chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11:30am (Mon. Sept 14) received vaccines for shingles and flu.  Felt fine most of the day, minor arm discomfort. 7:30pm slight headache began 10:00pm feeling nauseous, worsening headache, chills (particularly my feet were cold) Between midnight and 3am vomited once; nausea briefly abated then returned Second day (Tuesday Sept 15) still had a headache and arm is sore to the touch but mildly.  Not much interest in eating. 1:00pm took Tylenol.  Tired and low energy the rest of the day; eating small dry bites only. Third day (Wed. Sept 16) felt nearly back to normal.
I awoke with extreme bone pain pain in the marrow of the bones all long bones entire pelvis and spine?.. My heart rate would go up and down the bone pain was unbearable I was actually screaming for a couple of hours until my husband got a hold of my pulmonologist who had me take prednisone 40 mg I have been a registered nurse for 46 years and extremely aware of my body and of the human body After my second Pfizer shot which was on 4/22/2021 I had bone pain and have continued to have bone pain in my pelvis and difficulty at some time standing I am physically very fit I work 40+ hours a week and I?m not a crybaby?. The pain  was excruciating reminded me of when I worked and took care of sickle cell anemia patients it was the same type of pain that those people were described to me over and over again
No further AE; temperature excursion; This spontaneous report was received from a practice manager and 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 29-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621931, expiration date: 26-JAN-2022 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
After receiving my vaccine I began to have aching joints which progressed into inflammation in my knees, hands, lower back, and shoulders. I took Aleve to address the pain.
my Doctor had a broken blood vessel that was like really bad, like a little hemorrhage; my Doctor had a broken blood vessel that was like really bad, like a little hemorrhage; This is a spontaneous report from a non-contactable consumer.   A patient of unspecified age and gender receive dbnt162b2 (BNT162B2) at single dose on an unspecified date for immunization.   The patient medical history and concomitant medications were not reported. The patient stated that the doctor had a broken blood vessel that was like really bad, like a little hemorrhage on an unspecified date.  The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
can not focus, rolls head to one side; only happens when concentrates; started 5 days p/vax; 2DEC93 MD optomitrist, called discuss; 7DEC93 written f/u to MD; No response to request for more info;
dizziness; restlessness; sleepless night; had injection site pain; body aches; subcutaneous injection; general malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), RESTLESSNESS (restlessness), INSOMNIA (sleepless night), VACCINATION SITE PAIN (had injection site pain) and DIZZINESS (dizziness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MALAISE (general malaise), VACCINATION SITE PAIN (had injection site pain), MYALGIA (body aches) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection). On 04-May-2021, the patient experienced RESTLESSNESS (restlessness) and INSOMNIA (sleepless night). On 05-May-2021, the patient experienced DIZZINESS (dizziness). On 02-Apr-2021, MALAISE (general malaise), VACCINATION SITE PAIN (had injection site pain) and MYALGIA (body aches) had resolved. On 07-May-2021, RESTLESSNESS (restlessness), INSOMNIA (sleepless night) and DIZZINESS (dizziness) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter considered MALAISE (general malaise), RESTLESSNESS (restlessness), INSOMNIA (sleepless night), VACCINATION SITE PAIN (had injection site pain), DIZZINESS (dizziness), MYALGIA (body aches) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) to be related.    Concomitant product use was not provided by the reporter.  The patient received vaccine 1 on 01-Apr-2021, in left arm (subcutaneous) experienced injection site pain and body aches in combination with general malaise that recovered the next day.  The patient received vaccine 2 on 04-May-2021, in left arm (subcutaneous) experienced restlessness, sleepless night, next day experienced dizziness, malaise, and body aches that took 3 days to recover, but did not seek medical attention.  The patient received vaccine 3 (booster) on 01-Nov-2021 in left arm (subcutaneous) experienced general malaise and recovered the next day without medical attention.  Treatment information was not provided.
Pediatric patient received the first dose of the Moderna COVID19 vaccine; A spontaneous report, was received from a nurse, concerning a 17 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in pediatric patient received the first dose of the Moderna COVID19 vaccine (product administered to patient of inappropriate age).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), for the prophylaxis of COVID-19 infection.   The nurse who was the supervisor for outpatient monitoring reports an adverse event that a pediatric patient received the first dose of the Moderna COVID19 vaccine on 19 Feb 2021. The patient was a 17 years and 2 months old and declines to be contacted further for any further information. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, pediatric patient received the first dose of the Moderna COVID19 vaccine, was recovered on 19 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, with no associated AEs.
This is a spontaneous report from a contactable consumer, the patient. A 61-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included peripheral neuropathy, hypertension and migraines. The patient had history of allergies to lisinopril, amlodipine and Percocet. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), ASPIRIN, vitamin b1 (MANUFACTURER UNKNOWN) and vitamin D3 (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced Inflamed left toe joint within 24 hours of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with foot wrap and foot boot. The clinical outcome of the event inflamed left toe joint was not resolved. No follow-up attempts are needed. No further information is expected.
70 year old female with a past medical history that includes Hypertension, Hyperlipidemia, Adrenal insufficiency 2/2 pituitary tumor s/p resection, Hypothyroidism, previous TIA/CVA with known atrial ectopia that presented to the ED for evaluation of tachycardia with associated chest pain after receiving COVID vaccine #2.     In discussion with the patient, she reported that she was in her usual state of health. She proceeded to get her 2nd COVID vaccine. About 10-15 minutes after receiving the vaccine, she developed fast heart rates (80s at that time from a baseline closer to 50 as per the patient).  She noted that her heart rates continued to climb as high as the 150s on her pulse oximeter.  She developed associated chest pain/tightness with mild shortness of breath approximately 3 hours after her vaccine was given.  She presented to the ED at HUP for evaluation given the persistence of the symptoms.  Notably, she reports similar fast heart rates after her first vaccine which improved on their own and were NOT at that time associated with chest pains.   In the ED she was noted to be in Afib with a rapid ventricular rate in the 140-150s.  She was afebrile and without leukocytosis or electrolyte abnormalities.  Her TSH was low at 0.02 with free T3/T4 labs pending.  She had one negative troponin and an age-adjusted normal D-Dimer.  Her BNP was elevated to 636.  She received one dose of IV diltiazem 10 mg with improvement in her heart rate and recovery to sinus rhythm with PACs.  She was placed in the observation overnight for telemetry monitoring and echocardiogram.   While in the ED observation unit she was resumed on her home medications. She was monitored on telemetry and remained in normal sinus rhythm with occasional PACs. She had no recurrence of chest pain.
no adverse event; Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023) and NO ADVERSE EVENT (no adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-731651 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731651:Same reporter
Severe flu-like symptoms: sore throat. headache, rhinitis, cough for 4 days
Shortness of breath, chest tightening, nausea, lightheadedness. Chest pain while in the ER. Intubated after cardiac arrest. Transferred to ICU. Life support removed 3/22/21. Pt expected to expire today.
Extreme fatigue, localized pain. By 48 hour mark experienced swelling (hard lump under skin), red surface marking ~2 in diameter with slight ~3/8 in nursing at injection site, area hot to touch. Patient very minor cold day of injection.
3/27/21 - racing heart, fever, body aches, headache. Did not sleep entire night.  3/28/21 - Headache, fatigue 3/29/21 - Headache 3/30/21 - Acute unilateral facial numbing, burning and tingling of extremities, rash on arms and torso 3/31/21 - Immune system on high alert, liver pain
Headache starting 10 minutes after vaccine Extreme tiredness and malaise for two days Ringing in ears Chest pain randomly since then.
This case was reported by a other health professional via call center representative and described the occurrence of fever blister in a 54-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2T3JZ, expiry date 21st June 2016). The patient's past medical history included fever blister (had fever blisters occasionally). On 16th September 2015, the patient received FLUARIX QUADRIVALENT. On 18th September 2015, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was recovering/resolving. It was unknown if the reporter considered the fever blister to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient had had outbreak of fever blisters on her upper and lower lips, which progressed to blisters on both upper and lower gums. The patient had self treated with salt water rinses and the blisters were resolving.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 10 years old female patient who was vaccinated with 0.5 ml first dose of PENTACEL (lot number: C5518AA and expiry date: 15-Sep-2019) injection via intramuscular route in the left arm on 29-Oct-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines included MMR, HEPATITIS B VACCINE; and FLUZONE QUADRIVALENT for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was administered to a 10 years old patient. No adverse reactions have occurred at this time as a result of the vaccination. 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. Documents held by sender: none.
Patient received shingrix vaccination on Tuesday and presented to pharmacy on Thursday with warm, red area. Treating with ice and tylenol, planning to follow-up with dr. if doesnt improve.
My arm a little sore; I was a little bit sore.; I kind feel little nausea at my stomach and I have never had that; Tingling; I was a little bit sore.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5202) via an unspecified route of administration on 24Feb2021 (at the age of 58-year-old) at dose 1, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On an unspecified date in2021 the patient experienced my arm a little sore; i was a little bit sore, i kind feel little nausea at my stomach and i have never had that, tingling. Additional Context: When probed for the concern, reporter stated, I went out yesterday and I took the Pfizer, I took the shot yesterday and it just made my arm a little sore after the shot and that was fine and then this morning I was a little bit sore so I continued to do my normal exercise that I do in the morning and like about 10 or 11 O'clock I started getting nausea and stomach nausea and so I haven't eaten my dinner but I went back to sleep couple of hours ago and I just woke up. So, I read my paper and it said to contact you guys if I had any nausea or, I haven't had any headache just kind of tingling so I am thinking that, since that's my first one it might be working or it is just new to my body so I am trying to giving it a little time. I am fixing to put something in my stomach I hadn't ate dinner yet but I kind feel little nausea at my stomach and I have never had that. I don't have stomach problems or nothing like that, I didn't have until I took the shot so I am just kind of taking a step ahead to give it today and if it continues then least I have made the call so. When confirmed the vaccine as Pfizer's Covid 19 vaccine, consumer stated: Yes. LOT, consumer stated, Okay hold on 1 minute. It is Pfizer EN5202, looks like. Patient did not receive treatment for the adverse events. Outcome of the events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Less than 10 minutes following injection, patient complained of feeling lightheaded like she was going to pass out. On exam of patient in passenger seat of car, patient found to be slumped over pale, diaphoretic but responsive. Patient when asked stated she is a diabetic and has an insulin pump. Blood sugar was 111. Patient stated she had reacted to other medications in the past. No respiratory distress noted, no rash or hives. Patient was informed that we felt she should be evaluated in ER. Patient and husband both agreed. Patient transported to ER via wheelchair. Patient immediately placed on cardiac monitor, rhythm normal sinus without ectopy. Husband at bedside. Patient treated with zofran and was feeling some better. Lab work returned within normal ranges.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Child received vaccine 7/19/06. By 7/20/06 noc had noticed hives on trunk and B periorbital edema. The hives worsened by 7/21/06, date seen in office. Benadryl and oral steroids prescribed.
Patient reports tachycardia, Brain zap feeling, brain fog, sharp chest pain, frequent palpitations, multiple ER visits with elevated troponin levels since getting her Moderna booster.
Information has been received from a healthcare worker referring multiple unspecified patients of unknown age and gender. Their medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were administered improperly stored VARIVAX (strength, dose, frequency and route were unknown; lot number M015731 with and expiration date as 30-MAR-2018; M006156 with expiration date as 05-FEB-2018; M009768 with and expiration date as 23-FEB-2018; M017290 with and expiration date as 07-APR-2018 and M008171 with and expiration date as 16-FEB-2018). No Adverse effects were reported. This is one of the two reports that received from the same source. Additional information has been requested.
multiple outbreaks of herpes zoster; postherpetic neuralgia; hearing loss; cardiovascular issues; vision issues; seizures; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 23-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After received zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, hearing loss, cardiovascular issues, vision issues and seizures. As a result of these symptoms, the patient was seen and treated by medical providers and currently still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, hearing loss and seizures were considered to be medically significant events.