chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea, vomiting, headache, fever, body aches, fatigue, chills
Case number PHEH2014US003963 is an initial spontaneous report from the pharmacist received on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 14-year-old male patient. His vaccination history included administration seasonal influenza vaccine (manufacturer and batch number: unknown) on undetermined dates, which were well tolerated. He was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 006011A, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly in to the left deltoid on 06 JAN 2014 at 8:00 PM. This was the first application of FLUCELVAX. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Follow-up received from the pharmacist on 01 APR 2014: Updated vaccination history and batch number time, site of application of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
arm aches more; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm aches more) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm aches more). At the time of the report, VACCINATION SITE PAIN (arm aches more) outcome was unknown.            Treatment information was not provided.
Spiking heart rate up to 180 bpm while at rest, elevated heart rate at rest, elevated blood pressure over norm.  Three events of PSVT like symptoms since vaccination - 3/11 7:00am, 3/13 8:40pm, and 3/14 5:00pm.  Symptoms have appeared to lessen/resolve 6 days after vaccination without intevention.   Blood pressure was significantly elevated during this period.  Don't know if blood pressure was elevated immediately after injection.  Did not start monitoring until elevated HR symptoms appeared 38 hrs. after injection.   Treatment - visit with cardiologist 3/16 and wearing a heart montitor for 14 days  Do not know if the symptoms are related to the vaccine but started within 38 hrs. of vaccination.
I experienced two months after my J&J vaccine- soreness to my left arm with pain that lasted two weeks. I also experienced SVT, supraventricular tachycardia, my heart rate went up to 103 bpm and my heart rate could not go down. I went to ER where they helped my heart rate go down and I am still being monitored for SVT.
Received vaccines on 08/20/12.  Admitted to Hospital on 09/04/12, chicken pox diagnosed while at hospital.  Was diagnosed with T-cell Lymphoma during hospital stay. Still had "bumps" on body as of 11/19/12.
Moderate to severe headache; mild full body muscle aches, including around eyes; cloudy/foggy mind; alternating chills and sweats; skin hypersensitivity; stomachache; vomiting; fatigue; general malaise.
received third and fourth dose; received third and fourth dose; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd October 2018) and Shingrix (received 2nd dose on 13th March 2019).   On 28th January 2020, the patient received the 4th dose of Shingrix. On 19th October 2019, the patient received the 3rd dose of Shingrix. On 19th October 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 28th January 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The case was self-reported by the patient. The patient received 3rd and 4th dose of Shingrix, which led to extra dose administered. The reporter was inquiring if he should be concerned and what potential side effects could he experience from receiving four doses of the Shingrix vaccine.  Provided medical advice disclaimer. Referred to Healthcare professional and provided number to Medical information. No additional details were provided by the reporter. The reporter consented to follow up. The reporter provided permission to contact Healthcare professional.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-JUL-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-OCT-2016, the patient was treated at an urgent care facility (by unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 17-OCT-2016, the patient was treated at an eyecare facility by the ophthalmologist/MD, for a blistering vesicular outbreak, which was diagnosed as ocular shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, the event of blistering vesicular outbreak, which was diagnosed as ocular shingles was determined to be medically significant. Additional information has been requested.
pain in the injection site arm, pain lasted for a couple days after vaccination."; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the injection site arm, pain lasted for a couple days after vaccination.") in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the injection site arm, pain lasted for a couple days after vaccination."). At the time of the report, VACCINATION SITE PAIN (pain in the injection site arm, pain lasted for a couple days after vaccination.") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment details reported.   This case was linked to MOD21-076254, MOD21-076321, MOD21-076323, US-MODERNATX, INC.-MOD-2021-077940, US-MODERNATX, INC.-MOD-2021-077965 (Linked Report).; Sender's Comments:  MOD21-076254:cross linked case MOD21-076321:cross linked case MOD21-076323:cross linked case US-MODERNATX, INC.-MOD-2021-077940: US-MODERNATX, INC.-MOD-2021-077965: US-MODERNATX, INC.-MOD-2021-077745:cross linked case
A nurse reported a pt received vaccine on 7/24/2000 and subsequently developed an irregular heart beat, chills, and chest pain which resolved within 24 hours. Pt also developed an injection site reaction characterized by swelling and pain. She reported these events to her MD on 7/28/00 when the injection site remained mildly tender. Additional info received from the reporter on 01/25/2001 indicated that the pt recovered
This spontaneous report was received from a 65 years old female consumer reporting on herself, with "thyroid" and no drug reactions or allergies. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX, (lot number and expiration date not reported) (subcutaneous on her left arm, dose not reported). No other suspect therapies were reported. Concomitant therapies included levothyroxine sodium (manufacturer unknown) 150mcg tablet daily, multivitamin unspecified and vitamin D. The patient reported that on 08-MAY-2013 after receiving the ZOSTAVAX in her left arm, it became swollen, red, had fever and pain at the site. The patient stated she continued to have pain, she was given an antibiotic IV (not specified), and she stated she developed cellulitis, which she said, her doctor diagnosed, after getting the vaccine. The patient stated she had pain in her joints, and headaches, and is continuing follow up at her physician. The outcome for the above mentioned events was unknown at the time of the report. The patient was given treatment with KEFLEX 500mg "5-10" 2 times daily and "BASTERIN". No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention. Additional information has been requested.
We inadvertently administered the vaccine past the 30-day Use by Date. According to the manufacturer the vaccine administered on June 8 and 9, 2022 from lot number 065K21A likely did not  maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
child, nl @ time of exam & devel fever, pharyngitis & febrile sz the following day; CBC w/bands (postictal) nl LP
Immediate onset debilitating headache. Severe pain in left arm.  On 11/3 doctor gave Tramodol 50 mg. On 11/17, doctor gave same medication again.  On 1-16-14, doctor gave Amoxicillin for head congestion and asthma. On 2/2/14, was dizzy with headache.  Doctor gave Augmentin.  On 2-17-14 was given Doxycycline for dizziness, headache, congestion.  Chest x-ray.  Diagnosed with pneumonia.  On March 5, hospitalized for pneumonia and low oxygen levels.  Stayed until 3/9/14.  Released with medication.
Fever 101.5 starting 08/15/17, stiffening of arms and legs for appox 2 minutes. Sent to ED for evaluation. 8/16/17 not eating well and low grade fever 100.2. Had 2nd seizure with tonic and twitching movements. Diagnosed with otitis media at clinic. Referral to neurology 8/19/17 3rd seizure -now afebrile. Seizure last night about 20 secs.
A few hours after the booster I started feeling very tired, achy, and had some chills.  About a week later, I started to develop a rash around my eyes and my psoriasis flared.  The rash was red, itchy had hived and caused my eyelids to peel.  This lasted for a few months and I had to seek medical treatment from MD (Dermatologist) and various ophthalmologists for my eyes..  On  January 1, 2022, I developed shingles and my psoriasis flared again..  My immune system has not been the same since the booster.  I am currently receiving treatment for the shingles from Dr.
that the Ipol vaccine had expired with no AE; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old female patient who received an 0.5 ml expired dose of IPV (VERO) [IPOL] (lot number: P1F49, expiry date: 30-Nov-2020) via intramuscular route in unknown administration site on 09-Dec-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) And Hepatitis B Vaccine (Hepatitis B Vaccin)  It was an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  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.
MY MOTHER GOT COVID ON FEB 18TH WITH VERY MILD SYMPTOMS.  ON JAN 31ST, 2022 SHE WAS RUSHED TO THE HOSPITAL WITH LABORED BREATHING.  THE PARAMEDICS SAID ALL HER VITALS WERE OK, EXCEPT HER OXYGEN SATURATION WAS A LITTLE LOW AT 89.  THEY ASKED IF WE STILL WANTED THEM TO TAKE HER.    SHE DIED ON FEB 1, 2022 AT 11:40AM  FROM COVID 19 AND BILATERAL PULMONARY EMBOLISM.  NEITHER OF WHICH WERE PRE-EXISTING CONDITIONS.  MY MOTHER SHOULD NOT HAVE DIED.  THE PFIZER VACCINATION CAUSED THE PULMONARY EMBOLISM.
Swelling, redness and itchyness at injection site. Similar to a large mosquito bite welt.
Severe headache and neckache, achy muscles and joints, fever, injection site red, swollen, lump and very sore.  After about 5 days the injection site  very itchy and is still itchy after 3 weeks.
Information has been received from a physician assistant and other source referring to a 75 years old female patient. Information about concurrent condition, concomitant medication and medical history of the patient was not provided. On 25-OCT-2017 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N013541, expiration date 23-JAN-2019, 0.5 ml) intramuscularly in the left deltoid for prevention from pneumococcal disease. On 25-OCT-2017, hours after immunization, the patient developed fever with a temperature of 101.1 F and associated mild general fatigue. The patient complained on 27-OCT-2017 and came back in to the office. The patient was experiencing fever and the area around the injection site was warm to the touch. The physician assistant reported that the patient "was out of it". The physician assistant ordered unspecified bloodwork, urine test and a chest xray. All test results were negative. The patient returned to the office on 30-OCT-2017 and was feeling a little bit better. The fever and fatigue was resolved over the next couple days. No prescription drug treatment for the experience was required. The causality was not provided.
I got my 2nd Moderna shot on Tuesday, April 20, 2021 just after 2:00 pm  and only had a sore arm initially until about 9:30 am Wednesday when I started to feel fatigue set in. I ended up with a fever of 102, on and off chills, and body aches. I took Tylenol and it helped a lot. By 6 pm it was almost as if nothing happened...back to normal but only tired. A slight fever and chills came back later that night but was gone within about an hour.  Today is Sunday, April 25th and early this morning at around 2 am I woke up with diarrhea which continued on twice throughout the day. I don't think it was anything that I ate because my husband and I literally had the exact same dinner and drinks the night before and he is perfectly fine.  I've only had ginger ale with minced ginger to help settle my stomach.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2017, the patient was vaccinated with PROQUAD (dose, route of administration, site of administration, lot#, expiration date were not reported) for prophylaxis. On the same day, patient was vaccinated with second dose of PROQUAD subcutaneously, lot # N019826, expiration date 09-JAN-2019 (dose, site of administration were not reported) for prophylaxis. Second dose of vaccine was reconstituted with sterile diluent (MERCK) (lot # and expiration date were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 09:00 as dose 1, single (batch/lot number: Er26132) at the age of 40 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Parsonage Turner syndrome" (unspecified if ongoing); "walnuts allergies" (unspecified if ongoing); "shellfish allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: Covid-19 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
fever, chills, soreness at injection site, tachycardia, insomnia on and off for 3 days
After I went to sleep, I woke up the next morning, I had aches and pains and shortness of breath, I had to use an inhaler. On Sunday I had a telehealth appointment with an Urgent care, They gave Z-pack and a Medrol dose pack to open the airways, That helped for a couple days. On Wednesday after work it started to get worse and I started to get a sharp pain in my chest. I went to Urgent care they did an EKG, a chest X-ray and found Left bundle branch block. Sent me to an emergency room and admitted me for observation. They did an echo cardiogram and said I needed to follow up with my cardiologist
RED HANDS; CHILLS; FEELING WEAK; FEVER OF 103; This spontaneous report received from a patient concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043821A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced red hands. On 30-APR-2021, the subject experienced chills. On 30-APR-2021, the subject experienced feeling weak. On 30-APR-2021, the subject experienced fever of 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red hands, chills, feeling weak, and fever of 103 on 02-MAY-2021. This report was non-serious.
Patient could not use her right arm 12 hours after receiving ZOSTAVAX vaccine in right arm on 6-5-12. Visited dr on 6-14-12 and had an MRI and a work-up to rule out a hematoma or nerve damage. Pt was given steroids while awaiting results. Diagnosis is "right wrist drop".
doses administered after more than 1 temperature excursion; patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 12:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 12:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 80.24 years.  Concomitant products were not provided.  On 07-Jan-2021, Excursion time was 9 AM, temp was 34, total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vial was moved to clinic. Vaccine BUD date was 27-Jan-2021. Vial was stored on cooler 1, on 07-Jan-2021, Excursion duration at 9 AM: 34, 10 AM: 34, 11 AM:36, 12 AM:37, 1PM: 38, 2 PM: 38, 3 PM: 40, 4 PM: 40 and 5 PM: Not reported Vials only punctured right before administration. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.    Treatment medications were not reported.
Had the allergic reaction within 4-6 hours after receiving the yellow fever vaccine. Started with redness and itchiness to injection site. Pruritic rash spreads to the arms, back, trunk and some to the lower leg overnight.  He took Benadryl 25mg tablet 3x/day, and applied Benadryl cream to the affected area on 24 Feb. 05  with no improvement. On 25 Feb. 2005, he reported the reaction and was assessed . He was given Benadryl 50mg IM stat,prescribed with Medrol pack 4mg #21 tabs to use as directed, and to continue taking Benadryl 50mg 1 tab. 3X/day. Staff to be followed up in 5 days. Patient stated that he's not allergic to eggs, and claimed he's  been eating a lot of eggs lately since he started the Atkins diet. A UN physician reported the incident to Aventis Pasteur and spoke with a doctor.  We were informed that the allergic reaction is most likely be due on the gelatin component of the vaccine. Staff member reported improvement of the rash in 2 days, and rash completely cleared out on the 3rd day since the start of treatment of Medrol.
Pt developed rash on legs and back about three hours after receiving influenza vaccination on 3 November 2006.
Three days after vaccine, upper arm became swollen and tender to touch and bruising present. Symptoms got worse over the next 4 days and bruising and swelling have slowly been getting better. Now (2/1/19) - 14 days after vaccine (patient represented to clinic), arm is swollen 7 x 4 cm induration in center, ecchymosis 6 x 4 cm.