chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Tiredness; pain at injection site; Nausea; Heartburn; not feel good; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, between 3 and 4 weeks after receiving Shingrix, the patient experienced feeling unwell. On 17th July 2019, the patient experienced nausea, heartburn, headache and injection site pain. On 18th July 2019, the patient experienced fever and tiredness. The patient was treated with omeprazole (Prilosec) and paracetamol (Tylenol). On 18th July 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the nausea, injection site pain, feeling unwell and tiredness were unknown and the outcome of the heartburn was not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the fever, nausea, heartburn, headache, injection site pain, feeling unwell and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced a fever which started late afternoon on the following day after vaccination. Her fever was around 101 and it resolved that evening after taking Tylenol.  The patient reported nausea on the first day and tiredness on the 2nd and 3rd day and it stayed for the following week.  Her heartburn flared up the same day as the Shingrix vaccination later that night and now it was being controlled with Priolosec for a 14 day regime for heartburn.  The patient's headache started the first night or the second night and she has had a headache every day or every other day for the following week.  The patient also reported pain at the injection site which started later that evening of vaccination. The headache lasted for 1.5 weeks and patient did not feel good at all.  The patient reported that her body did not tolerate the Shingrix like she expected it to and she did not feel like doing much. The reporter gave permission to follow up.
This case was reported by a other health professional and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was in bed for a day. This case has been linked with US2019GSK022776 and US2019GSK022778, reported by same reporter.
Pt has rashes on legs, arms, belly, chest. Non-itchy. Non-painful. Happened within 24 hrs of getting 2nd Shingrix Shot. Got shingrix (Dose 2/2) 8/19, rashes started 8/20. Sometimes get worse, sometimes better. Some swelling of fingers. No airway swelling/difficulty breathing.  Pt called to report this. Treated with Prednisone 40mg Once Daily x 5 days.
Fever, pain on left arm, body aches, back pain  Used Tylenol ,  fever subsided on 1/30 pm but back pain continued lightly and constant throughout 1/31/21. Flank pain (moderate)  began on 2/1/21, consistent/current
Leg is red, swollen, itchy. Given TYLENOL and BENADRYL.
03/07/03: 1 pox on face. 03/08: 3 pox on face. 03/09: few on legs and arms, sore throat, more than 50 pox, wheezing resolved, increased temp.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender who since 13-APR-2015 had been vaccinated with doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not provided). Those vaccines were exposed to temperatures outside of the recommended range on 13-APR-2015. No adverse effects had been observed or reported. Additional information has been requested.
Stiffness in left arm, neck and right shoulder; Chest pain, back pain and lots of cramping in chest and back.
pt recvd vax & pt was hospitalized w/an infect which was felt to be poss encephalitis; reporter felt that the infect & poss encephalitis were not related to therapy w/MMR vax;
Muscle Charlie horses, stomach vomiting, severe head ache (still have) pain in leg and arm, fatigued elephant on chest, drainage in right ear started to get worse 6 days after vaccine and is getting worse each day. Vision is hampered by head ache
nausea; sore arms; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A non-contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN). The patient experienced nausea and sore arms on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.
Injection site hard; Injection site,  swelled up; Injection site, it red; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Injection site hard), INJECTION SITE SWELLING (Injection site,  swelled up), INJECTION SITE ERYTHEMA (Injection site, it red) and INJECTION SITE PAIN (Injection site sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INDURATION (Injection site hard), INJECTION SITE SWELLING (Injection site,  swelled up), INJECTION SITE ERYTHEMA (Injection site, it red) and INJECTION SITE PAIN (Injection site sore). At the time of the report, INJECTION SITE INDURATION (Injection site hard), INJECTION SITE SWELLING (Injection site,  swelled up), INJECTION SITE ERYTHEMA (Injection site, it red) and INJECTION SITE PAIN (Injection site sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 07-Apr-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
PT C/O OF FEELINH LIKE HER NASAL PASSAGE WAS CLOSING AND AIRWAY TIGHTENING
Hitting himself, bending fingers and toes; Exacerbating autistic syptoms; Exacerbating autistic syptoms; Crying; Screaming; Pressing face, looking for pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 9 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Dec2021 (Lot number: FL8094) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). Patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The following information was reported: on 29Dec2021, the patient experienced crying, screaming, hitting himself, bending fingers and toes, pressing face, looking for pressure every 15 minutes for about 5 days exacerbating autistic syptoms. Events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 28Jan2022, patient received dose 2 (tris), lot number: FL0007, intramuscular administered in arm left.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine to the reported events can not be excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
tested positive for COVID-19 after being fully vaccinated.  was vaccinated with the Janssen vaccine on 3/18/21 and developed COVID-19 symptoms on 4/4/21, with a positive test result on 4/12/21.  Symptoms included head ache, neck pain, fever, fatigue, congestion, and a sore throat.
Information has been received via the manufacturer pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F). On 18-DEC-2006, the patient had a positive pregnancy test; the date of the LMP was 11-NOV-2006, with an estimated date of delivery of 18-AUG-2007. The CMA confirmed that on 22-DEC-2006, the patient had a spontaneous miscarriage, through hospitalization was not reported and testing of the miscarried fetus was unavailable. It was not specified if the patient sought medical attention, nor if the patient had recovered from the spontaneous abortion. On 27-DEC-2006, the patient was vaccinated IM, with the second dose of Gardasil (Lot #654540/0800F). Upon internal review, spontaneous miscarriage was determined to be an other important medical event. This patient also experienced a pregnancy following vaccination with the second dose of Gardasil (WAES #0705USA01062). Additional information has been requested.
This spontaneous report was received from a licensed practiced nurse refers to a 18 months old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent (MRK). On 10-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N023969 and expiration date: 28-FEB-2018) subcutaneously at the temperature from -14 degree Celsius (C) to -10 C (-14 C) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the report received from the same reporter. Sender's Comments: US-009507513-1804USA005654: US-009507513-1804USA006161.
She got her vaccine, she had no reaction.  At 9:46 it hit her like all of a sudden.  She was on her couch reading, and she started with dizziness, her head started spinning.  That continued, (still has dizziness as of this morning).  She had blurred vision, got nauseous, started throwing up off and on up until yesterday, 6/14/22.  She had a slight headache, she had diarrhea, chills like she was shivering, and also break outs of sweats.  She has loss of appetite, fatigue and just feeling weak and her balance is going on with that.  Her vision is hard for her to focus, she can see but she has a hard time focusing on things.   She has not had any problems her vision in the past, she uses reading glasses and when it hit her she was reading.  She was sleepy with the first vaccine for 2 days, and soreness in the right arm.    She called her doctor, (her doctor has retired), and told to call them and that the other doctor would be able to help her.  They told her to call the pharmacist who gave her the shot, she did and was told that she may start feeling better later in the day, but the dizziness concerned him and her being nauseous.  He told her that she could take Ibuprofen and Benadryl.   She took something for the nausea and was able to eat some toast on 6/13/22.   She has been drinking and making herself eat, has fatigue and just not feeling good and doesn't seem to be able to get her strength back and cannot drive due to the vision issues.
VACCINES WERE ADMINISTERED ON 4-29-19. ON 5-2-19 PARENT (MOM) CALLED OUR NURSE TRIAGE LINE TO REPORT THAT PT HAD BROKEN OUT IN A RASH ON HIS ARM, FACE, AND BEHIND HIS THIGH. A FOLLOW UP CALL WAS MADE ON 5-3-19. PER DAD THE RASH HAD RESOLVED. NO OTHER PROBLEMS REPORTED
This spontaneous report as received from other health professional refers to multiple patients of unknown age and gender. On an unknown date the multiple patients was vaccinated with PEDVAXHIB (strength, dose unit, route, lot# and expiry date unknown) that was exposed to a temperature of 31F for 720 hours. No adverse effect reported. The outcome of patients received a dose of PEDVAXHIB that was exposed to a temperature of 31 F for 720 hours and no adverse effect reported was unknown. This case #1402USA010413 is linked to case # 1402USA007528 via same reporter link. Additional information has been requested.
Injection site was black and crusty broken skin (dime sized); Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) and VACCINATION SITE DERMATITIS (Injection site was black and crusty broken skin (dime sized)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Feb-2021, the patient experienced MALAISE (Felt sick). On 07-Feb-2021, the patient experienced VACCINATION SITE DERMATITIS (Injection site was black and crusty broken skin (dime sized)). At the time of the report, MALAISE (Felt sick) and VACCINATION SITE DERMATITIS (Injection site was black and crusty broken skin (dime sized)) had not resolved. Not Provided          No concomitant medications reported by investigator o No treatment medications provided by the reporter.
10:30 am - Patient became restless, began to complain of a feeling that his throat was closing. Pallor. BENADRYL administered. 10:34 am - EPIPEN 0.3 mg IM given. 10:50 am - Transport to hospital via Paramedics.
Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration; Received vaccine that expired on 10-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine that expired on 10-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine that expired on 10-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine that expired on 10-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Patient received vaccine on Friday 10/21/22. Patient woke up Saturday 10/22/22 with no appetite, very tired, threw up once, low-grade fever of 101 F, and rested on the couch for the rest of the day. She was feeling okay by dinner time. It was discovered that the pharmacist administering on 10/21/22 improperly diluted the Pfizer pediatric bivalent vaccine and most likely the adverse event that occurred was due to higher than recommended dose due to the improper dilution. The patient and primary care physician were contacted, and the patient's mom told us the adverse event that occurred the day after vaccination.
Patient generalized swelling on left upper arm from shoulder to elbow. Applied cold packs and took BENARDYL. Took approximately 1 week for reaction to subside.
mild fever; chills; fatigue; nausea; Dizziness; tingling of extremities; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), PARAESTHESIA (tingling of extremities), PYREXIA (mild fever), CHILLS (chills) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mood disorder since 1989. Concomitant products included VITAMIN D [VITAMIN D NOS], ACETYLSALICYLIC ACID (BABY ASPIRIN), SERTRALINE and LAMOTRIGINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (Dizziness), PARAESTHESIA (tingling of extremities) and NAUSEA (nausea). On an unknown date, the patient experienced PYREXIA (mild fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of UNK, qh. On 19-Mar-2021, DIZZINESS (Dizziness) and NAUSEA (nausea) had resolved. On 19-May-2021, PARAESTHESIA (tingling of extremities) had resolved. At the time of the report, PYREXIA (mild fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added new event tingling of extremities, added start date of events nausea and dizziness, added patient information, added batch number, a, dded treatment concomitant and treatment information Added other relevant history . Updated outcome of events of nausea, dizziness.
42 year old female who presents for evaluation of her throat. She had the first COVID-19 vaccine (Moderna) yesterday and within an hour noted a globus sensation which has not resolved. Denies hoarseness, odynophagia or otalgia. Is able to eat and drink well.    pt had COVID vaccine yesterday and on her way back started to feel intermittent throat tightness, which continues till today. On exam no throat or oral swelling, wheezing or hypoxia noted. VSS. Pt has tried benadryl as recommended by MD, but the concern continues.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 4:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. On 07-Jan-2021, Excursion time was 09 AM and 10 AM, with temperature as 34 and 34 respectively. Total doses given for the day was 96 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM and 10AM vaccine was moved to fridge on 05-Jan-2021 and. Vial was moved to clinic on 07-jan-2021. 6 vials from 9 AM and 10 AM were sent to clinic. Vaccine BUD date was 27-Jan-2021 for 9 AM,10 AM respectively. On 07-Jan-2021 no hourly temperature recordings available The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pt Treated in ER after falling while surfing given DTaP, not TD as ordered.