chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician assistant refers to a 88 year old female patient with no drug allergies. On 08-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number and expiry date was not reported), 0.65 millimeter (ml), subcutaneously and also received pneumococcal vaccine, polyvalent (23-Valent)(manufacturer unknown) on the same day. Approximately on an unknown date in May 2013 (reported as last week), the patient experienced significant outbreak of rash, open blisters and soreness after receiving ZOSTAVAX. The patient sought medical attention and the physician had asked the patient to use BENADRYL. The patient also presented anemia since an unknown date in MAY 2013. There have been no laboratory tests done. The reporter had not seen the patient but was told that the blisters started around the injection site the week after vaccination. The blisters had now spread to the entire body and was painful. The largest ones were the size of "half of a dime" and the other ones were smaller, "less than 3 millimeter in diameter". The blisters were on the hands, arms, face, back, and trunk. No treatment was given at this time. Physician assistant stated that the patient was not hospitalized, this was not life threatening, no significant disability, no intervention to prevent serious criteria, this was not cancer and there was no overdose. The outcome of all the reported events was not recovered/not resolved.
Rash on upper torso, hands, face, neck and arms. Rash on hands continue with itching.
Medicine taste in her throat; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Medicine taste in her throat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced TASTE DISORDER (Medicine taste in her throat). At the time of the report, TASTE DISORDER (Medicine taste in her throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had reported that his adverse event is currently fine and got resolved by itself.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Added event outcome and narrative was updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received vaccine 9/14/09 & developed left arm/chest T2/T4 distribution shingles like syndrome s/p injection in left arm.  He received vaccine at outside facility. Tx in process.
Patient started feeling itchy where she got her injection then it started to swell up on 7/19 It got better on 7/20 but still red and warm to touch on the injection site  advised patient to apply hydrocortisone 1% cream or benadryl gel otc and ice the area. Seek medical help if not resolved in 3-5 days.
8 x 5 cm area of induration with 12 x 8 cm warmth and erythema area to lt upper thigh. Began x 1 day post 15 mo immunizations. Pt (+) "scratching" at area <2 "small" pink indurated areas also noted to rt upper thigh on exam. TX: BENADRYL every 6 hours prn warm, moist compress.
arm swollen and red; arm swollen and red; rash in her hands in between the fingers and palms/rash is down the arm, neck and head, around the face, chest and back, around the waist, and down the legs;; little bumps almost like ant bites; itch real badly; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen and red), RASH (rash in her hands in between the fingers and palms/rash is down the arm, neck and head, around the face, chest and back, around the waist, and down the legs;), URTICARIA (little bumps almost like ant bites), PRURITUS (itch real badly) and ERYTHEMA (arm swollen and red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 09-Mar-2021, the patient experienced RASH (rash in her hands in between the fingers and palms/rash is down the arm, neck and head, around the face, chest and back, around the waist, and down the legs;), URTICARIA (little bumps almost like ant bites) and PRURITUS (itch real badly). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swollen and red) and ERYTHEMA (arm swollen and red). The patient was treated with HYDROCORTISONE ACETATE (CORTAIDE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 12-Mar-2021, PRURITUS (itch real badly) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen and red) and ERYTHEMA (arm swollen and red) had resolved, RASH (rash in her hands in between the fingers and palms/rash is down the arm, neck and head, around the face, chest and back, around the waist, and down the legs;) outcome was unknown and URTICARIA (little bumps almost like ant bites) had not resolved. Not Provided
excessive defecation (every 20 minutes), excessive gas, belching, tiredness, headache - lasted 2 days
Lot of inflammation; Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Lot of inflammation) and PAIN (Pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 08-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Lot of inflammation) and PAIN (Pain). At the time of the report, INFLAMMATION (Lot of inflammation) and PAIN (Pain) outcome was unknown.     Booster made patient to stay in bed. But about five days after taking Rinvoq, started to feel little better with joint pain.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624995, MOD-2021-624996 (Patient Link).
Soreness on scalp started Tues. 9/12, Blisters began on 9/14. P/A confirmed Shingles diagnosis. Visit to Dr. on 9/16.
This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-OCT-2015 - unknown stop date, Batch no: 11349221A, Route of administration: Intramuscular, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 02-OCT-2015, after starting / treatment with AFLURIA the patient received 1.0 ml IM dose of AFLURIA/Overdose. Action taken: Details manually to be entered. Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
Nauseated; very tired; Threw everything up; Dry mouth; Dizzy; Weak; Allergy attack / Allergies kicked in; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack) and HYPERSENSITIVITY (Allergies kicked in) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SAZiA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus disorder.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack) and HYPERSENSITIVITY (Allergies kicked in). On 04-Mar-2021, the patient experienced NAUSEA (Nauseated), FATIGUE (very tired) and VOMITING (Threw everything up). At the time of the report, DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack), HYPERSENSITIVITY (Allergies kicked in), NAUSEA (Nauseated), FATIGUE (very tired) and VOMITING (Threw everything up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No specific follow-up information recorded.
Mother of the patient mentions high fever, diarrheas, edema on right thigh and redness. Fever was 38.5 deg C during the first 24 hours fluctuation.
Shingrix - Late second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 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: Shingrix - Late second dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 A pharmacist called to ask for information regarding patient who received the first dose of Shingrix back in August 2019. The health care professional asked if the patient needed to restart the series. The health care professional did not provide lot number and expiry date of the first Shingrix dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
patient experienced syncope while waiting in the post vaccination waiting area, she was sweating profusely and was unable to respond for a short amount of time, less than a minute. after about a minute she recovered and could respond normally.
4-month-old patient was administered with adacel with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom adacekl was given with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 15V (CRM197)) for Immunisation.  On 20-Sep-2023, 4 month old patient received 0.5 ml, once suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE,Suspension for injection lot U7869AA via intramuscular route in the right thigh for prophylactic vaccination (strength and expiry date: unknown) (product administered to patient of inappropriate age) (latency same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 4-month-old patient was administered with adacel with no reported 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 the 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.
Patient was given  0.5 ml of Sodium Chlorine instead of the J&J vaccine
patient complained of whole arm redness, hives and fever in the evening of 103.4. patient took Tylenol for fever and Benadryl for hives
Delayed allergic reaction (9 days) around injection site (upper left arm) - warm, hard lump with itching.  Over the few days prior, I also had a few incidences of where I experienced sudden loss of strength in the arm where the injection was given.  I did not think much of it and thought it might have just been bad sleeping posture, but the swelling that came afterwards made me think that the symptoms may be connected.
I experienced extreme fatique and as of today,  July 7, 2021, I am just starting to feeling somewhat normal energy level.  As far as the vertigo, I am a hiker and whan I went to hike an area of the Grand Canyon that I had hiked in the past, vertigo kicked in and I was unable to complete the hike.  It was terrifying.  I have never had vertigo in the past.
Area of discoloration and induration measuring 2 cm in diameter with circular shape. No evidence of blush, hot, baseline pain. Patient afebrile. No symptoms other than possible tenderness to palpation.
Pt called and left voicemail that he had a  painful itchy blistery rash on his left arm. Pt reported this 6 days after injection, unable to reach pt after multiple attempts to try to confirm the exact onset and symptoms.
Fainted immediately after receiving vaccine. Rested, drank water and immediately improved. Mother took child to private MD to be evaluated, after leaving clinic child was diagnosed with vasovagal reaction.
On 4/13/21, two weeks after my Covid vaccine, I slept through my alarm clock and did not wake up until 11:00am. I felt like I was sick/feverish, but could not get my thermometer to read. I called my son, who came to the house and noted the thermometer was fine, but he stated I seemed confused. I was taken to a local hospital, but since I had no injuries or headache, they could not figure out what was wrong. By the time doctors realized I had an aneurysm that was leaking blood in my brain, ER doctors had to send me by helicopter to Hospitals to be "saved" from death. I spent 7 days in the ICU and 3 more in the hospital neurology floor before  I was able to be sent home.
Information has been received from a registered nurse concerning an employee who was vaccinated with the first dose of VARIVAR (Oka/Merck).  The patient may have been vaccinated with lot 661658/1135X and developed swelling and erythema at the injection site after getting the first dose.  At the time of reporting (04-DEC-2008) the outcome of the patient was unknown.  The nurse requested a lot search of VARIVAX (Oka/Merck).  A standard lot check investigation was performed.  All in-process quality checks for the lot number 661658/1135X were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Center of Biologics Evaluation and Research and was released.  This is one of several cases from the same source.  Additional information has been requested.
Herpes breakout on gums and lips with swelling and swelling of joints with severe pain (left ankle and right wrist)
Headache, Myalgia, slight injection site discomforts, reported extreme fatigue & chills Narrative:
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 ZOSTAVAX 19400 PFU (dosing regiment unspecified). No concomitant medications were reported. On an unknown date pharmacist reported that 2 patients experienced a good amount of swelling about 5 to 6 inches long at the injection site after receiving ZOSTAVAX. Pharmacists reported the injection site was red and warm. Pharmacist reported physician thought it could be cellulitis and prescribed KEFLEX as a prophylactic. The outcome of cellulitis, pharmacist reported the injection site was red and warm and a good amount of swelling about "5 to 6 inches long" at the injection site after receiving ZOSTAVAX was reported as recovered/resolved on an unknown date. There was no product quality complaint (PQC) involved. Patient sought medical attention and saw a doctor. Causality assessment was not provided. This case is linked to: 1410USA006526 (same reporter). Additional information has been requested.
The night after receiving my COVID booster my left axillary lymph node began to swell and become sore to the touch. % days later the swelling and soreness is still present.
Fever up to 103.4 lasted one day (day 9 following shot) Full body rash began 9 days following the shot  (still has but is lessening)
Patient was given regular Pfizer 12+ vaccine instead of the Pfizer Bivalent booster that he was supposed to recieve.
This spontaneous report was received from a Nurse Practitioner regarding a patient of unknown age. There was no information about concurrent condition and historical medication. On 15-AUG-2016, 16-AUG-2016, 17-AUG-2016, 18-AUG-2016, and 19-AUG-2016, the patient was vaccinated with improperly stored PROQUAD, lot# M004891, expiration date-25-JUL-2017, lot# I040414, expiration date- 13-APR-2017, lot no. I040960, expiration date- 16-OCT-2016 and lot# M004891, expiration date- 25-JUL-2017. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was developed. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reports that he felt lightheaded and thirsty. Stood up to go get a drink of water and in the process had syncopal episode. LOC lasted approx 5 seconds. Pt had not eaten breakfast prior to coming in. Pt was moved to a bed, hydrated, and monitored. Advised him to contact PCP.
Constant headache; entire bone and muscle aches to the point of not being able to move with out pain; entire bone and muscle aches to the point of not being able to move with out pain; swollen lymph nodes right armpit same side as injection, swollen lymph nodes back of the lungs; diaphragm painful muscle spasms; low grade fever for more than 48 hours; This is a spontaneous report from a contactable other hcp (self reported).   A 52-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL8982, expiry date was not reported) via an intramuscular route of administration at Arm Right on 05Mar2021 at 11:00 as single dose for covid-19 immunisation. Medical history included hypersensitivity, mycotic allergy and Darvocet. Concomitant medications included desvenlafaxine succinate (DESVENLAFAXINE SUCCINATE), clonazepam (CLONAZEPAM), tizanidine (TIZANIDINE), ibuprofen (IBUPROFEN) and paracetamol (TYLENOL). Patients historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number: EN5318 expiry date was not reported), via an Intramuscular route of administration at Right arm on an 12Feb2021 at 12:00 PM as a single dose for covid-19 immunisation. Patient did not receive any vaccine prior to covid vaccination. Patient did not tested for covid post vaccination. On 06Mar2021 at 05:00, the patient experienced constant headache, entire bone and muscle aches to the point of not being able to move without pain, swollen lymph nodes right armpit same side as injection, swollen lymph nodes back of the lungs, diaphragm painful muscle spasms, low grade fever for more than 48 hours. The patient did not receive any treatment. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
After three years of suffering, 19 Year old girl dies from GARDASTL vaccine injury; This spontaneous report was received from a consumer via a company representative through an online article referring to a 19 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dosage detail, route, strength, lot # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (it was unclear which the two products was involved). On an unknown date (reported as after three years of suffering), the patient died from vaccine injury.  It was unknown if an autopsy was performed. The reporter considered the event to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).; Reported Cause(s) of Death: vaccine injury
The day of vaccination, the patient presented to the emergency room with a complaint of dizziness and syncope. Reported that she became dizzy, presyncopal feelings, and had a witnessed syncopal event. The patient stated she does have vasovagal syncopal events after blood draws in the past. The patient was assigned an overnight admission for a potential post-vaccination adverse event, new onset atrial fibrillation, dehydration, and syncope. Patient was discharged the following day.
not received dose two due to pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received, 2 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, approximately twenty patients received dose one of Havrix about two years ago and had not received dose two, till the reporting date due to pandemic and the shut down. The reporter did not provide patient demographics, lot number or expiration date.  No additional details were provided.