chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took a full course of unrefrigerated Vivotif; Spontaneous report received on 29JAN2020.  A female consumer reported that she "took a full course of unrefrigerated Vivotif" (PT: Product storage error). She was receiving Vivotif for immunisation. The consumer took a full course of unrefrigerated Vivotif from 22JAN2020 to 28JAN2020. She did not know that the vaccine needed to be refrigerated until she finished the full course. Her healthcare professional recommended her to restart the vaccination. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took all four doses of Vivotif which were unrefrigerated (Product storage error). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took all four doses of Vivotif which were unrefrigerated (Product storage error). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.
Blacked out unconsciousness following her first dose of Consentyx; This spontaneous case was reported by an other and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out unconsciousness following her first dose of Consentyx) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SECUKINUMAB (COSENTYX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and SECUKINUMAB (COSENTYX) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out unconsciousness following her first dose of Consentyx) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out unconsciousness following her first dose of Consentyx) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested
On 8-23-07 Mother brought her daughter for more vaccines that weren't available on 8-21-07. Mom showed nurse pt's (L) arm which was red and swollen from last shots receive on 8-21-07.
The pt experienced a local reaction, redness at the injection site. Seen by an MD 48 hours post vax.
sore throat; runny nose; Feels bad; Cold; cough; weakness/low energy; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Dec2021 (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, Single; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "Feels bad"; NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "unknown", described as "Cold"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "cough"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "weakness/low energy"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of cough.  Additional information: Reporter stated that she got the second dose of the Pfizer BioNtech Covid-19 Vaccine on Thursday and after a couple of hours, she experienced weakness. On Saturday, reporter started to feel the other AEs (headache sore throat and colds with runny nose). She felt bad. She has a cold and a runny nose. She has a sore throat and low energy. She doesn't know what to do about it. She has been taking cough medicine. NCD number and expiry date was not provided. Any other products used, patient history and investigation assessment was not provided.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Anthrax lot #FAV110 administered after expired date due to administrative oversight.  No adverse reaction at this time.  Report submitted per agency direction.
PATIENT HAD SWELLING IN ARM AREA.  MORE SEVERE SWELLING IN ELBOW AND WRIST AREA IN THE RIGHT ARM (SAME ARM VACCINE GIVEN).  PATIENT TOOK BENADRYL, AND DID SEEM TO BRING SWELLING DOWN.
Information was received from a licensed practical nurse regarding a female patient of unknown age, who on 08-OCT-2014, was vaccinated with a dose of MMR II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
BRONCHITIS; ASTHMA; BODY ACHES; WITHIN HOURS ALL THE SYMPTOMS GONE; NO ENERGY; This spontaneous report received from a patient via other company (Pfizer, Inc) concerned a female patient of unspecified age, race, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that patient currently had a pink looking tongue. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced bronchitis, asthma, body aches and no energy (dose number in series 1). The patient had a rough health year. The patient recovered from bronchitis, asthma, body aches, and no energy on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received Pfizer vaccine (dose number in series 2), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported on an unspecified date in 2022 for prophylactic vaccination and within hours all her symptoms gone (Unexpected therapeutic benefit) (dose number in series 2). The patient reported that he was feeling so great and was not sick anymore.  The action taken with Pfizer vaccine was not applicable. The outcome of within hours all the symptoms gone was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My lips were tingling and my arms and legs felt suddenly so tired. They monitored me in the reaction tent for 45 minutes until I could sit up and walk.  By the time I got home I had a burning rash on my neck and my voice was suddenly hoarse as if I was sick.  Just rested and symptoms slowly subsided over the day. I must be hypersensitive to something because this is the third time I have had a reaction like this. The others were with the fly shot. Folks took good care of me.
expired dose of Infanrix (booster) was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 23-JUN-2023, the patient received Infanrix. On 23-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose of Infanrix (booster) was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 29-JUN-2023 A pharmacist reported about a patient who received expired dose of Infanrix (booster). The Vaccine Administration Facility was the same as primary reporter. The reporter was consented to follow up via postal.
This spontaneous report was received from a physician and refers to a 16 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2015, the patient was vaccinated with a first dose of GARDASIL lot # L018286 (dose, route of administration, expiration date were not reported). On 12-AUG-2016 , the patient was vaccinated with a second dose with GARDASIL 9 lot# L043214 (dose, route of administration, expiration date were not reported). On 25-OCT-2016, the patient received the third dose of GARDASIL 9 lot# M017983 (dose, route of administration, expiration date were not reported) for prophylaxis. No adverse effects were reported. The outcome of the event of interchange of vaccine products was unknown. The relatedness between the event of interchange of vaccine products and GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
First day headaches. Second day sore arm. Since Vaccine patient stated that she has been receiving headaches, vomiting, and chills.
major flare of RA; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration into left arm on 01Apr2021 15:15 (at the age of 59-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis (RA). The patient's concomitant medications were not reported.  The patient experienced major flare of RA on 03Apr2021 and was treated with pain medications. Outcome of event was not recovered.  Information on the lot/batch number has been requested.
Pt received 3 doe TD series with possible vaccine failure.  From follow up of 10/14/1998 "negative titer 1.5 drawn on 06/18/1998.
Blurry Vision - started around a week after vaccine - I have not been to eye doctor but vision has changed
HUNDREDS OF PUSTULE ON THE UNDERSIDE OF MY WRISTS, THIGHS AND ARMS; PUSTULES ITCH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced hundreds of pustule on the underside of my wrists, thighs and arms. On 23-MAR-2021, the subject experienced pustules itch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hundreds of pustule on the underside of my wrists, thighs and arms, and the outcome of pustules itch was not reported. This report was non-serious.
This is a spontaneous report from a contactable nurse reporting for herself. A 60-years-old female patient received PREVNAR 13, intramuscular in the left arm in 2011 at 0.5, ml single. Medical history included well controlled asthma and hypersensitivity both from an unknown date and unknown if ongoing. Concomitant medication included DULERA, ZYRTEC both as needed. The patient previously took ADVAIR, inhaler for asthma and experienced intentional product misuse and drug ineffective. She started using an ADVAIR inhaler maybe 10-15 years ago for asthma. The ADVAIR inhaler 250/50 was prescribed to be used 1-2 puffs twice a day. She used it as needed. When she had the reaction, she started using it. It did not really help. The ADVAIR inhaler has been switched to DULERA used as needed. The patient experienced significant left arm swelling, left arm hot and red, chest got a little tight; red, itchy, raised rash; it was about 5-6 inches long at the site of injection all 2011 with outcome of recovered. Therapeutic measures were taken as a result of significant left arm swelling, red, itchy, raised rash and injection site rash included MEDROL dose pack. The left arm swelling was not just at the site. It went all the way down her arm. There was no bleeding. She was not wheezing. All the symptoms were gone. Her side effects started within 24 hours, after getting the injection. She went to the doctor's two days later. It took 2-3 days after starting the MEDROL dose pack for the side effect to resolve. Follow-up (20APR2016): Follow-up attempts completed. No further information expected.
elevated liver function test; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FUNCTION ABNORMAL (elevated liver function test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 immunisation.     The patient's past medical history included Liver function test increased since 1989. Previously administered products included for an unreported indication: HEPATITIS B VACCIN (Hep B vaccine allergy years ago). Concomitant products included URSODEOXYCHOLIC ACID (URSO [URSODEOXYCHOLIC ACID]).  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Mar-2021, the patient experienced HEPATIC FUNCTION ABNORMAL (elevated liver function test). At the time of the report, HEPATIC FUNCTION ABNORMAL (elevated liver function test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Liver function test: increase (High) Increase.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
No additional AE reported; Healthcare provider states improperly stored vaccine involved in a temperature excursion was administered to a patient on 28NOV2022. No additional AE reported. No PQC reported.     Names of vaccines involved (including lot/exp): MMR II U022316 7/15/; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug reactions/allergies were not reported.  On 28-NOV-2022, the patient was vaccinated with improperly stored mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) 1 dosage form (dosage reported as "1"), lot # U022315, expiration date 15-JUL-2023 (strength, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Administered dose of suspect vaccine experienced temperature excursion of 57.49 Fahrenheit (F) for 1 hour and 45 minutes. There was no information about previous temperature excursion and if digital data logger was involved. No additional adverse event reported.
Allergic Reaction following her second Moderna covid 19 vaccine; This case was received via VAERS (Reference number: 496918) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic Reaction following her second Moderna Covid 19 vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0210Z1A and 006BZ1A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Allergy to animal (Report mentions allergy to Cat dancer), Allergy to metals (No details), Latex allergy (No details), Drug allergy (Neomycin), Drug allergy (Ativan), Environmental allergy (No details), Drug allergy (Risperdal), Drug allergy (Depakote) and Allergy to vaccine. Concomitant products included EPINEPHRINE (EPIPEN), CELECOXIB (CELEXA [CELECOXIB]), MONTELUKAST SODIUM (SINGULAIR), ETONOGESTREL (NEXPLANON), OMEPRAZOLE, FLUTICASONE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic Reaction following her second Moderna covid 19 vaccine) (seriousness criterion life threatening). At the time of the report, HYPERSENSITIVITY (Allergic Reaction following her second Moderna covid 19 vaccine) had resolved. Patient presented to the emergency room by EMS for allergic reaction following her second Moderna covid 19 vaccine.  She received her shot and began to feel her tongue swelling and she developed body wide itching. Patient received an injection of her Epi-pen at the facility and transferred to the emergency room. She was observed on a cardiac monitor for several hours and discharged home. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included administration of the patient's prescribed Epi-pen. This was administered at the vaccine facility. The patient was subsequently transferred to the emergency room. The patient was on a cardiac monitoring in the emergency room for several hours and was ultimately discharged home. It was noted per source that COVID vaccination will now be listed as an allergy for the patient.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Diarrhea; Throat constriction; Worsened breathing; Fatigue; Vertigo/Head spinning; This is a spontaneous report from a contactable consumer. A 19-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 16Mar2021 at 14:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was sometimes allergic for some types of fruit (edema of mouth, pustules in mouth). The patient did not receive any other vaccine in four weeks. The patient's medical history included phenylketonuria, thyroid gland disease, Crohn's disease. The patient's concomitant medication included zirtec, magnesium, acylpirin. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On the same day of COVID vaccination with in one minute, the patient felt throat constriction, worsened breathing, feeling of vertigo. The patient administered double dose of antiallergic drug Zyrtec and the symptoms re-solved. Only fatigue and mild vertigo were persisted. The next day after vaccination, the patient experienced diarrhea, and persisted till the day of reporting, and only mild form. The patient felt head spinning was still present. The patient received home treatment and patient was ready for possible adverse events, therefore the medication was available immediately. The outcome of the event diarrhea was not recovered and rest all other events was recovering.   Follow-up attempts are completed. No further information is expected.
Ever since the vaccinations that occurred on 7/30/18 happened, my son hasn't been the same. After receiving the shots, my son slept all day which isn't like him. The night of 7/31/2018 into the early morning of 8/1/2018 my son began to have 4 hour long episodes of screaming, arching of the back (due to inflammation in the brain) inconsolable screeches, limp in the legs and arms, wouldn't make eye contact or nurse.
Developed fever and headache 3 days after vaccines. Persistent and then developed seizures 5/20, 5/21. Diagnosed with meningoencephalitis. Hospitalized 5/21-5/26. 6/6/06 Received medical records from PCP which reveal patient was well on day of vax.  Developed fever, cough, HA, dizziness starting 3 days s/p vax & continuing for 12 days when developed seizures.  Patient was hospitalizaed from 5/20-5/26/06 w/ dx: encephalitis.  Continued w/seizures while hospitalized. Last office visit of 6/1/06 revealed patient had residual memory loss & minor motor seizures intermittently but was improving.  7/7/06 Received medical records from hospital w/final dx:  viral encephalitis w/new onset seizures.  Neuro & ID consults were included with records/ss. 60 day Follow-up Information 23-AUG-2006: Still being treated with neuroleptic medication. Speech is less advanced. No source of encephalitis identified.
Red, itchy lump at injection site appeared a week after the shot. The spot is hard like a large lump. There appears to be an itchy rash that is now the size of a quarter.
42 y/o female, hx of fainting ?when getting shots?. c/o SOB, stated ?I feel numb on my face from nose down to my mouth?. Also stated ?I feel like my throat is closing and having hard time swallowing?. Pt is hyperventilating, crying. Paramedics V/S taken HR 95, BP 149/88, O2 Sat 100%. Educated on calming and deep breathing techniques, given po fluids tolerating well. Pt now more calm and sent home without s/s acute distress.
The pt vomited X 1 the following morning, post vax. He possibly had a fever (mom does not know) and was given a fever reducer. She was better in the afternoon. By 19:00, she had jerky movements but awake. Also had a headache. By 22:00 went to ER and had no symptoms.
Sore Neck; 102 Fever; Very Fatigued; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (Sore Neck), PYREXIA (102 Fever) and FATIGUE (Very Fatigued) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced NECK PAIN (Sore Neck), PYREXIA (102 Fever) and FATIGUE (Very Fatigued). At the time of the report, NECK PAIN (Sore Neck), PYREXIA (102 Fever) and FATIGUE (Very Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 102 (High) 102.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
On 07/07/2001 the patient experienced a fever of 101F with redness and swelling, approximately thumb sized, at the injection site. That PM the patient noted an increase in the redness and swelling, and was fussy. The patient was treated with Tylenol for the fever and discomfort and with Benadryl.