chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concomitant products included ADVAIR, LUNESTA, Atorvastatin, gabapentin, ALLEGRA, CELEXA, PROAIR, SPIRIVA, buspirone and metoprolol. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth and injection site swelling. On 16th April 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site warmth and injection site swelling to be probably related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. Less than a day after receiving SHINGRIX, the patient experienced a lot of pain at the injection site. The patient had swelling at the injection site. The area was also hot to touch. It had spread all the way down towards her inner arm. No further details were known.
immediately got vision issues; non-reparable blood clot in eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4, (booster) 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 (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset Apr2022, outcome "unknown", described as "non-reparable blood clot in eye"; VISUAL IMPAIRMENT (non-serious) with onset 24Apr2022 at 18:00, outcome "unknown", described as "immediately got vision issues".  Clinical Course: The reporter's and his wife got the second booster of the Pfizer COVID-19 Vaccine yesterday 24Apr2022. His wife immediately got vision issues and by 6 pm last night, which was approximately 6 hours after the shot, she couldn't see anything on her right eye. Reporter's wife was diagnosed with a non-reparable blood clot in eye. Reporter wanted to know if there were any reports of this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8 pm on day of vaccination started feeling tired, went to bed. Awoke at 11 pm with severe nausea, neck stiffness, and muscle stiffness. Went to ER around midnight. Received medication for nausea.  Was in ER for about 1.5 hours. Returned home and went back to bed. Woke in the morning, nausea was gone. Muscles in back and shoulders were stiff the next day for about 12 hours.
Severe pain and loss of range of motion. Treated with pain medication and physical therapy. My condition has not improved.
pt recv vax & vomited once;also devel an inj site rxn characterized by redness, warmth & swelling;recovered next day;this is 1 of 2 pt from facility to have adverse exp p/vax;
experiencing a red circle; raised bump around injection site right deltoid; Expired BEXSERO vaccine was administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31-DEC-2022) for prophylaxis.   On 15-AUG-2023, the patient received Bexsero (injection, right deltoid). On 15-AUG-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired BEXSERO vaccine was administered). On 16-AUG-2023, the patient experienced injection site erythema (Verbatim: experiencing a red circle) and injection site swelling (Verbatim: raised bump around injection site right deltoid).     The outcome of the injection site erythema and injection site swelling were not resolved and the outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 16 August 2023: The reporter was the mother of patient.   The mother stated that the doctor's office called and notified her that the BEXSERO vaccine that they administered to her son  was expired.  Expired BEXSERO vaccine was administered on 15 August 2023 in his right deltoid by a Medical assistant.   The mother stated that the doctor wanted to re-vaccinate when their next BEXSERO shipment come in this week.  The reporter was not sure if this was safe and called today to question re-administration.  Medical information phone number and case number given to reporter for her physicians reference.   The patient who received expired vaccine was experiencing a red circle and a raised bump around injection site right deltoid 1 day after administration that had not resolved.   The reporter consented to follow up. The patient received expired dose of vaccine which led to expired vaccine used.
This spontaneous report was received from a nurse practitioner via Pfizer refers to an 88 year old female patient. The patient's medical history and concurrent condition were not reported. The patient's concomitant medication included methotrexate. On an unknown date in 2016 (reported as two years prior from Pfizer's aware date), the patient was vaccinated with ZOSTAVAX for prophylaxis (lot, expiry date, dose and frequency were not reported). On an unknown date, the patient experienced herpes zoster. Outcome and causality assessment were not provided by the reporter.
Rash on left arm covering entire bicep area.  Itchy, red, and hot to the touch.  A little ache that went away after 2 days.
This vaccine dose was given too early  on 12/13/2022.  This was the second dose the patient received.  HIs first dose was on 10/19/2022.  According to vaccine guidelines there should be a 6 month interval between the first and the second dose.
20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate to full anaphylaxis but remained a steady wheezing feeling for a number of hours after. It dissipated be evening but returned 4 days later along with tingling in my lips that comes and goes. It continues on and off 2 weeks post vaccine.  I do not have any other illnesses or reasons to think this other than a side effect from the vaccine. I do not have a history of asthma either.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 29-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and bacitracin for her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient fainted 4 minutes after vaccine given. Patient was able to talk but described "eyes in back of head". Blood pressure reading taken 132/76 pulse 72 then 128/82 pulse 85.Patient was responsive to our questions sitting on floor for 5 minutes. We then we observed him for and additional 15 minutes in our waiting area before he left.
bacterial cellulitis post right thigh vaccine she received 12/12/22.  Symptoms are swelling, warm to touch, redness.
big old red circles; itching; burning; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site erythema (1st dose received on an unknown date refer case US2021AMR186889).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced localized erythema, localized itching and burning sensation. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the localized erythema, localized itching and burning sensation were unknown.   It was unknown if the reporter considered the localized erythema, localized itching and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine had a reaction both times big old red circles, itching and burning. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186889:Same reporter
chills, shaking, delirium  I got progressively more cold and then i started shaking. when i got into bed i was thrashing around for hours.
Left arm had a 3inch circle that was raised, hot and itchy. Took Benadryl but didn't do much good and it lasted about a week.
pt had high pitched scream followed by episode of shock like sx of cool clammy skin; pt taken to ER;
This spontaneous report was received from a licensed practical nurse referring to a unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patients received improperly stored dose of (Merck) VARIVAX (dose, frequency and route of administration were not provided) lot # reported as L013066, expiration date 14-APR-2017. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
I had a breakthrough case of Covid-19. I was exposed on Sunday 05Sep2021 and noticeable symptoms began on Wednesday 08Sep2021.; I had a breakthrough case of Covid-19. I was exposed on Sunday 05Sep2021 and noticeable symptoms began on Wednesday 08Sep2021.; This is a spontaneous report from a contactable consumer. A 32-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in left arm as dose 2, single on 21Apr2021 (at the age of 31-year-old) for covid-19 immunisation and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in left arm as dose 1, single on 30Mar2021 (at the age of 31-year-old) for covid-19 immunisation. Facility type vaccine was Pharmacy or Drug Store. Medical history included attention deficit hyperactivity disorder (ADHD), depression, seasonal allergies all from an unknown date and unknown if ongoing and no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC); fluticasone propionate (FLONASE) and bupropion hydrochloride (WELLBUTRIN) at 300 mg all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks: wellbutrin XR 300mg, Zyrtec (OTC) and Flonase. Patient was not pregnant at the time of vaccination. As reported, the patient had a breakthrough case of Covid-19 and was exposed on 05Sep2021 (at the time of the report on Sunday) with noticeable symptoms began on 08Sep2021 (at the time of the report on Wednesday). Symptoms included nasal congestion, sinus pressure, mild chest congestion, and aches in the neck and shoulders. All the adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: via Nasal Swab (Rapid Antigen Test) resulted positive on 10Sep2021. Therapeutic measures were taken as a result of OTC nasal and chest decongestants. At the time of this report, the outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Arm became swollen and sore to the point where she could not raise it at all.  Had temp 100 degrees by 7pm.  Soreness, swelling and pain gradually diminished over the next 2 days.  No redness at injection site.
Expired Moderna Booster administered on 4/19/22. Patient without adverse effects. We will repeat the vaccines at patients earliest convenience.
Woke from sleep - crying then became limp, pale, quiet. cont. pale, hyporesponsive, grunting. Called 911.
Within 2 days patient experienced redness at injection site, went to urgicenter dx with cellulitis, prescribed, day 3 condition worse went back to urgicenter, they sent patient to ED, pt admitted for 3 days then released.
Shingrix vaccine was administered at the same time as the pneumococcal vaccine, therefore doubling ,maybe, any adverse effect,
In April, I became pregnant with my second child. After heavy advising, I recieved the first dose of the covid vaccine in May, my first month of being pregnant. I received the second dose in June, my second month of pregnancy.   On Sept 8th,  during a routine scheduled ultrasound, the fetus was found to have no heartbeat. Which resulted in an emergency induction of labor. I had a stillbirth delivery the next day, Sept 9th.
Swollen left arm with "sausage" fingers, swollen legs with pin-prick looking rash, migraine (lasted 3 days)
Saturday 1st Night - Flu like symptoms left arm pain at injection - Good all day  Sunday  2nd Night  Flu like symptoms left arm pain at injection - Good all day  Monday 3rd Night  Flu like symptoms left arm pain at injection - Good all day  Tuesday 4th Night  Flu like symptoms left arm pain at injection - Good all day  Wednesday am - woke up with rash / Itchy hives - 4:30 am - took Benadryl- 6:15 am rash/ hives became worse and went to ER and requested observation.   8-9 am rash and hives subsided.  Now - September 27th  Headaches- Eyes hurt- shortness of breath and left arm pain persists  Healthy male - 58 years - runs marathons- crossfit and endurance sports - I become winded walking up one flight of steps  Left arm gives out when lifting and increases pain
Extremely sore arm but for less than 24 hrs , headache for a couple days and very tired for a couple days. All mild and did not interfere with my productivity .
Patient was not exhibiting any side effects at the time of the call/; inadvertent administration of GARDASIL 9 on 19Jul2021 to a 71 year old male patient, outside of Prescribing Information recommendations; This spontaneous report was received from a registered nurse concerning a 71-years-old male patient. The patient's pertinent medical history, concomitant therapies, drug reactions, or allergies were not reported.     On 19-JUL-2021, the patient was inadvertently administered one injection of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis, outside of prescribing information recommendations (product administered to patient of inappropriate age) (route and anatomical location of administration were not reported; lot number T027778 has been verified to be valid for syringe formulation, expiration date 27-FEB-2023).    As of reporting time, the patient was not exhibiting any side effects, and no other adverse events were not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027778; expirationdate: 27-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient states he received COVID vaccine on 4/5/21 in his left arm. On 4/6/21 patient woke up feeling very fatigued and had no energy, still feeling somewhat fatigued today (4/7/21). Patient states around 1200 yesterday he had a very sharp pain in his left arm that went all the way down into his hand, he described it as someone was stabbing him with an ice pick. Patient denies immobility and was able to move his arm and hand without issue. Pain lasted until today at 0100, the pain was keeping patient up at night. Today, pain has happened once or twice intermittently and lasted a minute or two each time. Patient states pain is 8.5/10 when it occurs. Denies pain at this time. Patient denies chest pain and SOB. Patient states he also had intermittent diarrhea last night and this morning, but feels okay now.
Became sick with bronchitis,  muscle weakness, loss of energy, extreme sleepiness,  decreased appetite,  went to see Dr.,   antibiotics,  cough meds, somewhat better then relapse.
Patient reported that she had rapid heart beat after few hours of receiving the vaccine and she ended up in the ER. she is doing fine now and she has never had any reaction with the influenza vaccine before
Lethargic (pt demonstrated this same side effect when he received his previous vaccinations). O.5 ml given instead of 0.25 ml.
Diarrhea and headaches. Started 1 day post vaccine. Improving but not completely resolved 1 week post-vaccine
This case was reported by a healthcare professional and described the occurrence of erythema of arm at injection site in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown arm). In November 2011, less than one week after vaccination with FLULAVAL, the subject experienced erythema of arm at injection site, arm swelled at injection site, arm pain at injection site and arm warm at site of injection. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported events for this female, another female and herself with FLULAVAL. See cases A0953236A and A0953257A for details regarding the other cases.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, but 17-year olds may be given Moderna for compassionate/off-label use. His vaccine card indicates he received Moderna #1 on 3/26/2021, but there is no record of a first dose. The dose in the computer for 4/26 is second dose. Troubleshooting: Scribe and vaccinator did not validate age or the information available on vaccine card;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. Two records appear to have been created for this person. At the time the original unreported error was made we did not have a policy on checking ID. In the computer, he lists himself as of legal age.
not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number:UNKNOWN), via an unspecified route of administration on 21Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose 21Jan2021, had an appointment today for second dose. She states she was not feeling well on an unspecified date and was attempting to cancel the appointment but does not have phone number. The outcome of the events is unknown.   Information on Lot /Batch Number has been requested.   Follow-up attempts completed. No further information expected
ER 2/19/21 Chest pain at rest. Most painful lying down followed by sitting   Followed up with cardiologist
chills beginning night of vaccination. Then around 1:00am urgent need to urinate and again around 2:00am.  After the 2:00 bathroom visit I found myself on the floor of the bathroom between the toilet and the shower. I tried to get up but couldn't and managed to get out of the spot I was in but unable to get up. I continued to try but was unable to. after two hours of moving, trying to get up and resting where I was I managed to get to my bedroom (a distance of under 12feet).  I felt like my muscles weren't working properly. I called 911 to help me get off the floor and was taken to the closest ER. By 7am on March 12th I was able to get up and walk on my own. Although my arms and legs are bruised I feel much better today.