chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months 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.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE REACTION (Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months now). At the time of the report, VACCINATION SITE REACTION (Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months now) had not resolved.            No concomitant drug details were reported.  No treatment details were reported.
she has a large bruise on the arm (not the side of injection) that clinically appears to be a small biceps tear. Uncertain if related t immunization. No known injury.
Extreme pain and burning in  my left breast 3 days after receiving the first Pfizer vaccine in my left arm. It is extremely painful.
testing positive for COVID; testing positive for COVID; 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid the day after testing positive for COVID. Patient have taken all Pfizer vaccines and was grateful to Pfizer as this is the first time with COVID.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient received vaccination in the store and said that about 5 minutes later he had a sudden urgency to defecate and experienced severe diarrhea.
Patient with diplopia. Exam revealed upper extremity clonus on DTR testing of triceps and hyperreflexia on DTR testing of knees.   No other findings.   Doing well and feels well day after reported symptoms.
12/20/2020 Fatigued, brain fog, 12/21/2020 extreme fatigue and was sleeping more than normal, diarrhea, low grade fever 99.2, 12/22/2020 around 3am woke from sleep with a really bad headache, patient stated taking Tylenol to help with symptoms, never tested for Covid however she lives with her brother who had Covid in May, no travel history
Just after the shot on the 17th, I got light headed, dizzy, spacey, pounding headache.  Later in the evening I got very tired still had pounding headache.  Woke up around 0300 on the 18th to a sore throat, pounding headache, chest tightness, hot flashes, just felt like crap all day.  The 19th still have pounding headache but now I have a slight cough and my lungs feel tight, just don't feel good and tired.
About 3 days patient noticed mild bruising in a circular shape on right deltiod. Mild tender to palpation at injection site.
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0183, exp 9/2021) at approximately 1445. At 1450, patient reported to Pharmacist that he was feeling nauseous. Pharmacist walked patient unassisted to zero-gravity chair and notified Paramedic and PHN. At 1452, vital signs: blood pressure 114/86, respirations 16, O2 98%, pulse 96. Patient placed supine by Paramedic. Patient reported nausea, denied feeling sweaty, hot, or blurry vision. Patient reported no allergies, medical conditions, nor taking medication. Patient reported eating breakfast around 1000 but not drinking fluids. At 1455, patient drank water, juice, and ate Sunchips. PHN offered Benadryl but patient declined. Patient reported no primary care provider as the family just moved to the area. PHN explained when to call 911. At 1506, vital signs: respirations 14, O2 97%, blood pressure 118/74, pulse 88. Patient reported symptoms had resolved. At 1516, vital signs: blood pressure 120/74, pulse 80, O2 99%, respirations 14. Patient stood up monitored by Paramedic and PHN. Patient continued to reported no symptoms. At 1520, patient left walking with steady gait accompanied by family members.
This is a spontaneous report from a contactable pharmacist. A adult male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 20Feb2014 at 0.5 ml, single dose. The patient medical history and concomitant medications were not reported. The patient felt like he was drunk or dizzy on an unspecified date with outcome of unknown. The pharmacist asked if syncope and dizziness were reported.
Felt tired and some discomfort; Felt tired and some discomfort; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection)  via an unspecified route of administration on an unspecified date was as unknown  single, SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported.  The patient experienced felt tired and some discomfort (fatigue)  felt tired and some discomfort on an unspecified date and  The events were considered as non-serious by the  consumer  The outcome of the events was not recovered  No follow up attempts are possible. No further information is expected.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 136 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The vaccinating nurse brought it to my attention that she thought that the vaccination site was too high. When I caught up to the patient and observed the site it was too high and was at the level of the humeral head. I informed the patient that this was higher than we would like and to notify me if there were any unusual symptoms hereafter.  I gave her my contact information for follow up.
left side of face and neck felt full numb and tingling; left side of face and neck felt full numb and tingling; Tingling; This is a spontaneous report from a non-contactable nurse. A 25-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via intramuscular route in the left arm on 22Mar2021 at 10:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient medical history included penicillins and sulfa allergy. The patient was allergic to azithromycin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN). Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 10:30, the patient experienced face numbness, neck numbness and tingling, 30 minutes after receiving the vaccine, the left side of her face and neck felt full numb and was tingling. There was no facial droop, but when the face was poked, the left was duller than right. The patient did not receive any treatment for the reported events. The adverse events resulted in the doctor or other healthcare professional office/clinic visit. The clinical outcome of face numbness, neck numbness, tingling was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
1030AM p/vax pt stood up walked a few steps a/ c/o dizziness, unable to breathe, cold, having chills, spots a/eyes, numbness to legs, nausea, & ha/; pt appeared anxious & was hyperventilating; no loss of consciousness occured;
This child seemed to develope a tic (ear jerk to shoulder) 4 hours, post vax. It persisted for 1 week and gradually faded away over that week to 10 days. At 16 hours, post vax, he also had 3 brief episodes of about 10 seconds each, wherein he tensed and shook. But seemed conscious. My inference is that the child momentarily had tics; possible seizure.
Pt has a history of diabetes and hypertension.  She has been having weakness, nausea, and vomiting for the past 12 days.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 04-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot# L024997, expiration date: 06-OCT-2016), which was improperly stored for 42 days (incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Left upper arm has a slightly red area over deltoid of arm with localized swelling and slight tenderness. No abscess. Improving without treatment.
Pt vaccinated with DTP/OPV 24 hrs after (4th dose) developed fever to 104.5. Behavior normal feeding adequately.
Case number PHEH2013US016733 is an initial spontaneous report received from a nurse on 06 Aug 2013. This report refers to a 24-years-old female patient. Her medical history included allergy to penicillin, sulfa drugs and cephalosporins. Her concomitant medications were not reported. She was vaccinated with three doses of RABAVERT (batch number: 473011C) at a dose of 1 ml intramuscularly into left deltoid on 07 Sep 2011, 14 Sep 2011 and 05 Oct 2011 respectively. On 15 May 2013, she had equivocal rabies titers and the level was insufficient. It was reported that she required a rabies booster. The reporter assessed the event as medically significant. The outcome of the event was not reported. No further information was provided.
Developed golf-ball sized mass to left axilla 2 days following vaccination. Suspect inflammatory response, monitoring for changes.
About 2 minutes after HPV vaccine given, pt. fainted in her chair and hit head on countertop. Regained consciousness after about 4-5 seconds. Put her head between her knees to recover. Did not want to lie down. Given ice pack and juice.
Just a sore arm after day one.....then on day 3 noted significant increase in heart rate with any activity.  Just a relaxing walk - heart rate would jump to 130s.  The last time I had this- was when I had my pericardial effusion in the spring of 2022.   On day 9, developed slightly elevated temperature from baseline - with intermittent significant fatigue.   Working closely with cardiology to monitor - and see if it will pass on its own - or if medical intervention is needed.
Patient is a 12 month old girl who presents to clinic for evaluation of rash and suspicion for vaccine reaction vs. Measles. Patient received her 12 month vaccines, including MMR, Varicella, HiB, and PCV13, about 2 weeks ago (5/21/18). A couple of days after the immunizations she developed fever that ranged from 101-102F and persisted for 3 days. The fever resolved, but 5 days after the immunizations she developed a rash. The rash started on her face and subsequently spread, involving her entire body. But unfortunately this was all occurring while on vacation. They presented to an urgent care center at the onset of rash, and were told that this was most likely a vaccine reaction, but that it also had an appearance that could be consistent with Measles. Though, at that time she did not have conjunctivitis, coryza, or cough. After a few more days, now about 8 days after the immunizations, she seemed to be improving, was afebrile, and the rash was resolving. Then, about 11-12 days after the immunizations, the rash recurred. The second phase of the rash was similar in appearance to the first time, but was clearly more morbiliform (parents have photos). She still did not have fever, conjunctivitis, coryza, or cough. They were seen by an Infectious Diseases specialist who thought that the rash was most likely due to a vaccine reaction and gave them clearance to take a plane and return home. Since returning home patient has been overall doing well, but the rash seems to be resolving, now with a few scattered petechiae and larger non-blanching macules/purpura in her diaper area. PCP obtained a CBC which was normal; in particular, her platelets were 252. She was referred to clinic for further evaluation. Today, patient is overall doing well. She is active and playful. She is taking PO well. However, she continues to have rash; though, per parents report it is stable and evolving/improving. She is afebrile. There is no conjunctivitis, mouth sores, nasal congestion, cough, vomiting, diarrhea, or joint swelling/pain. There have been no known sick contacts. No known tick exposures; though, the family has been hiking. No recent antibiotics.
Day 2 after vaccine:  Woke with SEVERELY painful right wrist.  Unable to use at all (eating, holding toothbrush, typing, etc).  No previous falls or injuries and hadn't been to gym in previous 5 days.  No history of arthritis.   Day 3-5:  pain reduced each day but wrist visibly quite swollen.   (took ibuprofen 2/day)  Mobility and strength improving. Day 6:  Woke in the middle of the night, drenched in sweat.  This has never happened.  Room cool and I'm way past menopause.                  Wrist improving.   Hopefully, end of story???  Reported today to physician.
injection site paid; fatigue; headache; muscle pain; fever; chills; joint pain; muscle cramps.
-tachycardia, flushed -lung sounds clear -pulse come down, but cheeks reamined flush. -administered  25mg Benedryl; 40mg Pepcid AC 53 y/o F who c/o facial flushing after vaccination No other complaints Exam - cheeks flushed otherwise negative Plan - Benadryl & Ranitidine PO. home monitoring Possible mild allergic reaction
Information was received on 25-AUG-2017 from a student regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently given a dose of ROTATEQ (dose and lot number not reported) sooner than recommended in the prescribing information. No adverse effects were reported. No other information was provided. The outcome of the event was unknown. Additional information has been requested.
No adverse event noted. Fluad is approved for individuals 65 and older. Resident was 58 years old at time of administration
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 04-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
was inadvertently administered a dose of fluzone quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event; Initial information was received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 3 years old male patient who was inadvertently administered a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 08-Feb-2023, the patient was inadvertently received Total 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot number: UT7752MA, strength, expiry date: Unknown) via intramuscular route in unknown administration site for Immunisation that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event was inadvertently administered a dose of fluzone quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported 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 the 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.; Sender's Comments:  01489379: 01493585: 01493618: 01493871: 01493882: 01493896: 01493906: 01495050: 01495133: 01495161: 01495184: 01495203: 01495215: 01495235: 01495279: 01495295: 01495310:
She reported the arm she received the injection often goes out while driving .; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She reported the arm she received the injection often goes out while driving .) in a 54-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She reported the arm she received the injection often goes out while driving .). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She reported the arm she received the injection often goes out while driving .) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  It is unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  Treatment Medication use information was not provided by reporter.
Lightheaded and shaking after couple of minutes of vaccine shot. EMT monitored me and signs went away after about 20 - 30 minutes. Drove home after. Sore arm at injection site later that evening and next day. Soreness went away late next day.  No further issues from 1st vaccine.
Swelling, redness, and pain of left arm at injection site.  Area of erythema measured 10 x 12 cm.
Nausea, apathy, muscle pain, cold shivers for 24 hours. Fatique after that. Sore throat. Headache 3rd day.
Initial unsolicited report received from a physician on 13 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of Influenza vaccine / flu shot (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (several years ago). The patient's medical history and concomitant medications were not reported. On an unknown date, one week following the vaccination, the patient had developed fluid around the heart. Laboratory data was not reported. The patient was treated with unspecified medication and released. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: fluid around the heart. List of documents held by sender: none.
Information has been received from a physician concerning a 26 year old patient who on unspecified dates was vaccinated with a first and second dose of RECOMBIVAX HB (lot# not reported). On an unspecified date the physician tested the hepatitis B titer on this patient and the patient had a negative titer. This was after 2 complete RECOMBIVAX HB series. Follow up information received indicating the patient was not a patient in their practice, but the child of a patient. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 61 year old female patient with sulfa allergy. No medical history was reported. On 24-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000494, expiry: 14-APR-2014). No concomitant medications were reported. On 28-JUL-2013, the patient developed shingles after receiving ZOSTAVAX. Patient sought medical attention: contacted the pharmacist. Patient received treatment with Atarax and Valtrex. No laboratory diagnostics studies were performed. The outcome of shingles was reported as not recovered. Varicella zoster virus identification program (VZVIP) packet faxed. This is 1 of 3 reports from the same reporter. Additional information has been requested.
seizure; This case was reported by a consumer via call center representative and described the occurrence of grand mal seizure in a 12-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) (batch number U6213AA ?, expiry date 12th March 2021) for prophylaxis.   On 25th April 2019, the patient received dTpa vaccine (intramuscular). On 25th April 2019, 5 min after receiving dTpa vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was unknown.   It was unknown if the reporter considered the grand mal seizure to be related to dTpa vaccine.  Additional details were provided as follows: The reporter was the mother of the patient. The patient received the dose of Diphtheria, Tetanus and Pertussis (Tdap) vaccine and about 5 minutes after the dose, the patient experienced a grand mal seizure and was taken to emergency room (EM) by ambulance. The brand name or manufacturer of the vaccine was unable to idenfify bt the reporter. The reporter did not consent to follow up.