chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 17:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) Negative, notes: Tested negative on 05Dec and 06Dec; (06Dec2022) Negative, notes: Tested negative on 05Dec and 06Dec; (10Dec2022) Positive, notes: Tested positive 10Dec; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 29Nov2022 to 04Dec2022.  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.
Patient had received her vaccine around 4:15pm. Patient was feeling fine immediately after receiving the vaccine. Around 4:27, the patient stated to her grandmother that she felt nauseous. As she stood up to walk to the bathroom, the patient fainted. One epinephrine pen was open but was not administered to the patient. The patient regained consciousness within a minute or two. The patient was given water and after a few minutes, she was able to sit and rest for a few minutes. The patient was then told contact her physician of the reaction.
Still have arm pain on the injection site; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the arm on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 20Jan2021 and still had arm pain on the injection site on an unspecified date in 2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
lump at the injections site and the lymphoid under my left arm got inflamed. It was very painful.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA057309 and 2023SA057733.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes (product storage error) (unknown latency), and was administered to patient post temperature excursion with no reported adverse event (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
The nurse reports that on an unspecified date, a 17 year old male patient was inadvertenly administered one dose of PROQUAD; No adverse effects were reported; This spontaneous report was received from a nurse and refers to a 17 year old male patient. The patient's concomitant therapies included sterile diluent. No information was provided regarding the patient's concurrent conditions, medical history, or drugs reactions.   On an unknown date, the patient was inadvertenly administered one dose of vaccinated (Product administered to patient of inappropriate age)  with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) 1 dose, lot #R013126, expiration date of 04-NOV-2019, for prophylaxis (strength, anatomical site of injection and route of administration were not reported). No adverse effects were reported.   The outcome for the events was unknown.
Body sore; This is a spontaneous report from a contactable consumer. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on 27Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control, for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration on 06Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 28Apr2021, the patient experienced body sore. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body sore was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt states he is light headed, diaphoretic, pupils dilated.  States he feels this way sometimes when eating greasy foods. VS obtained: At 1326 BP: 88/palp. HR 62, OSat 99%, RR: 20.  @ 1340 BP 128/80, HR 76, OSat 99% RR 16.  PT placed on floor with feet elevated.  Pt states he feels normal again.
Pt recv vax on 4/22/96; on 11/9/98 pt exp varicella disease
swelling & whelp around site of inj noticed 8AUG95 @ 4PM; all swelling & whelps disappeared 8AUG95 @ 5PM; MD thinks poss allergy to pertussis;
On the morning of November 8th I started getting red, itchy patches of skin across my face, chest, and arms. This continued for a few hours and faded after I took Allegra. The rashes continued the next day and were also followed by hives. The rashes came and went throughout the day (were never consistent for more than an hour at a time). I went to the doctor where I got bloodwork done to rule out viruses. My hives were consistent and I was prescribed methylPREDNISolone Tablets, USP by telehealth on 11.12. I continue to have rashes and am on my third day of the methylPREDNISolone Tablets.
A report was received from a health care professional on 01Nov02 concerning a 50 year old female vaccinee who was inadvertently administered Fluvirin SC and experienced local redness and warmth at the injection site one day after receiving Fluvirin on 24Oct02. On 24Oct02 the vaccinee was inadvertently admin 0.5ml Fluvirin SC. On 25Oct02 the vaccinee experienced local redness and warmth at the injection site. The vaccinee had recovered at the time of the report. The reporter has assessed the relationship of the vaccinee to the event as probable.
Post herpetic Neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications.   On or around 08-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, lot number and expiration date were not reported).  On an unknown date (reported as "shortly after receiving defendant's zoster vaccine live (ZOSTAVAX) vaccine), the patient experienced severe post herpetic neuralgia and severe herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not presented prior to using the product. The patient also experienced mental and emotional distress due to to resulting physical limitations and seriousness of her conditions. As a consequence of the Company´s wrongful conduct, the patient 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. As a direct and proximate result of the Company's conduct, the patient had suffered and incurred a damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia and herpes zoster was not recovered/not resolved. The reporter considered post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Herpes zoster and post herpetic neuralgia were considered to be disabling.  Additional information has been requested.
Fever 100.1, tired, GI upset, significant nightmares. Recurrent nightmares 11/30/12. On 12/6/12 mother contacted our office to report above and additionally child called from school reporting "hearing voices" and seeing visions from her nightmares.
chills; HA; ear pressure; congestion; scratchy; ST; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 23Feb2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset 02Jan2022, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 02Jan2022, outcome "recovering", described as "HA"; EAR DISCOMFORT (non-serious) with onset 02Jan2022, outcome "recovering", described as "ear pressure"; NASAL CONGESTION (non-serious) with onset 02Jan2022, outcome "recovering", described as "congestion"; SCRATCH (non-serious) with onset 02Jan2022, outcome "recovering", described as "scratchy"; OROPHARYNGEAL PAIN (non-serious) with onset 02Jan2022, outcome "recovering", described as "ST". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chills, headache, ear discomfort, nasal congestion, scratch, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
About 4 hours after injection there was neuropathy (tingling) in both hands.  A couple of minutes the same sensation in both feet that simultaneously migrated to mid-calf in both legs.  This lasted 20-30 minutes then completely vanished.  Has not returned as of 04/12/2022.  Mentioned to doctor's nurse 4/11 in conversation on different topic.
After the vaccine, I had soreness and just not feeling good for about three days. I was exposed to COVID-19 at the hospital when I had surgery and with my sister. I tested positive for COVID-19 on 12/16/2023. I got a prescription for PAXLOVID. I tolerated the medication, but it tasted terrible and made me nauseated. I had a rebound case of COVID-19 and tested positive again 12/27/2023. From 01/06/2023 to 01/12/2023, I had ongoing gastrointestinal issues. On  01/16/2022 I went to the emergency room because my stomach pain got worse. The emergency room doctor said I had colitis. I was referred to a gastroenterologist and he said I did not have the right symptoms for colitis. I am on a diet to eliminate foods to see if that will help my colon. At this time, they don't know what caused my symptoms.
covid test result: Positive; covid test result: Positive; breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31Jan2022 22:00, outcome "unknown", COVID-19 (medically significant) with onset 31Jan2022 22:00, outcome "not recovered" and all described as "covid test result: Positive"; INFECTION (medically significant) with onset 31Jan2022 22:00, outcome "not recovered", described as "breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive. Therapeutic measures were not taken as a result of covid-19, infection. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt stated that she thought the placement was not into the muscle.  She was getting radiating nerve pain down the back of her arm.  She came in with the bandaid still intact and it looked to be more towards the back of her arm, almost subcutaneously.
IMy hair started to fall out. It was massively shedding. I noticed first bald spot and went to urgent care. I have since been diagnosed with Alopecia Areata which is ongoing. I received Kenalog injections to my scalp. Additionally I am using Minoxil 5% foam and Opzelura 1.5%. I am still losing my hair.
Improperly stored dose of GARDASIL 9; no adverse effects; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date 14-JUN-2020 for prophylaxis (strength, dose, route, anatomical site and frequency were not reported), that had a temperature excursion of 32.1 F for 8 hours which was detected by a data logger. The reporter stated that the vaccine had no previous temperature excursion and that the patient had no adverse effects.
This spontaneous report as received from a medical assistant refers to patient(s) of unknown age. On an unknown date, 3 doses GARDASIL (lot#, expiration date, dose, route not reported) that had been improperly stored were administered to unspecified patient(s). No adverse effects reported. Additional information has been requested.
Date and time adverse event started: 2 weeks ago, caller unsure of exact time (3/18/2021) dizziness, wheezing, congestion, states lungs feels like "it is filled with fluid". Has taken neb tx to alleviate symptoms but has no relief. Recommended to see primary provider. Caller states will take patient to urgent care today, 3/18/21.
FluMist given 12/15, developed fever to 102 with headache, sore throat, cough on 12/16-12/19.  Chest pain-pleuritic 12/20.  Physical exam: HR: 121; Temperature 98; Lungs clear.
Day 1: sore left arm muscle, day 2: upper back/shoulders/neck aches, headache. Day 3: felt allergies were worsening, started to take claritin twice per day to help, worst over next few days so that was taking 2 claritin twice per day. Day 7, bilat. Eyes super itchy. Day 8, vaginal itching, tried estradiol with no relief. Day 9, anal itching. Day 10 all over body hives/itching.  Day 11 started bid allegra and 20 mg prednisone. S/s slowly abated over many days.  Exteme fatigue often . By 1/15/31,  felt mostly normal.
1 cm, small, red, raised area left deltoid. Tdap injection site with arm stiffness and pain. Treatment: Ice to area, MOTRIN as needed.
fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nausea, fatigue
Arm pain & swelling, back of neck & entire back ache, chills, fever nauseous vomiting headache  lasted 12 hours
This case was reported by a other health professional and described the occurrence of expired vaccine used in a 3-month-old female patient who received ENGERIX B (batch number AHBVC103AA, expiry date 30th May 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expirenced expirenced vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: HCP stated that 7 doses of expired ENGERIX-B were administered to patients. She said that her office does not pay attention to expiration dates very well. All patients received a dose from the same lot number and expiration date from above on form. This case is one of the 7 case reported by the same reporter for the same vaccine.
Pt was vaccinated on 3/11/2003. On day 9 site became red and painful. On day 11 the pt. who is a physician treated himself with levofloxacin. Redness did not extend beyond bandage. Has resolved completely.
Felt absolutely fine after 2nd injection. 10:30AM  the next day I started like I had the flu and felt extremely ill out of nowhere. 10:35 am I passed out sitting down at work. I woke up and immediately passed out again. My coworkers said I shook like I was having a seizure as I went down both times. Ems was called and checked vitals. Everything was perfect. Ems wanted me to go to hospital but I refused due to cost
This case was reported by a physician via call center representative and described the occurrence of localized muscle pain in a 67-year-old male patient who received BOOSTRIX (batch number ZN937, expiry date 5th July 2019). Concomitant products included Pneumococcal Vaccine. On 12th May 2017, the patient received BOOSTRIX. On 13th May 2017, 1 days after receiving BOOSTRIX, the patient experienced localized muscle pain. The patient was treated with ADVIL. On an unknown date, the outcome of the localized muscle pain was not recovered/not resolved. It was unknown if the reporter considered the localized muscle pain to be related to BOOSTRIX. Additional details were reported as follows: The concomitant product included pneumococcal 23. On the same day of vaccination after going to the gym that evening, returning home and waking up the next morning, the patient experienced severe pain in deltoid with range of motion. The patient returned back to the physician's office that morning and was icing area and took ADVIL with no further treatment options provided at that time. No other symptoms were reported regarding the event. The batch number reported for BOOSTRIX (2N937) did not exist and was updated to ZN937, as per sales database.
EXTREME BITTER TASTE; BURNING IN MOUTH; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient was previously treated with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 8-APR-2021 at left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1)  The patient received second covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 16-DEC-2021 at left arm for covid-19 prophylaxis. Age at time of vaccination 66 years old. Concomitant medications included prednisone, and zolpidem.  On unspecified date in APR-2023, the patient experienced suspected covid-19 infection (Dose number in series 2) and received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: GG4631 expiry: UNKNOWN) dose and frequency were not reported, administered from 11-APR-2023 to 12-APR-2023 for covid-19 treatment.  On 11-APR-2023 at 19:00, the patient experienced extreme bitter taste and burning in mouth (Dose number in series 2), lasts for approximately 10 hours. Patient was taking other medications within 2 weeks of starting COVID-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from extreme bitter taste, and burning in mouth, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.