chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient developed a sore arm that lasted for about 3 days. He would be emailing his experience to Centers for Disease Control and Prevention (CDC), the pharmacy and to GlaxoSmithKline. This case was linked with the case US2018127822, reported for the same patient.
Stiff neck and pain to touch to bottom of her head on the left side; Soreness to back of her head, under her ear to the bottom of her head; Had left arm soreness after the injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck and pain to touch to bottom of her head on the left side), HEADACHE (Soreness to back of her head, under her ear to the bottom of her head) and VACCINATION SITE PAIN (Had left arm soreness after the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Spinal fusion. Concurrent medical conditions included Hypertension.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Had left arm soreness after the injection). On 14-Mar-2021, the patient experienced HEADACHE (Soreness to back of her head, under her ear to the bottom of her head). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck and pain to touch to bottom of her head on the left side). The patient was treated with OXYCODONE for Head pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck and pain to touch to bottom of her head on the left side), HEADACHE (Soreness to back of her head, under her ear to the bottom of her head) and VACCINATION SITE PAIN (Had left arm soreness after the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication  The patient experienced back of head on the left side was painful to touch and avoided sleeping on the left arm. The patient was on pain management for back.  The patient experienced big ache to back of her head and back.
My first adverse event I had muscle and body aches and joint pains. It was all over my body and I couldn't sleep. I had a low-grade fever; I had a sore arm where I got the injection on the right arm. I put my symptoms in the questionnaire. I would take Tylenol every 6 hours and drink water. I spoke to my doctor via email. I was unable to perform my schoolwork, due to being in a lot of pain. I tried to rest as much as I could. This was mainly the issues, and this was on the 27th. On the 28th I was able to return to school, but my muscle and body aches were still hurting. I'm not sure how it long it lasted, but I did put it in the questionnaire. It did last for a few days. I had some aches in my hips and legs. It wasn't as bad as the day of my injection. I was mainly taking the acetaminophen. This past Monday on Nov 15 I had the same symptoms minus the fever, The pain and soreness returned in my neck and my upper shoulder blade. Then both arms it felts like I got injections. My neck was really sore, and it felt like I got the shot all over again. I took some Tylenol and I had to go to school. I thought I was getting a virus, but my temperature was normal. I took a muscle relaxer, but nothing helped. I called my nurse advisor on Monday and used a heating pad. They told me to use an ice pack, she suggested Motrin, but I didn't use it due to it hurting my stomach. They made an appointment to see my doctor Tuesday 16. Doctor offered more muscle relaxers and offered Lidocaine patches.  I've been using heating pads and lidocaine cream. I've been using muscle relaxer about every six hours and the pain is getting better. The pain is mainly only on my neck and right between my shoulder blades.  I've been using some essential oils to help with the pain.
Patient presented to ED with Afib with RVR. Patient was confused. Tested positive for COVID 19 on 8/17/2021. patient admitted to inpatient 8/17.  Patient developed COVID PNA  Transitioned to comfort  care on 8/23/2021 and was discharge home with hospice.
Sore arm; Very severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and DIARRHOEA (Very severe diarrhea) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma. Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for Lymphoma.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and DIARRHOEA (Very severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) on 06-Feb-2021 for Diarrhea, at a dose of UNK dosage form. On 06-Feb-2021, DIARRHOEA (Very severe diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Within an hour of the vaccination, the patient  experienced very severe diarrhea. He had to rush home to take a shower. The severe diarrhea lasted within an hour.  The patient takes an IV IgG treatment every 6 weeks; he had one 2 weeks before the vaccine on 27-Jan-2021; he is a lymphoma survivor.
Patient had localized injection reaction with redness, swelling, warmth surrounding injection site. She has now recovered, with the immediate rxn settled down. She still feels quite tired & has malaise.
Fever; chills; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration as unknown single for COVID-19 immunization. Patient experienced fever and chills after receiving mRNA vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
approx 10min p/vax pt had red blotchy area 4inches diameter rt deltoid 3 inch blotchy area lt shoulder & 1x3inch blotchy area @ base neck;dec redness p/10min;DPH ordered;
PAIN AT INJECTION SITE; This spontaneous report received from a patient via an unspecified company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain at injection site was not reported. This report was non-serious.
Severe swelling at injection site, travelling all the way down to left elbow, very Red and inflamed.
Redness and induration left upper extremity - patient states painful - was seen in the office 11/5/07
pt called to say she had chills, fever,cough,nausea and sinus drainage to such an extreme that her symptoms required her to call off.
adult patient received a dose of the pediatric DT with no reported adverse event; Initial information received on 02-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 32 years old male patient who received a dose of the pediatric DIPHTHERIA AND TETANUS TOXOIDS, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Mar-2023, the patient received a 0.5 ml, once dose 1 of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot: C5864AA, Exp date: 07-Apr-2023) via unknown route in the right deltoid (form, strength: unknown) for prophylactic vaccination.  On 02-MAR-2023 the patient received a dose of the pediatric DIPHTHERIA AND TETANUS TOXOIDS, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported "Caller states the patient has not had any vaccines and is getting them for the first time. He is on the catch-up schedule for his school. First time product used : Yes Still using product : No."  Action taken with DIPHTHERIA AND TETANUS TOXOIDS was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
All immunizations listed were given. Child broke out in a red rash to face and arms. The rash on the arms were raised. Called EMS and patient was taken to local hospital.
Extreme chills at night Overall body aches, including headache Fluctuating feelings of very warm to very cold General malaise Treated with Tylenol Lasted 24 hours
lost a wife and farm from the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: death (death), outcome "fatal", described as "lost a wife and farm from the shot". The reporter was reporting on the shot. When asked the product he is calling about he says the Comirnaty shot though he doesn't know why we say that and why he chose that option because it isn't called that. He lost a wife (patient) and farm from the shot. The patient date of death was unknown. The reported cause of death was "lost a wife and farm from the shot". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: lost a wife and farm from the shot
This spontaneous non-valid report as received from a pharmacist refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided. On 25-FEB-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot number, expiration date and site of injection were not provided). On 25-FEB-2019, the patient experienced reaction, described as "red, swollen, warm, red ring lower than the injection site and sore". The patient was given a treatment for the events. The patient did not sought medical attention. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. This case is non-valid due to lack of patient's identifiers.
This case was reported by a nurse and described an adult pt who tested positive for hepatitis B surface antigen after receiving hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical condition was notable for renal failure (cause not reported) treated with hemodialysis.  On 10/06/03, the pt received the first dose of Engerix-B (either lot ENG5372A2 or Lot ENG5461A2).  On 10/09/03 a test for hepatitis B surface antigen was "positive".  The nurse considered the event to probably be related to the use of Engerix-B.  The nurse reported that "several" pt's experienced the same event, however, pt identifiers were not provided.
Burning during injection.  Muscle and joint ache in arm after injection.  Redness and fever of injection site.  Next day ache down right side of body from head to toes.  Continue to have headaches and muscle tiredness down right side of body.  Jaw pain, ear numbness, and numb right side of face.  Doctor seen on 10-5 and she prescribed prednisone.  Currently on day 6 of treatment with only slight improvement of symptoms.
within 30 minutes of receiving the vaccine I had red spots on my arms, later the spots spread to my torso and on my leg. They were neither like a rash nor hives, as they were flat, closed, circles and not itchy or swollen in any way. They cleared within a few days.
Infant experienced infantile spasms following HIBTITER; However, MD did not recognize sx until 6 to 8 wks p/immun; Infant was afeb & referred to a Peds Neurologist;
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 25-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Pt recvd vax 23OCT91 felt fine until approx 1PM 23OCT91; Pt did not seek medical help; c/o SOB, copious clear expectoration, fever of 104, took ASA, forced fluids, was afebrile & feeling fine by 8AM 24OCT91;
Treatment of COVID-19; Treatment of COVID-19; 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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 15:00 as dose 3 (booster), single (Lot number: 33130ba) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MUCINEX, start date: 12Jul2022, stop date: 21Jul2022; IBUPROFEN, start date: 12Jul2022, stop date: 21Jul2022. Past drug history included: Septra, reaction(s): "Known allergies: Septra". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment given from 14Jul2022 to 18Jul2022 for covid-19.
Received TD instead of PPD to left inner FA which caused swelling and redness over site.
parent reported pt irritable 1wk p/vax;would wake up @ noc trembling;took pt to MD 31OCT96 c/o having diff walking & stumbling;parents report pt very stiff in AM;dx GBS;pt screams when try to bend legs;did not walk 2NOV96 to 1DEC95;
This is a spontaneous report received from contactable other HCP (patient's parent). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 27, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. The patient developed trigeminal neuralgia, onset 2021, with outcome of unknown. Trigeminal neuralgia was evaluated at a physician office visit. Additional information: Patient's age is not specified but mentioned as older teenager or young adult. Do not have an exact age or any other known issues. Patient's mother asked if there was any known issue of trigeminal neuralgia with the COVID-19 vaccine. She said she was taking her daughter to the doctor now. Her daughter had her 2nd shot of the vaccine on Friday the 27th. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
pt recv vax 19MAR96 & 27MAR96 pt devel a red blistery type of rash on the stomach;pt recovered from red blistery type rash approx 2 days later;no further details were provided;
After 2nd dose of COVID vaccine, patient developed altered mental status, fever, generalized weakness, fatigue, unable to ambulate independently (too weak).
After about 5 minutes of receiving his covid vaccine the patient became pale and was sweaty. I took his blood pressure and it was 105/64 with a pulse of 62. I brought him a cold pack from fridge to put on his wrist and neck. We watched him closely afterwards. I asked that he wait for 30 minutes so we could watch him. He felt better before he left and had a healthy appearance.
Patient and mother feel hair loss and thinning are due to GARDASIL vaccine.  Patient uses straightening iron and products and picks hair.  Referred to derm.
62 yo female s/p full Pfizer COVID vaccination: dose 1 on 1/19 and dose 2 on 2/9. PCR test resulted positive on 8/4. Pt received casirivimab/imdevimab infusion on 8/7.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (lot# K009758 with expiry date: July 2016 and lot# reported as: K021935 with expiry date: 10-NOV-2015; strength, dose and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Pain at injection site and area.  Injection given higher than usual and pain felt unusual.  Pain worse upon moving arm out from body, over head, and behind body (seems to correspond to engaging deltoid muscle).  Difficult to put on and take off jackets or take shirt off over head.  Some discomfort sleeping on left side/upper arm.  Pain seems to be getting worse and not better with time.  No pain or injury to that arm before flu shot.  Started right after vaccine administration and has been there ever since - no relief at all.
Fever, headache, chills, dizziness, body aches - no treatment, 7pm on 5/11/2021 to 2:30pm on 5/12/2021 Injection site pain/frozen shoulder - 5/11/2021 to 5/14/2021
The patient started on 11/07 with a fever and headache which progressed over 9 days with malaise, hives, itching, fever up to 102F, body aches and coughing up to 9 days after the vaccine.
5 minutes after receiving the J&J vaccine, I went lights out.  As I was sitting in the monitoring area, I was completely fine and then a wave came crushing down on me and I was out for about 5 minutes.  The nurses said it looked like I was having a seizure.  The EMTs called it a syncope event.  I am a member of the military and and have been pumped full of vaccines.  I get my annual flu shot every year.  I have survived 6 rounds of Anthrax vaccines and every other vaccine the military has pumped into me.  This is the First Time I  have ever REACTED this way.  It was CRAZY!
feels unwell; dizziness; vomiting; This is a spontaneous report from a contactable consumer (sister) or other non hcp. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 16Feb2021 11:00 as 1ST DOSE, SINGLE  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feels unwell, dizziness, vomiting on 16Feb2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested  Follow-up attempts are completed. No further information is expected.
Sudden red, itching oval at vaccination site; feeling unwell,  Is a photo useful?
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: Confirmed by positive antigen test; (05May2022) Positive, notes: Positive tests continued thereafter for another six days; (unspecified date) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medications in two weeks of vaccination. Rebound covid symptoms started five days after end of Paxlovid course of treatment. Confirmed by positive antigen test. Positive tests continued thereafter for another six days.  Product Quality investigation result: Lot No: FJ1620: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
I had a sore after receiving the vaccine for about a day. I had cold like symptoms or a sinus infection in half of my head. I tested positive for COVID-19 on 01/17/2023. I had a telehealth visit with my doctor but did not get a prescription. I took TYLENOL to help with my symptoms.