chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 39 year old male. 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: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 31-MAY-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 39 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 31-MAY-2022, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759052, 20220759222, 20220759160 and 20220759113.
They just say it's inner ear infection; Dizzy/Dizziness/Light-headed; Diarrhoea; got the runs; Headache; Nauseated; not doing good; sore arm; hurting like tetanus; Pain; Back cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing); "Bipolar disorder" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Sarcoid" (unspecified if ongoing). Concomitant medication(s) included: COUMADIN taken for thrombosis. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Dizzy/Dizziness/Light-headed"; DIARRHOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Diarrhoea; got the runs"; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Nauseated"; MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "not doing good"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "sore arm"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "hurting like tetanus"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Pain"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "Back cramps"; LABYRINTHITIS (non-serious), outcome "unknown", described as "They just say it's inner ear infection".  Additional information: Reporter seriousness for Dizzy, Light-headed, Diarrhoea, Headache, Nauseated, not doing good, sore arm,for hurting, got the runs: Unspecified. Reporter stated, She is dizzy, light headed, got the runs, got a headache, she s nauseated, Diarrhea. Persisting, we have not got any therapist so far. It is persisting. It has not gone away or has not gotten worse. It is still there. When asked for any other help, reporter stated, What do we do for the side effects. Reporter stated, "My question is she is having dizziness and nausea, and the runs and a headache, back cramps and she just feels terrible, her arms hurt for 2 days and she wants to go back to the emergency room because they just say that it's inner ear infection. And we want to know what we can do to get her out of the pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6/5/19 fussy 9 pm Tylenol 6/6/19 3 AM tonic clonic seizure - 4 - 5 min Called EMT  T  103.9  O2 or duonebs given - postictal - no cough  330 ED - 105.8  O2 98%  HR 142 crying  neg flu  neg RSV  Tylenol (R) Discharged 7 AM 6/6/19
Had shortness of breath and admitted to hospital for blood clot/pulmonary embolism on 4/28/21   * Hematologist suggested I should report  for information purposes. Not stating this is believed to be the cause of the event - just reporting as requested
ABOUT 8PM,  i started with having hot flashes, i took two tylenol and went to bed.  I woke up around 1am,  had to go to the bathroom, then i became really dizzy and vomited.  Thought i was done, and vomited again.  about an hour later i was back up vomiting again.  Around 9 am i got up to take some more tylenol, but had to run to the bathroom to vomit again.  I stayed in bed until 5am 11/22/2021.  I was still shaky but was able to make it through the day without vomiting.
Right arm swelled considerably same day of immunization. Patient returned to pharmacy to have pharmacist look at her arm and assess the reaction. Pharmacist recommended that she go to the hospital. Patient states she went to emergency department and was then admitted. She was diagnosed with cellulitis and was hospitalized for 4 days.
face was swollen; sore to touch rashes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was swollen) and RASH (sore to touch rashes) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced SWELLING FACE (face was swollen) and RASH (sore to touch rashes). At the time of the report, SWELLING FACE (face was swollen) and RASH (sore to touch rashes) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-044534 (Patient Link).
None - adverse effects. Wrong dose of flu vaccine given (FLUZONE) 0.5 ml given instead of 0.25.
I had a long drive on that Friday, and I was thinking I was just tired from that drive but the next week i was having a fever all week, but I had a doctor's appointment, so I took a COVID-19 Home Test, and it was positive. I was so tired and achy with no appetite. My sinus' have been clogged and full of junk that is yellow and chunky, and I feel as if I may have a sinus infection.
Administered 0.5ml dose of Pfizer booster to the patient instead of the indicated 0.3mL dose.  Expected vaccine reactions: extra arm ache; No residual symptoms.
lymph node under my injection site is swollenlen; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph node under my injection site is swollenlen) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node under my injection site is swollenlen). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node under my injection site is swollenlen) 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.   No concomitant medication  were reported. No Treatment information was provided
Patient was given Monovalent Pfizer vaccine instead of Bivalent, none reported at time of report
Pneumonia, shortness of breath, cough; dizziness; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In or around 31-AUG-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccination, on an unspecified date, pt suffered shortness of breath, cough, dizziness and was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, pt's symptoms had resulted in physical limitations not present prior to using the product. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Additionally, pt sustained severe and permanent personal injuries, 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. Finally, pt had suffered and incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages. At the reporting time, the pt was not recovered from the events and they were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was considered to be a medically significant event.
Site of injection, great big round circle size of half dollar that is hot; Injection site itchy; Injection site red; Injection site painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Site of injection, great big round circle size of half dollar that is hot), INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PAIN (Injection site painful to the touch) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Site of injection, great big round circle size of half dollar that is hot), INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PAIN (Injection site painful to the touch). At the time of the report, INJECTION SITE WARMTH (Site of injection, great big round circle size of half dollar that is hot), INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PAIN (Injection site painful to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided/unknown by the reporter. The patient's daughter, who is a Health Care Professional, told her to see her doctor for cephalexin in case the reaction got worse.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15-Apr-2021 included no new information.
Itching in legs; Tingling in legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in legs) and PARAESTHESIA (Tingling in legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRURITUS (Itching in legs) and PARAESTHESIA (Tingling in legs). At the time of the report, PRURITUS (Itching in legs) and PARAESTHESIA (Tingling in legs) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient gender was updated.
a 14 year old patient received a dose of PROQUAD; No known adverse effects; Information has been received from a nurse referring to a 14 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(1 dosage form, strength, frequency, lot#, therapy type, expiration date were unknown) subcutaneously for prophylaxis(inappropriate age at vaccine administration). No known adverse effects.
Pt admitted on 8/5/2021 after transferred from ER. He was dx with covid with worsening symptoms. History is extremely difficult to obtain from this per individual as he is extremely difficult to understand but I think he was originally diagnosed with COVID last week.  He has prescriptions for Decadron, ivermectin, and hydroxychloroquine from an emergency room physician  on 07/29/2021.  He reports that he was actually in the emergency room on Wednesday 07/28/2021.  It is extremely difficult to tell when the patient 1st began having symptoms.   Pt discharged  on 8/10/2021.
lack of efficacy- contracted COVID-19; lack of efficacy- contracted COVID-19; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  dose 1 intramuscular administered in Arm Right on 05Feb2021 (Lot Number: EM9810) at age of 37-year-old, dose 2 intramuscular, administered in Arm Right on 24Feb2021 (Lot Number: EN6202) at age of 37-year-old, both at single dose for covid-19 immunisation. Medical history included asthma. It was unknown if covid prior vaccination. Concomitant medications included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10). The patient previously took amoxicillin and experienced drug hypersensitivity. No other vaccine in four weeks. The patient experienced lack of efficacy- contracted covid-19 on 25Aug2021. Events resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 25Aug2021.  The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
patient felt light headed roughly 5min after shot, pt Mom states patient did not eat since 12pm
Little dizzy; Lightheadedness; Waited over 20 min without resolution of nausea .Patient with hx of Gerd on PPI . Patient without cardiopulmonary symptoms . Patient encouraged to take PPI and make dietary changes x 24 hrs .Patient reported dizziness during questioning (mild) . Ambulance.
The patient reported severe right arm pain, subjective fevers/chills, and rash all over her body. She reported the pain in her right arm was so severe she could not move her arm. These symptoms began around 5:00 PM the day she received the vaccine, and resolved within 24 hours.
Pt brought to ED with weakness, lethargy, inability to swallow, dehydrated and poor nutritional status; found to be positive for COVID; given IV ABX and Remdesivir; decided against PEG tube for placement; preferred hospice care; pt passed away in the hospital
Mild flu symptoms, warm red arm, lump and bruise lower down the arm from the vaccination site.
Narrative: 36 y/o M received the Moderna COVID booster on 12/28/21. He  presented to ED on 1/9/22 w/ urticaria and pruritis x 1 day; received methylprednisolone 125 mg IV, diphenhydramine 25 mg IM, and topical hydrocortisone cream in the ED and discharged home w/ prednisone, diphenhydramine, and hydrocortisone cream. Symptoms initially improved then worsened again w/ edema to hands and lip. He presented to derm clinic then to ED and received methylprednisolone 125mg IV, famotidine, and diphenhydramine; discharged home w/ cetirizine, hydroxyzine, and medrol dose pack with allergy  clinic consult f/u placed. Ongoing assessment to determine potential symptom triggers-resuming regular chronic meds one at time starting with sertraline>quetaipine>prazosin. Per ID consult, pt had no rxn to first to doses but cannot exclude Moderna booster as a possible cause of allergic rxn.
One day post vax a pt with a history of varicella exposure experienced a 4 inch hard raised area at the injection site. The reaction lasted approximately 72 hours and then resolved.
Admits to decreased vision in R eye a few days after COVID vaccination. was followed up with ophthalmology who stated there was blood in his eye obscuring his retina.
Two hours after receiving the Covid 19 booster vaccine,  my heart experienced a rapid beating with palpitations.  My blood/pressure was up and down as high as 171/96 when I usually have a normal blood/pressure.  This continued for 8 hours.  I called my family doctor at 11:00 pm and he said not to worry about a stroke or heart attack as this was a reaction to the vaccine.  He advised to push fluids and in the morning to call if worse.  I went to doctor's office 3 days later to be checked out.  He couldn't hear anything wrong.  He said to give it a couple of days and rest and push fluids.  Eight days later I am still experiencing a faster heartbeat than normal.  I'm not sure what to do next.
Got COVID twice/ vaccine that didn't work; Got COVID twice; 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 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "overweight smoker" (unspecified if ongoing); "overweight smoker" (unspecified if ongoing); "had about 12 surgeries in the past 10 years" (unspecified if ongoing), notes: about 12 surgeries in the past 10 years because of back, knee, and shoulder problems. The patient's family history included: "asthma" (unspecified if ongoing), notes: The patient was an overweight smoker with asthma/ patient's children had asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Got COVID twice/ vaccine that didn't work"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Got COVID twice".  Additional information: The patient was an overweight smoker with asthma and had about 12 surgeries in the past 10 years because of back, knee, and shoulder problems and got COVID twice and thought it was just allergies - patient's family had the same mild symptoms and patient's husband was a cancer survivor and patient's children had asthma and autism. Stop spreading fake information and pushing vaccine that didn't work.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up the following day with mild fever (100 degrees), aches/muscle soreness, and headache. Took fluids and rest then Motrin around mid day and throughout rest of the day. Woke up the following day feeling fine.   Basically 1 day of feeling terrible/flu-like symptoms and then back to 100% right after.
Shot given at 8:30 am. Tingling tongue, roof of mouth and back of lips by 8:40 am. Tingling throat by 9am. Tingling down left arm by 10 am.  Feeling of warm goo running down left leg and puddling in shoe at heel by 11 am. Right arm and hand tingling by 4;30 pm. Speech affected and speech pattern by 7 pm.  To Er for diagnosis of parasthesia. Have had varying areas tingling or having that deadened feeling since. Mostly focused in tongue, arms and legs.
Pain behind and including Left Eye.  Tx: Prednisone (acetate) eye drops. return to normal, but see 2nd shot ( have not returned to normal)!
Breakthru Infection: Had bleeding gums 07/12/2021 Cold like symptoms up until 7/16 when I Fully realized by loss of smell and such. Ongoing:Possible Delta but not confirmed
5 month old female patient was administered FLUZONE QUADRIVALENT with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 months old female patient who experienced 5 month old female patient was administered fluzone quadrivalent with no adverse event (Product administered to patient of inappropriate age), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2020, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7000AB via intramuscular route in the left thigh for prophylactic vaccination.   It was an actual medication error due to Inappropriate age at vaccine administration. It was reported that 5 month old female patient was administered fluzone quadrivalent (product administered to patient of inappropriate age).  Final diagnosis was Not Applicable 5 month old female patient was administered fluzone quadrivalent.  At the time of reporting, the patient had no adverse 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 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.
Sore arm; Red / arm; This case was reported by a pharmacist and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) and (batch number 9227H, expiry date 28th February 2022) for prophylaxis.   On 21st July 2020, the patient received Shingrix (intramuscular). On an unknown date, the 1st dose was an unknown dose. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced red arm and sore arm. The reaction lasted for 3 months. The reporter did not consent to follow up.
mom called & reported t103 3 hr p/vax; instructed to give APAP & take to ER it does not subside; MD notified; DT ordered for future; 5JAN95 spoke w/mom; temp still 101, however it never got over 103;