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 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6665), in left arm 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. Concomitant medication(s) included: ONE-A-DAY [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE MONONITRATE], start date: Jan2022. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 18Oct2022 to 22Oct2022.
9 days after my second Moderna Covid Vaccine I  felt a large (golf ball) size lump in my left breast (center and front, just above the nipple).  It is not sore.  It has since decreased in size but is not gone.  I realize lymph nodes can swell as a response to the vaccine.  This why I did not report this event more promptly. However this is 4 weeks ago and the lump is still there.
This spontaneous report as received from a certified medical assistant (healthcare worker) refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of VAQTA (dose and route were not reported) lot number K009506, expiration date 22-SEP-2016; lot number K010579, expiration date 12-FEB-2017 and lot number K010577, expiration date 22-SEP-2016, that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The shot was given very low on my arm. I checked with a local pharmacist the next day. She said the vaccine was, indeed, administered too low. How does that affect the efficacy?
States flat, faint rash on forearms, wrist and across back of hips; no itching. Also on Rx of amoxicillin; finished last dose Tuesday 11/2 evening.
Hot flashes radiating from feet to my head still going on 2 weeks. Extreme fatigue last  2 weeks. Nausea on off for 2 weeks Vomiting for first 3 days. Extreme muscle pain for over week, to the point of unable to do much. Diarrahea that is yellowish tint for over a week. Extreme dizziness.
Patient is a 58 year old FEMALE  who was brought down to ED from her work office here with sudden onset of     chilling, weakness, nausea, body aches, and near-syncope which she blames     on flu/COVID vaccines given approx 5 hours before. She was asymptomatic     until around 30 minutes ago. Denies chest pain, palpitations, HA, ST,     swelling, rash, back pain or incontinence. Did have urge to have BM at the     time as well, not diarrhea. Feels some better now but still weak. No  vertigo, slurred speech, visual changes. No significant PMHx. Treated with 15mg IV ketorolac, 4mg IV ondansetron, and 1000ml IV normal saline.
About 8 to 10 weeks after the 2nd dose vaccine,  I started to get a bullseye rash on my chest.  I was prescribed doxycycline since my doctor thought it could be Lyme's disease.  The rash continue to spread so I went back to the doctor.  I was diagnosed with pityriasis rosea.  I followed up with dermatologist for a confirmation.  There is no treatment for this diagnosed and takes 8 to 10 weeks for it to run its course and resolve on it own.   As of now, I still have a faded area of where the rash used to be.
High pitched ringing in right ear (like a dog whistle), left ear ringing to a lesser extent
Swelling left upper thigh 4-5 inches. Redness, warm to touch. Lumping.
Case number PHEH2015US003414, is an initial spontaneous report received from a nurse on 13 Feb 2015, with a follow up report received on 18 Mar 2015. This report refers to a 58-year-old female patient. Historical condition and concomitant medication were not reported. On 13 Feb 2015, the nurse was about to vaccinate a subject when the MENVEO (batch number: A14057) accidentally splashed onto nurse cheeks and face. It was reported that before vaccine withdrawal, nurse did not attach the needle tightly with the syringe. She tried to withdraw the syringe from Men-CYW-135 vial and the vaccine component splashed on her face (cheeks). She immediately washed her face and insisted that it did not enter into her eyes. The patient also reported that there was no fault with the vaccine and the incident happened due to human error. Patient did not experience any event except inadvertent exposure of vaccine. Follow up report received on 18 Mar 2015: Information regarding patient demographics was updated and batch number of MENVEO was update from M14057 to A14057.
In the same arm as shot my arm pit lymph nodes swelled to size of tennis ball, burning, pain, joint pain, then by the next day more swelling in arm pit to my chest and breast, then up my clavicle, neck and throat. Even more pain and extreme exhaustion then the injection site turned red and swelled. I ended up in urgent care where they put me on antihistamine, Pepcid, steroids, and ibuprofen. I was told I was having a severe allergic reaction to the flu vaccine, and to never take it again.
it was rpt from RN concerning a pt who devel zoster p/exposure to a child who had been vax. addl info req
Extreme fatigue, muscle cramping of my legs and arms, dizziness, my thinking was as if I had brain fog. Felt ill until taking B12, Zinc and Magnesium which helped a small amount.
Headache, Myalgia, Fever, CoughWheeze, tested positive great than 14 days after fully vaccinated Narrative:
vac dates: 1/4/2021 1/22/2021  covid + 8/6
RASH TO UNDERARM AND STILL PAINFUL TO THE SITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included gastric bypass, and hysterectomy, and concurrent conditions included osteoporosis, shellfish allergy, and coconut allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a,and expiry: 21-SEP-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-JUL-2021, the subject experienced rash to underarm and still painful to the site. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash to underarm and still painful to the site. This report was non-serious.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/18/2023 Discharge Date: 3/1/2023  PRESENTING PROBLEM: Weakness [R53.1] Generalized weakness [R53.1] COVID [U07.1]   HOSPITAL COURSE: Patient is an 80 year old female with hx of dementia, CVA w residual R sided weakness who presented with dizziness and intermittent confusion/memory loss. She was brought to the ER due to concern for acute CVA. Workup including CTH, CTP, CTA HN, and MRI negative. Given the memory loss, underwent EEG which showed nonspecific encephalopathy. Neurology was consulted. Patient was found to be positive for COVID and if was felt to be the reason for patient's confusion. PT/OT saw patient during her hospital stay. PMR consulted and recommended SAR. Patient stayed in the hospital until out of COVID precautions. She received supportive care for COVID 19. She was started on ASA 81mg daily. She was discharged in stable condition on 3/1/2023.
Information has been received from a physician assistant concerning a female patient who in 1998, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient may have failed to seroconvert. In 2000, antibody lab work was performed. "It was reported that the antibody test they used was not effective to test for varicella immunity." No product quality complaint was involved. Additional information has been requested.
No adverse effect; one patient received improperly stored VARIVAX and VAQTA; This spontaneous report was received from a nurse referring to a 12 month old female patient. The patient's pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent. On 23-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot R035221 and expiry date 04-DEC-2019 and hepatitis a vaccine, inactivated (VAQTA) lot number S023499 and expiry date 24-AUG-2020 (product storage error) (strength, dose, route and anatomical locations were not reported) for prophylaxis. The temperature excursion details of varicella virus vaccine live (oka/merck) (VARIVAX) include temperature of (-9 degree Celsius to -8 degree Celsius) -7.8 Celsius with a time frame of 1 hour and 37 minutes. The previous temperature excursion include temperature of (-9 degree Celsius to -8 degree Celsius) -8.6 Celsius with a time frame of 1 hour. The temperature excursion details of hepatitis a vaccine, inactivated (VAQTA) include temperature of (above 9 degree Celsius) 9.7 Celsius with a time frame of 2 hours and 18 minutes. There was no previous temperature excursion. The call was because of a data logger. The diluent used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. No adverse events were reported. No product quality complaint (PQC) was reported.
Engerix-B administered intravenously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received HBV (Engerix B) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th January 2023, the patient received Engerix B (intravenous) and Engerix B Pre-Filled Syringe Device. On 13th January 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:13-JAN-2023 Reporter's Comment: The reporter reported that the patient received Engerix B vaccine by intravenous route. The healthcare professional asked about the patient information, but it was declined because it was not accessible at the time of the call. The reporter did consent to follow up via email. Additional supportive information: The patient received Engerix B was by intravenous route, which led to intramuscular formulation administered by other route.
Patient received Fluzone HD (first time eligible for the HD) at 9:30am 10/9/23.  At 3:30pm, neck, face, feet and hands began to swell.  Patient took 25mg of Benadryl and continued Benadryl Q6H.  She also reports slight difficulty breathing that night with racing heart. In the morning, patient drove herself to the hospital.  Hospital monitored her for about six hours and also gave her a dose of her metoprolol.  About twenty four hours after the onset, she reports feeling much better and better quickly. Spoke to patient today 10/22/23 and seems to be fully recovered.
flu; Initial information received on 20-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was reported "took the flu shot twice in the past got the flu both times. I will pass."  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was unknown for the event flu.  There would be no information on the batch number for this case.
Vaccine given Mon, rx on Wed red, oval, hot to touch. Pt saw MD, gave KEFLEX 500 BID x10.
temp. 102R emesis X 3 Treated with alternating Tylenol and Motrin and oral fluids.
Warm, swollen, itchy arm wkth red macular rash about 4 inches in diameter around injection site. Started 7 days following immunization. Is perisiting but improving now at 12 days after immunization.
Losing vision in right eye; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EP7534 and expiration date: not reported), via an unspecified route of administration,  in Left Arm on 2021 (as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0151 and expiration date: not reported), via an unspecified route of administration, in Left Arm on 2021, as DOSE 2, SINGLE both for covid-19 immunization in Pharmacy or Drug Store. Medical history included cancer (Cancer survivor),  and allergies to many medications (Too many medications to list). Concomitant medications included levothyroxine, buspirone, hydroxyzine and sucralfate. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. It was unknown if the Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced losing vision in right eye on Mar2021.The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the adverse event. The Outcome of the event was not recovered at time of report.
Swelling of entire right arm.  Not treated with exception of Benadryl, improved spontaneously.
Had fever of 105 about 10 hrs p/vax; APAP alone did not dec fever; Fever did not go below 103 for 2 days; Pt okay now;
Small pimples in clusters at site of Varicella immunization. There is induration under that area as well as regional lymph node enlargements.
30MAR92 AM woke w/pain & swollen glands; 1APR92 PM noted rash; 2APR92 seen by MD;
Redness, swelling, 101 temp left arm. Varivax given sub-q back of left arm. Softball size red area (immunization given with 25g 5/8 needle)
pain & swelling started 2 days p/vax to rt upper arm;rt upper arm w/5 to 6 cm reddened area c/o itching to area;pain radiates to rt neck;no SOB;
Immediately following vaccines, patient developed syncope; striking her head on a windowsill in exam room. Patient evolved with concussion symptoms.
PATIENT EXPERIENCED WEAKNESS AND SORENESS WHEN LIFTING OBJECTS. THE PATIENT ALSO REPORTED A NUMB SENSATION.
Patient accidentally received 1st dose of Moderna on 10/12/2021 even though they were under 18. This was discovered today (11/9/2021) as they were coming in for their 2nd dose. Per immunizer, Pt reported feeling fine after their dose of Moderna. Per CDC guidelines, pt can receive Pfizer as their 2nd dose. Pt was given Pfizer as their 2nd dose today and they reported feeling fine after their 15 minute waiting period.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. ON an unknown date the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # and expiration date unknown) subcutaneous for shingles prevention. According to the pharmacist, the patient developed a headache "almost immediately" after receiving the vaccination, and the headache lasted for three weeks. The patient saw an unspecified physician for medical attention. At the time of reporting, the outcome of this event was unknown. The causality between the event and the vaccine was unknown. Additional information has been requested.
Patient presented to pharmacy 5/15/23 to report adverse reaction to Boostrix vaccine from 4/21/23. He stated that he had the typical localized reactions for a couple days after the vaccine (redness, swelling, pain) but that these symptoms went away. But for the last few weeks he has had what he described as burning pain in the whole shoulder joint/upper arm. It does not get worse with movement, and he has full range of motion.  Patient plans on going to his primary care provider to see what might be going on.
Pt was walking out mom said pt was passing out, Dr and mom carried pt to room, rs. taken, all normal. Approx is 15min. Pt was able to get up, drank some water then left.
symptoms started ~8 hours post vaccine with alternating violent shivers,  teeth chattering vs sweating, high fever blurred vision lasting for 4 days (significant, unable to read) headache, sensitivity to light weakness, soreness inability to walk for 24 hours unable to eat for 3 days
fever, a 100.2 Fahrenheit; Headache; achiness; Sore arm; This is a spontaneous report from a contactable consumer(patient). A 76 years old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EM9810), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The Historical Vaccine was first dose BNT162B2(LOT number ET1686) for COVID-19 immunization. The patient received the 2nd dose of the vaccine yesterday. She was very happy to get it and she had of course achiness and a headache and a sore arm in Feb2021. She also had fever, a 100.2 Fahrenheit in Feb2021. Her husband will help her take it again, sometimes she cannot hear at the thermometer when it beeps. All she wanted to know they were going up to see her daughter and son-in-law, her grandchildren and her son-in-law's parents today. Of course they would all be wearing mask and when they would be outside, they would be in garage. She wanted to know if it was catching.  She did not want to give COVID to anybody. The patient underwent lab tests and procedures, which included Body temperature 100.2 Fahrenheit fever in Feb2021. The outcome of the events was unknown.
My son received the second dose of the Pfizer vaccine for COVID-19 on 5/19/2022. On the evening of 8/26/2022, he was coughing a little after he got home from school. When he was at dinner, he had chills and a fever. We gave him a home test, and he tested positive very quickly. We weren't really surprised about this, as we knew he had been previously exposed a couple of days earlier. When we talked to him a little while later, he told us that he had begun to feel sick a few hours earlier while he was in aftercare, but he just hadn't told anyone. After the initial fever, there was no recurrence of the fever. He had a cough, fatigue, and runny nose that lasted for about 3-4 days. The symptoms weren't severe and were more like those of a bad cold. On about the eighth or ninth day after the first day, he tested negative on a home test. By this point, he had resumed his normal energy levels, though he still had a lingering cough, which finally abated after about the tenth day.
pt recv vax 8NOV90 during pregnancy;@ 39wks gestation pt delivered child w/multiple malformations;@ time of delivery it was noted that placenta & umbilical cord were heavily stained w/meconium which indicated prev fetal hypoxia
Information has been received from a physician concerning a patient who on 04-JAN-2008 was vaccinated subcutaneously with varicella virus vaccine live (Oka/Merck) (Lot # 656826/030BU) instead of zoster vaccine live (Oka/Merck). The physician noted it was human error and not product confusion. The physician stated " the patient has not experienced any difficulties". No further information is available.
1600, Started out with feeling low energy, drained. Following that, 1800, body aches. 1830, headache. 2000, dry throat, localized swelling, redness, warmth left deltoid where vaccine administered. 0000, 10/10/2015, symptoms other than localized warmth and redness resolved w/ advil OTC. No medication since initial dose.
Seen at woman's clinic: Left arm swollen and red x 2 weeks. RN called us. She recommended warm compresses and Motrin (Phone NIS: unable to contact pt for more information).
When checking out after the 15 minute wait time, patient said she didn't feel very well and fell down hitting her head on the pharmacy counter.  When she came to, she said she felt "weird",  lightheaded and clammy.  We offered her a drink of water and before she could take a drink, she passed out cold. She was out for about 20 seconds and then came to again and we took her down to 1 layer on top and gave her a bag of ice while waiting for the ambulance to arrive.  She was treated/observed by the ambulance crew and after another 15 minutes, agreed she was good to go home with her 2 friends that she had ridden with to get her vaccine.
shingles outbreak; sensitive skin upper body; cough; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 14:15 as dose 3 (booster), single (Lot number: gl0446) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Naproxen/ aleve, reaction(s): "Known allergies: Naproxen/ Aleve", notes: Known allergies: Naproxen/ Aleve. Vaccination history included: BNT162b2 (Dose Number: 2, booster, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 10May2022, when the patient was 65-year-old, for COVID-19 Immunization; Jnj (Dose Number: 1, Batch/Lot No: withheld, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: Jul2021, when the patient was 64 years old, for COVID-19 Immunization; Flu, administration date: Nov2021, when the patient was 64 years old, for Influenza immunization. The following information was reported: COUGH (non-serious) with onset 29Dec2022, outcome "recovered" (03Jan2023); RHINORRHOEA (non-serious) with onset 29Dec2022, outcome "recovered" (03Jan2023), described as "runny nose"; SENSITIVE SKIN (non-serious) with onset 29Dec2022, outcome "recovered", described as "sensitive skin upper body"; HERPES ZOSTER (non-serious) with onset 29Dec2022, outcome "recovered", described as "shingles outbreak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of herpes zoster, sensitive skin, cough, rhinorrhoea.  Additional information: If COVID prior vaccination: No, if COVID tested post vaccination: Yes. Other medications in two weeks: None, Shingles outbreak-sensitive skin upper body. Cough and runny nose for 6 days.  No follow-up attempts are possible. No further information is expected.