chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient felt like death after receiving a dose of Shingrix and Afluria; This case was reported by a pharmacist via call center representative and described the occurrence of near death experience in a adult female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 31st December 2021) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On an unknown date, the patient received Shingrix and AFLURIA. On an unknown date, unknown after receiving Shingrix, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter did not provide complete date of birth. The reporter did not provide lot or expiration date for dose of Afluria. The patient received the vaccines in separate arms. The patient felt like death after receiving a dose of Shingrix and Afluria on the same day. It was unknown if the reporter considered the near death experience to be related to AFLURIA as well. Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230407:same reporter
Menstrual period that was 9 days late with extremely heavy bleeding and abnormally large clots (larger than a quarter), PMS symptoms that lasted for 2+ weeks before my period started (cramps, sore breasts, tender/tingling nipples, dizziness, acne)
Narrative:  Patient reports having SOB the evening after COVID vaccine was received; no PMH of respiratory disease. Evaluated in the ED, RR 14, non-labored breathing. Albuterol inhaler 2 puffs q6h prn ordered.
COVID 19; Drug ineffective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillan, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant), outcome "unknown".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) negative; (30Jun2022) Positive; (03Jul2022) Still Positive. Tested positive after testing negative. No symptoms since 24Jun2022. Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient used Paxlovid from 21Jun2022 to 26Jun2022 as treatment of COVID-19. Other medication details: ibuprofen and acetaminophen both from 21Jun2022 to 23Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PARAESTHESIA (tickling on the same arm of the injection). At the time of the report, VACCINATION SITE PARAESTHESIA (tickling on the same arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment for the event was reported.
Information has been received from a medical assistant via a company representative concerning two 16 year old female patients. Concurrent condition, concomitant medication and medical history were not provided. Approximately in July 2016 (about three months ago), the patients were received the first dose of GARDASIL 9, (lot#, expiration date and dose were not reported) intramuscular. Approximately in September 2016 (about one month ago), the patients experienced fainted after each girl received the second dose of GARDASIL 9 (intramuscular; lot#, expiration date and dose were not reported). The patient did not seek medical attention. No treatment was given for the events. No lab test was performed. The outcome of fainted was reported as recovered. Additional information is not expected due to the reporter did not allow to be contacted.
2nd dose given one month after 1st.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17-APR-2023, the patient received the 2nd dose of Shingrix. On 17-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given one month after 1st.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 17-APR-2023 The pharmacist reported a second dose of Shingrix was administered one month after the first dose to an immunocompetent patient. No dates available per health care professional (HCP). No additional adverse event (AE) details available per HCP.  The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
The person lied about their birthdate, making them eligible to receive the vaccine.  They put down they were DOB was one date and their actual DOB is different.  At the time the person was not eligible to receive the vaccine based on FDA guidance.
Information has been received from a registered nurse referring to a 4 month old patient of unknown gender. On 01-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K017573, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt felt fine after shot. 6 hrs later site of injection was very painful. Next day it was so painful she could not get dressed, could not go to work. Not swollen, not red, not warm. Just very painful. By 1/21/09, it was better and she was able to go to work. Took ASA q4h on 1/20 to help with pain but only got minimal relief.
2 weeks after the vaccine I woke up to ?Covid Arm,? with a quarter sized red spot that had a lump, heat to it, and it itched.  The following day, (today) it itches and burned less, but is still there.
Patient reported small Macopapular rash that extended from elbow down to wrist of left arm.
moderate fatigue lasting 7 days, mild nauseous especially post eating lasting a few days, heavy chest pressure (still experiencing this after 30 days) with mild labored respiratory breathing and increased blood pressure to clinical high. Low grade headache (everyday for past 30-days).
I've had the shots, still suffer the shingles/ Suspected Vaccination failure; Still suffer the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. Patient had the shots,still suffer the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Tinnitus developed after about 10 days in both ears. Otherwise, healthy 38 year old with no prior tinnitus issues.
Severe chills, low-grade fever, headache, nausea, body aches in shoulders and legs. Acetaminophen 1000mg. Lasted 18-20 hours.
he reported that his arm is a little sore at the injection site; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 05Feb2021 (Batch/Lot number: Not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, at dinner, patient reported that his arm was a little sore at the injection site. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt recvd a series of Engerix-B on 13MAR91; 18APR91 & 16SEP91 & upon completion of series pt was dicovered to have not responded;
pt recv 1st ,2nd & 3rd respectively; pt exp fatigue; lab eval 20jan94 showed anti HBs less than 10; pt refused booster doses of vax; by dec94 pt recovered;
Swelling/redness/warm to touch of injection site right thigh - post immunization of IPV. Redness measures 9 x 10 cm.
This spontaneous report as received from medical assistant refers to a nine patients of unknown age and gender. On an unknown date, patients were vaccinated with doses of PROQUAD (Merck), .5 ml, subcutaneous (lot # and expiration date were not provided) that were improperly stored. The vaccines experienced a first temperature excursion on unknown date, the second temperature excursion was on 05-JAN-2015 and it was reported that improperly stored PROQUAD (Merck) were administered since the initial temperature excursion. Nine patients received improperly stored PROQUAD (Merck). No adverse effects reported. Additional information has been requested.
Modera COVID-19 EUA:  I developed a round, itchy reaction about the size of a silver dollar at the injection site 9 days after I got it.  The reaction lasted about 4 days and responded to topical cortizone-10.
Extreme fatigue for 2 days.  Slight headache and slight body ache.
I have had a heavy chest pain all day today. It feels like pressure on my chest and hurts to inhale deeply.
I had a fever, shortness of breath, wheezing, lethargic and severe cough with nasal congestion. I was negative for COVID-19, they tested me again and found a possible pneumonia. They prescribed me albuterol, I didn't feel better until after 3 weeks.
Initial report received 09 April 2009 from a health care professional. A four-month-old male patient with a history of eczema and an egg allergy, had received a second dose intramuscular left thigh injection of ACTHIB, lot number UF620AB (Sanofi Pasteur SA lot number B0406-1), a second dose intramuscular left thigh injection of DAPTACEL, lot number C3084AA, a second dose intramuscular right thigh injection of IPOL, lot number B04575 (lot number invalid), and a second dose intramuscular right thigh injection of PREVNAR, lot number D26083 (manufacturer Wyeth) on 02 April 2009 and within 10 minutes of receiving the vaccines, the patient developed labored breathing, cyanosis of the lips and general hives. The patient received corrective treatment with an EPIPEN Junior, oxygen and BENADRYL and had been hospitalized for 24 hours (also reported as one day; dates of not reported). It was unknown at the time of the report if any laboratory or diagnostic testing had been performed. The patient had not been receiving any concomitant medications at the time of vaccination and he had not experienced any reactions following receipt of the same vaccines two months earlier. According to the reporter, the patient recovered from the event (date of recovery not reported). Documents held by sender: None.
Nausea, fever which comes and goes between 100.00 degrees and 101.7 degrees. Usually around 101 degrees. Chills.
patient reported nerve pain in right leg and tingling in feet that started after receiving a vaccine 10 days prior. After this vaccine it progressed to "partial paralysis" causing a hard time with mobility.
This spontaneous report as received from a registered nurse refers to 2 patients of age ranging from 9-18. The patients were vaccinated with VARIVAX (lot number reported as "0661AE", dose and duration not provided) on unknown dates "last month", in June 2012. No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients experienced injection site soreness, injection site swelling and injection site redness. The patients had sought medical attention via calling the office and were given BENADRYL and ice for the adverse events. None laboratory diagnostics studies were performed. The outcome the patients' adverse events were unknown. This is one of several reports received from the same source. Additional information has been requested.
Complained of tingling in hands/face. Dizziness when standing. VS pt was verbal with with history of P.O.T.S. Awake and alert x3, no s/s of SOB/resp distress. At 1308: BP 104/76, HR 90, SPO2 90%.  At 1317: BP 102/62, HR 85, SPO2 98%, pt complained of tingling/nausea/ ears tingling, awake and alert x 3, c/o throat closing/ tightness. Benadryl was given about 50 mg At 1330: O2 sat 100%, pulse 110, BP 113/72. She stated her throat was closing and she was starting to have difficulties breathing. She mentioned that when she has anxiety she never had tingling and she has no history of allergies
Pt. c/o coughing & wheezing starting 5 hours after HPV-GARDASIL vacc. on 8/9/11. Seen by MD 8/9/11- Pulse Ox= 93% RA; HR 94; BP-120/90; injection site clear of redness/swelling. Rx: Albuterol via Neb. QID - c/o increased T. 8/14 pm-8/16 pm; seen 8/16 - T-99.5; P. Ox=98%.
Initial unsolicited report received from a nurse on 24-Oct-2017. This case involves a male patient (onset age not reported) who was vaccinated with a dose of FLUZONE QIV ADULT (batch number: UIV55BA) and PNEUMOVAX (batch number, expiry date and route of administration were not reported) in arm on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch and elbow to shoulder area was swollen. The patient's laboratory data and corrective treatment were not reported. The events outcome was not reported.  Upon internal review the case was considered as serious because of important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: The patient experienced cellulitis post vaccination with FLUZONE QIV Adult. Time to onset was not reported. The patient's medical history and tolerance to previous vaccinations was also not reported. The patient received Pneumovax on the same day inches apart from FLUZONE QIV Adult. The site of events was not reported. It might be possible that the infection was due to improper aseptic technique followed during vaccination which exposed inner layers of the skin to surface pathogens. There is also a possibility of alternate etiology of cellulitis being totally unrelated to vaccination and due to underlying preexisting infectious etiology. Additional information regarding latency, site of events and medical condition at the time of vaccination should be requested to assess the case. Till then the causality cannot be assessed with respect to one vaccine.
Complained arm with vaccine hurt. Went to bed.  Made a large noise which woke me at around 1:30 am. I found him unresponsive  with wound on his forehead.  Called paramedics. Took to hospital and then to rehab.
day after vaccine was administered to this Long Term Care resident, his arm was noted to have a rash over 22cm X 16cm area at the injection site.  It became red, warm and painful.  The redness and rash lasted approximately 4 days.  Provider was consulted for evaluation.
10/27/2011 Right arm, deltoid area warm to touch, pink tinged, tenderness with some swelling under the right arm.  10/28/2011 Right tear duct is slightly swollen today.
TDAP given R del IM 2-24-10, pt states that night it was red, itchy. Took TYLENOL, next am small rash noted below inj site and inj. site was sm blister. 2-25-10 then began itching and getting sore. Pt went to ER 3-2-10 11 am. Did not call HD was put on antibiotics and prednisone.
my first one I had a lot of pain in my arm; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. It was reported that when she received the first dose of BNT162B2, she had a lot of pain in her arm on an unspecified date. Outcome of event was unknown.  Information on the lot/Batch number has been requested.
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 22Feb2021 at 16:45 (04:45 PM) (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. Medical history included seasonal allergy (patient had allergic reactions to seasonal allergy shots before). The patient concomitant medications included pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]); ibuprofen (ADVIL [IBUPROFEN]), both drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 22Feb2021 at 17:30 (05:30 PM), the patient experienced became flushed, my cheeks were burning, a rash formed from my face down my chest, I became dizzy and lightheaded, very sick to my stomach. Adverse event: Became Flushed, my cheeks were burning and a rash formed from my face down my chest. I became dizzy and lightheaded and very sick to my stomach. A nurse monitored patient, gave patient water, cold rag. The patient received water, cold rag as treatment for all the events. Outcome of all the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
In the evening patient starting with N/V, this was day 7 of oral typhoid.  Next day he also had diarrhea.  Did not report fevers/chills, did feel fatigued and spent most of the day sleeping on Sunday.  On 2/22/17 he was feeling better and eating more solid foods(able to keep down).
administered Kinrix to a 1 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 29-MAR-2022 Additional Supportive Information: A 1 year old patient was inadvertently administered Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up via phone.
This spontaneous report has been received from a pharmacist via a field representative referring to a female patient of unknown age. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 in an unspecified arm for prophylaxis (strength, dose number, route of administration, batch/lot # and expiration date were not reported). On unknown dates, after receiving PNEUMOVAX 23, the patient had extreme redness and swelling at injection site, diarrhea, and developed pneumonia. At the time of the report, the outcome of the events was unknown. No causality assessment was provided. Upon internal review, pneumonia was considered to be medically significant.
Medication error. Patient vaccinated underage. Patient 16 years old. Patient observed for 15 minutes. No adverse effects noted during observation time.  Reviewed with patient mother that patient should not have been vaccinated as she is under 18. Patient mother acknowledged and stated she mistakenly signed daughter up for vaccine and didn't fully read the disclosure for age.
hot; very large knot; very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE LYMPHADENOPATHY (very large knot) and VACCINATION SITE PAIN (very sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE LYMPHADENOPATHY (very large knot) and VACCINATION SITE PAIN (very sore). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE LYMPHADENOPATHY (very large knot) and VACCINATION SITE PAIN (very sore) outcome was unknown.            Patient stated that the knot was as big as hand and sticks out a lot.  No concomitant medication was reported.  No treatment medication was reported.
Headache, right side of head with shooting pain into ear. Muffled hearing in right ear. Swelling right side face ...pox, under right side chin and right cheek, blood pressure increase, extreme fatigue, dizziness, foggy.
Both legs - muscle fatigue, weakness, twitching. Pain in muscles and shin bones. Lower back pain.  Continuing now 2+ weeks after vaccination.
This spontaneous report was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patient were vaccinated with ROTATEQ suspension 2 (lot # K012432; expiry date: 28-MAY-2016) (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored vaccine. No adverse effects reported. The outcome of incorrect product storage was unknown. There was no product quality involved. This is one of several reports received from the same source. Additional information has been requested.