chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uncontrollable hand movement and twitching in his sleep.  Same twitching, hand movement began while he was eating his dinner.  He began looking to one side and staring.  Parents were unable to get his attention.  He was taken to ER.  There it was indeterminate if it was a seizure.  CT scan normal.  24 hr EEG performed with hospital admission.
received a dose of Engerix B already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 7th July 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 7-Jul-2022 Reporter's comment: The registered nurse reported that on the day reporting the patient received a dose of Engerix B which was already expired on 6th April 2022. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix B, which led to expired vaccine used. Suspect was coded as per reported information.
Patient was administered ZOSTAVAX Sat. Apr 15,2017 at 4:30 PM. Patient said she had shingles two different times. On Mon. the patient came in and said she had a reaction to the injection. The area looked inflamed and had a bumpy rash. She went to the doctor on Tues., 4-19-17. The doctor said sometimes people do have a reaction. He prescribed VALTREX GM 21 to be taken every 8 hours.
itchy at injection site; red at injection site; developed a rash around the injection site approximately 3inches by 2.5 inches; sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE PAIN (sore arm at the injection site), VACCINATION SITE RASH (developed a rash around the injection site approximately 3inches by 2.5 inches) and VACCINATION SITE ERYTHEMA (red at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALPRAZOLAM and AMLODIPINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). On 15-Mar-2021, the patient experienced VACCINATION SITE RASH (developed a rash around the injection site approximately 3inches by 2.5 inches). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). The patient was treated with PARACETAMOL (TYLENOL) on 10-Mar-2021 for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE RASH (developed a rash around the injection site approximately 3inches by 2.5 inches) and VACCINATION SITE ERYTHEMA (red at injection site) had not resolved and VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
At the time of my first shot I was 10 weeks pregnant ,  second dose I was 13 weeks.  My baby was diagnosed with CPAM a lung malformation (lethal continental anomaly) at my 20 week checkup.  Due date was 7/21/21.
red welt under one breast; red spot on top of the other one; This is a spontaneous report from a contactable consumer or other non HCP.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation.  The patient medical history was not reported and concomitant medications were not reported. Caller (Patient) stated she got the first dose of the Covid vaccine on Friday (05Feb), 3 hours later (on an unknown date in Feb2021) she noticed a red welt under one breast an a red spot on top of the other one. She asked if it was the side effect of the vaccine and she asks if she should take the second dose. The action taken in response to the event s for bnt162b2 was not applicable. Outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested.
Nausea 2nd vaccine. Reported same with first vaccinet lasted 2 HR. Feels OK to go home.
Information has been received from a healthcare worker, concerning a 73 year old female patient with codeine and shellfish allergy and none pertinent medical history, who on 07-MAY-2012 was vaccinated with PNEUMOVAX 23 (lot# 671607/1169AA, Expiration date 06-MAY-2013), 0.5ml, IM on the left arm. Concomitant therapy included PAXIL, ezetimibe (+) simvastatin (MSD) and ibuprofen. It was reported that following vaccination the patient experienced on the left arm redness and swelling at the injection site and warm to the touch. On 09-MAY-2012 the patient was diagnosed cellulitis. Also it was reported that cefalexin as a treatment was given. The patient sought medical attention - she visited the office. None lab diagnostics studies were performed. At the time of reporting the patient status was recovered. This is the one of several report received from the same source. Additional information has been requested.
Also, the last time I got the flu; Initial information received on 08-Nov-2021 regarding an unsolicited valid serious case received from a consumer (patient) via Regulatory Authority.  This case involves an unknown age male patient who experienced last time got the flu (influenza) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious last time i got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event influenza was reported as unknown.  There will be no information available for the batch number for this case.
Patient came in for Moderna booster, stated he is on medications that suppress his immune system. Patient qualified to receive 3rd dose of Moderna vaccine. At time of vaccination, patient brough in vaccination card showing prior Moderna doses on 4/7/21 and 5/5/21 from another facility. Patient did not inform staff that he has been vaccinated with Pfizer recently. This was discovered upon billing for the vaccination and was confirmed within the registry. At time of report, no adverse event reported
3/21/14 Mom and child report soreness, redness, and itching to right arm. Mom reports seen in ER and told normal reaction. PHN observed arm and it (3/21/14) was red and warm. RN instructed Mom to follow up with PMD if continues. PHN observed no swelling.
Patient was administered expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine). On 16-Mar-2021 at 11:45 AM, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) to be not related.    No concomitant medication were reported.  No adverse event was reported.
aches; fever; chills; extreme stomach pain; back pain; joint pain/Sore finger joints and achy feeling in lower back gets worse at night but is still with me.; very loose stools; This is a spontaneous report from a contactable consumer. This 68-year-old-female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2 solution for injection), via an unspecified route of administration, administered in Arm Left on 23Mar2021 12:30 (Batch/Lot Number: EN6208) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 was no. The patient experienced aches , fever, chills, extreme stomach pain on an unspecified date, back pain, joint pain/sore finger joints and achy feeling in lower back gets worse at night but is still with me and very loose stools on 02Apr2021.  Reported as I had the expected aches, fever and chills for about a day. I did have extreme stomach pain for about 12 hours also. But around 02Apr started having back pain and joint pain and very loose stools. Sore finger joints and achy feeling in lower back gets worse at night but is still with me.  Don't know if this is related but it seemed suspicious.  Had a visit with my doctor for a yearly and mentioned back pain. No treatment was received for adverse event.  The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected
Fever for 12 hours Swollen and sore area at site of injection for 24 hours Headache for 24 hours Severe muscle and joint pain for 24 hours Continued muscle and joint pain and tenderness concentrated in low back/sacroiliac/lumbar spine for 72 hours  All treated with Tylenol 500mg and a heating pad
Pt recv vax on 10/21/97; 3-4 wk post vax pt exp lumps in her breast
Patient called us today to say that he had to go ER on 5/7/21 due to rash all over and tingling  in his throat.  He said he started shortly after the vaccine on 5/5/21  but thought it was his allergies. He noticed later that night that he was developing a rash all over his body.  He went to ER on 5/7/21 and they treated him for allergic reaction due to the vaccine. They gave him Benadryl and Steroid for 2 days.
TWO SEIZURES AFTER SHOTS; This spontaneous report received from a patient via a company representative via media concerned a patient of an unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events reported following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced two seizures after shots, and was hospitalized on an unspecified date for 10 days (Dose number in series 2). As per the reporter,  "Johnson and Johnson I Had two Seizures after shots. 10 days in Hospital". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two seizures after shots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220933526-covid-19 vaccine ad26.cov2.s- two seizures after shots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
there was swelling and hives that are itchy and red. pt has used a cold compress for swelling and will use benadryl tonight to help with reaction. pain started yesterday and today the swelling and hives began to develop
In peri-menopause, went 8 months without a period.  I was nervous about getting the booster since after the 1st vaccine I started my period (after months w/out).  I did not want to start my period again.  I got the booster and 4 weeks later I started my period. It was very heavy and would not stop.  I bled for 4 weeks straight until I went to the doctor who prescribed some hormone pills to stop the period.  I later had an ultrasound and found that my uterine lining is extra thick and I require a D&C.  D&C will be performed on Monday, May 23.
Patient received 4th Covid-19 Pfizer booster at pharmacy on 04/02/2022. On 04/04/2022, she awoke with leg weakness/numbness. She was sent to the emergency room and labs were obtained. Work-up was benign. She continues to have these symptoms. EMG pending.
lost balance; Every joint in my body aches; Terrible headaches; Body Aches; Fever; Throwing up; This spontaneous case was reported by a health care professional and describes the occurrence of BALANCE DISORDER (lost balance), PYREXIA (Fever), VOMITING (Throwing up), MYALGIA (Body Aches) and ARTHRALGIA (Every joint in my body aches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included LOSARTAN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN LOW), METOPROLOL, ATORVASTATIN, AMITRIPTYLINE, INSULIN and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever) and VOMITING (Throwing up). On 03-Mar-2021, the patient experienced MYALGIA (Body Aches). On an unknown date, the patient experienced BALANCE DISORDER (lost balance), ARTHRALGIA (Every joint in my body aches) and HEADACHE (Terrible headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (lost balance), PYREXIA (Fever), VOMITING (Throwing up), MYALGIA (Body Aches), ARTHRALGIA (Every joint in my body aches) and HEADACHE (Terrible headaches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Hospital admission for Acute osteomyelitis of calcaneum - given IV, started on broad-spectrum antibiotics, transferred to another facility for further management. S/p left below knee amputation and debridement right heel, stravix placement, 02/13, Patient continued to improve remarkably and antibiotics was transitioned to PO keflex. She was discharged back to the 1st facility. ED visit on 3/7/22 for hyperkalemia. Treated and released. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient was administered the 1st dose of COVID at 4:12, reported SOB at 4:20pm. PA on site assessed patient, all vitals normal (1220/70, Pulse 67, initial O2 94%, final O2 99%). PA administered 2 puffs of albuterol.   PA administered 2 puffs of albuterol. Patient was observed for 15 additional minutes.  PA provided education on possible delayed anaphylaxis reaction and gave Epi pen to take home as preventive measure. VAERS report was completed.
Pain at site, copious amounts of clear nasal drainage, sneezing constantly, fever of 100-101, chills, aches and pain everywhere, cough with some wheeze for 24 hrs then everything disappeared.
Fever; This is a spontaneous report from a non-contactable other hcp (Nurse). A patient of unspecified age and gender received BNT162B2 (BNT162B2), Formulation solution for injection, Batch/Lot number was not reported via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
For unknown reason (not documented in chart) patient received the first Pfizer COVID-19 Vaccine dose on 09/03/21, the  second dose of Pfizer COVID-19 Vaccine on 09/24/21 and the third/booster dose on 01/07/2022 which is earlier than the required 5 months and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
No additional AE reported; Intercepted product administration error; This spontaneous report was received from an other healthcare professional and referred to a patient with unknown age and gender. The patient's concurrent condition, concomitant therapy and medical history were not reported.  On 27-APR-2023, the reporter had picked up pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (lot # W021512 has been verified to be a valid lot number, expiration date was reported as 08-OCT-2023, dose, route and anatomical location were not provided) for prophylaxis, pushed air out of corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe, no liquid came out, let air out of corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe and was going to administer corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) to patient until reporter had read label for how pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) was specific for pneumococcal 15 with corresponding, intended patient trying to get diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX) booster at event time. On 27-APR-2023, the patient was administered corresponding diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX) booster (lot, expiration date, dose, route and anatomical location were not provided) for prophylaxis. The pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe was recapped, closed luer lock and was never administered to any individual prior to or at current call time (intercepted product administration error). The medication error near miss. No additional adverse event (AE) reported (no adverse event).
Myalgia, muscle stiffness, pt reports onset approximately 24 hours after vaccine administration- has had lab work, below with negative findings.
pt recv vax 21MAR96 & that noc began sx of fever 100,pain in all joints;soreness in arm & site of inj;states has arthritis in hands but today all joints are painful;25MAR96 f/u phone call pt reports sx ceased yesterday;sx persisted x48h
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-DEC-2017, the patient was vaccinated with VAQTA lot # N019924 with expiration date on 02-SEP-2018 (strength, dose, route of administration were unspecified) for prophylaxis. The suspected vaccine was improperly stored in temperature between 9 Celsius degrees and 25 Celsius degrees for 1 hour and 6 minutes. No adverse effects was reported. The digital data logger was involved. No previous temperature excursions were reported. This is one of two case reports received from the same reporter. Sender's Comments: US-009507513-1712USA009061.
patient got a sick as a dog; Initial information was received on 11-Nov-2020 regarding an unsolicited valid non-serious case from a social media (Facebook) via consumer or non-health care professional (patient).  This case involves patient (with unknown demographics) who was sick (got sick as a dog) (illness), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (got a sick as a dog) (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Vaccine FLUVIRIN and PNEUMOVAX given on 10/16 in upper left arm 1 inch apart. Patient returned 10/19 said she had been sick and could barely eat. She complained of legs and teeth hurting. She had a large red area on left arm.