chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, joint pain and tremor. On an unknown date, the outcome of the fever, chills, joint pain and tremor were recovered/resolved. It was unknown if the reporter considered the fever, chills, joint pain and tremor to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient informed the pharmacist that she experienced a similar experiences after 1st dose of SHINGRIX as that of 2nd dose (for tolerance of 2nd dose see case US2018180120).
Incorrect route of drug administration (Incorrect route of drug administration) A non-serious report of FLUMIST sprayed in eyes has been received from a consumer concerning a 38-month-old female.  During administration of FLUMIST on 25-Nov-2008, the patient was accidentally sprayed in the eyes.  Her eyes were washed with warm water.  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.
Fever for three days despite having both Acetaminophen and ibuprofen alternating every three hours. Extreme sensitivity on skin to temperatures even lukewarm temperatures felt very hot. Body aches from head to toe pale skin dark circles under her eyes
Patient developed herpes zoster on or about November 4, 2021. Vaccine administered October 25, 2021 along with the flu vaccine (flu vaccine given at the same time she received the Moderna booster COVID-19 vaccine).
Swollen lymph gland under arm, rash on upper body redness and swelling at injection site rash lasted one day swollen lymph gland and soreness at injection site site there after 4 days
about 13 hours after the shot, I woke up in the middle of the night (1:30am) to go to the restroom and grab a glass of water. As I was finishing to go to the bathroom and before I was able to wash my hands, I got light headed and fainted in my bathroom and fell abruptly on the floor. I landed on my upper spine and lower neck along with my right elbow and hand. My pinky finger and index finger are still tingly/numb more than 24 hours later and I have an intense stiffness in my spine and neck from the fall.
Patient given pediatric influenza. Parent notified and encouraged to bring patient back for correct dosage of influenza.
Arthritis in feet; Cold like symptoms; Vaccinations had sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis in feet), NASOPHARYNGITIS (Cold like symptoms), VACCINATION SITE PAIN (Vaccinations had sore arm) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Arthritis in feet), NASOPHARYNGITIS (Cold like symptoms), VACCINATION SITE PAIN (Vaccinations had sore arm) and FATIGUE (Fatigue). At the time of the report, ARTHRITIS (Arthritis in feet) had not resolved and NASOPHARYNGITIS (Cold like symptoms), VACCINATION SITE PAIN (Vaccinations had sore arm) and FATIGUE (Fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of arthritis in feet, vaccinations had sore arm, fatigue and cold like symptoms with SKYRIZI was no reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Symptoms started 9-6-08 Sat. approx 7:00 pm. Went to local ER 9 pm 9-6-08 trouble breathing but no SOB, throat felt thick and trouble swallowing n/v, slight fever-was on no meds- no vaccine in last 4 wks and been '98 since last TD 9/18/08-records received for DOS 9/7/08-DC DX: Angioedema, reaction to tetanus, diphtheria, and pertussis shot. Received vaccination on 9/5/08 and the next day became short of air, itching and felt like tongue was swollen and had choking feeling. Presented to ED with expiratory wheezing, generalized swelling of left upper extremity with associated erythema. Pulse rate increased 107. Observed in ICU and released.
no systemic c/o; felt large warm lump @ site of inject red, raised & tender to touch; 3 days later lump & redness measured 2 x 2 1/2 inches; pt states it was much bigger day p/shot;
I had chills and a slight fever the second day after my second shot.  I also had a bad headache.  I have continued to have a headache every day after I had this second shot.  It never goes away.
I am terrible, I feel horrible; I can hardly walk; Do not feel good; I am as weak as I can be, I have no strength; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced do not feel good (feeling abnormal) (non-serious) on 26Aug2021 with outcome of not recovered , i am as weak as i can be, i have no strength (asthenia) (non-serious) on 26Aug2021 with outcome of not recovered , i am terrible, i feel horrible (feeling abnormal) (non-serious) on 27Aug2021 with outcome of not recovered , i can hardly walk (gait disturbance) (non-serious) on 27Aug2021 with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of do not feel good (feeling abnormal), i am as weak as i can be, i have no strength (asthenia).
rash on the left eye/ rash on his left thigh, a lot of little bumps; rash on his left thigh, a lot of little bumps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, NDC/EXP: unknown, LOT: EN6198), administration date: 25Feb2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, NDC/EXP: unknown, LOT: EN6207), administration date: 18Mar2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Single, DC/EXP: not provided , LOT: EW0153), administration date: 14Oct2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: SKIN DISORDER (non-serious) with onset 14Apr2022, outcome "unknown", described as "rash on his left thigh, a lot of little bumps"; RASH (non-serious) with onset 14Apr2022, outcome "unknown", described as "rash on the left eye/ rash on his left thigh, a lot of little bumps". Therapeutic measures were taken as a result of rash, skin disorder.  Additional Information: Reporter received the second booster dose of Pfizer-BioNTech COVID-19 Vaccine 2 days ago (13Apr2022). Previous day morning (14Apr2022) he began developing a rash on the left eye. He wanted to know if this was a reported side effect for the vaccine. The second booster, was a rash involved in it. on Thursday morning he woke up with rash on his left thigh, a lot of little bumps. He says his first dose was 25Feb2021, LOT: EN6198. He says his second dose was 18Mar2021, LOT: EN6207. He says his third dose was 14Oct2021 with LOT: EW0153. Caller clarifies that his fourth dose or second booster dose was on 13Apr2022, after which he got the rash to his thigh the next morning, provides LOT: FM0698. He put rubbing alcohol on it just once, and the rash didn't change. Reporter provides no further details about the unspecified rubbing alcohol. He says the rash is on the left outside thigh and top, and is on the same side he got the shot on, clarified to he got the second booster dose injected in his left arm.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP (unspecified) on the same day. Patient complained about sore throat a week prior to vaccination. A week later some kind test was performed and it showed that a group A strep in the blood was found. On approximately 30-MAR-2009, after getting the first dose of GARDASIL the patient experienced fever and pain in the hip after getting the vaccine. The patient died on 03-APR-2009. The patient sought unspecified medical attention. Additional information has been requested. 4/24/09 ER record received for DOS 4/1/09 with dx: Fever.  Pediatric Viral syndrome.  Pt presented with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx:  Post-vaccination reaction. Pt presented again to ER with fever of 102'F, body aches, inability to walk 2' to leg pain, nausea, vomiting, rash and polymyagias.  PE (+) for extremity pain and swelling, rash, as well as not sleeping and acting differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-4/2009 with Final DX:  Necrotizing fasciitis (gram (+) cocci with septic shock).  Pt expired 4/4/09. Pt admitted from local facility for eval of fever with difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious myositis.  Tx with IV abx however IV access was lost and pt became hypotensive and with eveidence of septic shock with cardiovascular instability.  Pt intubated and despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received with COD:  Necrotizing Fasciitis (Gram (+)) with septic shock.
This spontaneous report as received from a female consumer of unknown age refers to herself with allergy to REGLAN. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength and dosage unknown, injection for the prevention of shingle). There was no concomitant therapy. The patient stated on unknown date she was diagnosed with shingles before and after she received ZOSTAVAX. There were no treatment, lab diagnostics, studies were not performs. The outcome of the event was reported as not recovered. The causality of the event and therapy with ZOSTAVAX was unknown. Additional information has been requested.
3-4hrs p/vax became febrile following day AM had brief 1-2 mins sz had prev febrile seizure;
Pain in joint involving shoulder region; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joint involving shoulder region) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concurrent medical conditions included Psoriasis (moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Pain in joint involving shoulder region). At the time of the report, ARTHRALGIA (Pain in joint involving shoulder region) had not resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of Pain in joint involving shoulder region was not provided for Humira.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Patient contracted COVID after being fully vaccinated Fatigue, congestion, cough, sore throat, headache, diarrhea, chills
Dizziness, pain & body aches, diarrhea, nausea, vomiting, fever.
Two doses of Fluarix in the same day; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number 9CE79, expiry date 30-JUN-2024) for prophylaxis.   On 02-OCT-2023, the patient received Fluarix Tetra 2023-2024 season. On 02-OCT-2023, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced overdose (Verbatim: Two doses of Fluarix in the same day). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2023 The nurse reported that two doses of Fluarix were administered to a patient in the same day which led to overdose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
On 04/24/22-04/26/2022 I had nasal drainage, cough and fatigue. Had telehealth appointment on 04/26/22 and was prescribed an antiviral took medicine and I felt almost normal on 04/28/2022 and have felt progressively better and felt completely back to normal on May 1, 2022. Do have a little dizziness here and there every once in a while.
patients daughter reported to us that the patient died on 9/4 or 9/5.  the patient was otherwise healthy.  the patient told her daughter that her arm itched some at the injection site.  the family is not doing an autopsy
Information has been received from a health professional concerning a 4 month old female who was vaccinated with an oral second dose of Rotateq. "Within 24 hours," the patient experienced hematochezia, vomiting and fever and was hospitalized. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available. Additional information has been requested.
Local symptoms: Pain-discomfort, General Symptoms: Chills, headaches, joint pains, muscle pains, fatigue, Diarrhea.  Narrative:
12 hours after receiving the vaccination I started having flu like symptoms with a low grade fever. also had fatigue, muscle and joint pain. Lasted for about 36 hours
Case number PHEH2017US004505, is an initial spontaneous report received from a nurse on 09 Feb 2017. This report refers to a 72 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 05 Oct 2016. Further she was vaccinated with FLUVIRIN (batch number: 168904, Expiry date: 31 May 2017) on 02 Dec 2016. No adverse event was reported following this medication error.
Myalgia, Arthralgia,  Injection site soreness and hands cramping Narrative:
6AUG98 2wk post vax pt broke out w/a few chickenpox lesions on legs;as they scabbed over & healed a few new ones appeared this has cont over the past 5wk w/one wk was clear of any skin lesions;
After getting the vaccination later that evening started to get a fever of 102, arm started to swell and get red. Felt just miserable.
Patient had lipoma at injection site in right deltoid with diagnosis of cellulitis spreading down to the right hand. Patient was treated with cephalexin, prednisone, hydroxyzine and famotidine. The swelling is clearing up with the medications.
Patient received full body hives shortly after receiving vaccine. Patient had hives for ~ 2 weeks.
12/12/2022 diagnosed with covid; excessive coughing to the point of pain.  prescribed medicines didn't help.  Other symptoms include fever, chills and body aches.  Shortness of breathe forced me to use rescue inhaler.
Vaccine to 16 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine to 16 year old) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine to 16 year old). On 09-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine to 16 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received contains no new information.
07/21/2006 Next day hard and red (warm) small area drained (7millimeter) clear fluid. 07/24/2006 Area still draining, no redness present.
Initial unsolicited report received from a nurse on 03-Feb-2016. This case involves a 39-year-old female patient, who was vaccinated with Fluzone (batch number: UH894AA) (dose, dose in series and site of administration were not reported) via intramuscular route on an unknown date in 2013. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unknown date in 2013, following vaccination, the patient experienced frozen shoulder. It was reported that the patient required ER/doctor visit. Laboratory investigations were not reported. Patient was prescribed antibiotics and physical therapy with no positive result and then received a steroid injection to the shoulder and her symptoms improved. On an unknown date, patient recovered from the event. Documents held by sender: none.
Mild headache, mild dizziness, fatigue, moderate joint and muscle pain mainly in neck, shoulders, upper extremities. Currently managing with rest and did not seek medical care.
Fever for 18hrs, Headache, Body ache, diarrhea, stomach cramps, swelling of injection area.
No additional information available or provided; underwent a multiple temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 30-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T027789, expiration date 27-FEB-2023, 0.5 milliliter) after a temperature excursion for prophylaxis (product storage error). Temperature excursion was 54.1 F for 1 hour and 43 minutes; 47.8F for 1 hour and 0 minutes; 46.4F for 1 hour and 54 minutes; 46.6F for 6 hours and 0 minutes; 40.0 F for 1 hour and 18 minutes; 32.1 F for 1 hour and 6 minutes; 32.9F for 13 hours and 18 minutes; 33.8F for 60 hours and 12 minutes. No adverse event was reported.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, an unspecified number of patients were vaccinated with unspecified doses in series of improperly stored ROTATEQ (dose, site and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, body ache, Fever, chills, vomit, GI pain. Started at 5pm the same day I took Vaccine and latest until 3am. Next day it cleared up. Except for body ache and dull head pain.
Imbalance, Severe brain fog, numbness/tingling of extremities, extreme fatigue/weakness, insomnia, heart palpitations on non exertion, night time leg jerking, constipation, numbness rectum, eye sensitivity to light, ear fullness/plugging, nausea, light headedness, weight loss, difficulty concentration unable to work, eyes feel fatigued, mood changes, severe anxiety
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756491A, A0756494A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Headache & Myalgia Narrative:  woke up with headache and body aches
Migraine headache, fever for 3 hours. Took Advil. Diarrhea for 12 hours. Took Immodium
PT REPORTED BURNING AT TIME OF INJECTION, LATER BRUISED AROUND INJECTION SITE WHICH TURNED INTO LEFT UPPER ARM REDNESS AND SWELLING WHICH SHE SAID WAS HOT AND TENDER TO THE TOUCH-TREATMENT WITH ICE PACKS AND CLARITIN.
Chest pains 5 days after.  Never had like that before  And  big red welt  about three inches by 2 inches  2 weeks later. And arm is now aching
Pt recv vax on 3/23/98; 6 hr post vax pt exp viral upper respiratory infection w/ red/raised rash at rt leg vax site spread to abdomen, neck & head, itching