chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to 2 anonymous patients of unknown age. On 13-JAN-2016 the patient was vaccinated with improperly stored VAQTA (lot # L039659 (also reported as L03659), exp: 15-MAR-2017) since last excursion. The product was exposed temperature of 49.3 F degrees for 40 minutes. The temperature excursion was recorded by a data logger. The product had been previously exposed to temperature of 50.2 F for 1 hour and 10 minutes. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, fever between 100-101 degrees F, rash on both arms, body fatigue, itchy throat
On the evening of12/15/2021 I came down with a bad cough. I went in to urgent care and they did an x-ray.  I was wheezing and whistling in my chest. The doctor diagnosed me with bronchitis.  They gave me an inhaler if I had any trouble breathing, and an antibiotic; which I don't remember the name.  They gave me a ZPAK, which is the only one I have ever used. I guess I felt better in about a week to 10 days.  The cough lingered, but it wasn't bad.
Information has been received from a 26 year old female consumer with no known drug reactions/allergies and no pertinent medical history who on 28-APR-2010, was vaccinated with a dose of VARIVAX (Merck) (manufacturer unspecified). Secondary suspect vaccination included "a tetanus shot in the same arm during the same visit". On 29-APR-2010, the patient's arm, where she got the vaccine was large, red and swollen. The patient did not know if this was her first or second dose of VARIVAX (Merck) (manufacturer unspecified), she stated she might have gotten a varicella vaccine when she was a baby but her mother did not remember. No diagnostic tests were performed. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
negative immunity and later in 2013 patient had a titer that came back negative; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 36-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 4th dose of Hepatitis B vaccine, the 5th dose of Hepatitis B vaccine and the 6th dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: negative immunity and later in 2013 patient had a titer that came back negative). The outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 17-Jul-2023 The medical assistant reported that a patient who was an emergency medical services had 2 full series of Hepatitis B vaccination over several years, 1st series was as baby series then the 2nd series around 7th grade after testing showed negative immunity and later in 2013 patient had a titer that came back negative and bloodwork came back negative again, no immunity to it. The reporter was calling and asking how to proceed and their office currently stocks Engerix-B that's why they were calling GlaxoSmithKline. The reporter did not know the brand name or manufacturer of the Hepatitis vaccines that the patient received. Another adverse event would be reported for other similar situations. The reporter consented to follow-up. The case was linked with case US2023098117, reported by same reporter for different patients. The patient received 2 full series of Hepatitis B and had negative immunity, which led to therapy non-responder.; Sender's Comments:  US-GSK-US2023098117:Same reporter
Patient was fully vaccinated with Pfizer COVID-19 vaccine on 1/29/21 and 2/22/21. Patient admitted to reporting hospital on 9/6/21 as a transfer from Hospital. Admitting diagnosis is worsening COVID pneumonia requiring intubation. Patient was reported to arrive at ER after having 10-14 days of symptoms relating to cough. Over the last 5 to 6 days she then began having progressive difficulty breathing. Pt is still currently admitting at another hospital.
63 y.o. female with a history of asthma and COPD who presents to the emergency department via EMS for evaluation of a breathing problem. The patient reports that a few days ago she developed a cough, rhinorrhea, loss of smell, and right-sided chest pain that has been constant since onset but worsens with coughing. The patient has been using her Albuterol inhaler with no improvement. The patient is on 3 L of supplemental O2 at baseline and has had to increase this with onset of her symptoms, and she has still had difficulty breathing, so she decided to come to the ED. Here, the patient denies vomiting, diarrhea, fever. Of note, the patient is vaccinated for COVID. She is not currently on steroids.  Albuterol inhaler did not improve and she increased her oxygen to 4 L/min without improvement in her breathing. Patient was found to have COVID 19 as well as CAP 2/2 strep pneumonae.  Patient treated with abx, steroids and improved to her baseline 3-4L NC. She was discharged with refills of her medications and will complete a 7 day course of abx for her CAP.     COVID-19 pneumonia COPD exacerbation Chronic hypoxic respiratory failure CAP 2/2 strep pneumonae -Patient states that she is on 3-4 L/min of oxygen via nasal cannula at baseline -She presented with shortness of breath, worsening cough -Likely COPD exacerbation in the setting of COVID-19 pneumonia -Patient started on 6 mg IV Decadron on 1/6.  Further steroids were discontinued at that time as she appeared to be on her baseline oxygen requirements.  However, with worsening cough, shortness of breath. Patient started on IV Solu-Medrol 80 mg BID on 1/8. -PTA aclidinium bromide BID, Symbicort BID--refilled at d/c -Sputum cx from 1/8 growing strep pneumonae-- given ceftriaxone changed to ceftin at d/c -she was at her baseline 02 requirement at discharge -cleared by PT to return to prior living situation.    Hypertension: Blood pressures stable -Continue PTA clonidine and amlodipine   Tachycardia-resolved Intermittent right-sided chest pain -Could be related to shortness of breath, coughing.  Concern for mild withdrawal from methadone and presentation. -Continue Tylenol PRN  -Continue PO Oxycodone 5 mg q8h prn    Chronic pain Hx opioid use disorder, on methadone Well controlled on methadone 90 mg daily.  Patient stated that she did not take methadone for 2 days due to shortness of breath -Continue PTA methadone   Major depressive disorder: Continue PTA Paxil   Anxiety: Continue PTA Buspar
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. 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 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 of several reports from the same source. Additional information has been requested.
Administered diluent only; Administered diluent only; Inappropriate age at vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 68-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 3rd March 2023, the patient received Menveo. On 3rd March 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 03-MAR-2023 Reporter's comment: The pharmacist called to report that the administration of the Menveo diluent without previous reconstitution of the lyophilized conjugate vaccine component to a patient. The reporter asked for recommendations about patients re vaccination The reporter did not provide lot number and expiration date of Menveo vaccine. The reporter consent to follow up. Additional Supportive Information: The patients received Menveo diluent without previous reconstitution of the lyophilized conjugate vaccine component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. 68 years old patient received Menveo vaccine, which led to inappropriate age at vaccine administration.
Body was aching all over; developed a lump on his left armpit; it doesn't feel hard, but it is the size of an egg, and it hurts and bothers him; area does not feel hard, like a lymph node, rather it is soft; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's fiance). A 53-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left (on right arm muscle and was placed too high, on his arm) on 12Jun2021 10:50 AM (at age of 53-year-old) at dose of 0.3 ml, as single dose for Covid-19 immunization. medical history included Smoker. Concomitant medications were not reported. Patient received previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EW0187; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left on 22May2021 10:30 AM (at age of 53-year-old), at dose of 0.3 ml, as single dose for Covid-19 immunization.The patient was not administered with additional vaccines on the same date of Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The reporter stated that she asked the patient to take the vaccine and patient also felt he should get the vaccine, but at first, he was hesitant. The reporter reported that within a few days or so, on 12Jun2021 19:00, the patient developed a lump on his left armpit; it doesn't feel hard, but it is the size of an egg, and it hurts and bothers him (after second vaccine). The reporter concerned mostly, with the lump under armpit, which was turning into a blood clot. The patient thought that it was not placed correctly and might be for that reason he had these effects. area does not feel hard, like a lymph node, rather it is soft. On 13Feb2021, the patient's body was aching all over, after second vaccine. The patient received treatment with Tylenol every 6 hours for body pain, and stated it was effective as the patient felt better. The reporter stated that Pfizer was unable to provide medical advice but might have resources to help answer some questions and the reporter encouraged to seek medical attention. The outcome of the event body was aching all over was resolved on 14Jun2021, while the outcome of the other events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
She start developing a rash at the site of the shot which is getting worse and is going down to the arm and also to the joint area. The rash is patchy, blanchable, warm rash. No fever or tick bite. The rash is about 10 cm wide and 15 cm long. Possible reaction to pneumonia shot. Will do ibuprofen 400-600 mg every 8 hours with food, we will start Bactrim and I circle the rash and if worsening patient will call back. Also cold compresses's 15 minutes 2-3 times per day.
pt says her right arm hurt for a couple of days since taking the vax and has become very fatigued.  She had some chills and nausea.  She then started feeling like she was going in and out of consciousness.  This happens when she has not have enough sleep since due to the fatigue.  She says she started her menstrual cycle and it is much heavier than normal and came two week early.  She says she still has these symptoms and is concerned.
Redness, swelling, heat, tenderness, and burning at injection site down back of arm toward elbow.  Using acetaminophen and cold packs.
4/6/21 @ 09:10a - Received Moderna #1 / Just felt "tired" 4/7/21 @10:00p - After a shower, noticed some generalized scalp and skin itchiness, thought it was from the hot water. Had felt tired all day, but this was the first time I felt the itchiness, It was very "light", but was all over my body, moving from arms to legs, face, etc. No rash noted, no cutaneous reaction at injection site.  4/8/21 all day - Very light itchiness persisted, got worse after going outside (Phoenix temp in 90's). At times, my face and mouth felt scratchy. Still no raised rash or cutaneous reaction at injection site, but my skin looked a bit "irritated" in patches that resolved.   Treatments:  4/8/21 @8:00p - Benadryl 50mg / Famotidine 20mg / Felt better, itchiness subsided, was able to relax 4/9/21 @00:12a - Benadryl 25mg 04/9/21@ 01:30a - Benadriy 25mg - fell asleep  4/9/21 @ 09:00a - Zyrtec - Felt OK 4/9/21 @ 10:00a - Famotidine - Felt OK, but later got itchy again 4/9/21 @ 1:10p - Benadryl 25 mg / will repeat in 4 hrs or increase to 50mg per medical advice
Beginning Sat., 01/08/22, (L) shoulder had red area which has gotten larger as the days have gone by and now on Monday, 01/10/22 the entire (L) shoulder is entirely red as well as hot to touch, hurts to touch, swollen, bruised at injection site, itches some.  I have never had any kind of reaction to an injection in the past.
Pt's rep called. Pt experiencing signs of "bad" flu. Temp - nausea - fever - diarrhea - vomiting.
2 days p/vax pt devel irritability & low grade temp;seen @ ER 20MAY96 adm to hosp w/bulging fontanel;dx aseptic meningitis;
No additional adverse events or product quality complaints were reported; Temperature excursion for PROQUAD which has been administered; This spontaneous report was received from a nurse and refers to a 11-year-old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 27-AUG-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # U006313 (rHA) and expiration date 24-AUG-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 38.8 degree fahrenheit (°F) for 8 hours on 26-AUG-2021; no previous temperature excursions were reported.  No adverse symptoms were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2108USA007980: US-009507513-2108USA008076:
Patient started Rabies post exposure vaccine on 09/01/2003.  Patient started with diarrhea, vertigo, nightsweats, and confusion after her 4th vaccine on 09/15/2003.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 16:15 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalasporin, reaction(s): "Known allergies: cephalasporin"; Cipro, reaction(s): "Known allergies: cipro". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacture), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
mom stated pt devel inc temp, n/v, rash on arms & chest approx 1 1/2-2hr p/inj;seen by MD 2 days later some sx, also epigastric tenderness;tx w/APAP & zantac;
This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received in December 2018, refer case US2019GSK073562). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), pain in hand, shoulder pain, neck pain, headache and mobility decreased. On an unknown date, the outcome of the fainting and mobility decreased were recovered/resolved and the outcome of the pain in hand, shoulder pain, neck pain and headache were unknown. It was unknown if the reporter considered the fainting, pain in hand, shoulder pain, neck pain, headache and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2019, the patient received a dose of SHINGRIX at the clinic. In 2019, the patient was fainted and experienced a lot of pain in her hand and hand motion was not normal. The patient was unable to move her hand but at the time of reporting, felt better after getting massage therapy. The pain in hand was goes to shoulder, neck and head. At the time of reporting, the patient had headaches. The patient mentioned that, a case was legal. The reporter consented to follow up.
Large red oval patches on trunk, legs, and both arms, and back. Pityriasis rosea was diagnosed. Never had a skin condition.
Pt developed ITP with platelet count of 3 at the time of diagnosis.  Also had low ANC at the time of presentation which improved spontaneously.  He presented with petechiae and multiple bruises.  He ultimately required a dose of Winrho and a 2 day hospitalization for observation.
nodule on her thyroid; /three weeks to a month after the first dose/hesitant of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THYROID MASS (nodule on her thyroid) and INTENTIONAL DOSE OMISSION (/three weeks to a month after the first dose/hesitant of the second dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THYROID MASS (nodule on her thyroid) and INTENTIONAL DOSE OMISSION (/three weeks to a month after the first dose/hesitant of the second dose). At the time of the report, THYROID MASS (nodule on her thyroid) outcome was unknown and INTENTIONAL DOSE OMISSION (/three weeks to a month after the first dose/hesitant of the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment drug medications were not reported. It was reported that the patient's wife had a biopsy on 25Oct2021.
HEADACHE; ACHY ARM; This spontaneous report received from a patient concerned an 89 year old male. The patient's weight was 73.6 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary hypertension.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included selexipag for drug used for unknown indication, tadalafil non-company for drug used for unknown indication, and macitentan for pulmonary hypertension. On an unspecified date, the subject experienced headache, and achy arm. Laboratory data (dates unspecified) included: Pulmonary hypertension (NR: not provided) ICD-9 and ICD-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and achy arm was not reported. This report was non-serious.
Fever, chills for 2 days. Headache for 2 days. Nausea, vomiting, diarrhea and fatigue continuously still.
I had paresthesia, fatigue, and jerking movement at the limbs when trying to fall asleep. I went to my doctor multiple times. I had blood work to rule out diabetes and thyroid issues. My doctor recommended a MRI of my brain to rule out MS and neurological disorders which came back normal. I was also ordered an MRI of the spine which was normal except for some bulging discs. I tried different medications for nerve pain, gabapentin and Lyrica which did not help or relieve my pain. I am now on Norco which helps with pains. I still have these issues to this day.
Afebrile. "Pimple" on face 2 days after Gardasil vaccine. "Pimply" rash all over back 2 days after Gardasil vaccine. Itchy mostly at night, rash lasted 3 days. Pt not seen here. Reported verbally by mom.
Information has been received from a 72-year-old male with no pertinent medical history or allergies who on 11-JAN-2007 was vaccinated "orally with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included hydrochlorothiazide (manufacturer not specified), lisinopril (manufacturer not specified), metoprolol (manufacturer not specified), NIASPAN and LIPITOR. On 14-JAN-2007 the patient "developed a red rash on his left hand with bumps that are under the skin after receiving ZOSTAVAX". The patient did not seek medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
redness and very hot and at injection site  i drew a circle  where the redness started to moniter the redness is spreading and there is streaking  and its hard but in one area is soft like if there is an abcess