chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next morning after the PREVNAR vaccine my son developed a deep cough. It continued for several days. I checked on the vaccine manufacturer's web site and a cough was stated as a possible side effect.
18 yo Male client received Janssen vaccine at 12:54. Immediately following injection, client slumped over in chair and began seizing. Seizure lasted 2 seconds, client immediately became alert and responsive. Client stated he got ?cloudy? but feels normal post event. Client assisted to floor to lay down. After 20 seconds client wanted to get up stating he was feeling normal. Client escorted to observation area where he was observed for full time without further events. No EMS called Ambulatory upon leave with his family
This case was reported by a physician via sales rep and described the occurrence of hives in a 57-year-old male patient who received Shingrix for prophylaxis. In August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced hives, tingling, rash, headache and fatigue. On an unknown date, the outcome of the hives, tingling, rash, headache and fatigue were unknown. It was unknown if the reporter considered the hives, tingling, rash, headache and fatigue to be related to Shingrix. Additional details were reported as follows: At 5:30 pm on Tuesday, the patient received Shingrix vaccine in an unknown arm. By the next morning, the patient developed a tingling and then rash under the arm, which spread to the same side torso. The physician told the patient that it looked like hives. It was not sure if it was resolved. The patient also had usual' symptoms of headache and fatigue, as described by the physician. The physician reported this adverse event to VAERS as well. The physician believed that these reactions were as a result of Shingrix vaccine.
the patient got the vaccine 18 days before and the contracted COVID; the patient got the vaccine 18 days before and the contracted COVID; This is a spontaneous report received from a contactable consumer. This consumer reported for a friend (patient) that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient got the vaccine 18 days before and the contracted COVID. The friend wanted to know should he proceed with the second dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
pt recvd vax;found to be anti HAV pos;confirmation test was neg;MD do not believe has HEP because pt has no signs or sx of any type of hep disease;Physicians consider the first anti HAV to be poss a false pos;
painful neck; dizziness; nausea; Pain at the injection site; painful neck and shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 30th April 2022) and (batch number 2S9CL, expiry date 29th August 2022) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In August 2020, less than a week after receiving Shingrix, the patient experienced neck pain, dizziness, nausea, injection site pain and shoulder pain. On 27th August 2020, the outcome of the neck pain, dizziness, nausea, injection site pain and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the neck pain, dizziness, nausea, injection site pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient who after receiving the first dose of Shingrix experienced pain at the injection site, nausea, dizziness, painful neck and shoulder, the symptoms lasted for 4 days after the vaccination that was on 27th August 2020. The reporter consent to follow up.
Got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) in a 27-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Jul-2020 and the estimated date of delivery was 16-Apr-2021. On 10-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy. The patient had a vaginal delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 3460 grams (7lbs 10oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Perinatal complication for the infant included jaundice, bilirubin in high risk zone. slow weight gain was observed after the 1 month post-partum. Length was 51.44 cm and head circumference was  34.93 cm. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2020, Pregnancy test: positive (Positive) Positive. On 08-Aug-2021, Group B streptococcus neonatal sepsis: positive (Positive) Positive (26 Mar 2021). On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. Infant abnormalities at 1- month post partum included slow weight gain.   This case was linked to MOD-2021-232123, MOD-2021-232123 (Parent-Child Link).   See case MOD-2021-232123,MOD-2021-232123 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 patient demographic details medical history and lab data was updated,perinatal complications, pregnancy outcome. was updated second dose information was updated
Extremely painful vaginal ulcers.. Patient was taken to hospital.  Needed to be admitted for pain control but no beds were available.  Two weeks later, they are still there and very painful. Patient can't walk.
Site red and swollen. Right upper arm 5cm larger than left. Red area 16cmx16cm in size. Was having shoulder and neck discomfort. No fever. Went to ER. Put on Duracef 250 mg q12 hours for 5 days.
No adverse reactions, 2 Fluzone HD doses given for 2021-2022 season
About 30 hours after the injection my arm was swollen and hot to the touch, shoulder, elbow and wrist joints of right arm were very sore and hurt to move. Swelling decreased over the next 3 days, however the soreness and pain in the joints has not decreased and some days increases exponentially until i cannot bend or move my arm.
Pt vaccinated w/DTP/OPV developed screaming & unresponsiveness.
AFTER THE FIRST INJECTION THERE WAS NO REACTION. AFTER THE SECOND INJECTION STARTING 8 HOURS AFTER THE INJECTION SHE HAD SEVERE MUSLCE WEEKNESS AND COULD NOT MOVE.  SHE HAD A FEVER GREATER THAN 101 AND PIERCING PAIN IN THE HEAD AND MUSLCE ACHES THAT LASTED ABOUT 48 HOURS.  SHE HAD TO CALL OFF OF WORK. ABOUT 12 DAYS AFTER THE 2ND INJECTION SHE DEVELOPED REDNESS, TENDERNESS, SWELLING IN THE LOWER LEGS.  WENT TO MED EXPRESS AND A DOPPLER WAS DONE FOR BLOOD CLOT.  IT WAS NEGATIVE.  THEY SYMPTOMS PROGRESSED AND SHE WENT TO HER PCP.  DIAGNOSED WITH CELLULITIS AND WAS PUT ON KEFLEX.  UPON EXAM YESTERDAY IN OUR OFFICE IT WAS CONFIRMED THAT SHE HAS ERYTHEMA NODOSUM.
No adverse effects or symptoms following administration; Caller is a medical assistant who reports administration of VARIVAX following temperature excursion.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 10-MAY-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose of 0.5 milliliter (ml) once (vaccination scheme frequency, route of administration and anatomical site of injection were not reported; lot number U024221 that was verified to be a valid lot number with an expiration date reported and established as 08-APR-2023) for prophylaxis, following a temperature excursion  of 12 degrees Fahrenheit (F) with a time frame of 22 hours (product storage error). It was reported that there was no previous temperature excursion.  There were no adverse effects or symptoms following the administration (no adverse event).
Pt states that ~ 20 minutes after receiving the COVID-19 vaccine on her right deltoid, the R side of her face felt numbness and tingling on the R-side of her face. States her muscles felt weaker. Improved after waiting another 10-15 minutes. Advised to monitor and record her symptoms, speak with her doctor if necessary, and enroll in the V-safe reporting app.
Upset stomach; soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 16:00 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Haemodialysis", start date: Jun2012 (unspecified if ongoing); "Open heart surgery" (unspecified if ongoing); "Heart valve replacement", start date: 2017 (unspecified if ongoing); "pacemaker", start date: 2017 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Mar2021, outcome "recovered" (15Mar2021), described as "soreness at injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Upset stomach".  Additional information: Patient was having side effects from the Covid-19 vaccine. He had soreness at the injection site. He was unsure if it was what he ate or a reaction to the vaccine. Yesterday he had an upset stomach. He read where that was mentioned in the paperwork. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) were reported as none. Relevant Tests were reported as none. Patient was unable to clearly read the handwriting on the card as it was illegible. He think the Lot was EL92CR1.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's wife called to report psychiatric side effect of patient feeling "funny" and  have uncontrollable anger and irritability starting 30 minutes after vaccine was given.  Advised patient to contact md and go to ER if symptoms did not resolve, continued, or got worse.
Patients mother states that approximately 1 hour after receiving the vaccinations, the patients "heat rash" spread to the arms, legs, chest and face. Denied chest pain, shortness of breath, lip/tongue or throat swelling. Only reports spreading of rash that she had prior to visit that is itchy. She has applied cortisione and given benadryl with some improvement of symptoms. Mother states that she did not follow up with pcp or urgent care because she felt that it was not "that serious."  Mother instructed to continue to monitor the pt for any new or worsening symptoms and to begin giving the chld childrens zyrtec or claritin in addition to benadryl at night according to manufacturers instructions as needed for itching and follow up with Pediatrician in the next 2-3 days or ER for any new or worsening symptoms. Mother verbalized understanding and denies any further concerns
Stopped smiling, staring, fussy/crying, could keep awake, will not respond to sound.
This spontaneous report was received from a consumer (patient's wife) referring to a 65 year old male patient. The patient's had triple heart bypass surgery, in the 1980s he had a staph infection in the same arm and had shingles 10-15 years ago. On an unknown date in 2005 (13 years ago), the patient had PREVNAR. Concomitant therapies includes VYTORIN, JARDIANCE, metformin, TOPROL, lisinopril and gabapentin. Information on drug reactions/allergies was reported as none. On 11-APR-2018, the patient was vaccinated with PNEUMOVAX 23 1 injection (strength, dose, lot # and expiry were not reported) and ZOSTAVAX 1 injection (strength, dose, lot # and expiry were not reported), at the same time in the same arm for prophylaxis. On 12-APR-2018 (reported as the next day), the patient did not feel well, was nauseous and complained of pain in the arm where the vaccines were administered. On 12-APR-2018 (that same day), the patient developed diarrhoea and the injection site arm became "bright red and boiling hot" to the touch. On 13-APR-2018 (reported as by Friday), the nausea and diarrhoea had stopped but the swelling in his arm extended from the injection sight to his elbow. On 13-APR-2018 (reported as that day), the patient contacted the clinic where the vaccines were administered and asked for help. An unspecified physician recommended to take BENADRYL. The patient took unspecified dose/intervals of BENADRYL and also loratadine. On 14-APR-2018 (reported as by Saturday afternoon), the swelling in the patient's arm began to decrease. At the time of the call, the reporter said that the patient's arm was pink at the injection site and still "painful but not as bad" as it was. Lab diagnostics/studies was not performed. The patient sought medical attention for the events. The outcome of malaise, vaccination site swelling, vaccination site warmth, vaccination site erythema and vaccination site pain were reported as recovering/resolving. On 13-APR-2018, the outcome of nausea and diarrhoea were recovered/resolved. Causality assessment was not reported. No further adverse event information was provided. There was no product quality complaint (PQC) reported.
Male patient 41 years old went to the vaccination center September 1 of 2021 to get his second dose MODERNA. He reports that after his first dose on August 11, of 2021 he had an adverse effect swollen nodules under his axilla and rash on the lower limb. Patient refers the next day he had red dots and muscular pain. Patient informed not getting any treatment during that time. Reports having the same type of allergy before.
COVID-19 tested positive; COVID-19 tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220146089 (Janssen).  A male patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 14Mar2021 (Lot number: 1805029, Expiration Date: 23Aug2021) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jan2022, outcome "unknown" and all described as "COVID-19 tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive, notes: tested positive with Bi Nax Now antigen test (NR: not provided) positive.  Clinical information: The patient received Covid-19 vaccine ad2 6.cov2.s, dose number in series was 1 administered. On 14Mar2021 to left arm for prophylactic vaccination. No adverse events were reported following with Covid-19 vaccine ad26.cov2.s. The patient additionally received non-company suspect vaccine included: BNT162 (Pfizer), patient received unspecified concomitant medications. On 23Jan2022, following vaccination with BNT 162, the patient tested positive with Bi Nax Now antigen test positive. The outcome of covid-19 teste positive was not reported (dose number in series was 2). Causality as per reporter (Drug/Vaccine): Possible Causality as per Mfg. (Drug/Vaccine): Possible for JANSSEN COVID-19 VACCINE.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (administered vaccine Jan 15, 2022; past the BUD date of Nov 1, 2021) and product storage error (vaccine stored in refrigerator and administered on Jan 15, 2022; past the BUD date of Nov 1, 2021) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Jan 15, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 15, 2022, patient experienced administered expired product (administered vaccine Jan 15, 2022; past the BUD date of Nov 1, 2021). On an unknown date, patient experienced product storage error (vaccine stored in refrigerator and administered on Jan 15, 2022 past the BUD date of Nov 1, 2021). At the time of the report, administered expired product (administered vaccine Jan 15, 2022; past the BUD date of Nov 1, 2021) and product storage error (vaccine stored in refrigerator and administered on Jan 15, 2022 past the BUD date of Nov 1, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. BUD date: Nov 1, 2022. Expiration date: Mar 19, 2022.
Rash started around mouth and face and than to the rest of his body. Next came a fever of upto 103 degrees. His lips turned blue he cried none stop. Went to primary care doctor who said he was having a reaction and took him to ER. He was examined and given fluids and sent home. Followed up with primary care following day. He maintained pain for about 2-3 weeks. Went back to the primary care doctor who did nothing. The rash subsided after 4 months.
Pt had seizure at home, evening of vaccination seen in ER by neonatologist Dx seizure.
After IM injection to left deltoid patient complained of "tingling" in left arm and left hand. When pharmacist contacted patient later that day and next day patient was still experiencing same sensation.
I was having trouble breathing.; I felt like I was going to faint/I was dizzy.; I was dizzy and hot; I broke out in a sweat; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0217), via an unspecified route of administration, administered in Arm Left on 26Jun2021 at 13:15 (at the age of 18-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no medical history and past drug history. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Jun2021 at 13:30, the patient experienced patient was having trouble breathing, felt like patient was going to faint, patient was dizzy and hot, patient broke out in a sweat. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Events resulted in Doctor or other healthcare professional office/clinic visit/physician Office Visit. No treatment was received for events. Patient had no prolonged hospitalization. On 27Jun2021, the outcome of events was resolved.  No follow-up attempts are possible. No further information is expected.
Lethargy after administration, 5 hours later seizure lasting 45 minutes, aborted with ATIVAN and fosphenytoin, 2nd seizure in ED <5 min, intubated, extubated overnight. Infectious work-up including CSF studies and RPP negative. CT head without contrast WNL, EEG pending.
Dizziness, vertigo, vomiting, tinnitus, heartbeat in ear, unbalanced, breaking out in a sweat, so sick can?t hold my head up, so weak can?t walk.
Swelling of the leg, itching, hardness at injection site. Fever. Irritable. Lethargic
Severe welts like burns on whole body with uncontrollable itch  ive had for 5 days just got prednisone none
Unexplained death/SIDS 6/12/2008 Autopsy received with COD Sudden Infant Death Syndrome. Manner of Death:  Natural. Neuropathology report DX: Gliosis of the Medullary Nuclei.
Within a few weeks of my second vaccine I started having tinnitus. I did not realize it was vaccine related until recent reports. I couldn?t figure out why I had tinnitus, but now I know.
Cellulitis (R) thigh. Tx: AUGMENTIN ES 600 - 42.9/5ml sig: 2 tsp BID x 10 days.
Patient received the vaccine approx 23 hours after vial puncture. Vial was kept in the fridge after puncture. I contacted Moderna who verified the vaccine efficacy was maintained due to refrigeration, however, due to no preservatives in the vial, sterility may be compromised after 12 hours from puncture. This would increase risk for microbial contamination in the vial.  Vaccine was administered 12/20/22.  Pt was notified of error on 12/23/22. Pt aware the vaccine was viable , but risk of microbial contamination. Patient denied any signs or symptoms of infection at the injection site.  Pt advised to contact the doctor is she experiences any signs or symptoms of infection.   Pt verbalized understanding.
Information has been received from a physician via company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 15-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. The highest recorded temperature was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a certified nurse midwife, via a company representative, concerning a 25 year old female patient who on 01-MAR-2007 was vaccinated in the hip, with the first dose of GARDASIL (Lot #02630 - invalid). There was no concomitant medication. The nurse stated that on 27-MAR-2007, the patient developed Bell's palsy on the left side of her face, and added that the "patient's face is uncontrolled." The nurse confirmed that the patient visited the ER, but the date and details were not provided at the time of this report. Bell's palsy was considered to be disabling by the reporter. Additional information has been requested.