chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received SHINGRIX (batch number N7H72 ?, expiry date 8th February 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, fever and headache. On 23rd August 2018, the patient experienced injection site rash, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the nausea, fever, headache, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis were unknown. It was unknown if the reporter considered the injection site rash, nausea, fever, headache, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis to be related to SHINGRIX. Additional details were provided as follows: The case reported via medical assistant. At 11:05 am, the patient received SHINGRIX and the following day, she experienced a headache with nausea and a low grade fever. Two days later (or 3 days after vaccination), she developed a rash that started at the injection site and over her entire trunk and dorsal back area running down into her left groin. The rash looks like dermatitis and was red, swollen and systemic and the rash was located everywhere on the patient's body except her face. The rash did not hurt but it was severely itchy. The patient visited a medi clinic and they put her on a steroid and it made the rash worse. On 22nd August 2018, the patient started to receive Steroids. Medical assistant indicated to medical information that the rash was similar to a hypersensitivity rash, not a shingles like rash (no vesicles).
VARIVAX administered 6/8/10. (6/9/10 - 6-11-10) Redness at site with dime size swelling at injection site/-? Injection.
Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023090154   Additional Information: GSK Receipt date: 29-JUN-2023 The patient self-reported this case. The patient experienced a sore arm only when he had his first Shingrix vaccination administered. The reporter consent to follow up. For tolerance of 2nd dose, refer case US2023090154, reported by same reporter.; Sender's Comments:  US-GSK-US2023090154:Same reporter
sl cold sx, pox rash, 1wk;pt had full-blown case per mom;
Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced PSORIASIS (Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up). At the time of the report, PSORIASIS (Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up) had not resolved.    No concomitant medications were provided by the reporter. Patient had taken Humira drug in the form  of Solution for injection in pre-filled pen. No treatment information were provided.
From initial information received on 06/03/2003 from a medical assistant, regarding an adverse event occurring in the US, it was reported that a 4 year old female patient received her fifth dose of DAPTACEL, Lot # C1383AA, in the upper right thigh and her fourth dose of IPOL, Lot # W08162, in the lower right thigh on 05/29/2003.  On 05/31/2003, the patient developed a large localized reaction of redness, warmth/hot and induration at the injection sites.  The recovery status was not reported.  Per the reporter, there were approximately 20 un-identifiable patients to be reported that had similar adverse events to these products.  Some of the events ranged from being a half dollar to a grapefruit in size.  Most of them occurred after being administered with the fifth dose.  Some of the patient's had ER visits.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm and injected limb mobility decreased were unknown. It was unknown if the reporter considered the swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The age vaccination was not reported. The patient received SHINGRIX on an unknown deltoid. The caller stated that the physician reported to him that the patient experienced severe swelling in the arm in which he received the SHINGRIX vaccine. The patient's swelling started either the same day or the day after receiving the injection. The caller stated that the patient had limited use of his arm and had to go to physical therapy. The caller stated that the physician said that he could be reached for more details regarding the event.
throat congestion; She developed a sore throat; with possible low grade fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 10Nov2022, outcome "not recovered", described as "She developed a sore throat"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 11Nov2022, outcome "not recovered", described as "throat congestion"; PYREXIA (non-serious) with onset Nov2022, outcome "not recovered", described as "with possible low grade fever". The events "she developed a sore throat", "throat congestion" and "with possible low grade fever" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Approximately 59-year-old female had Comirnaty bivalent booster around 3-4 weeks ago. Her primary and 2 earlier boosters were also Pfizer vaccines. She developed a sore throat on 10Nov2022 with negative rapid antigen COVID test at that time. Continued to had sore throat and throat congestion on the day of reporting, with possible low-grade fever. Took another COVID rapid antigen test which was positive. She had been evaluated by her primary care physician and was following his recommendations. This is being reported as a breakthrough infection following the Comirnaty bivalent booster vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296516 Same patient/vaccine, different dose/event;US-PFIZER INC-PV202200102748 Same reporter/vaccine, similar event, different patient;
Menstruation was much heavier than normal; Also a few days later I noticed an achy pain in my right arm that has persisted longer than a month now.; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 31Jan2022 at 16:00 (Lot number: unknown) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing) and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included unspecified multivitamin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FJ1611; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 03Jan2022, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Menstruation was much heavier than normal"; PAIN IN EXTREMITY (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Also a few days later I noticed an achy pain in my right arm that has persisted longer than a month now." Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19 and the result was negative.   The lot number for BNT162b2 was not provided and will be requested during follow up.
He got his vaccine, the following morning about 2:00 AM he had chills, woke him up, and not able to get back to sleep.  He has never had a reaction to a vaccine before, has had 4 COVID vaccines other than a sore arm.  Also gets annual flu vaccines with that as well.  The chills passed, he was OK, and they recurred the following evening as well, 9/16/22, less intensity.  Then he had them again on 9/17/22, much less intensity and that was the final occurrence.  He has been fine since then.  He just waited out the symptoms until he improved.    He did get an itch from the 4th vaccine, down his arm which did go away which took a while.
This spontaneous report as received from a physician refers to a 13 year old male boy. On 30-AUG-2012, the patient was vaccinated with the first dose in series of GARDASIL injection (lot number, dose, route and site of administration were not reported) and an unspecified number of other unspecified vaccines. The mother of the patient reported that the patient experienced facial twitching on an unspecified date after administration of GARDASIL. The patient did not seek medical attention. The facial twitching resolved on an unspecified date.  This case is linked with MARRS 1309USA007209 (same reporter link). Additional information has been requested.
fluctuating Temperatures up to  103.7 Painful Body aches throughout all joints Chills Symptoms lasted 36 hours  Right leg fluctuating tissue/faccia pain  lasting  2+weeks, MD states related to  virus/vaccine
Headache; dizziness; low blood pressure reading; This is a spontaneous report from a contactable consumer, the patient.  An 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot Number: unknown) via an unspecified route of administration in the left arm on 03May2021 at 16:00 (at the age of 18-years-old) as a dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 28May2021 at 18:00, the patient experienced headache, dizziness and low blood pressure reading. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The patient underwent lab tests which included blood pressure measurement as low blood pressure reading on 28May2021. The clinical outcome of the events was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-OCT-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 PFU (lot # M032360, expiration date 18-AUG-2017, dose not reported) subcutaneously. The dose of vaccine was improperly stored at 30 degree Fahrenheit for 1 hour. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient had allergic reaction; rash all over the body after received, Hep A#1, PCV#4, MMR#1, VARICELLA#1, vaccines.
rash small bumps on legs and arms. itchy.  pus filled when scratched. took benadryl. dry patches from rash still present.  eczema like.
Went down for nap, woke up screaming off and on x5 hrs, inconsolable.
Patient was due for next pneumonia vaccine. Rph misread the report and administered Prevnar20 which pt had already had last year instead of pneumonvax
Symptoms began 1/31, started with feet pain, then achy legs. Pain/muscle aches so bad by 1/1 that she had difficulty walking. Then by 2/2 evening symptoms were completely gone.
Swollen, hot, indurated local swelling 2 1/2" x 2"
Patient reports that that evening she was cooking dinner and had sudden back pain so she had to sit down. It spread to her legs and calves. So she laid down but couldn't roll over. She fell asleep and experienced chills and a fever during the night. Saturday morning she woke up with fever still and incredibly tired. She couldn't get out of bed to eat or drink anything. She thought about calling 911 or our 24-hour on-call service but she couldn't even make it to the phone. She slept all day. Sunday she could move better and was still a little achy but she was able to get out of bed and eat/drink. Monday she felt even better but still achy/no more fever. She called our Pharmacy first thing Monday morning. She denied needing medical attention or medications.
Patient received her flu shot, then her daughter received her shot.  They sat in the lobby for 15-20minutes due to first time flu shot for her daughter.  They had checked back in with the nurse and was released to go.  They were outside when she suddenly had chest discomfort/tightness, began to sweat and became very nauseated.  911 called, client evaluated 12 lead EKG negative, released to go home.  Spoke to client today 11/10, she stated that yesterday she develop a rash on her left shoulder and back, the rash later disappeared and she developed some swelling to the left side of her neck and burning sensation in her left shoulder.  She still has the burning sensation slightly today and mild swelling in her neck.  Denies difficulty breathing or swallowing.  She also has mild sore throat, low grade fever and body aches today. Denies any chest discomfort. Client has received flu shots in 2001 & 2000 without problems.  Denies feeling ill that day, no allergies to eggs
muscle soreness at injection site; This is a spontaneous report from a contactable pharmacist (Patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that received COVID-19 vaccine and approximately 9 hrs late the patient experienced muscle soreness at injection site on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT REQUESTED A SECOND DOSE OF MODERNA, AND RECEIVED PFIZER BY MISTAKE.
Itchiness within 10 minutes of injection. Red bump the next day that is warm/hot to the touch. Very tender.
This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 45-year-old female subject who was vaccinated with TWINRIX administration interval too long. On September 2003 the subject received 1st dose of TWINRIX (1ml, unknown route, left deltoid). In 2013, 4 years after vaccination with 3rd dose of TWINRIX, 9 years after vaccination with 2nd dose of TWINRIX,  10 years after vaccination with 1st dose of TWINRIX, the subject experienced not responding to therapy. Relevant test results includes "serology following the 3 dose series of TWINRIX was as follows: anti-HB's less than 5 IU/L (hepatitis B surface antigen). No serology done to measure Hepatitis A response following the same 3 dose (TWINRIX) series." According to the nurse, she would consider this subject to be similar "to some who was unvaccinated." At the time of reporting this outcome of the event was unspecified.
Itchy skin; Pinkish skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) and ERYTHEMA (Pinkish skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy skin) and ERYTHEMA (Pinkish skin). At the time of the report, PRURITUS (Itchy skin) and ERYTHEMA (Pinkish skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
passed out/Loss of consciousness resulted in concussion; concussion; became dizzy; Was experiencing body aches; increased thirst following vaccination; This is a spontaneous report from a contactable physician for a patient.    A 20-year-old female patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in Arm Right on 28Apr2021 08:30 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on an unknown date (Batch/Lot number was not reported) for COVID-19 immunization.  The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications (received within 2 weeks of vaccination) included celecoxib (CELEXA), trazodone, oral contraceptive nos (reported as oral birth control) taken for an unspecified indication, start and stop date were not reported. The patient got up at 2am 29Apr2021 to use restroom, became dizzy and passed out. She was experiencing body aches and increased thirst following vaccination. Loss of consciousness resulted in concussion. The adverse events result in: Doctor or other healthcare professional office/clinic visit. The events did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. The patient was not diagnosed COVID-19 prior to vaccination. Since the vaccination, the patient had not the patient been tested for COVID-19. The patient did not receive treatment for the events. The outcome of the event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event Loss of consciousness is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.
Administered 3/07/2015. Came by store on 3.08.15 evening and presented with a quarter size red area with inflammation surrounding. Pt. instructed to take ZYRTEC and apply 1% hydrocortisone. As of Wed 3.11.15 symptom subsided and totally by Sat. 3.14.15.
Left arm 6cm area of erythema, non-tender, swollen and itchy  Had telemed appt on 2/1/21. Dr prescribed Zyrtec
Chills, moderate to severe muscle pain, headache and low grade fever beginning the day following the second injection and lasting for 23 days. I remained at home and utilized the maximum prescribed doses of medication to treat my autonomic neuropathic pain including the maximum dose of Tramadol four times per day alternating with a total of 2000 mg of tylenol for the pain. Aslo utilized maximum prescribed doses of baclofen from 10 mg to 20 mg, amytriptyline from 25 mg to 50 mg, oxcarbazepine from 150 mg to 300 mg and lidocaine ointment from prn to twice daily. July 15th contracted shingles, July 31st developed cough, headache, and low grade fever. August 6th treated in ER for acute asthma.  August 20th I was treated in urgent care when  I developed acute non-recurrent maxillary sinusitis and a recurrence of shingles. My symptoms finally cleared on September 3rd. Aside from my autonomic neuropathy, I have never experienced long term symptoms of asthma or sinusitis.
patient  complaint of dizzy, light-headed, vertigo.  patient was lowered to the floor. feet were elevated. Negative findings: SOB, wheeze, stridor, angioedema, nausea or vomiting, syncope. vital signs: bp 100/80, heart rate 78, oxygen saturartion 98%.  15:40 bp 122/72 good color.  Assessment mild vasovagal reaction. Plan to d/c to home in care of husband with instructions to push fluids and follow up with pcp if further symptoms.
it was rpt on 5/9/96 pt recv 1dose varivax, same day incl  mmrII, dtp & opv & in 5/7/98 devel ``very mild'' chickenpox, ``multiple fluid filled lesions'' treated w/benadryl