chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles outbreak after shingrix dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4FK7Y, expiry date 29th September 2023) for prophylaxis.   On 9th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Aug-2022 Reporters comment: A medical assistant reported that the patient developed a shingles outbreak after receiving the first dose of Shingrix. The reporter consented to follow up.
Diffuse small macular erythematous lesions over back,abd,chest,arms and face.  RT cheek-Erythema Maculo-papular rash LT cheek-Erythmea Maculo-papular rash  Fever 102 Started 8 days after immunization of MMR along with rash.
Pt reports getting the second moderna vaccine, Tuesday 09/28/2021 around 230pm. Around 1130pm that evening pt reports having a terrible headache  with nausea and vomiting. Pt states having diarrhea that started wednesday morning and continued headache, nausea and vomiting. Pt was seen at clinic 9/30/2021 for dehydration and sent to Emergency Room for outpatient fluid bolus and IV zofran.
the spots are dry; started to develop into what looked like a rash but the spots are more isolated; pinkish color spots on my stomach/Second dose: pinkish spots on his stomach/spots are on his stomach and around his waist line; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0172; expiration date: Aug2021) via an unspecified route of administration, administered in Arm Left on 24Apr2021 at the age of 31-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included leukemia (from ages 3 years to 5 years). The patient's concomitant medications were not reported. Previously too first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0150) at Left Arm on 03Apr2021 (Early in the day) as dose, 1 single for covid-19 immunisation and reported felt gross, felt groggy on 03Apr2021. On 29Apr2021, after 5 days of vaccination, the patient experienced pinkish color spots on my stomach/second dose and around his waistline, started to develop into what looked like a rash, but the spots are more isolated, on 25Apr2021 felt terrible, the spots are dry on an unspecified date. It was reported that when he received the second Covid-19 vaccine he felt fine the day of. The next day he felt terrible. He received his second dose on 24Apr2021. Then on 29Apr2021, he started noticing pinkish spots on his stomach. It started to develop into what looked like a rash but the spots are more isolated. The spots are on his stomach and around his waistline. The spots haven't gone away and there are quite a few. The spots are not itching. He would say the spots are staying about the same. Some more have developed but mostly staying the same. It looks like the spots are dry but that could be from him being active and moving around or maybe is skin a little dry. Did not any AE require a visit to emergency room, physician office. No prior vaccinations (within 4 weeks). The outcome of event was felt terrible was unknown and rest all was not recovered.  Follow-up attempts are completed. No further information is expected.
couldn't breathe; This is a spontaneous report from a contactable consumer or other non hcp.     A 54-years-old male patient received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient stated he's getting 2nd vaccine shot from Pfizer and couldn't breathe and was freaking out from COVID-19 and almost went to hospital. Patient stated he died twice from a car accident years ago. Patient stated he can't survive without Lyrica but cant afford. Medical history included covid-19 unknown date of First Dose and surgery. The patient's concomitant medications were not reported.  On an unspecified date The patient experienced couldn't breathe.  The outcome of the event was unknown.  Information about lot/batch number has been requested
Unable to sleep; Stiff neck; Pain at the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep), MUSCULOSKELETAL STIFFNESS (Stiff neck) and VACCINATION SITE PAIN (Pain at the injection site (left arm)) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00CD21A and 21721A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INSOMNIA (Unable to sleep), MUSCULOSKELETAL STIFFNESS (Stiff neck) and VACCINATION SITE PAIN (Pain at the injection site (left arm)). At the time of the report, INSOMNIA (Unable to sleep), MUSCULOSKELETAL STIFFNESS (Stiff neck) and VACCINATION SITE PAIN (Pain at the injection site (left arm)) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Concomitant products included Blood pressure pill and Anticholesterol pill for an unknown indication Treatment medication was not provided.
Post vax, the pt developed erythema with an overlying single vesicle at injection site. Probably Varivax site with Prevnar site.
Expired vaccine used/no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was received.  On an unknown date, the patient received a 0.5 ml single booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot C6016AA (exp: 09-Oct-2019) via intramuscular route in the right arm.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  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 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.
This email and a text I recieved says that I just recieved my first dose, and should get a second dose.  I actually have had 3 doses. First: Moderna 03/04/2021 at Health Dept Second: Moderna 04/01/2020 at Health Dept Third: (Full dose, nut just a booster) 11/26/2021 at a facility   Please correct your records.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe
She was responsive and coherent, but then would mention an episode was coming on and she would shake for about 1 minute, almost like seizures. When it would stop, she was able to pick up the conversation right where it left off. She had no appearance of an allergic reaction. Upon talking to her, she did mention that this has happened to her in the past and it was unrelated to a vaccine but the doctors were still trying to determine the cause.
Patient was 17y10m old and was given a Moderna Covid shot as a booster rather than Pfizer
Patient reported to ED, and stated tested positive for COVID earlier the day, he reported that he had been having SOB, worsening over the last couple of days.  Reported weakness in his legs and chest discomfort across his diaphragm.  EMS reported he was 60% on room air.  He was noted to be in atrial fibrillation.  He was admitted to Hospitalist team, requiring Vapotherm, alone with nonrebreather at max setting.  Was placed on Remdesivir, Baricitnib, and Dexamethasone.  Transitioned to DNR/DNI, and patient was transitioned to BIPAP, was having difficulty tolerating BiPAP.  Patient was transitioned to comfort care and expired on 10/02/2021
This spontaneous report as received from two registered nurses reporting together refers to an unspecified number of patients of unknown gender and age. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of VARIVAX 0.5 ml, subcutaneous (dose number, lot/batch number and expiration date were not reported) that underwent temperature excursions. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient felt anxious and tightness around her throat.  Verbalized she was nervous.  Pt. was evaluated by Fire Rescue,  vss  nad.  Pt. was discharged home and advised to call 911 for worsening symptoms.
Covid 19+ Elevated lactic  Consult infectious disease for COVID-19 infection Patients wife reports patient was experiencing SOB but denies any other signs of infection, no fevers Check patient inflammatory markers, C-reactive protein, CPK, D-dimer, ferritin, LDH Start decadron Check Liver function to evaluate if patient is candidate for remdesivir (spoke with patient's wife and she gave consent to remdesivir if patient qualifies) Rule out underlying infectious process, start IV antibiotics Check urine, sputum, and blood cultures Check procalcitonin level
Experienced extreme fatigue,  headache and mild chills approximately 7 hours post vaccination.  Symptoms lasted 24 hours. Took no medications.
hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around February 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not presented prior the used of zoster vaccine live (ZOSTAVAX). The patient was also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient's condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) conduct, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of deafness was not recovered. The reporter considered deafness to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, deafness was determined to be medically significant event.
Starting about 4 hours after injection, I has 24 hours of fever and intense muscular and joint pain.   The symptoms resolved in 24 hours.  THEN my sense of smell disappeared and remains suppressed as of today (5 days later)
pt recv vax; devel classic presentation of chicken pox all over w/ approx 10-20 lesions; MD indicated that this was a "varivax failure";f/u indicated no tx & no fever;
Pain in arm just below injection site   Hurts to lift arm or lift anything. Seems to slowly be getting worse? Definitely is not getting better. I haven't pulled a muscle or such that I'm aware of. Has hurt since the injection, and gradually hurt more.
Temp went up to 103 degrees / 3 days arm hot and red 5 days.
Local reaction - area red- warm to touch. Mild swelling noted to left upper thigh 2 mm circular in size
just a sore arm; This is a Spontaneous report from a Pfizer sponsored programvia a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Feb2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced just a sore arm and mentioned no reaction from it on an unspecified date. Her HCP wanted her to start taking MedrolPak, a steroid, for 6 days. She wanted to know if it was okay to take it or not. She added that she had not started taking it yet. The outcome of the event was unknown.   Information on the LOT/Batch number has been requested  Follow-up attempts are completed. No further information is expected.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old female patient who received fourth dose of ACT-HIB lot UI937AA, Exp. Date 05-Nov-2019 via unknown route in the left thigh, on 08-Mar-2019 that was reconstituted with sterile water instead of the ACTHIB diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to wrong solution used in drug reconstitution. It was unknown whether the patient had any adverse reactions. 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 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. List of documents held by sender: none.
Patient reports being deathly sick the night after gettting her second shingle vaccine.  She had a high temperature last night and reports also having every bone in her body hurt. She states that she is severely fatigued and is having a hard time getting up. She is taking tylenol and a prescription NSAID for pain. The fever is no longer present at this time.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not mentioned. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L046885, expiry date: 23-NOV-2017 and lot# M000757, expiry date: 06-JAN-2018 (dose# and site of administration not reported). The vaccine underwent temperature excursion at -13.50C for 181 hours. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested.
Flu like symptoms with a sore arm.  Fever, chills, body aches.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information on patient's concurrent condition and medical history was not reported. On an unspecified date of November 2015, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, lot number and route were unspecified). The patient was then administered another dose of ZOSTAVAX on unspecified date of March 2016. No adverse effect was reported. No further information was provided. Additional information has been requested.
3 days after receiving the shot, the inside of both lips swelled up and I noticed small bumps and some red dots.  Used Dukes Magic Mouthwash for 9 days,  Valacyclovir 1 GM, 1 tablet a day for 7 days.  No  changes in the lips were noted.  It is now 11/05/2023 and my lips are still swollen.   My doctor has now prescribed Methylprednisolone 4 mg dospak 21s
Immediate pain on injection. In the following days nerve pain continued and hard to lift arm with large red swelling extending down the tricep from the injection site. Swelling resolve in a week and a half. Nerve pain persisted for 2 weeks.
Rash and welts from head to thighs, severe headache, esophageal pain, fever of 101.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 04-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up feeling achey, flu like symptoms, temp to 100 and arm hurting-sore and felt warm Advised on rest, hydration and Motrin as needed.  48 hrs later-feeling better, arm still achey but otherwise better
Patient called the pharmacy today to report that weeks after receiving his 2nd shot he's still experiencing pain and still unable to lift his arm passed a certain point. The pain was worse in the first couple of days, has gotten better but sill lingering .
Area of injection swelled up; Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Area of injection swelled up) and PRODUCT COLOUR ISSUE (Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced VACCINATION SITE SWELLING (Area of injection swelled up) and PRODUCT COLOUR ISSUE (Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish). On 22-Dec-2021, PRODUCT COLOUR ISSUE (Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish) had resolved. At the time of the report, VACCINATION SITE SWELLING (Area of injection swelled up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated  that the color was not white, but more opaque and yellowish and that color was not only seen in the vial, but in the product inside as well. Reporter further stated that inside the syringe the color of the vaccine looked normal, and that the discoloration was only seen in the vial.   No concomitant drug was reported.  No treatment drug was reported.
lost her sense of smell and taste; lost her sense of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 04Jan2021 at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient stated that after she got the vaccine today (04Jan2021), she lost her sense of smell and taste. She asked if she can still get the vaccine and if it was normal. Outcome of the events was unknown. The case was reported as non-serious.  No follow-up attempts are possible, information about the lot/batch cannot be obtained.