef.
This spontaneous report was received from a nurse refers to one-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 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 involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054.
Noticed by baby sitter, on 12/12/08 morning time with redness, hard around area warm feeling induration 60 X 50 mm with out pain
Pt complained of throat feeling swollen and trouble breathing.  Pt was able to talk with ease throughout incident.  Paramedics called, pt treated with albuterol nebulizer on scene.  Pt declined transport and came by pharmacy around 4:00pm the same day to report she was doing well and no further progression had occurred.
HEART PALPITATIONS, FREQUENT PVCs - USUALLY COMES IN WAVES OF 4-8 PER MINUTE THAT LASTS FOR AN HOUR OR MORE THEN DECREASES TO 0-2 PER MINUTE AND REPEATS - NO NOTICABLE PATTERN OTHERWISE, MILD BACK ACHE LESSENING EACH PASSING DAY, PAIN, CONTUSION, AND MUSCLE HARDNESS AT INJECTION SITE - NO IMPROVING MUCH OVER FIRST THREE DAYS, STIFF MUSCLES - PARTICULARLY IN LEGS AND FEET
Eperiencing aches at 4am; Hot and cold chills at 4 am; Fever at 4 am; Weakness at 4 am; Headache at 4am; Hot and cold chills at 4 am; This is a spontaneous report from a contactable consumer or other health care professional.     A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) unspecified route of administration on 04May2021 11:00 as dose 2, single for covid-19 immunization. Patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization.The patient received DESCOVY on May2020 for treatment of PrEP. Patient Medical history included prophylaxis against hiv infection from an unknown date and unknown if ongoing. Other relevant history was not reported. No laboratory and diagnostic tests were reported. The patient's concomitant medications were not reported. The patient experienced aches (pain), hot and cold chills (feeling of body temperature change), hot and cold chills (chills), fever (pyrexia, weakness (asthenia) and headache on 05Mar2021 04:00. The outcome of the events were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1st dose 5Apr2021, 2nd dose 31Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 5Apr2021, 2nd dose 31Jul2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 044A21A) for COVID-19 vaccination.   Concurrent medical conditions included Vasculitis (Autoimmune disorder (Vasculitis)) and Factor V Leiden mutation.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 5Apr2021, 2nd dose 31Jul2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 5Apr2021, 2nd dose 31Jul2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Factor V Leiden mutation: positive (Positive) Positive.   No concomitant medications were reported.  No treatment information was provided.
Flue like symptoms; Sore arm; Sore throat; Very sore and crack lips; Fever; Joint hurt; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips), PYREXIA (Fever) and ARTHRALGIA (Joint hurt). At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips), PYREXIA (Fever) and ARTHRALGIA (Joint hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-023612, MOD-2021-025872, MOD-2021-025828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporter contact details was updated.
Typical sore arm and sleepiness initially.  After a few days, a sore and swollen lymph node under the right arm that persisted.  On October 5, 2022, a red line ran from the underarm lymph node down the arm.
lightheaded, vasovagal  no loss of consciousness. Supine, legs elevated. Resolved
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 at 08:00 as dose 1, single (Lot number: Eh9899), in left arm, on 19Jan2021 at 09:00 as dose 2, single (Lot number: EL3247), in left arm, on 18Jul2021 at 12:00 as dose 3 (booster), single (Lot number: Ew0198), in left arm and on 24Dec2021 at 12:00 as dose 4 (booster), single (Lot number: 331308a) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin likely not certain" (unspecified if ongoing), notes: Penicillin likely not certain. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: pos test happened 5 days after stopping Pax and testing neg; (unspecified date) Negative, notes: pos test happened 5days after stopping Pax and testing neg; (2022) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks product was Paxlovid, other medication in 2weeks start date was 04Jul2022 and other medication in 2weeks stop date was 08Jul2022. Other medical history was Healthy. The patient was treated with Paxlovid for COVID-19 treatment.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Narrative: COVID infection following COVID vaccine series 05/11 Janssen, dose#1 09/10 pt cc: SORE THROAT exposure: unknown 09/15 COVID swab, result: detected
Migraine in temple area, low grade fever, malaise and fatigue, muscle aches and pains- that I still have 6 days after vaccine.
Patient diagnosed with Erythema multiforme 8 days after Gardasil dose #2 was administerd.  On day 8 following injection patient developed urticaria and respiratory difficulty which resulted in an emergency room visit.  The next day the child was taken to her family doctor who diagnosed the condition as being related to the Gardasil injection.  Patient received Valtrex from her family physician for treatment.  She had been given an injection of steroid in the emergency room.  When I saw the patient on day 3 following the urticarial eruption she had widespread hive like lesions covering her entire body including scalp.  She also had a cough and sore throat but no other respiratory involvement.
WITHIN 48 HOURS FEVER OF 105 DEG. F.  Collapse and shock. Persistant Crying lasting for 4 hours w/in 48 hours.  Prolonged seizures 2 weeks  within 4 days after vacc. decreased level of consciousness, inability to move arms/legs;walk, talk, hold bowels or urine.  anorexia. unable to make eye contact when addressed by name for 1 month. very distressed and afraid. prolonged sleep(16 hours at a time)and crying/starring spells 2-6 hours at a time(for 2 weeks)
The vaccine was taken on Tuesday afternoon. Three hours later the vaccine arm started hurting.  On Wednesday morning slight headache, tiredness,  muscle pain, arm pain. Wednesday night Nausea and dizzines until Thursday around 10 AM. Felt well and still some arm soreness. I took Tylenol for the headache once.
sever sore throat; difficult to swallow; headache; chills; sweats; light head/woozy; fever 100.7--101.0; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 16:30 at single dose in left arm (at the age of 68-year-old) for COVID-19 immunization. Medical history was none. He had no Known allergies. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), simvastatin and metoprolol. The patient did not receive other vaccine in four weeks. On 27Apr2021 16:30, the patient experienced headache, fever 100.7-101.0, chills, sweats, light head, woozy, severe sore throat, difficult to swallow, lasted up to 6 days slowly got better each day. His primary is concerned about and so was he about the throat, he prescribed an epipen for him to have. He had many reservations about his 2nd shot. He had lived a very healthy life very rarely being sick. No treatment was received for the events. The outcome of all events was resolved on 03May2021.  Information on the lot/batch number has been requested.
I woke up the following morning covered in blood.  I am not on my period my period is not due for another 7 days.  Vaginal bleeding confined for over the day until now it?s been 2 days of heavy bleeding.  My legs are hurting almost feel like they are on fire.  Cramping  and numbness at times.  My stomach and uterus are also cramping to the point I can?t stand straight. Dizziness and a terrible migraine
A spontaneous report has been received from a Health Professional concerning a 33 year old, Female patient, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient experienced TESTED POSITIVE FOR FLU B and OFFICE NURSE WAS SICK FOR 3 DAYS which started on 23-Dec-2014. The outcome of the event of TESTED POSITIVE FOR FLU B AND OFFICE NURSE WAS SICK FOR 3 DAYS is unknown. The report was considered to be non-serious.
Woke up aching all over - even scalp, jawline to right ear in pain like ear infection, pulsing pain in head above right ear, and red bumps on forehead.
pt woke up itching yesterday AM per mom;little red dots the size of the red area of a pencil on upper arms, back, upper thighs;they started turning into welts;mom gave DPH;no marks initially 1hr later had hives again;
Flu like symptoms (chills and body aches and pains.); Flu like symptoms (chills and body aches and pains.); Flu like symptoms (chills and body aches and pains.); Flu like symptoms (chills and body aches and pains.); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), CHILLS (non-serious), PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Flu like symptoms (chills and body aches and pains.)".  Additional information :The symptoms occurred about 6-8 hours after taking the shot and lasted 1-2 days   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel an inj site rxn characterized by redness & soreness,day p/vax given;pt has recovered;
Pt called the office 2/7/13 - reaction started Tues, 2/5/13. T - 100.0 area red, painful the redness size of pt's palm, welts 2" ling. Pain was pretty bad, pt took TYLENOL. Tingling, numbness, would come and go. 2/13/15 call to pt. arm still slightly sore but able to function better.
pt recv vax & devel Hep B; MD told pt that it was due to the vax; No further details were provided;
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 28-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with GARDASIL (lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced nausea, fever and body aches. The patient had sought unspecified medical attention. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information regarding Flumist nasal solution was received from a mother, regarding her 6 year old who was feeling irritable. At 6 years of age, the patient received a dose on 12/10/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/10/03. Dose regimen was 0.5mL (IN). Concomitant medications were not reported. On 12/12/03, 2 days post immunization, the child was feeling irritable by lunchtime. No additional information was available at the time of this reports.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot#M045653 with expiry date: 03-JUL-2018 (dosing details, anatomical location, route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32F to 35F (35F) for 4 minutes; 32F to 35F (34.7F) for 11 minutes and 32F to 35F (35F) for 4 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA009622: US-009507513-1708USA009622: US-009507513-1708USA011663:
This spontaneous report was received from a pharmacist and refers to a 16-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9, (lot number and expiration date not reported) and then on 27-MAY-2016, the patient was vaccinated with a dose of GARDASIL 9 lot number L004014 with expiration date 04-MAR-2017 which was outside of their prescribed information, both vaccines intramuscularly, (dose and anatomical location were not reported for the both vaccines above described) for prophylaxis. No adverse effects reported. Additional information has been requested.
Lower back pain  Back spasms  Permanent lower back pain  I feel like there?s damage done. I?m waiting for more diagnosis
Information has been received from a physician concerning a 9 month old female who on 16-APR-2009, was inadvertently vaccinated with a dose of VAQTA pediatric formulation (dose, route and lot number not provided) due to a human error. No adverse effect reported. it was not specified if the patient sought medical attention. Follow up information has been received from a health professional concerning a 9 month old female who on 16-APR-2009, at 1:20 p.m. was vaccinated intramuscularly in her left leg with a dose of VAQTA (lot number 659186/1258U) instead of a dose of hepatitis B virus vaccine rHBsAg. The child had no problems. It was reported that the physician gave a verbal order for VAQTA. No further information is available.
Pt received Anthrax 3 on 11/16/99 with no significant local or systemic symptoms. 11/29 pt received influenza without reaction and was in good health until 12/15/99 when pt developed fever of 103.7. Pt progressed to altered mental status with agitation and confusion. Admitted to emergency room on 12/20/99. During hospital stay, developed seizures needing phenobarbitol. Pt was intubated and given anesthetic for several days. Dx with encephalitis of unknown etiology. Has permanent neurological deficits. Stable but not fully recovered.
Several hours post vax the pt experienced an inability to open her eyes and a rash at the injection site. The pt was treated with Benadryl.