chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient female 36 years of age, oriented in time, place, date. Reports that after getting the second vaccine dose MODERNA "felt rush" (accelerated). Patient reports that it could be anxiety and that her last meal was at 2pm (a snack) and also started her period today. She has Uterine fibroid. 4:09 pm verbalizes feeling better. Patient is moved to take vitals B/P: 130/90, pulse 93, O2 99%, glucose 99%. Patient is recommended to monitor symptoms, and to visit her doctor if they worsen.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 29-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number L000454, expiry date 06-JAN-2017 (dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was passenger in car with husband. It began forty min after I had shot and lasted about 4-5 min. It started with a little tingling on my upper lip. It then moved from there to some slight pressure in my nose and then moved from nose to throat that felt scratchy. It appeared to me to be an allergic reaction, rather mild. It did not trigger an asthmatic response and as it moved from one spot to the next, the symptom at the prior spot ended.  I have had no other issue since then.  Today, the day after the shot, my arm is a little sore if I lift it. I was a little tired last night but that is it. I contacted the pharmacy this morning after thinking about it through the night as I thought it was an event that should possibly be reported.  They asked that I fill this out which I am doing. Will it be OK for me to have the second vaccine? If so, I would most likely like to have it in a physicians office. Is it possible to get it to the allergist I once used? I would feel comfortable with him giving it to me. If I have to see him in advance, I will make an appointment. I would love to chat with someone on this. THANK YOU.
Raised, red, painful, warm to touch area (8 cm X 8 cm) on same evening after doses given. Area was below the injection sites and ran down to elbow. Pharmacist reporting did not see patient's reaction.
Client vaccinated with Pfizer vaccines for Covid x 2 in April, 2021.  Symptoms started 12/12/2021 - sore throat, runny nose.
the vaccines were mistakenly given to 10 year female patient/No AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA256298.  This case involves a 10 years old female patient who mistakenly received vaccine 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1906 (Expiry date 22-May-2020) via intramuscular route in the left arm on 10-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred.  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.  List of documents held by sender: none.
Itching, red eyes, throat swelling, difficulty swallowing. Treated w/IV SOLU-MEDROL, REGLAN.
Pt rec'd flu vaccine 12/22/14. She was feeling fine. Says that within 1 hour she was covered head to toe with itchy hives and had chills and aches but no fever. Pt had same reaction with TAMIFLU last year she has no allergies to egg. She's never had flu shot before. We told her that future flu shots should be at MD office.
From initial information received on 4/15/04 from a HC professional regarding an adverse event occurring in the USA it was reported that a 56 year old female pt received a TD ADS ADULT vaccination, administered in the LA on 04/07/04. approximately 15 minutes post injection, the  pt complained of numbness and tingling from the injection site to her hand. As of 04/15/04 the numbness in her hand was still persistent.
Throat feel a little sore for 5 days now; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat feel a little sore for 5 days now) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat feel a little sore for 5 days now). At the time of the report, OROPHARYNGEAL PAIN (Throat feel a little sore for 5 days now) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
CLIENT RECEIVED A DOSE OF PFIZER FOR CHILDREN UNDER THE AGE OF 5. THE CHILD WAS 6 AT THE TIME OF VACCINATION.
This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (developed shingles from the Moderna COVID-19 vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced herpes zoster (developed shingles from the Moderna COVID-19 vaccine). At the time of the report, herpes zoster (developed shingles from the Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2022-468516 (patient link).
Moderna COVID-19 Vaccine EUA caused my left upper arm to be tender/uncomfortable and instead of waning, it has increased to the point that it is effecting my activities of daily life including able to lay down to sleep. I am taking OTC pain medication but it is not very effective.
Case number PHEH2014US003658 is an initial spontaneous report from the pharmacist received on 21 FEB 2014 with a follow up information received from a pharmacist on 13 MAR 2014. This report refers to a 13-year-old female patient who was accidentally vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 20  NOV 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration). Upon follow up receipt on 13 MAR 2014, it was reported that the reporter called the patient and was not able to get in touch with her or patient's family. Reporter also had no information about patient's physician and since the reporter could not get in contact with the patient, she was not able to obtain her physician's information. The reporter did not have any further information to provide.  Follow up information received from a pharmacist on 13 MAR 2014. Reporter did not have any information to provide.   Following an internal review on 18 AUG 2014 of the data received on 13 MAR 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
he was vaccinated and within 45-60 min began to notice a tingling feeling in upper eyelid. He stated it looked like his left eye was half asleep with swelling of upper lid and sensation of fullness in jaw.  No problems with vision. No recall of eye redness, tearing, nasal congestion, cough, problems talking, swallowing or breathing, and no skin symptoms. He took Benadryl and symptoms persisted for 36-48 hrs. This was second episode. Had a previous episode with vaccination in 1999  Symptoms: EDEMA, UNSPECIFIED(R609).
Pt had chills starting 4/18/21 evening that lasted through the night.  She then had 1 seizure that self resolved.  Pt reported to pharmacy today with a rash on the left full forearm.
Eight days  from injection, pt developed a red, itchy bump at injection site about 3/4 inch. It is warm to touch. Patient marked the border with a circle and over the next day it doubled in size.
Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I couldn't move, extremely tired, shortness of breath for 1/2 day, no energy, rash, runny nose & sore throat, tingly sensation on extremities (still occurring), ringing/piercing sound in my ears, headaches.  It has been over 3 weeks and I still don't feel energetic & like myself.
PT REPORTS LOCALIZED (R) UPPER ARM PAIN EVENING OF 4-16-2009.  REDNESS, SWELLING AND TENDERNESS TO TOUCH NOTED 4/7/2009.  MOM STATES DOSING PT WITH TYLENOL AND APPLYING ICE PACKS TO SITE FOR COMFORT.
temp. went to 106deg.; 12 hours after the shot I had a chill; I was weak all over; I could not walk; Tired all the time; walk holding on to wall; fell and could not get up; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 04Feb2021 at 08:30 (Lot Number: EN9581) as dose1, single (at the age of 77-years-old) for COVID-19 immunisation. The patient's medical history included diabetic. No known allergies. The patient received other medications in two weeks included metformin, losartan, pantoprazole and glimepiride. On 04Feb2021 at 20:30 (reported as 12 hours after the shot), the patient experienced a chill and temperature went to 106 degree. The patient reported she was weak all over, could not walk, fell and could not get up, had to be lifted up and put in bed, next day was some better and able to walk holding on to wall. The patient was still having problems with legs and was tired all the time and was having to use a cane. The patient underwent lab test which included body temperature: went to 106 degree on 04Feb2021. The patient received no treatment for the events. Covid prior vaccination reported as yes. The patient did not get tested for COVID post vaccination. The patient had no other vaccine in four weeks. The patient was recovering from the events.
Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
Patient experienced shaking in the middle of the night (early morning hours of 4/8).  He said he did not have a fever.  He then was having severe diarrhea and began drinking pedialyte as well as went to an IV hydration therapy session.  He continued to have diarrhea and took Immodium.  On Friday 4/9 he reported confusion and continued to have diarrhea.  He said he felt like he had been "hit by a truck".  Pt did begin to start feeling better on 4/10.
I95.9 HYPOTENSION 11/28/2021 BACTEREMIA R09.02 HYPOXIA 6/13/2022 BACTEREMIA I95.9 HYPOTENSION 11/28/2021 ACUTE RESPIRATORY FAILURE R09.02 HYPOXIA 6/13/2022 ACUTE RESPIRATORY FAILURE I95.9 HYPOTENSION 11/28/2021 PRESENCE OF HEART ASSIST DEVICE R09.02 HYPOXIA 6/13/2022 PRESENCE OF HEART ASSIST DEVICE I95.9 HYPOTENSION 11/28/2021 ACUTE RENAL FAILURE, UNSPECIFIED R09.02 HYPOXIA 6/13/2022 ACUTE RENAL FAILURE, UNSPECIFIED I95.9 HYPOTENSION 11/28/2021 PALLIATIVE CARE R09.02 HYPOXIA 6/13/2022 PALLIATIVE CARE I95.9 HYPOTENSION 11/28/2021 ESRD (END STAGE RENAL DISEASE) R09.02 HYPOXIA 6/13/2022 ESRD (END STAGE RENAL DISEASE) I95.9 HYPOTENSION 11/28/2021 ESRD (END STAGE RENAL DISEASE) R09.02 HYPOXIA 6/13/2022 ESRD (END STAGE RENAL DISEASE)
FEEL VERY HOT IN THAT PART WHERE THEY APPLIED THE VACCINE; GOT A SKIN WELT ON THE PART WHERE THEY APPLIED THE VACCINE; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced feel very hot in that part where they applied the vaccine, and got a skin welt on the part where they applied the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got a skin welt on the part where they applied the vaccine and feel very hot in that part where they applied the vaccine was not reported. This report was non-serious.
Eight days after the injection, a burning rash about the size of my palm appeared out of no where.  I could not tolerate topical creams on it and it disappeared after several days. It did not appear or disappear gradually. It didn't impede any arm movement. I had hives accompany the rash that also disappeared after several days.
she has cancer and undergoing treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "not recovered", described as "she has cancer and undergoing treatment". Therapeutic measures were taken as a result of neoplasm malignant.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
(L) upper arm with 11x7 induration and 11x13 erythema. Ibuprofen, BENADRYL, ice and topical hydrocortisone cream.
Information has been received from an RN concerning a female pt who on 21OCT2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Within 24 hours of vaccination, the pt developed an injection site reaction that was hot to touch. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an injection site rxn. No further info is expected.
multiple myeloma; This is a spontaneous report received from contactable physician from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation; pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunization; varicella zoster vaccine (VARICELLA ZOSTER VACCINE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLASMA CELL MYELOMA (medically signiifcant), outcome "unknown", described as "multiple myeloma". The physician stated that this was reported during a conversation that patient received vaccines at local pharmacies, including Covid vaccine, pneumococcal vaccine, and perhaps shingles vaccine, and patient subsequently was diagnosed with multiple myeloma. The reporter did not know whether any of the vaccines were Pfizer products and did not have much information available but wanted to report because the doctor expressed concern regarding administration of concomitant vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided, there is not sufficient evidence to support a causal relationship between the event "multiple myeloma" and COVID-19 Vaccine, PCV13. This case will be re-assessed when additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200239418 same reporter/drug/event, different patient
COVID-19 INFECTION; COUGH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no relevant medical history and no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced cough. On 07-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced headache. On 11-JUN-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 12-JUN-2021, the subject experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection on 28-JUN-2021, cough on JUN-2021, fever on 10-JUN-2021, and headache on 12-JUN-2021. This report was non-serious.
Patient was administered a 3rd meningitis vaccine (Menveo).   When Menveo was put in the immunization section of EMR it was noticed that patient had 2 Menactra vaccines.  Mother was informed that patient was given a 3rd meningitis vaccine and was not concerned. Patient waited an additional amount of time and had no reaction and was allowed to leave.
Pt. received vaccines in thighs d/t the amt of vaccines (5) & deltoids so small. Pt received vaccines in a.m. around 3:30 pt. fell to his knees crying & wouldn't walk or let his mom touch his legs. Parent brought pt. in & he was treated with pain medication.
Patient's husband called pharmacy following day and reported redness and swelling of the arm of injection site and patient was complaining of some soreness. Asked if patient could come into pharmacy to show injection site. Site was red and warm to the touch with swelling. Patient said the site was sore to touch but not sore to move arm. She said soreness had started night before on the day of the vaccination. Recommended an OTC pain reliever and antihistamine to help with injection site.  Recommended also for patient to follow up with clinic that day. Patient went and received medications for reaction.
shoulder and arm soreness, restriction in range of motion, unable to dress/undress for 3 days and couldn't lift beyond heart level; after 3 days, began to improve but still can't lift arm overhead
after my injection, a few hours later, i started having a stiff shoulder. it has now become frozen shoulder. i contacted my doctor and let her know. i cant use my left arm. extremely painful. no range of motion.
approximately 2 weeks after secondvaccine, experience dull - moderate chest pain - center left in heart area approximately 2 inches above and to the right of left nipple area.    Experienced it off and on for 6 hours.     Since then, had same thing recurrence 5 times - similar dull/moderate chest pain same area.
Approx 5 minutes after patient received vaccination, he stated he felt "hot and light headed".  He vomited within the next five minutes.  Patient remained in the clinic for 15 more minutes.  He stated he "felt better and no longer lightheaded."
headache; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 17Feb2021 10:30 ((at age of 67 years) Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included estradiol/medroxyprogesterone taken for an unspecified indication, start and stop date were not reported. On 18Feb2021, patient experienced headache, nausea, fatigue. Outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
had a rash on her torso for 6 months following this; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a patient.  This case involves an elderly female patient who had a rash on her torso for 6 months following this after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date in 2017, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer at an unknown dose (strength, frequency, formulation, lot and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a rash on her torso for 6 months following this (rash) (unknown latency) following the administration of influenza vaccine.  It was reported stated she had a reaction that went on for half a year and she is debating whether or not it is safe for her to take the flu vaccine this year. she received a Sanofi flu vaccine in 2017 (not sure which one) and had a rash on her torso for 6 months following this. She states that this was reported to us and she spoke with a Sanofi medical doctor including several correspondence. She states that the Sanofi Medical Doctor advised her to not get another Sanofi flu vaccine. She states that this is going to be a bad year for the flu and asks if we would recommend that she get another Sanofi flu vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
no adverse event, moderna confirmed 216K22A was  viable until 2/21/23 despite  beyond use date of 1/22/23