chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19 test result last Jan2022/tested positive that year; Covid-19 test result last Jan2022/tested positive that year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), 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 Jan2022, outcome "unknown" and all described as "Covid-19 test result last Jan2022/tested positive that year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. Clinical course: The patient called in asking to send her Covid-19 test result last Jan2022. She mentioned that she tested positive that year and she needed proof.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
An expired vaccine was dispensed and administered to a patient in the ED. The pharmacist examined the product prior to dispensing and the nurse examined it prior to administration. The vaccine expiration date of "18APR14", written in the format of DD/MM/YY, was misinterpreted as April 14, 2018. The date format is commonly written as MM/DD/YY. Upon surveying multiple medications in the pharmacy, it is apparent that expiration date format is not consistent amongst products. Although bar coded medication administration (BCMA) is widely utilized in hospital systems to reduce error of medications being administered, expiration dates are not captured in the bar code of the medication. Hence, visual check of the expiration date by the healthcare providers remains the only method to ensure medications to be given are in good condition. Variations of expiration date format create a barrier in accurate and straightforward interpretation, especially in the acute care hospital setting where efficiency and multi-tasking are expected. In the industry where safe and reliable patient care is paramount, presentation of medication information should be made as simple as possible. Standardization of expiration date format would be beneficial to the safe provision of patient care.
THE PATIENT REPORTS GETTING CELLULITIS.  HER ARM IS RED AND SWOLLEN AND SHE IS ON ANTIBIOTICS.
Pt called stating he had PREVNAR 13 and Influenza on Tues 11/25/14 - symptoms Wed 11/26/14 - slight generalized muscle pain. Symptoms increased to severe muscle/joint pain on Thurs. 11/27/14. Pt also reported double vision on Sat and Sun 11/29/and 11/30 but resolved by 12/1/14.
ENlarged Tonsils with pus; Discomfort in the throat and little pain; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (ENlarged Tonsils with pus) and OROPHARYNGEAL PAIN (Discomfort in the throat and little pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not provided).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced TONSILLAR HYPERTROPHY (ENlarged Tonsils with pus) and OROPHARYNGEAL PAIN (Discomfort in the throat and little pain). In January 2021, TONSILLAR HYPERTROPHY (ENlarged Tonsils with pus) and OROPHARYNGEAL PAIN (Discomfort in the throat and little pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol 500mg every 6 hour for the first day when she felt symptoms. No antibiotics were taken.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Notified by corporate office that upon audit, noted that this client received multiple vaccine injections in different clinics due to parents indiscretion to possibly obtain more gift cards.
About 12 hours after injections, a mild headache started. It worsened over the next 12 hours. Injection site has mild redness and moderate pain and swelling. I am also experiencing pain in what I assume to be the lymph nodes under my arms, especially the arm I received the injection in. General body fatigue and soreness is mild
Severe headache by late afternoon/early evening of Sun Feb 13, 2022.  At first, I thought I was hungry, but the headache persisted for the next 2 days. I thought I might have been mildly dehydrated, so I increased water intake for the next 2 days. I also thought I had developed a "crick" in the neck from sleeping on the wrong side, so I did neck rolls and stretches. I also thought I have had a sinus headache, so I kept my room dark and very quiet. Normally, my headaches last only a few hours or after a good night's rest. The severity of this one lasted through the night of Tues Feb 15th.  It was milder by Wed morning and unnoticeable by Wed night. It was completely gone by Thurs night.
Patient was given incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
This spontaneous report as received from a pharmacist refers to a 17 year old female patient. Patient's medical history was not reported. Patient had no previous allergic reactions to drug. Approximately in October 2014 (2-3 weeks ago) the patient was vaccinated with first dose of GARDASIL (strength, lot number and expiry date unknown) 0.5 ml, one dose intramuscular. No concomitant therapies were reported. Approximately in October 2014 after vaccination, the patient began to experience hair loss and was diagnosed with alopecia. Patient called to physician for medical attention to the events. No treatment was given to the patient. No laboratory test was conducted. Action taken with GARDASIL was unknown. The outcome of the patient began to experience hair loss and was diagnosed with alopecia was reported as not recovered/not resolved. The investigator did not provide the causality of patient began to experience hair loss and was diagnosed with alopecia to GARDASIL. No further information was provided. Additional information has been requested.
The adverse event I want to report is the fact I tested positive for Covid-19 through my school 6 days after being fully vaccinated. So I tested positive 6 days after my 14 days from the shot. I only have mild symptoms currently. I just wanted to let you know this for the accuracy of vaccination data
could not walk; she started to develop pain symptoms; She was diagnosed with HSP; She is now experiencing chest and lung pain; She is now experiencing chest and lung pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date end of Jun2021 (Batch/Lot number: unknown) as dose 1, single (age at vaccination is 18 years old) for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2021 (unspecified if ongoing), notes: Had no symptoms. The patient's concomitant medications were not reported. The following information was reported: GAIT INABILITY (medically significant) with onset Oct2021, outcome "unknown", described as "could not walk"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "she started to develop pain symptoms"; HENOCH-SCHONLEIN PURPURA (non-serious) with onset 2021, outcome "unknown", described as "She was diagnosed with HSP"; CHEST PAIN (non-serious), PULMONARY PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "She is now experiencing chest and lung pain". Details were reported as follows: While on an airplane in October, she started to develop pain symptoms and could not walk. She was in a wheelchair for three weeks. She was diagnosed with HSP, an autoimmune disorder that affects small blood vessels. She is now experiencing chest and lung pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
After 10 minutes after administering the vaccine, the patient fell on the floor dazed. Face was completely red. After a few minutes he was able to respond. Called 911 and the ambulance arrived. The paramedics attended to him. He was able to stand and was assisted to the ambulance for further evaluation.
Received the shot around 10:15 am on 30 April 2021 at a public vaccination clinic at a community center.  I didn't expect any side effects as no one I know has had any from the first shot.  However, within about 2-3 hours started to feel mild body aches similar to when you have the flu coming on and minor fatigue.  Nothing debilitating.  Ended up taking a few long naps during the day and not getting much work done.  By the evening I had a very slight headache at the base of my neck which was probably related to the sore muscles.  Also noticed that the soles of my feet were a little sore which seemed unusual.  Went to bed around 11:30 pm on 30 April.  Woke up around 3 am on 1 May and just felt "off."  I could still feel body soreness but also had developed a strong metallic taste at the back of my mouth and into my throat.  Drank a lot of water to try to see if that changed anything but it didn't.    Woke up around 7 am on 1 May.  Body was very sore (like from a major workout), bottoms of feet still tender, minor headache and strong metallic taste.  Tried to work on some things but ended up going back to bed around 8 am for a few hours.  Woke up around 10 am and feel much better.  Minor body aches (including the sore feet, which is weird) and just a minimal metallic taste.
Information has been received from a physician concerning a 52 yr old white male, physician's assistant, with a penicillin allergy (blisters) and a drug hypersensitivity (muscle aches, liver) who on 27Feb06 was vaccinated SC in the left arm with second dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). On 28Feb06 the pt developed marked swelling and erythema of the left upper arm, and subsequently neuralgia type pain. The pt is being treated for the next 4 months with lyrra 75g in the am and 50g in the pm. It was reported that the pt was pain free while being treated with lyrra. Subsequently, on an unspecified date the pt recovered. It was reported that the pt had no adverse events following prior vaccination. Additional information is not expected.
Day 1, 2 & 3:  Red, swollen, hard, itchy lump at injection site (approx 3in x 3in) circular in pattern Day 4, 5, 6 appeared to have gone away except it was still hard and raised Day 7 itching returned Day 8 & 9 (so far) reappeared Red, swollen, hard, very itchy (approx 3in x 3in) circular in pattern - worse than the first 3 days
Pt received vaccines on 10/9,  got IV contrast dye on 10/10, then called 10/11 to say that her right arm was red and swollen and also both thighs were red and swollen. She went to the hospital on 10/14 because her legs became blistered and was treated for an allergic reaction. The hospital was not able to determine the cause of the reaction.
Patient stated he had not had a covid vaccination. Patient stated he wanted his first covid vaccination. Nurse administered the vaccination. Later in the day staff reported that the patient had indeed received 2 covid vaccinations before this date, so todaysvaccination would have been his 3rd dose of pfizer. I left messages for the patient to follow up on this, he has not responded at this time.
Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; Jynneos vaccine had a temperature excursion; Affected Jynneos was administered; Case reference number US-BN-2022-002030 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via agency (reference number: USBAV22-1123) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 18-Aug-2022, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) had a temperature excursion (explicitly coded as 'product storage error').  On 22-Aug-2022, the patient was vaccinated with the affected Jynneos vaccine (batch number: FDP00003), at dose reported as 0.1 mL, administered intradermally (explicitly coded as 'underdose', 'inappropriate route of vaccination' and 'product administration error'), for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 24-Aug-2022 included the local BN case ID.  Case is linked with cases US-BN-2022-002028, US-BN-2022-002045, US-BN-2022-002046, US-BN-2022-002047, US-BN-2022-002048 and US-BN-2022-002049, concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally, for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally, for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Patient is a 86 y.o. female patient of, MD with history of anxiety, arthritis, A-fib, incontinence, hyperlipidemia, GERD, hypertension, ulcers, prediabetes, presented to Hospital with COVID and generalized weakness  COVID-19 infection Patient is vaccinated Continue Paxlovid ID is on board Patient is on room air, saturating well Will DC dexamethasone   Generalized weakness Chronic fatigue disorder PT/OT evaluation Plan for PT at home    Hypertension Hyperlipidemia Continue Lipitor, Lasix,Potassium replaced,, metoprolol Cozaar  Dc iv fluid      Depression anxiety Continue Celexa   Urinary incontinence Patient requesting a pure wick   Paroxysmal atrial fibrillation Cardiac monitori  Generalized weakness Chronic fatigue disorder PT/OT evaluation Plan for PT at home    Hypertension Hyperlipidemia Continue Lipitor, Lasix,Potassium replaced,, metoprolol Cozaar  Dc iv fluid      Depression anxiety Continue Celexa   Urinary incontinence Patient requesting a pure wick   Paroxysmal atrial fibrillation Cardiac monitoring Not on anticoagulant Continue her Toprol   UTI Urine culture sent, no growth  Was started on Macrobid, will DC at discharge
Breakthrough case admission after 2 vaccines Pfizer 4/22/21 lot# ER8732;  Pfizer 5/13/21 lot# ER2613
Expected level of arm soreness, followed by feverish chills during the night. Morning lethargy and disorientation.
sore injection site day after vaccine, tired/sleepy, muscle aches, metallic taste, then sharp chest pain on 11/9/2021 w/ soreness along the sternum,, on 3/3 & 5/2022 had chest pain soreness along sternum and ribs, swollen joints.
This is a spontaneous report from a contactable consumer (patient's mother) from Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It has been reported that, the patient might have been infected with the virus prior to receiving the COVID-19 vaccine. On 20Mar2021, after receiving the first dose, (reported as Saturday evening around 5:00-6:00 PM) patient experienced, chills, aches, and temperature. On 21Mar2021, 2 days after vaccination, (reported as Sunday), patient had a rapid test for Covid, and it was positive. It was also reported that, he didn't have any reaction, apart from Covid but patient felt fine that day. Patient will finish isolation on 30Mar2021 and was scheduled to receive the second dose on 07Apr2021, but Pharmacist that he should take a test to confirm that he was negative to get the second vaccine. Outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 85 years old male patient. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. The pharmacist reported that on 01-AUG-2017, a patient inadvertently received PREVNAR 13 (unknown lot number and expiration date) instead of intended dose of PNEUMOVAX 23 (wrong vaccine administered). No dose of PNEUMOVAX 23 was administered. No adverse effects reported. There was no product quality complaint involved.
Nausea, headache, sensitivity to smell starting approximately one hour after received vaccination, patient took an ondansetron and laid down and fell asleep for two hours, when awakened, patient states nausea had resolved and headache diminished as well as sensitivity to smell.
Initial case was retrieved from the scientific literature on 16 December 2010. "In 2008, potential temperature compromise of one lot of trivalent inactivated influenza vaccine (TIV) led to the revaccination of 13,210 patients within 28 days of receipt of their initial TIV dose. We conducted a retrospective cohort study to determine if these individuals experienced a higher rate of medically attended events (MAE) than those receiving only one TIV dose. We found no increase in MAE among those rapidly revaccinated (odds ration 1.08; 95% confidence intervals 0.80, 1.45), which may reassure individuals of the safety of revaccination with TIV should it be necessary, thereby leading to increased compliance with influenza vaccination recommendations." Between 14 and 21 October 2008, 19,351 patients were vaccinated with trivalent inactivated influenza vaccine which had been affected by a possible temperature compromise during shipment. Of those patients, 13,210 were subsequently revaccinated with a second dose of trivalent influenza vaccine (TIV) (influenza vaccine manufacturer and lot number not reported) within 28 days of the first vaccination. O those patients, 52 patients experienced a total of 54 adverse events, including adverse event of medication (9), allergy (unspecified (3), cellulitis (7), fever (5), headache (14), infection following vaccination (1), limb swelling/pain (12), lymphadenitis (2), and urticaria (1). In 23 patient records, a specific medication other than TIV was listed as the cause of the adverse effect. Among all patients vaccinated only female sex was significantly associated with any adverse events, and incidence was highest among those revaccinated 1 to 3 days after receiving the initial dose. In addition to the events previously described, the unexposed cohort group also had reports of anaphylaxis and complication of care following one dose of TIV. Outcome was not reported.
made patient blind in one eye; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "made patient blind in one eye". Clinical details: patient received a Pfizer booster and it made patient blind in one eye.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue- started at 7am and slept most of day, continued to experience fatigue into the next day 3/26/21.  Nausea- woke up at 7am on 3/25/21 with nausea that lasted until 7pm on 3/25/21.  Migraine- took Tylenol every 4-6 hours from 7am on 3/25/21 until 9pm on 3/25/21.
PATIENT REPORT SEVERE SORENESS ON AND AROUND THE SITE OF INJECTION FOR THE PAST THREE WEEKS.
woke up from sleep with tightness in chest about 3:00 am April 26th, couldn't take deep breath and could hardly breath, left arm started going numb when  i got to the ER at 4 am. Felt like my heart was going to beat out of my chest. couldn't lay down. had a sharp pain in the left side of my chest. This lasted almost the whole day Monday the 26th, would get a little better then woke up again on the 27th with the same pain.  My pain was at about an 8.5/10. I would take tylenol and ibuprofen to control the pain. After about 5 days the pain had gone completely away.
Severe diziness a few minutes after the shot, I was admited to hopital ER for monitoring followed by face swelling later. Numbness on upper lip and tongue which was felt for the next few weeks.  Prescriptions given at the hospital: Benadryl, Famotidine, Methylprednisolone sodium succinate, sodium chloride, xanax Prescription given to take at home for four days after: Benadryl 25mg, prednisone 20mg
Tongue feels thick in back of throat. Denies respiratory distress, headache. Received Covid vaccine at 10:32.  11:18  Client continues to deny respiratory distress. States less feeling of thickness to tongue.  Offered benadryl - client refused.  11:32 Client states she no longer has feeling of tongue thickness and is leaving to go home.  Disposition:  Stable upon leaving to go home; offered benadryl and refused benadryl.
Bell's Palsy. Visible May 5, 2021, resolved in 2 weeks without treatment..
Lower backache began early afternoon.  By bedtime, significant amount of pain - causing restlessness and limited mobility.  By morning, pain had increased comparable to that of sciatic nerve pain experienced ~20 years ago.  I have not had that degree of pain since then. I was not able to walk without assistance.  Treated with NSAIDs and pain diminished over next 24 - 48hours. Only contributing factor seemed to be flu vaccine.  I was not experiencing any pain prior to vaccination and onset was within hours of receiving vaccine.  The injection was "audible" which is also unusual, and painful at the location of administration - more so than typical.  Pain was extreme and debilitating, but transient.