chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE THROAT; BURNING EYES; BODY ACHES OR BODY WAS PAINFUL TO THE TOUCH; MIGRAINE; NIGHTMARES THROUGHOUT THE NIGHT; DIZZY; FEELING COLD; SHAKING; CHILLS; INJECTION SITE PAIN; FEVER OR BODY WAS BURNING UP LIKE A FURNACE; FELT FATIGUED; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:50 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches or body was painful to the touch. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced nightmares throughout the night. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever or body was burning up like a furnace. On 09-APR-2021, the subject experienced felt fatigued. On 09-APR-2021 19:00, the subject experienced burning eyes. On 10-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning eyes, nightmares throughout the night, dizzy, chills, fever or body was burning up like a furnace, and felt fatigued on 10-APR-2021, was recovering from injection site pain, body aches or body was painful to the touch, migraine, and sore throat, and the outcome of feeling cold and shaking was not reported. This report was non-serious.
Event:  Anaphylactic shock   49-year-old female without known significant past medical history, who presents with concern for anaphylactic shock.  Patient was reportedly stung 2-3 times on the left buttocks by what she thinks was a yellowjacket while mowing the lawn.  She states that she had onset of shortness of breath, nausea, vomiting her 13-year-old daughter has an EpiPen, and administered it in her left thigh.  On EMS arrival, the patient reportedly had a blood pressure of.  40/20 initially.  She appeared altered and in distress.  Patient was loaded and brought to the emergency department.  She also was given Benadryl in route.  On arrival, the patient is alert, diaphoretic, tremulous after having received epinephrine. Normotensive on manual pressure. She is given Solu-Medrol, Pepcid, additional dose of epinephrine given her report of a sensation that her throat was closing.  She did not have any hives, nausea, vomiting, hypotension at that time.    EKG after the patient was given epinephrine showed some ST depressions in the inferior leads and lateral precordial leads.  This is likely secondary to epi, but given this, will obtain troponins.  Troponins normal.  Subject will be released on 4 days of prednisone and emergent follow up with Cardiology.
PAIN IN ARM AND PAIN IN LEFT LEG; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, and batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-APR-2021, the subject experienced pain in arm and pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm and pain in left leg was not reported. This report was non-serious.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, concomitant medications, drug reactions or allergies provided. On 17-SEP-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (strength reported as 0.5 (units not provided) (lot# K004148, expiration date 10-MAY-2016, dose, anatomical location and route of administration were not reported) and a dose of PREVANR 13 (lot# J67645, expiration date 03-MAR-2016, dose, anatomical location and route of administration were not reported). No adverse reactions were reported. Additional information has been requested.
NEUROPATHY ACUTE CORONARY SYNDROME, UNSPECIFIED HYPOTENSION HYPOXIA 12/5/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous case, initially received on 08-Dec-2016, was reported by a health authority and concerns a(n) female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for Indication not reported from 2015 to 2015. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: Pneumococcal Vaccine, Indication: Indication not reported. Special circumstances: Drug administration error without adverse event. It was reported that the patient received pneumonia and flu shot in the same arm.
While training a student administered a vaccine to a couple (husband and wife). After administering the vaccine the student completed the vaccine card for the couple. The first dose on the vaccine card stated "Pfizer vaccine" given on 02/10/2021, and the student told them they would be receiving the second dose of Pfizer vaccine, they agreed. The consent form that was completed showed they were there for the second dose. After vaccines were administered, when entering vaccines into computer, it was noted that their first vaccine was Moderna. Meaning, they received Moderna as the first vaccine and they received Pfizer as the second dose.
not adverse event; Patient was vaccinated with a dose of Gardasil 9 prepared two days before; Patient was vaccinated with a dose of Gardasil 9 prepared two days before; This non-valid spontaneous report was received form a nurse and concerning a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On 08-JUL-2019, an unknown patient was to be administrated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), however the mother of the patient refused the vaccine after the needle was already attached to the syringe.  On 10-JUL-2019 (also reported as two days after), an unknown patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly for prophylaxis (strength, dosage schedule, anatomical site, lot number and expiration date were not reported). This dose of the vaccine was the one which had the needle attached to the syringe (wrong technique in product usage process/Product preparation issue). No adverse effects were reported.   The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not reported.    This case was considered non-valid due to the lack of patient identifiers.
A mother reported that her 2-month son received Acel-Imune in July, 2000 and subsequently experienced flu-like symptoms including lethargy. He recovered
Dose 1 Pfizer and Dose 2 Moderna; Dose 1 Pfizer and Dose 2 Moderna; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna), COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna) and NO ADVERSE EVENT (No adverse event) in a 17-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COMIRNAT (Dose 1. the maroon cap Pfizer Covid-19 vaccine). Past adverse reactions to the above products included No adverse event with COMIRNAT.    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 INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna), COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna), COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna) and COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-623916 (E2B Linked Report).; Sender's Comments:  MOD-2022-623916:4 year old male case
I had the vaccine and about a month later I was diagnosed with Campylobacter which is a bacterial infection and they told me it was definitely not related to the vaccine. I took Azithromycin.
A nurse reported that a 45 year old female received an injection of DT Toxoids Adsorbed, Purogenated on 8/19/00. On 8/23/00, the pt experienced flu-like symptoms. She also developed an injection site reaction characterized by "extreme" soreness, erythema and edema. This is 1 of 4 pts from this facility who had an adverse experience following receipt of TD Toxoids Adsorbed, Purogenated lot 471038.
Caused a Flare-up of Bullous Pemphigoid (flushed burning skin, with bullous blisters)
Narrative:  Patient experiencing new onset Headache on left side of head. Reviewed Sign and symptoms of blood blot. Patient sought emergency care. Patient is currently on birth control.
missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Case number PHEH2013US022747 is an initial spontaneous report from the health care professional received on 28 Oct 2013. This report refers to a 11-year-old female patient. She was vaccinated with MENVEO, (batch number: A12119) subcutaneously on 25 Oct 2013. On 28 Oct 2013, she experienced redness and swelling at the injected area. The outcome of the events reported as condition unchanged. The seriousness and causality of the events were not reported.
The day after I had major chills, joint pains, nausea, really sore, extreme flu like symptoms. It was a miserable 24 hours, then after I felt like I had about 20 energy drinks and this lasted for about a week.
On 02/20/2022 I was having so much pain during bowel movements. It became debilitating at some point. I called my doctor on the 23rd and told him over the counter medicine was not working. I was having a lot of gas and cramping with diarrhea. I was buckling over when in the bathroom. I was going until there was nothing left. And bowel movement would result in cramping pain and me be depleted every day. He prescribed me medicine called Hyoscyamine. I was going on a cruise, and I would wake up with cramping and diarrhea three times out of the night. I came home on March 5thgoing into now, I?m in the last three days and I have had a somewhat normal bowel movement, without pain. Theses felt like attacks, now It has been a full four days with no cramping pain.
contracted COVID 19; contracted COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Although patient symptoms were mild and patient took Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
15 minutes after injection patient developed a rash that continued to spread. Itching  but patient denied shortness of breath, swelling to lips. Patient treated with diphenhydramine 25 mg /10 ml by mouth at time 15:05. Patient symptoms resolved and discharged home after observation.
Sore throat and lympadenopathy to posterior and anterior cervical chains beginning 7/17/04.  Advised warm compresses and OTC analgensics prn discomfort
THE PATIENT WAS ADMINISTERED THE WRONG VACCINE. HE WAS HERE TO GET THE FLUAD QUADRIVALENT BUT THE TECHNICIAN GAVE HIM THE PFIZER COVID VACCINE BY MISTAKE.  THE PATIENT HAD PREVIOUSLY RECEIVED 2 DOSES OF THE MODERNA COVID VACCINE ON 2/11/21 AND 3/10/21. LATER THAT DAY THE PATIENT STATED HE HAD A MILD HEADACHE BUT FELT FINE OTHER THAN THAT.
Patient received the moderna booster and reported no issues or allergies to the first to moderna vaccines . Patient was advised to pull up and wait 15 minutes. Husband was driving the vehicle and pulled up and stopped. As soon as the husband stopped the car he got out and started screaming . Patient has flat affect with eyes open not responding to any type of stimulation . Patient continue to be in daze would not verbally responded to questions for over 10 minutes . Patient was laid back in car seat and then began to sweat and started responding slight at that time .
I have  a rash. red patches, mostly on my torso, but some on my face. Began to notice the evening of my second dose shot. This is four days later and still have the red splotches.
seizure-like activity, lasting 45 seconds, 72 hrs after vaccination.  No treatment given.
Per pt swelling started the evening of shot. Today, induration 9 x 7 cm and red. 2 x 4 cm very hot, tender to painful at sq injection site. Pt given ZYRTEC, TYLENOL, cool compress, KEFLEX 500 to cont. and f/u 1 wk.
Chicken pox rash noted on forehead, abdomen, buttocks back of neck.  Approximately 20-30 pox total, rash appeared 8/31/06 doctor diagnosed vaccine, virus chicken pox 9/1/06 .
fever, couldn't stand up, couldn't walk, unable to move my legs and feet, severe headache problems breathing went to Emergency room. Admitted to the hospital. Stayed for 4 days
Enlarged heart and continued heart palpitations.  Ejection Fraction 25 %.  No prior heart problems.  Diagnosed 11 days after getting vaccine.
Pt recvd 1 dose of Recomvivax HB on 26OCT89 & 2 doses of Engerix-B 12DEC89 & 27APR90 & was found to be a non-responder;
Developed extreme , incapacitating ocular inflammatory process . Diagnosed with anterior necrotizing scleritis, along with posterior scleritis and concomitant  dry eye...all inflammatory processes of eyes, with no prior history of ocular inflammation. No rheumatologic disease.  Has been extremely resistant to treatment, requiring long term  steroids , Humira weekly. Patient with continual ocular pain, scleral thinning ,  some vision  loss.
p/vax pt was running temp (sometimes very hot, sometimes not-did not take temp @ home);pt was having trouble breathing;had to be propped up w/pillow to breathe or be held by mom all noc;child had inc trouble breathing;father took to hosp
22 hours after vaccination and one hour after taking morning pills, patient developed full body rash and itching.  Morning meds she consumed were: Losartan, amlodipine, pravastatin, escitalopram, baby aspirin, vitamin D3.  Episode of rash and itching improved with oral Benadryl 50 mg.  The next day patient took her meds same time and one hour later developed rash.  Took Benadryl and rash resolved.  Patient then stopped medications for 1 week and had no occurrences of rash.  Restarted medications morning of 3/10/21 and developed full body rash with itching and early anaphylaxis, one hour after medication consumed.  It should be noted, patient has been on these medications for several years without reaction.  Reaction started after she had received the Moderna COVID19 vaccination.  On 3/10/21 when she had full body rash with anaphylaxis, patient presented to our clinic and was given 2 rounds of IM epinephrine, IM Benadryl 50 mg, IM Solu-Medrol 125 mg, and oral Zyrtec.  Episode took 2.5 hours to resolve.  Patient prescribed tapering course of prednisone, Zyrtec once daily, famotidine 20 mg once daily for the next 7 days, outpatient.  We will be restarting one medication at a time to assess for medication reaction.
Dizzy, Tiredness, for 30 minutes and then it was hard to breath after 35~40 minutes. My heart beats were really fast.   It last about 15 minutes. I started to have fevers, muscle pain, and felt very cold.  On my 5th day, my throat was swollen, I felt dizzy, and felt like I am going to throw up. I had cough too.  It lasted over four days, starting from my 5th day after vaccination.  All these symptoms got better after 8 days.  Although these symptoms are gone, I still feel a bit of chest & heart pain whenever I feel tired.
Given Infanrix instead of Boostrix; 11 YO received infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 21-FEB-2023, the patient received Infanrix. On 21-FEB-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Given Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 YO received infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 06-MAR-2023 The Clinic Manager called to enquire on how to proceed for the patient as, 11 year old patient was inadvertently administered Infanrix instead of Boostrix. The patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration The reporter did not consent to follow up.
Shaking, pain in right arm, feverish, mild headache, general malaise (flu-like symptoms).
normal symptoms; This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE REACTION (normal symptoms) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (normal symptoms). At the time of the report, ADVERSE REACTION (normal symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-075532 (Patient Link).
SEVERAL HOURS AFTER GETTING VACCINE MY INJECTION SITE  AND MOST OF LEFT ARM WAS SORE AND WARM TO TOUCH. IT WAS HARD TO USE MY LEFT ARM TO WORK ON COMPUTER TUESDAY. ON TUESDAY MY ARM WAS THE SAME BUT VERY PAINFUL WENT TO GET ADVIL TO TAKE FOR THE PAIN. TOOK 2 200 MG AT 5PM.  7PM STILL SORE AND WARM
Soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm). In March 2021, PAIN IN EXTREMITY (Soreness in his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-060654 (E2B Linked Report).; Sender's Comments:  MOD-2021-060654:Mother's case
Information has been received from a registered nurse concerning an elementary school aged child who on 18-JUL-2000 was vaccinated with a dose of varicella virus vaccine live. On 02-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Information has been received from a registered nurse concerning a 64 year old male patient with coronary artery disease and dyslipidaemia and a history of cardiac pacemaker, stent and catheterisation cardiac, and no known drug allergies who on 26-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 in his abdomen. Concomitant therapy included CRESTOR, aspirin, nitroglycerin, PLAVIX and BYSTOLIC. On 26-APR-2010 the patient experienced swelling from his nipple line to his scrotum, the area was red and itchy. The patient went to the emergency room at 3 am. He was not admitted but was administered BENADRYL injection and released. The patient was also examined by his physician on 27-APR-2010 (no comments were reported). The patient's swelling from his nipple line to his scrotum and the area was red and the area was itchy persisted. Follow-up information had been received from the registered nurse via phone call who reported that while the patient was in the hospital for a heart catherization, the patient was vaccinated with the PNEUMOVAX 23 (lot number unknown). The reporter did not know by what route the BENADRYL was given. The health care professional contacted during telephone follow-up could not supply the following information: lot number. Additional information has been requested.
SLIGHT SORE ARM; A SLIGHT HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight sore arm, a slight headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, a slight headache and slight sore arm was not reported. This report was non-serious.