chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss persists; Cannot hear correctly; Right ear feels numb; Soreness in injected right arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss persists) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness in injected right arm) and FATIGUE (Fatigue). On 20-Apr-2021, the patient experienced HYPOACUSIS (Cannot hear correctly) and HYPOAESTHESIA (Right ear feels numb). On 27-Apr-2021, the patient experienced DEAFNESS (Hearing loss persists) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss persists), HYPOACUSIS (Cannot hear correctly), HYPOAESTHESIA (Right ear feels numb), VACCINATION SITE PAIN (Soreness in injected right arm) and FATIGUE (Fatigue) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Treatment information included paracetamol.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-092179 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
07/18/2021: 1530 hours: injection of vaccine,   07/19/2021 0200 hours: headache, chest pain, back pain, shoulder pain, fever starts>takes 400mg ibuprofen 0900 hours: woke up, no fever 1100 hours: fever starts again; takes 400mg ibuprofen 1300 hours: fever subsides 2100 hours: fever starts; takes 400mg ibuprofen At the time of this submission, pain in specified areas as well as fever persist.
FIRST NIGHT-  1/23/ 21- RIGHT ARM PAIN, OVER 12 HOURS;  NEXT DAY- 1/24/21- GENERAL FATIGUE , MALAISE , NAUSEA OVER NEXT FEW DAYS-  AT NIGHT, "HOT",  LIKE HOT FLASH, AND NIGHT SWEATS (NOT SURE IF RELATED, JUST FELT WORSE THAN USUAL. (JAN 31,  HUSBAND STATED THAT I FELT "HOTTER THAN NORMAL" TO HIM DURING NIGHT. CONTINUE TO HAVE LOW ENERGY . URI  SYMPTOMS, RUNNY NOSE AND SNEEZING.  POSSIBLY RESPIRATORY - SENSATION - HAVING TO TAKE A DEEP BREATH, BUT NOT ACTUALLY SHORTNESS OF BREATH.
Pt noticed itch lesion on back. She came in today and she has a cluster of vesicles on an erythematous base, thus Herpes Zoster.
Back ache; Body aches; Nauseous; High fever; Chills; Felt tired; Headache; A spontaneous report was received from a pharmacist concerning, a 49-year old, female patient, who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced fever, chills, feeling tired, headache, nausea, body aches and back ache.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.    On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient began to experience high fever, chills, felt tired, and a headache. On 08 Jan 2021, the patient reports a worsened headache, nausea, body aches and back ache. Treatment for the event included paracetamol and ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome events, fever, chills, and feeling tired, were considered unknown.   The outcome events, headache, nausea, body aches and back ache, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had COVID for the first week of December of 2020 and around the fourth day of being symptomatic, I developed tinnitus, which I continued to experience as a low-grade, high-pitched ringing in my ears in the months following. I reported this to a PCP . Immediately after getting my second dose of the Pfizer COVID vaccine, I began experiencing some of the symptoms I had when I had COVID (migraine, low-grade fever) and my tinnitus got much worse. It is now significantly louder and makes it difficult to focus or sleep at night. Nobody seems to know whether or not this will be permanent. If it is, I don?t know what I?m going to do.
I experienced a rash shingles on 12/22/2020 the next day of vaccination. The rash lasted for a week in a half.   I seen my primary care doctor on 12/29/2020
This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown age and gender. The reporter stated that RECOMBIVAX HB were exposed to 5 hours each day with a lowest temperature of 28 F from 03-JAN-2014 to 17-JAN-2014. The reporter also stated that during this time period, there were approximately 15 to 20 patients who received this vaccine. No adverse experiences reported. The outcome of the events were unknown. This is one of several reports from the same source. Additional information has been requested.
Patient was given Pediatric dose of Pfizer vaccine and is greater than 11 yrs old.
Hospitalization for acute metabolic encephalopathy, COVID-19 infection, TIA, elevated troponin level, abdominal pain, hyperglycemia, hypomagnesemia, elevated liver enzymes, physical deconditioning on dates 9/8/23- 9/11/23. Treated with no COVID-19 medications.
12 hours after second dose of vaccine around 1:30am I woke up with chills and body aches and a temp of 99.4. Took 650mg of tylenol. When I next checked it around 9am it was 100.4. Still with severe chills and body aches, felt very flu like and had to call into work. A shower made me feel worse. Around 10am temp was 100.7. Around 10:30 I took another 650mg of Tylenol. At  11:30 temp was 101.2. Still with chills and body aches. Went down to 100.2 at 4:30pm and took 650mg of Tylenol. Was still between 100.2 and 100.4 all night. This morning 1/19/21 around 06:30am it was 100.0  and I was very fatigued and had a headache. Had some chills and body aches overnight as well. Took Tylenol 650mg. Last I checked my temp at 10am it was 97.7.  Still with headache and fatigue.
Received vaccine at 830 AM and by 1030 AM left deltoid swollen, hard to touch and soreness.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), on 17Mar2021 as dose 2, single (Lot number: ER2613), in right arm, on 25Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: fp4554) at the age of 70 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (01Sep2022) Negative, notes: Covid symptoms resolved after finishing Paxlovid on day 5. Negative antigen test day after finishing Paxlovid; (04Sep2022) Negative, notes: negative antigen test 3 days after finishing Paxlovid; (07Sep2022) Positive, notes: Covid symptoms returned (nasal congestion) and positive antigen test on 6th day after finishing Paxlovid; (09Sep2022) Positive, notes: Positive antigen test on 8th day after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2weeks was Yes. Anti-Viral Details: Product: Covid 19 Treatment. Brand: Paxlovid. Treatment start date: 28Aug2022. Treatment stop date: 01Sep2022. Lot number: 2692129. Indication: Treatment of Covid-19. Known allergies was No.
Post vax, the pt developed leg muscle weakness, soreness all the time; especially after running. Also, fatigue is an issue.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 05-JUN-2021 for preventing illness. No concomitant medications were reported. On 23-JUL-2021, the patient tested positive for Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. Reporter stated that over the weekend patient began experiencing night sweats, chills in the night time, fatigue, muscles aches, body aches. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187779. This case, from the same reporter is linked to 20210757977.; Sender's Comments: V0: 20210760407-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Pt presented to ER with 24 hours of elevated HR of 140-160 bpm. Labs, ekg completed. Diagnosed with suspected pericarditis.
This spontaneous report was received from a school nurse via a company representative regarding a 12 year old non pregnant female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 15-MAR-2016 (reported as the day before), the patient was vaccinated with a dose of GARDASIL or GARDASIL 9 (1 shot, via intramuscular route in an unspecified arm, dose and lot # were not reported) (it was not specified). On the same day, the patient received two others vaccines (unspecified). On an unspecified day in March 2016, the patient complained of pain down her arm. The affected arm was the one in which the vaccine was given. The patient was provided an ice pack and began to feel relief within minutes. The patient's outcome was recovering/resolving. The relatedness between the event and suspect therapy was not provided. Additional information is not expected as no contact details were provided.
Redness, warmth, swelling, tenderness, pain. Pt noticed symptoms upon waking on 8/25, the morning after receiving the immunization,and persisting until the time of the clinic visit on 8/28
pt recvd vax & cried unconsolably for 5-6 hrs after vax; pt had high pitched cry; no t; tx w/ apap;
Congestion in ears, nose, and throat; burning in throat and ears, significant pain at injection side
Patient not considered immuncompromised and under age 50 but was given a 2nd booster doses of Moderna.
hives are on her fingers, forearms, butt, legs, and sometimes on the cheeks of her face as well; itchy; hives started around the injection site; rash now it is scattered; Mother went in for the second Pfizer Covid vaccine, one week later she developed a similar rash that started around the vaccination area; her lungs felt like they were iced & breathing cold fresh air that last bout one hour; During that time she also experienced extreme backache; This is a spontaneous report from a contactable consumer (patients son). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as around 19Feb2021 (not sure)), as dose 2, single, for COVID-19 immunisation. Medical history included cancer, which was controlled and super small, and it was being monitored and was not taking any medication for it. Concomitant medication included unspecified medications. istorical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as around 29Jan2021 (not sure)), as dose 1, single, for COVID-19 immunisation and experienced hives and rash. Reporter was unsure of exact dates for when the patient got the vaccine doses and provided a rough timeline. The patient did not receive any other vaccines prior to COVID vaccine. One week after vaccination, the patient developed a rash that started around the vaccination area and then it was scattered. The patient experienced hives that started around the injection site and then on her fingers, forearms, butt, legs, and sometimes on the cheeks of her face and was itchy. On 18Mar2021, the patient felt her lungs were iced and was breathing cold fresh air that last about one hour. Patient denied difficulty breathing. During that time, she also experienced extreme backache. She took Ibuprofen for the back pain. The doctor prescribed some steroids, and the hives seem to not care about the steroids because the patient was still getting the hives and it was not responding to steroids. The outcome of urticaria was not recovered while the outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was administered the shot and waiting in the waiting area for 15 min. After  few minutes she complained of dizziness. Pharmacist  on site helped her lay on the floor. She started passing out. Paramedics were called . We took her pulse and Blood Pressure which were fine.By the time paramedics came she was feeling okay and was talking.  The paramedics waited with her till somebody came to pick her up.
rash; swelling of 4 inches; left arm where she got the injection site turned red; left arm where she got the injection turned sore; sharp pain in the knee; got a sty on her upper eye lid; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (got a sty on her upper eye lid), VACCINATION SITE ERYTHEMA (left arm where she got the injection site turned red), VACCINATION SITE PAIN (left arm where she got the injection turned sore), VACCINATION SITE RASH (rash) and VACCINATION SITE SWELLING (swelling of 4 inches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.     On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HORDEOLUM (got a sty on her upper eye lid) and ARTHRALGIA (sharp pain in the knee). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm where she got the injection site turned red) and VACCINATION SITE PAIN (left arm where she got the injection turned sore). On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (rash) and VACCINATION SITE SWELLING (swelling of 4 inches). At the time of the report, HORDEOLUM (got a sty on her upper eye lid) and ARTHRALGIA (sharp pain in the knee) had resolved and VACCINATION SITE ERYTHEMA (left arm where she got the injection site turned red), VACCINATION SITE PAIN (left arm where she got the injection turned sore), VACCINATION SITE RASH (rash) and VACCINATION SITE SWELLING (swelling of 4 inches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included something for thyroid and cholesterol. Treatment details not reported by reporter.
Pt was given 0.2ml of Pfizer Covid Vaccination - pediatric configuration or orange top on 3/12/22 at 1400. Spoke with doctor who advised, per CDC guidelines, pt should wait 21 days before receiving 0.3ml of Pfizer Covid Vaccination - adult configuration or grey top. Confirmed the information with patient and patient's father - they expressed understanding.
Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number mb744, expiry date 1st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th December 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 19th December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received pediatrix dose of Engerix B instead of an adult dose, which led to underdose and adult use of a child product. The reporter did not consent to follow up.
Client c/o itching all over body, denies difficulty breathing, no hives present,  @11:45am Benadryl 50mg given IM +×1 per protocol  BP 132/70 HR 80 RR 20 SPo2 96% on room air
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer (patient's wife). This case involves a 62-year-old male patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date and dose not reported) via unknown route in unknown administration site. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that by consumer that- her husband is 62 years and his doctor's office gave him the FLUZONE HIGH DOSE vaccine. It was unknown whether the patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Rash at the site where the vaccination was given.  The area is red, itchy, and slightly swollen with a raised bump.
Here in office today 6/18/01 with chicken pox on set 6 days ago.
Arthralgia, Fever, Tachypnea, CoughWheeze, Rash, used inhaler Narrative:
approx 3d after 2nd Moderna Covid19 vaccine, c/o new onset abdominal pain, hematemesis, nausea, dark tarry stools. 5d after vaccine evaluated by ER for above symptoms, CBC normal, guaiac negative. at f/u 8d after imm described some improvement, ongoing nausea
tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with unknow results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever 102.5, coming down to 98 but then returns, is taking Tylenol
Date of Admission: 11/28/2022   Date of Discharge: 12/3/2022   Diagnoses on Admission Order: No associated diagnoses for current labs covid19 Discharge Summary     Hospital Principal Problem (Discharge Diagnoses): Dementia due to Alzheimer's disease
local rxn @ site, red, warm, swollen, SOB;DPH given;
pt exp SOB, chest pain, & rapid heart beat;in hosp pt devel flu sx;dx idiosyncratic rxn to med;dx supraventricular tachycardia, esophageal problems-gastric erosions;temp inc;vent tachycardia;virus may have attacked area of heart;
3rd dose 1/5/2008. 1/11/08 - seen with complaints of intermittent joint pain -severe stages her activity - lasts from seconds to hours had been happening for several months. CBC, Sed Rate normal. Seen 2/6/08 - increasing frequency of episodes. Bone scan done which was normal. 4/22/08. Returned again with shoulder/scapula, leg pain. Nausea with occasional swelling and facial rash. No fever. Referred to Rheumaotogly. - Normal work up- continues to have intermittent bone, leg pain and swelling.  9/22/2008 Office notes recd from PCP beginning 1/5/08 with HPV#3. Returned 2/6/08 with c/o episodic back pain x 4 months. Located in lower and thoracic regions, as well as R scapula, L hand and both legs.  PE WNL.  Returned 4/22/08 with c/o constant body pain x 6 months. Recent R knee effusion with joint pain and swelling, myalgias. Referred to Rheum. 10/21/08 Partial record received from rheum dated 6/12/08. Pt questionaire with c/o tiredness, H/A, loss of hair, chest pain, loss of appetitite, abdominal cramping, joint pain, low back pain, muscle pain, neck pain, bruising, rash on cheeks and sun sensitivity.  11/10/08 Reaminder of Rheumatology consult received. Pt reports pain began in Oct 2007 with back pain which then spread to bone pain of the arms and legs. Pain is intermittant and associated with joint swelling and rash. ROS (+) for weight loss which has been regained, frontal H/As, R upper chest wall apin, occ abd pain, back pain, myalgias, hair loss, scabbing. No objective abnormalities on PE. No Dx.