chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Scarring where the rash occurred; Shingles/ Lack of effect; Rash on torso, in patches; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included valaciclovir hydrochloride (Valtrex).   On 18-JAN-2023, the patient received the 1st dose of Shingrix (left arm) and Influenza vaccine (right arm). On 30-JAN-2023, 12 days after receiving Shingrix and Influenza vaccine, the patient experienced shingles (Verbatim: Shingles/ Lack of effect) and patchy rash (Verbatim: Rash on torso, in patches). On an unknown date, the patient experienced scar (Verbatim: Scarring where the rash occurred). On 06-APR-2023, the outcome of the patchy rash was resolved (duration 2 months 7 days). The outcome of the shingles was unknown and the outcome of the scar was not reported.   It was unknown if the reporter considered the shingles, patchy rash and scar to be related to Shingrix and Influenza vaccine.     It was unknown if the company considered the shingles, patchy rash and scar to be related to Shingrix and Influenza vaccine.   Additional Information: GSK receipt date: 06-Apr-2023  The case was reported by patient's wife.  The reporter stated that the patient received first dose of Shingrix and on 30 January 2023, the patient developed a rash on his torso on the right side, front and back.  The rash was right above his nipple on his front side and the rash was in patches extending to the mid-line of his back.  The reporter stated that the patient also had the flu vaccine (unknown which manufacturer) administered at the same time in the right arm.  The patient contacted his physician on 01 February 2023 and the rash confirmed as Shingles.  The physician started the patient on Valtrex.  The reporter stated that today on the day of reporting the rash has cleared up but the patient does have some scarring where the rash occurred.  The reporter consented to follow up. This case had been linked with US2023050865, US2023AMR051192 same reporter.; Sender's Comments:  US-GSK-US2023AMR051192:Same reporter - wife case US-GSK-US2023050866:Same reporter - wife case
Gave immunizations Typhoid, Tdap, Hep A and MMR. After MMR she said she didn't feel well. She passed out in chair and had what appeared to be a vagal response. In 30-45 sec. she came too. She was assisted to couch where she rested with cool cloth. After 20-30 min.
Erectile dysfunction; Pfizer: 05Jan2022, Moderna vaccine same date: 05Jan2022; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jan2022 15:45 (Lot number: FL3198) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 05Jan2022 (Lot number: 021L21A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Vaccination history included: Moderna Dose number: 1 (Lot number: 041B21A) and Dose number: 2 (Lot number: 021L21A), both vaccine location: left arm, administration time: 12:00 PM, administration date: 17May2021 (as reported), when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: ERECTILE DYSFUNCTION (medically significant) with onset 06Jan2022, outcome "not recovered", described as "Erectile dysfunction"; PRODUCT USE ISSUE (non-serious) with onset 05Jan2022, outcome "unknown", described as "Pfizer: 05Jan2022, Moderna vaccine same date: 05Jan2022". Therapeutic measures were not taken as a result of erectile dysfunction. Patient started experiencing erectile dysfunction since Pfizer booster. He didn't have the problem on 04Jan2022. As of 31Jan2022, he was still having the same problem which never happened before 04Jan2022. He does not have Covid related or any health problem. He had 2 Moderna shots before. Also reported that other vaccine same date product was Moderna (lot number: 021L21A) on 05Jan2022 as "dose number: 2" (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Narrative:  STATED DIARRHEA/HA/FEVER LASTED 22 HOURS.
Local circumferential injection site reaction with swelling, mild warmth, and mild hyperemia. Approx 8 cm diameter.
Redness at the injection site; Swelling at the injection site; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, METOPROLOL SUCCINATE (TOPROL) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient became very pale, sweaty and felt like she was going to pass out approximately 5 to 10 minutes after vaccination.  After drinking fluids she quickly recovered.
Parent returned to clinic 1/29/09 with child. Noted edematous/reddened upper Right arm. Extremity freely mobile;child complained of pain & itching at times. Encouraged to continue with comfort measures,(compresses & aspirin-free pain relievers).Incident resolved, per mom ,02/03/09.
patient under age 65 were given the Fluzone HD Quad with no reported adverse event; patient under age 65 were given the Fluzone HD Quad with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to case 2021SA342449(same reporter).  This case involves a 12-year-old male patient who was under age 65 were given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 13-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ769AC and expiry date: not reported] via an intramuscular route in right deltoid administration site prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day].   It was reported "the caller was the director of clinical services. 4 members of the same family, under age 65 were given the Fluzone HD Quad, all the same lot and expiry date".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Headache, Myalgia, SkinRash, Tachypnea, CoughWheeze, UrticariaPruritus, 1st dose fatigue, headache difficulty breathing. lymphnode 2nd doseheadache, myalgia, difficulty breathing, hives, sore tongue Narrative: advised no further covid vaccination
I have been running a low fever ever since I got the second shot and I have been coughing up a lot of fluid . I was fine before the second shot . Want to know if this is normal? Can you get Covid 19 from the shot?
This non-serious spontaneous case, initially received on 29-Oct-2018 (combinedly processed with follow-up received on 02-Nov-2018), reported by other non-healthcare professional (consumer), concerns a 41-year-old adult pregnant patient. On an unspecified date, the pregnant patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). At the time of this report, no adverse event was reported.
7cm x 5cm indurated hot are lt thigh; cellulitis secondary to vax;
vaccines given and 2-3 minutes later client said he was feeling dizzy. Helped patient to floor. Laid on back with feet elevated on chair.  BP taken 10:58 121/82, p 64.  Patient stated he felt better, moved to sitting position on chair. repeat BP 10:04 140/83.  Patient had not eaten, given crackers. left office to sit in waiting room. No further complaints. Left waiting room at 10:30.
Pain at injection site; Tachycardia like 120 heart rate; Dizziness; Fatigue; Fever; Stressing; Threw up; This is a spontaneous report from a contactable Other healthcare professional (Nurse Practitioner, also the patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730), intramuscularly on 20Dec2020 at single dose on right deltoid for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced tachycardia, dizziness, fatigue, fever, stressing, threw up on an unspecified date in Dec2020, and pain at injection site on 20Dec2020. The patient received Covid vaccine yesterday on 20Dec2020 and he woke up and he threw up twice and he have fever 102 and tachycardia like 120 heart rate and some dizziness and he took some Tylenol (taken as treatment) and just drinking water. Feeling a little better right now. Tylenol was taken this morning as a treatment for fever of 102. For Causality, consumer stated, he believed so, because like he hasn't been around, he obviously worked around people who were sick, but he was fully gown and fully PPE. He was fine until this morning. Last night the only symptom he was having was pain at injection site which was expected. Of course, he can expect a low grade fever or maybe just some fatigue, he thought he was just stressing, he had fever went to 102 and he developed tachycardia and dizziness which was getting better after medicine and drinking fluid. Therapeutic measures were taken as a result of tachycardia, dizziness, fever. The outcome of the events tachycardia, dizziness, fever was recovering, the outcome of the other events was unknown.
Became sick with COVID-19; Case reference number US-BN-2022-001551 is a spontaneous case report initially received on 13-Jul-2022 from health care professional (reference number: USBAV22-0547) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at a dose reported as 1mL, administered intramuscularly, for pre-exposure prophylaxis.  On an unspecified date, an unknown amount of time after the vaccination, the patient became sick with COVID-19.  At the time of this report, the outcome of the event was not resolved/ongoing.  The reporter assessed the event as non-serious and not related to the vaccine.   Additional information received from Bavarian Nordic on 14-Jul-2022 included the local case ID.; Reporter's Comments: A patient of unknown demographics experienced as non-serious event of COVID-19 on an unspecified date, an unknown amount of time after the vaccination with the first dose of Rabavert for pre-exposure prophylaxis. COVID-19 is not listed for RabAvert according to the insert and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was not resolved. The event of COVID-19 has been considered as not related to the suspect vaccine, but to incidental infection. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics experienced as non-serious event of COVID-19 on an unspecified date, an unknown amount of time after the vaccination with the first dose of Rabavert for pre-exposure prophylaxis. COVID-19 is not listed for RabAvert according to the insert and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was not resolved. The event of COVID-19 has been considered as not related to the suspect vaccine, but to incidental infection. This case is considered as non-serious.
First 24hr symptoms (no concern at time): - Moderate ache/pain in injection site arm ~4hrs after injection - Fever starting ~12hrs after injection leading to rough sleep through night (reached and held 101dF for ~6hrs) - Body aches ~14-48hrs after injection  Beyond 24hr symptoms (concerning): - Severe migraine/headache pain toward front of head/behind eyes lasting 20+hrs (I infrequently suffer painful migraines and this one took the all-time miserable record for intensity and longevity) - Generalised body pain/aches/fatigue for ~2.5days  - Extreme restless leg sensations starting in AM of day 2 and continued for 48hrs - Severe brain fog and what I can only describe as brain "Zingers" with a periodic sensation (every 5-10mins) of an electrical zap coming from the back of my head and causing an unusual vertigo/dizzy and muddy thinking (this was very alarming and unlike anything I've ever felt in my life).  This continued for before slowing fading.
This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of PEDVAXHIB, lot# reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (route of administration was not reported). The administered dose of the vaccine experienced a temperature excursion 32 Fahrenheit (°F) to 35° Fahrenheit (°F) for 6 hours, as recorded by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010561.
initially neck pain which evolved to involve a burning pain down to the sacral spine, low grade temp 100.8 F,  chills, nausea, extreme fatigue, and diffuse joint pain.  I'm a retired Family Nurse Practitioner and have had multiple vaccines in the past (TDaP, Hepatitis B series, Pneumococcal, Influenza, COVID) and have never had a vaccine reaction.  This reaction frightened me.
Patient reports open wound at injection site one month post-vaccination. Per patient, wound will scab over, fall off, and does not heal. Patient called pharmacy on 1/9/2023 to report AE and inquire about OTC treatment options. We advised patient to come into the pharmacy for further evaluation.
Initial information received from health care professional on 02 September 2008. A 59 year old female patient with no reported past medical history received an injection of ADACEL (C2997AA), IPOL (AO491-4), TYPHIM VI (AO923-3), and an initial injection of Hepatitis A (AHAVB251AA, manufacturer unknown) on 25 July 2008 (route and site reported). On 29 July 2008 the patient developed a sunburn like reaction on both arms 72 hours post vaccination. The reaction was not seen by the reporter. A skin biopsy was positive for cutaneous lupus. The patient had not recovered at that time.
joint pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the covid-19 vaccine two weeks ago and had a side effect of joint pain. The patient asked if she can anticipate having the same reaction after the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
This non-valid spontaneous report was received from a nurse and refers to an unspecified patient. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported. On 10-OCT-2018, the patient was vaccinated with an expired dose of ROTATEQ orally (lot # M041814 and expiration date in an unknown date in June 2018) for prophylaxis. Furthermore, ROTATEQ was stored properly. Additionally, no adverse events were reported. This is an invalid report because of lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from the nurse refers to a 6 month old female patient (currently the patient is 7 month old). The patient's birth weight was 5 lbs. On 10-OCT-2018, the patient was vaccinated with expired dose of ROTATEQ (lot # M041814, expiry date June-2018, dose 3) orally for prophylaxis. Concomitant therapies included vaccination with PENTACEL and PREVNAR 13. Patient did not experience any adverse reaction (reported as 'No reaction').
Headache, NauseaVomiting, Site pain, headache severe Narrative:
Pt developed severe nausea, vestibular migraines, severe vertigo, abdominal pain, hypotension and tachycardia.  Systolic blood pressure ranging 60-80 and heart rate 120-170.   Few months later pt diagnosed with POTS.  Pt started on midodrine with small improvement in BP and HR.   Multiple blood draws, MRI of brain and neck negative, LP negative, pulmonary stress test neg, tilt table test positive for POTS.  More labs tests still pending at this time.  Generally not improved, slight improvement in headaches with new med Qulipta and slight improvement on varying days in blood pressure and heart rate on midodrine.  On disability at this time as lost job.
5 hours after the vaccination, I was extremely tired and feeling under the weather.  I started getting a headache.  Around midnight, I developed severe chills, fever 101 and I took Tylenol.  I did not have any body aches except on my arm which was stiff and sore.  The chills lasted until 5am.  I had a little nausea and vertigo and my headaches started to worsen.  On day 2, I went to use the bathroom and noticed blood when I urinated.  The blood was very dark and clotty.   I had blood with every urination.  I went to the ER (Hospital) and they ran a bunch tests and everything came back normal.  They did a CT scan- also normal.  I was discharged to follow up with a urologist and OBGYN.  The following day, I did have a bloody nose which lasted for 10 minutes.  I had severe headaches for about 5 days and also experience brain fog.  I did follow up with both specialists and did additional CT scan.  Both CT scan came back normal.  I also did ultrasound with the OBGYN and biopsy of my uterine lining.  Everything came back normal. The source of the bleeding is still unknown.  The bleeding lasted for 12 hours from inital onset and resolved.  I am on estrogen and progesterone patches.  I did experience a small spotting incident on 7/26/2021 for a few days.
Approximately 1 minute after administering the  vaccine  the patient fainted.  Within 15  seconds the patient was awake and oriented.  His  last memory before fainting  was experiencing pain in his arm after the injection .  The patient was monitored for at least 20 minutes and given some water and a protein bar.  .When questioned whether he often faints, he said the only other time he  had fainted  was in the past when he was experiencing  stomach pain.    He appeared to be doing very well when he left the pharmacy with a friend.
Red, hot, swollen area 5cm in diameter, non-tender on left deltoid.
A non-serious, spontaneous report of "received FLUMIST in a single nostril" in a four-year old female patient was received from a nurse. No medical history or concomitant medications were reported. FLUMIST was administered in one nostril; second half of the dose (0.1 ml) was also given in the same nostril. The patient wiped her nose after the dose was given. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date at patient's medical care provider). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site lump, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site lump, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient received 2nd dose vaccine at the pharmacy because the patient medical provider no longer provides the vaccine as it was hard to get. The patient experienced Knot on arm 1 inch x 2 inches red and warm to touch.