chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe dizziness; Nausea; Intense headache; Fever 100.5; Minor injection site pain; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 08Mar2021 at 15:30 (at the age of 50-years-old) in left arm as a single dose for covid-19 immunization. Medical history included covid-19 prior to vaccination from an unknown date and unknown if ongoing. No known allergies were reported. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced minor injection site pain on 09Mar2021 at 13:00 and 24 hours later he also experienced severe dizziness, nausea, intense headache, fever 100.5 on 10Mar2021. Post vaccination, the patient had not been tested for covid-19. The patient underwent lab tests and procedures which included body temperature: 100.5 on 10Mar2021. The patient did not receive any treatment. The outcome of all the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vaccine patient stated his vision began to be  blurry and he felt clammy, sweaty and  like he wanted to pass out.  Pt was transferred  to the observation area. Pt laid down on the stretcher and was given some graham crackers and water. Shortly after the patient stated he was feeling better . Vitals as follows: 1120 SITTING  BP 109/74 HR 71 RR 71 SpO2 99; 1124 LYING BP 110/72 HR 74 RR 20 SpO2 99; 1128 BP 104/71 HR 76 RR 20 SpO2 100; 1135 standing BP 107/63 HR 71 RR 18 SpO2 98
It looks like COVID arm; warmer; It was bigger, warmer and itchy; It was bigger, warmer and itchy; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE REACTION (It looks like COVID arm), VACCINATION SITE WARMTH (warmer), SWELLING (It was bigger, warmer and itchy) and PRURITUS (It was bigger, warmer and itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Psoriatic arthritis. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Psoriatic arthritis.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 14-Apr-2021, the patient experienced VACCINATION SITE REACTION (It looks like COVID arm), VACCINATION SITE WARMTH (warmer), SWELLING (It was bigger, warmer and itchy) and PRURITUS (It was bigger, warmer and itchy). At the time of the report, PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE REACTION (It looks like COVID arm), VACCINATION SITE WARMTH (warmer), SWELLING (It was bigger, warmer and itchy) and PRURITUS (It was bigger, warmer and itchy) outcome was unknown. Not Provided          On 13 Mar 2021,the patient received first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.  Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: conmed updated, medical history, event outcome of headache was updated recovered. On 20-Apr-2021: non new information
No additional AE details; patient was inadvertenly administered a GARDASIL 9 vaccine past it's expiration date; This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, drugs reactions or allergies and medical history were not provided.  On 25-APR-2022, the patient was inadvertently vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # T005928, expiration date 12-APR-2022 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).  This report was considered as non-valid due to lack of the patient's identifiers.  Follow-up information has been received from a registered nurse and updated the unspecified patient of unknown age and gender to a 33-year-old female patient. The patient had no known drug allergies (NKDA). The patient had cervical cancer.  On 25-APR-2022, the patient came for the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, and administrated in right deltoid. The type of medication checked and given. Patient waited after infection and after no adverse reaction left clinic. On checking the injection, the reporter then noted that the expiration date on laid injection was 12-APR-2022. After called the pharmacy and spoke with reporter, pharmacist, explaining what had happened. The reporter called Merck and told there would be no loss in strength of the vaccine in that time frame. A quality investigation report (QIR) was completed. The current location of vaccine/vaccine-device was disposed off. There was no prescription drug treatment for the experience required. There was no product quality complaint. At time of current moment report to pharmacy, doctor was ongoing medical assistant quality investigation report (QIR) done.
Muffled hearing in left ear for a little over a week. Hearing test resulted in sudden hearing loss. Prescribed prednisone and within days it was better  and hearing test showed improvement.
No adverse result from FLUMIST administered 10/14/2010 & 10/22/10.
0n the afternoon, after I got my shot my arm hurt, no big deal. The next morning, 03/25/2022, when I woke up, I had the worse vertigo. I got out of bed and I could not stand up straight. I fell and chipped my tooth. I was really nauseous and had a headache. That continued for the about the next 5 days. I kind of figured it was a side effect, I had a zoom appointment with the doctor. She prescribed an anti-nausea medicine and a sea sickness type medicine, and she told me to see an ENT specialist so they can do an Epley maneuver. I made an appointment with the ENT for the next week. By the next week, I was feeling better, the vertigo resolved, and I cancelled the appointment.
developed severe erythema multiforme over trunk which has not resolved in 7 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 at 10:45 as dose 4 (booster), single (Lot number: fk9893) at the age of 70 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "depression" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: CELEXA [CELECOXIB]; SYNTHROID; CRESTOR. Past drug history included: Soma, reaction(s): "Known allergies: soma". Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown; Within 10 days of the first booster developed mild hives on the arms and trunk which resolved after a month.), for Covid-19 Immunization, reaction(s): "Mild hives"; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: ERYTHEMA MULTIFORME (medically significant) with onset 25May2022, outcome "not recovered", described as "developed severe erythema multiforme over trunk which has not resolved in 7 weeks". Therapeutic measures were taken as a result of erythema multiforme, reported that the patient was treated with steroid cream and antihistamines. Clinical course: The patient did not received any other vaccine in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Stated that, Within 1 week of the second booster developed severe erythema multiforme over trunk which has not resolved in 7 weeks.  Follow-up attempts are completed. No further information is expected.
FLUZONE QUADRIVALENT was inadvertently administered to a patient over the age of 65 when the patient requested to receive FLUZONE HD QUADRIVALENT/no AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient (over of 65 years age) who inadvertently received a 0.5 mL dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [lot number and expiry date not reported] via an intramuscular route at the left arm, on 14-Sep-2020 for prophylactic vaccination, when she had requested to receive INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong vaccine administered).   Medical history, medical treatment, vaccination and family history were not provided.  Patient did not receive any other vaccines as concomitant medication.   It was a case of actual medication error due to wrong vaccine administered. [latency: at the same time of vaccination]   At the time of report, no adverse event was reported.  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.
About 5 minutes after the vaccine, the patient complained of "bad headache, sweating, very dizzy, can't see".  Patient looked very pale but was still responsive and able to answer questions.  We called 911.  Paramedics arrived about 20 minutes later.  Paramedics check patient's blood pressure, pulse, lung, and everything was within normal limits.  Paramedics asked patient if she had any rash, itching, difficulty breathing, swollen tongue, lips, which she denied.  Paramedics told patient everything was normal, and asked patient if she wanted to go to the hospital which patient declined.   Patient left pharmacy with her mom afterwards.
patient aged 63 received Fluzone high dose/ no AE; patient aged 63 received Fluzone high dose/ no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case from a non-health care professional.  This case involves a 63 years old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ274AB and expiration date 26-May-2020) via an intramuscular route in the right deltoid on 21-Oct-2019.  Medical history and concomitant medications were not reported.  It was of an actual medication error case due to inappropriate age at vaccine administration and overdose.  No adverse event reported at the time of reporting.  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.
Received vaccines on 12/20/10. Day after noticed left side of face at eyebrow and mouth droopy - noted in mirror smile asymmetrical. Did not see M.D. The weakness on left side of face resolved in 3 days.
acute herpes zoster neuropathy; acute herpes zoster neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient with unknown age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2015 the patient was prescribed and administered with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions by a pharmacist. On an unspecified date (reported as subsequent to patient's inoculation), the patient was treated by a doctor for acute herpes zoster neuropathy. It was claimed that as a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of acute herpes zoster neuropathy was considered as not recovered. The causality was assessed as related by the lawyer.  Upon internal review, acute neuropathy was determined to be medically significant.
Pfizer COVID-19 vaccine EUA:  Administration error. Booster dose given too soon. Received 3 doses of Pfizer COVID-19 vaccine on 08/11/2021, 09/01/2021 and 12/10/21 respectively. There was not 6 months between 2nd and booster (3rd dose). This appears to be an error. The dose was given before 03/01/2022. No adverse effects reported.
PATIENT REPORTED TINGLING SENSETION ON TIP OF THE TONGEU  AND ARM , , NO PROBLEM BREATHING. PT BP WAS CHECKED 3 TIMES, NORMAL, TONGUE NUMBNING GOT WORSE AFTER 15 MIN , WE GAVE 50 MG BENADRYL, BP STILL OK  AFTER 20 MINUTES PT REPORTED NUMBNESS GONE  REFUSED 911 HAD NO PROBLEM BREATHING  , PT ADVISED TO CALL MD TOO
lichen planus rash which covered her entire body; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 67-years-old female patient who had lichen planus rash which covered her entire body after receiving covid-19 vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy to chemicals.  On an unknown date in 2021, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer and COVID-19 vaccine not produced by Sanofi Pasteur (formulation, batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date in 2021 the patient had lichen planus rash which covered her entire body (lichen planus) (unknown latency) following the administration of influenza vaccine and covid-19 vaccine.  Action taken: not applicable.  It was reported the patient received a corrective treatment with oral steroids, topical steroids, and light therapy for the event (lichen planus rash which covered her entire body).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event lichen planus rash which covered her entire body.
The EMS Medic arrived at the POD site at 6:12 pm. They evaluated and monitored the client at the site, and decided there was no need to transport the client to the hospital. Client walked to her car, stating that ?she felt fine.?
vaginal yeast infect; 1 wk; Micronazale (OTC) x 1 wk;
FEBRILE SEIZURE. FOLLOW UP APPT WAS DONE ON 10/14/2008 AT PEDS CLINIC.
No adverse event occurred, reporting vaccine administration error.  Customer was given Booster Shot of Pfizer too early.  Circled 3rd Dose on intake form, but later indicated this was booster they were seeking.  Patient was unaware of 3rd dose/immunocompromised requirements and that there was a difference in timing.    Patient did not meet criteria for 3rd dose, only booster.  Last dose 4-7-21, would be due 6 months after (10/7/21), was administered early on 9/28/21.
I had chills day one.  For 2 plus days I have had moderate muscle pain in my legs, buttock and back. I was unable to sleep on day one. I had half sleep on day 2.
3 or 4 days later I broke out almost like blisters , maybe like a chemical reaction. I?m still dealing with it
I have been in menopause for 2 years. I have not had a period for those two years. I started post menopausal menstrual bleeding on 07/31/2021 which lasted for 5 days.
Double vision, extreme instability, diarrhea. Taken to emergency room where he was checked via MRI and CAT scan and ultrasound for stroke. No sign of stroke and some improvement in vision by second day in hospital.
Patient complained of a red rash on immunization arm. Stated bumpy and a little itchy. Location was from elbow to wrist and started a 'few days' ago, has stabilized and not progressed.
Initial report received from a healthcare professional on 26 March 2013. A 30-year-old female patient, had received a dose 1 of ADACEL vaccine (lot number: U4612AA, site of vaccination was not reported) intramuscularly on 26 March 2013. The patient was pregnant at the time of vaccination. The last menstrual period was on 17 July 2012. The patient's estimated date of delivery was reported as 23 April 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 26 March 2013, the patient had not experienced any adverse events. As of 26 March 2013, the patient's outcome was unknown. Documents held by sender: none.
Left arm has been sore since vaccine injection and got better until day 8 when the arm became sore and warm to touch. On day 10 a red rash appeared on the arm around the injection site
Approximately 2-5 minutes post vaccination, patient reported that she felt pins and needles sensation radiating bilaterally. Patient was breathing fast so asked patient if she has any difficulty breathing/swallowing and she said "no."  Patient was given some water and monitored for roughly 15 minutes. Patient said that pins and needles feeling subsided and she felt better.  Patient got up do do some shopping and complained that she was feeling  dizzy and felt the pins and needles feeling come back. Gave patient Diphenhydramine 50mg in case of being allergic to any vaccine components.  Asked if patient wanted to sit and be monitored. Patient sat for another 5 minutes then said she felt better. Instructed patient to take 1 tablet of diphenhydramine 25mg every 4 -6 hours if still felt tingling feeling.  Patient also instructed to go to urgent care/emergency room if not better.
Fluid like blister-like on arm. Lower back, and body ache. Burning urination.
pediatric dose of Engerix-B was administered to an adult; pediatric dose of Engerix-B was administered to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 69-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date).   On 18th October 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 18th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse Practitioner reported that the pediatric dose of Engerix-B was inadvertently administered to an adult female patient, which led to underdose and adult use of a child product. The HCP gave permission for follow up.
Extreme weakness; Swelled lower lip; Inflammation in lower gum; lower lip is swelled up too and very dry; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extreme weakness), LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum), LIP DRY (lower lip is swelled up too and very dry) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Joint pain and Back pain. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and CELECOXIB (CELEBREX) for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 18-Feb-2021, the patient experienced ASTHENIA (Extreme weakness), LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum) and LIP DRY (lower lip is swelled up too and very dry). On 17-Feb-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 18-Feb-2021, ASTHENIA (Extreme weakness) had resolved. At the time of the report, LIP SWELLING (Swelled lower lip), NONINFECTIVE GINGIVITIS (Inflammation in lower gum) and LIP DRY (lower lip is swelled up too and very dry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant medications included Unspecified medicines for joint pain, back pain and reflux  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non-Significant Follow up received: Reporter contact information updated
This spontaneous report received from a registered nurse referred to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Case number PHEH2013US021849 is an initial spontaneous report from pharmacist received on 17 Oct 2013. This case refers to 28-year-old female patient. The patient was 28 weeks pregnant. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 14 Oct 2013. On the same date, after the vaccination, the patient developed redness and warmth on her arm. The redness had spread along her upper arm and down the elbow since administration. The warmth had persisted. The physician prescribed KEFLEX because the physician suspected a bacterial infection along the arm. The outcome of warmth was reported as persisted. The outcome of other events was not reported. The seriousness and causality of events was not reported.