chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a 64 year old male patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-DEC-2015, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On or about 18-AUG-2016, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Woke up to arm feeling hot, itchy and bumpy at the injection site.  Plan is to take benedryl.
Patient developed rash after receiving Hep B #2. Rash blanching red papules to chest Right arm and face. No hives noted.
Patient said she is having pain at the site of injection, swelling, a bump and she feels like it is feverish and warm at the site of injection.
Approximately 12 hours after receiving the vaccine, I developed a significant headache and lethargy.  Both lasted roughly 24 hours.  By Day 2 post-vaccine, all symptoms were gone.  Approximately 1 week later, I developed pain in my legs where the knee and calf connect.  It was not overwhelming and only lasted approximately one day.
Developed migratory dermatographic urticaria. Currently taking levocetirizine 5mg once daily. It's controlled while medication is in effect, but as soon as it wears off, itchness comes back.
1 day of not feeling well; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (1 day of not feeling well) 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 MALAISE (1 day of not feeling well). At the time of the report, MALAISE (1 day of not feeling well) had resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
sudden hearing loss in her right ear; worsening vision in her right eye, described as vision being not as clear or precise as it used to be; This case was reported by a consumer via call center representative and described the occurrence of sudden hearing loss in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 2 weeks after receiving Shingrix, the patient experienced sudden hearing loss (serious criteria GSK medically significant) and blurred vision. The patient was treated with prednisone. On an unknown date, the outcome of the sudden hearing loss was not recovered/not resolved and the outcome of the blurred vision was unknown.   It was unknown if the reporter considered the sudden hearing loss and blurred vision to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported, but it could be 57 or 58 years old. Two weeks after vaccination, the patient experienced sudden hearing loss in her right ear for which she visited specialists and took a course of prednisone with no resolution. The patient also experienced worsening vision in her right eye, described as vision being not as clear or precise as it used to be. The reporter consented to follow up. Emergency room visit was required. No further details were available. This case had been linked with US2020033015, reported by same reporter.
exposed at a dinner party and tested Ag positive 24Feb2022 but no sx so far; exposed at a dinner party and tested Ag positive 24Feb2022 but no sx so far; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 25 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 16Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Feb2022, outcome "unknown" and all described as "exposed at a dinner party and tested Ag positive 24Feb2022 but no sx so far". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (24Feb2022) positive, notes: covid test type post vaccination=Unknown. Additional information: Exposed at a dinner party and tested Ag positive 24Feb but no sx so far. Facility type vaccine was Workplace clinic. Sequiris vaccine administered in vaccine 4 weeks on 16Nov2021. Unknown if Covid prior vaccination. Tested Covid post vaccination. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events Vaccination failure , covid 19 and the suspect drug BNT162B2 cannot be excluded.
Child returned to clinic 34 hours after immunizations with right deltoid area red, swollen and warm to touch. Reddened area measured 7 cm X 7 cm-treated with Keflex,
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported for the reporter's brother. The age at vaccination was not reported. The patient experienced soreness of arm at injection site for 3 to 4 days after 1st dose of SHINGRIX. For tolerance of 2nd dose refer linked case US2018136202, for same the patient.
No adverse effects reported; improperly stored doses of PROQUAD was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 18-APR-2019, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin, rHA) (lot # R008206 and expiration date 16-SEP-2019) (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for a time frame 1 hour 15 minutes and -14 °C to -10°C for a time frame 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010084: US-009507513-1905USA010082: US-009507513-1905USA010085: US-009507513-1905USA006081: US-009507513-1905USA010081: US-009507513-1905USA010092:
had the flu shot and still got the flu.; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who had the flu shot (INFLUENZA VACCINE) and still got the flu.  The patient's past medical treatment(s), vaccination(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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for flu.  On an unknown date the patient had the flu shot and still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu shot and still got the flu.).  At time of reporting, the outcome was Unknown for the event had the flu shot and still got the flu.
BODY ACHING; CHILLS; PAINFUL INJECTION; FEVER; This spontaneous report received from a patient concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 12:20 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aching. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced painful injection. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aching, chills, and fever on 09-APR-2021, and painful injection on 08-APR-2021. This report was non-serious.
Patient described never having previously had side effects from his chemo infusions. 3 days following vaccination, patient reported nausea, fatigue, lethargy, intermittent SOB. Those symptoms have improved but he has developed a reaction to all meats he eats. He said that whenever he has tried to eat deer, elk, beef or chicken he has immediately felt nauseous and it makes him gag.
fever of 103.7; Cough; body aches; Joint pain; chills; This is a spontaneous report from a contactable Nurse reporting for herself.  A 54-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose in left deltoid for COVID-19 immunisation at the age of 54-year-old. Lot number was EL1284. Medical history included Asthma since 1991 and ongoing, high blood pressure since 2020 (6 months before the report) and ongoing. Concomitant medications were unknown. On 07Jan2021, the patient experienced fever of 103.7 at 1:30PM, chills at 9:00AM, body aches at 11:00AM, Joint pain at 09:00AM, cough at 1:00PM; the events were considered medically significant. The patient was not treated for the events. On 13Nov2020, test showed she had COVID-19. On 07Jan2021, body temperature was 103.7 Fahrenheit. The patient did not recover from the events. The nurse considered the events were related to suspect vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Incident was called to the health dept several days after the incident. The nurse who took the call did not initiate a report and has since left the health dept. VAERS form initiated on 1/4/01. Per doc no. 215040, 60 day follow-up, she uses "gait training walker".
Pt is complaining of pain that started  a day or two afterwards that  has become progressive and is causing numbness to  fingers 3-5 on the right hand.  Pain starts at the deltoid and moves down the arm to wrist and hand.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (unknown age) who was vaccinated with ACT-HIB which was reconstituted with sterile water vs. the supplied 0.4% NaCl diluent on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. 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 and Module VI of the 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.
3-4 days after vaccine noticed lymphadenopathy in right axilla, same side vaccine was given.  Pain was about 3-4/10. Did not attribute to vaccine then 1/18/2021 5 days later swelling and itching at injection site.  No warmth to touch.  Now day 7 and still with pain in axilla and swelling arm still present.
Shingrix three doses; This case was reported by a pharmacist via and described the occurrence of extra dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number BM27F, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 7th September 2021, the patient received the 3rd dose of Shingrix. On 7th September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consented to follow-up.
Patient had bleeding at the time of injection that produced a small knot. Patient states that heat, swelling and soreness worsened by the end of the same evening of 5/18/18 to the point it was difficult to lift her arm. She presented to the pharmacy on 5/24/18 with a healing bruise at the injection site and red blotchy patches up to 2 inches across 3/4 of the way from her deltoid muscle down to the interior elbow. She stated that the swelling was better but that it was still hot and sore.
PATIENT ARM IS BRUISED ALL AROUND HIS BICEP. HE HAS STABBING PAIN AT THE INJECTION SITE. ACHING PAIN ALL THE WAY DOWN HIS ARM. CANNOT RAISE HIS ARM ABOVE HIS SHOULDER WITHOUT BEING IN SEVERE PAIN.
new onset nephrotic syndrome May 17, 2021, kidney biopsy will be done 8/9/2021 kidney function normal, UA otherwise bland no prior history of micoralbuminuria associated with her DM
For the 10 days following the booster dose the itching escalated; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (For the 10 days following the booster dose the itching escalated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 019B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (For the 10 days following the booster dose the itching escalated). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and Bed rest for Pruritus. At the time of the report, PRURITUS (For the 10 days following the booster dose the itching escalated) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For the 10 days following the vaccine the booster dose the itching escalated. She had seen multiple doctors and dermatologists who had treated it with antihistamines including Zyrtec & Benadryl, and a steroid ointment, & they had said that it was not related to the vaccine. She was on a low histamine diet which helped calm it down.  No concomitant medications were reported.   This case was linked to MOD-2021-435255 (Patient Link).
Initial information for this unsolicited case was received on 23 February 2015 from a healthcare professional via another manufacturer. An unidentified patient, gender, age and date of birth were not reported was vaccinated on an unreported date with DIPHTHERIA/TETANUS ADSORBED TOXOIDS, manufacturer, batch, route and site of administration were not reported. On an unreported date, the patient experienced a serious reaction. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. The patient outcome was not reported. Documents held by sender: None Based on information received on 23-FEB-2015, the following information suspect product was coded via generic name N/A DIPHTHERIA AND TETANUS TOXOIDS have been amended.; Sender's Comments: This is a poorly documented case of an unidentified patient with an unknown medical history who was vaccinated with DIPHTHERIA/TETANUS ADSORBED TOXOIDS vaccine, manufacturer unknown and at an unspecified time experienced a severe adverse reaction. Information about concomitant medications, diagnosis and laboratory tests to support the potential diagnosis are required. In the absence of this information, no final conclusion can be drawn.
Patient called the pharmacy on 11/23 and reported the following after receiving her second Moderna dose on 11/22: feeling cold, hot to touch, tired and achy, trouble breathing, difficulty walking. Pharmacist on duty recommended following up her physician.
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 22-MAY-2015, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt dx with VZ 1-14-14. Rx for acyclovir given. Sib also Dx with VZ. Both pts are up to date with vaccines including varicella. Unsure if episode qualifies as "failed vaccine" - ordered by physician to report. Sib also Dx'd.
Initial information has been received from a pharmacist concerning a 31 years old female patient. In August 2012, the patient was vaccinated subcutaneously with the first dose of (Merck) VARIVAX (dose, lot number and expiration date were not reported). No other co-suspects were reported. No concomitant medications were reported. In September 2012 the patient became pregnant 1 month after her first vaccination with (Merck) VARIVAX. She was not pregnant when she administered the first dose of (Merck) VARIVAX. On an unknown date in 2012, the patient miscarried (medically significant). On an unspecified date in 2012, the patient was subsequently tested and her titers showed no immunity for varicella. On 23-JAN-2013, the patient was vaccinated with the second dose of (Merck) VARIVAX subcutaneously (lot #, expiration date not reported). At the time of report, the patient was not pregnant. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
had shingles shot had them/suspected vaccination failure; had them left lower stomach and thigh; itched terrible; did not hurt that much; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles shot had them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had them left lower stomach and thigh), pruritus (Verbatim: itched terrible) and pain (Verbatim: did not hurt that much). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the pruritus was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case  was received from the patient via interactive digital media. The patient had them on the left side of lower stomach in the crease of his/her thigh did not hurt.  That much but itched terrible and he/she still got itch there. The patient had the Shingles shot some years ago and thought that helped him/her.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.