chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 3 years ago, never completed the series; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 3 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comments: The case was reported by the husband of the patient. The reporter reported that the patient received first dose of Shingrix three years ago but never completed the series. The reporter reported that the patient plans on getting the second dose as soon as possible. Details reported for 1st dose. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was linked with case US2023007568, reported by same reporter.; Sender's Comments:  US-GSK-US2023007568:Same reporter
Pt tolerated administration well. Shortly after, pt stopped breathing multiple times for a few seconds at a time. Pt began breathing again due to stimulation of rubbing his back and it did not occur again while in the office. Ambulance was called and transported pt to the hospital where he was admitted for the episodes as Mom stated pt had experienced the same thing after birth while in the NICU.
Splitting headaches, extreme fatigue, nausea, feeling hot without fevers, joint and muscle aches.
Suddenly needing to clear throat consistently about every two minutes.  Dizziness. Face turned red. Right eye lid droopy.  The following day arm hurt, tired and woke up with a very very sore neck.
Only adjuvant was administered; only adjuvant was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows:  The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Patient complained of left sided chest pain radiating to both arms, back and jaw and nausea. EKG showed acute anterior infarct. Patient taken emergently to cath lab for acute myocardial infarction.
not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Patient received influenza and Gardasil IM immunization in different arms. Patient looked and acted fine. Patient put on coat and left the office. Patient was in the lobby waiting for the elevators and stated she didn't feel well, "like I'm going to throw-up". Patient sat down and coloring of face turned yellowish, then green. Mother of the patient went and got assistance from the nurse. Patient went flaccid, unable to communicate and unresponsive. Nurse asked for assistance of the medical doctor. Patient was assisted into a supine position with legs over the arm rest of the two person chair. After about 1 min or longer, patient started to make eye contact and verbally respond. Patient sat still for 15 min and ate crackers and drank sweet tea. Patient was able to walk out of the clinic.
fever of 102.3 F; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unknown route of administration on 28Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. The patient had fever of 102.3 F on 29Apr2021. The outcome of event was unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Initial unsolicited report received from a nurse on 24-Jul-2018. This case involves an adult patient (age and gender not reported) who was vaccinated with an expired dose of 0.5 ml TENIVAC batch number: U5280AA, expiry date: 16-Mar-2018 via intramuscular route in the right deltoid on 30-Mar-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
patient received a dose of YF-VAX via intramuscular route/no AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA233343, 2019SA233337 and 2019SA233345 (same reporter).  This case involves an 18 years old patient (gender not reported) who a received a 0.5 mL dose of YELLOW FEVER VACCINE - US [YF-VAX] (LOT UI933AA, and expiry date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate route of vaccination as patient received a dose of YF-VAX via intramuscular route.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Significant swollen injection site, followed by fever, chickenpox rash "well over 100 bumps" Dx by ER doc with chickenpox. All over back of legs, buttocks, groin area. Pt. is fully recovered.
Hives and headache.  Went to primary care physician and received prednisone.
3 weeks post #2 Moderna vaccine developed initial symptoms (pain, rash)  of Shingles outbreak
Burning pain in the middle of my chest along with shortness of breath.  Pain spreads from my chest to my right arm and makes the muscles in my right arm sore.
I reported before that I had an elevated blood pressure of 140/125 which I never had before in my life after feeling a bit dizzy or weird which led me to take blood pressure. I am writing too because I also joint pain in my whole body beginning a few days after. Since then I have continued to have high blood pressure with high as much of 150 but mostly in the 130?s  for systolic and as high of 99, normally in the nineties for diastolic. Even when my systolic is 133, not hugely elevated my diastolic pressure usually is between 94 and 97.  I never had high blood pressure before this vaccine.  But since then my blood is rarely normal.   Additionally, I have continue to suffer from joint pain but not as badly as the first 6 months after it. I?ve two booster shots. The first one, surprisingly affected me positively, my joint pain going away completely for the first few days, after which unfortunately, it came back.  Second one I changed and got Moderna. I was hoping to get the same relief I felt from my Pfizer booster hoping that it could be permanent, but not such luck. I didn?t improve my joint pain even for a few days.
Had experienced flu-like symptoms 24-48 hours after vaccination and had recovered by 72 hours. Approximately seven days after vaccination experienced severe chest pain with heavy pressure on the chest causing an urgent care visit. Chest X-ray was done and EKG performed at urgent care to rule out infection and serious cardiac events. Trouble breathing with pain worse while laying down. Symptoms improved three days after onset and improved about one week after onset.
Sudden onset of constant, bilaterally equal, tinnitus.  No prior history of tinnitus or hearing problem.  No excess cerumen in ear canals.  No precipitating illness or injury.  Outcome of tinnitus permanent, as of VAERS patient self-report.
Pt. was vaccinated at Hospital on described dates. On 7/31/2021 patient arrived at Medical Center with complaints of COVID diagnosed on 7/26/2021 and having an increase in cough, shortness of breath, nausea and diarrhea. Patient was admitted on 7/31/2021 and remains hospitalized at this time.
The shots do not work; very sick with COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), outcome "unknown", described as "The shots do not work"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "very sick with COVID". Clinical course: The shots do not work. None of them. I had 3 shots; and was still very sick with COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two doses were greater than 6 months apart; Body aches; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 18th November 2019 and experienced body aches and injection site pain, refer case US2022006705).   On 24th September 2021, the patient received the 2nd dose of Shingrix .5 ml. In September 2021, 12 hrs after receiving Shingrix, the patient experienced general body pain and injection site pain. On 24th September 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the general body pain and injection site pain were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the general body pain and injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022006705  Additional details were provided as follows: The case was reported by the husband for his wife. The patient's husband stated that after her second dose of Shingrix she had body aches and pain at the injection site for about 2 days. The reporter stated that the patients side effects started about 12 hours after each vaccine and had resolved. The reporter also stated that his wife's two doses were greater than 6 months apart, which led to which led to lengthening of vaccination schedule. The reporter wanted to know if she needed to restart the series. Spoke per content and patient was referred to health care professional. The reporter did not consent to follow-up. This case has been linked to US2022006699, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006699:Same reporter. US-GLAXOSMITHKLINE-US2022006705:Same reporter.
g itching all over the body since last 4-5 weeks / Itching all over legs, belly and arms; could not sleep well; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (g itching all over the body since last 4-5 weeks / Itching all over legs, belly and arms) and INSOMNIA (could not sleep well) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (g itching all over the body since last 4-5 weeks / Itching all over legs, belly and arms) and INSOMNIA (could not sleep well). The patient was treated with FLUOCINOLONE ACETONIDE, HYDROQUINONE, TRETINOIN (TRIDERMA) (topical) for Itching, at a dose of 1 dosage form and COAL TAR (REVITADERM PSORIASIS TREATMENT) (topical) for Itching, at a dose of 1 dosage form. At the time of the report, PRURITUS (g itching all over the body since last 4-5 weeks / Itching all over legs, belly and arms) and INSOMNIA (could not sleep well) outcome was unknown. Not Provided          No concomitant medications provided   This case was linked to MOD-2021-090531 (Patient Link).
next day devel flu sx, h/a, vomiting stayed in bed 15OCT; better on 16OCt;
Pt recv vax on 3/31/99; on 4/3/99 pt exp fever (104), rash, hives, allergic rxn similar to scarlet fever
achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (Batch/lot number: EJ1685, Pfizer product), via an unspecified route of administration in in left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was receiving concomitant therapy. The patient previous received first dose of BNT162B2 on 08Dec2020 and experienced left arm a little sore at the injection site. The patient experienced achy knees/ achy joints/ achy right elbow, headache, her temperature was 96, but not a fever, achy back, all on 07Jan2021. She got her 2nd vaccine (COVID-19 Vaccine) on 06Jan2021 and this morning, the longer the morning goes on, she felt achy, has a headache, feels like she has a fever but does not. Had temperature taken this morning going into work and it was 93. Just now, her temperature was 96, but not a fever. She stated that this was nothing major, but the information she received said to call and report anything. First temperature taken this morning was from a forehead thermometer. The type of thermometer used for her second temperature this morning was not provided. She was a secretary for environmental services at the hospital she works at. She stated that she thought she could go to work and had to leave. She was going to bed as soon as she hangs up. Height: she used to be 5 feet 8 inches. She was counting on feeling better by tomorrow. She further described her achy feeling as her joints are achy including her knees, back and her elbow, but only her right elbow. She received the injection in her left arm. All she wanted to do now, was to crawl into a warm bed. She stated that she was fine after the first shot. Her arm was a little sore and that was it. She had her first COVID-19 Vaccine injection in her left arm. The soreness at the injection site lasted 2 days and then recovered completely. She did not provide her concomitant medications, stating that she took the same medications that she usually took and had not started anything new. She stated that she was 60 and has the what she had, but she did not have anything of concern; further stating that she had no breathing difficulties or anything like that. The patient underwent lab tests and procedures which included body height: 172.72 cm, body temperature: 93, body temperature: 96, all on an unspecified date. The outcome of events was not resolved.
3-22-04 4:45P Pt stated immediately after receiving the influenza vaccine in her left arm she has had constant pain. Denies any redness or swelling at that time. Pt stated left arm became progressively worse with movement and pain continued. On 3-19-04 pt saw internal medicine physician. The diagnosis was possible nerve damage. Pt referred to neurologist and EMG is scheduled on 3-29-04 at 10:00A. Client stated at this time she is unable to raise left arm for certain everyday tasks. She cannot shampoo hair, fasten seat belts, pull up nylons, and shut her car door with her left arm. Pain rated (9 1/2) on a scale of 0 to 10. She stated her pain is from left elbow to left shoulder. 4/19/04 TC received from client stating MRI of Left shoulder completed 04/09/04 showing normal aging but no cervical spine problems. Stated she was referred to a physical therapist who believes the "frozen shoulder" she now has may be due to a inflammatory process that may have "directly resulted from the flu shot injuring a nerve" She had no prior injury to the arm prior to the Flu shot and he highly suspects this has caused the symptoms. She will continue with PT.
At day 10 I woke up, my injection site was swollen, hard, feverish and itching.
Jynneos was administered nine weeks after being thawed; Jynneos was administered nine weeks after being thawed; Case reference number US-BN-2022-004623 is a spontaneous case initially received on 08-Nov-2022 from a nurse via Communication (reference number: USBAV22-1892) and concerns an adult male patient born in 1991.  Patient's medical history and concomitant medication details were not provided.  On 21-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00002), at a dose 0.5 mL, administered subcutaneously, for monkeypox prophylaxis.  On 19-Oct-2022, 28 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00002), at a dose 0.5 mL, administered subcutaneously. As reported, this vial was administered seven days after the expiry date, which was nine weeks after the vaccine was thawed (explicitly coded as 'expired vaccine used' and 'product administration error').  On 25-Oct-2022, 34 days after the first dose, the patient was vaccinated with the third dose of Jynneos (batch number FDP00002), at a dose 0.5 mL, administered subcutaneously.  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received from on 08-Nov-2022 included the local case ID.; Reporter's Comments: An adult male patient was vaccinated with the second dose (0.5 mL) of Jynneos (28 days after the first dose), administered subcutaneously, with a vial that expired seven days before the vaccination (nine weeks after the vaccine was thawed) which is considered as expired vaccine used and product administration error. 34 days after the first dose, the patient was vaccinated with the third dose of Jynneos, at a dose 0.5 mL, administered subcutaneously. Product administration error and expired product administered are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events. Patient's medical history and concomitant medication details were not provided. Product administration error and expired product administered are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the second dose (0.5 mL) of Jynneos (28 days after the first dose), administered subcutaneously, with a vial that expired seven days before the vaccination (nine weeks after the vaccine was thawed) which is considered as expired vaccine used and product administration error. 34 days after the first dose, the patient was vaccinated with the third dose of Jynneos, at a dose 0.5 mL, administered subcutaneously. Product administration error and expired product administered are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events. Patient's medical history and concomitant medication details were not provided. Product administration error and expired product administered are both assessed as not related to suspect product but to human factor. The case is non-serious.
Red raised bumpy rash with itching and burning and dry skin on neck, shoulders, chest, arms, back, hips  abdomen and thighs