chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 21-JUL-2013, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by a pharmacist. On an unknown date, the patient experienced shingles (herpes zoster) and on an unspecified date in 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
6 hrs following inject respiratory sx began; tx ATB; Also exp somnolence; @ 24 hrs pulmonary, laryngeal & cerebral edema; semi comatose from 24-72 hrs; Also exp pain inject site;
Mom reports that child had a 4"X3" red swollen area on her arm, and a 2"X2" darker red/purple, hardened area in the middle of the bigger area. This area was warm to touch.
Dizziness, Headache, Myalgia, Diarrhea, Pain, Swollen Axillary Lymph Nodes Narrative: Symptoms lasted approximately 3 days.
Mom called Triage on 7/18/2020 (triage service outsourced during after hours) to report that son c/o tongue feeling swollen post vaccines given on 7/17/2020. Per triage note, no other symptoms. Advised to give Benadryl as directed. This RN spoke with mom on 7/20/2020 @ 1130 to confirm concerns. Per mom symptoms seem to be improving gradually using Benadryl. RN advised mom if not completely improved in the next 48-72 hours to call our office back for further advise. Mom agreed to do so.
a patient was administrated an expired dose of Menactra, No AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves an 11-years-old male patient who was vaccinated with a 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6208AB and expiration date 08-Jul-2020) via an intramuscular route in the right arm for prophylactic vaccination on 05-Aug-2020.  The patient's medical history, medical treatment, vaccination and family history were not provided.  The patient concomitantly vaccinated with a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Patient presented to the pharmacy the morning after receiving the shot with redness around the right arm in the area of the injection sites and swelling of the lymph node area of the right armpit. The patient had no swelling of the neck or other complaints, so the patient was advised to follow up with her physician. An attempt was made later in the evening to follow up with the patient to see if she had seen her physician, but  she did not answer.
Disease recurrence; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 17Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing); "mild psoriasis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flagyl, reaction(s): "known allergies: Flagyl". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID test type post vaccination: Nasal Swab; (Nov2021) Positive, notes: COVID test type post vaccination: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300054550 same patient, different events after different doses of the vaccine;
Left leg was under extreme pressure, could not walk, fever, whole arm was sore. Red blotches on wrist. Dizziness, nauseousness.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 11-FEB-2015, the patient was vaccinated with VARIVAX (Merck) lot # L006385, expiration date- 25-FEB-2017, which was exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 9F, Time frame- less than 1 hour and there was temperature excursion earlier also. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; This case was reported by a other health professional via sales rep and described the occurrence of fever in an unspecified number of patients who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On an unknown date, the patient received Fluarix at an unknown dose. On an unknown date, unknown after receiving Fluarix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Fluarix.  Additional case details were reported as follows: This case was reported by medical assistant. The age at vaccination was not reported. The reporter did not give consent to follow up.
I have a family history of Hypothyroidism. My mother had Hypothyroidism. After getting my first two doses of the vaccine. When I had my Thyroid levels checked my Levels were high. I was prescribed Levothyroxine. I had had my levels checked in June of 2020.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt. came into the pharmacy to get a 2nd dose of Covid-19 vaccine. 1st dose was on 6/1/21, with a hx of an adverse reaction of dizziness/pale Asked pt & her dad if she was fine after that incident-Pt. states she was totally fine when she got home so wanted to get 2nd dose. Shot was given ~4:15pm, and when I checked pt. if she's ok, she started to pale and told me she was dizzy. Called paramedic ~4:25pm and around 4:55pm paramedic teams walked pt. out, pt. seemed fine, and confirmed she was fine
Patient complained of macular rash signs on both posterior upper arms (left and right deltoids) and symptoms of body aches and soreness all over her body to the Triage Nurse (in person) on 11/17/2016. Patient was encouraged to take Motrin 600mg every 6 hours with food as needed for pain, and Benadryl 25mg as needed for her rash on 11/17/2016. On 11/21/2016, the patient reported no rash and reduced bone pain.
10:55 am after giving meningococcal vaccine patient said she felt like she was going to faint. She rested her head back and was unconscious 45 seconds. Patient was pale. Given one glucose tab and water. Patient felt back to normal 10 minutes later.
Body aches, headache, fever, chills, loss of appetite 24-36 hours, headaches and fatigue continue, Tylenol, fluids, rest.
temperature was 100.5 F; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included klinefelter's syndrome. Concomitant products included levothyroxine.   On 1st September 2021, the patient received the 1st dose of Shingrix. In September 2021, 2 days after receiving Shingrix, the patient experienced fever and dizziness. On an unknown date, the outcome of the fever and dizziness were recovered/resolved.   It was unknown if the reporter considered the fever and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received his first Shingrix dose and 2 days later had dizziness and his temperature was 100.5 fahrenheit. No additional information was reported. The reporter consented to follow up.
This spontaneous report as received from an other health professional refers to an unknown number of patients of unknown age. On unknown dates in 2017 (reported as starting on or after 11-MAY-2017), the patients were vaccinated with PNEUMOVAX 23 for prophylaxis. On unknown dates, the patients experienced incorrect product storage. No adverse effect was reported. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011654: US-009507513-1708USA011804:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an left deltoid. The patient's injected arm was sore for 1 week. No other symptoms reported for the first dose. For tolerance of 2nd dose of SHINGRIX, refer case US2018145478.
Information has been received from a health professional concerning a 3 year old male who on 11/08/03 was vaccinated with a dose of varicella virus vaccine live (Lot # not available). On 11/14/03 the pt developed shingles.  The child was not hospitalized. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Lots of red bumps on stomach back and arms. They do not itch, they do not hurt, but there is a lot.
CHILD WAS GIVEN MMR, VZV AND DTaP VACCINES WHICH WERE ORDERED FOR SIBLING.  DR NOTIFIED, PT EXAMINED. NO TREATMENT NECESSARY. VIS STATEMENTS GIVEN TO MOM WITH REASSURANCE. 11/13/13 PRESENTS TO OFFICE S/P ER VISIT OF 11/13/13 WITH C/O RASH ON HANDS/ARMS, FACE ASYMETRICAL, NOT ACTING LIKE SELF, CRYING ALL THE TIME, NOT SLEEPING LIKE NORMAL. 11/18/13 PER MOM RASH NOW ITCHING AND WITHIN SKIN INSTEAD OF ON TOP, NOW STUTTERING BOTH SENTENCES AND SINGLE WORDS.
patient woke up achy; hardness of arm; redness in between elbow, up the arm, to shoulder and neck; arm red and hot to touch; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (patient woke up achy), VACCINATION SITE OEDEMA (hardness of arm), CERVICOBRACHIAL SYNDROME (redness in between elbow, up the arm, to shoulder and neck), VACCINATION SITE ERYTHEMA (arm red and hot to touch) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (patient woke up achy), VACCINATION SITE OEDEMA (hardness of arm), CERVICOBRACHIAL SYNDROME (redness in between elbow, up the arm, to shoulder and neck), VACCINATION SITE ERYTHEMA (arm red and hot to touch), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN (patient woke up achy), VACCINATION SITE OEDEMA (hardness of arm), CERVICOBRACHIAL SYNDROME (redness in between elbow, up the arm, to shoulder and neck), VACCINATION SITE ERYTHEMA (arm red and hot to touch), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Underage recipient received dose 1 in two dose series. (17 at time of administration)
On 4-30-12 - patient in clinic to pick up rx. Noted past week had feeling of fever, c/o throat hoarseness, flu-like symptoms since taking vaccinations on 4-17-12. Noted at time s/s almost gone. However, planned see optometrist 5-3-12 d/t eye. See line to left eye. Noted abnormal sight of left eye.
pt recv vax 15APR97 & approx 2hr later pt immed devel a gen allergy-type rash that was not varicella-like;pt also devel swelling of fingers;mom felt was most likely result of amoxicillin but not sure;taken to ER tx DPH & sent home;
No adverse event; HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.; Excursion cumulative duration19.3 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours). On 17-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours) and POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.).    No concomitant information was reported. It was reported that first time excursion started on 15-Dec-2022. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. No treatment information was provided.
Within 24 hours after administration of 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours.
My daughter ran a fever from 7/5/2014-7/10/2014 of 99.9-100.1. I treated it with tylenol. On 7/12/2014 she began to get a small rash that looked like chicken pox. On 7/18 she got a staph infection and got boils in her diaper area that spread to he inner thighs as well.
I positive for COVID-19 on 01JUN2022, I was feeling very sick and worn over. As of 15MAR2023 I had a Pulmonary function testing and it came back positive for Fibrosis. I have upcoming doctor visits that will tell me more.
Headache following administration same day - progressively got worse; coupled with vision problems.  Like no other headache/migraine - crippling pain not dulled buy ibuprofen, motrin, butalbital, or hydrocodone. 12/11/08-records received for DOS 11/18-11/20/08-DC DX:Intractable headache of two weeks duration with failure of outpaitient treatment. Severe low back pain. Recent lumbar puncture. Admitted with severe headache described occipital headache with radiation over head.
8/14-patient tested in the facility ED for fatigue, weakess and cough. at that time it was also found that she had a UTI, but was not exceedingly ill with COVID related to respiratory issues. Patient presented on 8/16 with worsening weakness, flushing of face and cough, new pneumonitis on imaging. patient was hypoxic into the low 80s. fever of 101F. patient then hospitalized and treated for COVID-19 with remdesivir 200mg x1day and remdesivir 100mg x4days.
Given booster at around 12 noon.  By 8 p.m. feeling unwell, tired, went to bed early.  Awoke at around 2 a.m.(Nov 2) with nerve pain in lower back radiating into hips, groin and legs as far as my knees.  Nerve pain continued into the day.  Took 500 to 1000 mg of acetominophen with little effect on pain. Accompanying this pain are muscle spasms and both have continued with very little abatement until the present, November 16, 2021.  Little energy, sleeplessness nightly, and starting to become despondent. Had a virtual drs. appt on Nov 9, 2021 with PCP to discuss symptoms with a follow up appointment in the office to get a kenalog shot in each side of my lower back.  Some relief but pain is now recurring...  I have been taking 600 to 800 mg of ibuprofen under drs recommendation 2x daily for inflammation with very little effect.  Went and took a Covid-19 PCR test with the Health Department on the chance that maybe I had Covid on Monday, Nov 8th, 2021, Negative.
Swelling; Sickness; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ILLNESS (Sickness) and CONDITION AGGRAVATED (Condition aggravated) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Rheumatoid arthritis.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate Free. On an unknown date, the patient experienced SWELLING (Swelling), ILLNESS (Sickness) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SWELLING (Swelling) and ILLNESS (Sickness) was resolving and CONDITION AGGRAVATED (Condition aggravated) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced oral conceptive caused to not eat. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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 spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 09-NOV-2015, the patient was vaccinated with an improperly store dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Moderna COVID-19 Vaccine EUA - Morning after vaccine, red hour glass shaped at vaccine site that was raised and had a knot underneath it and hurt. By mid week redness went away and arm felt pretty normal. 7 days after the vaccine, the same thing happened all over again, redness, knot, soreness.  This is the 9th day after vaccine and it is still there. It itches a little like it is trying to heal, but is still red and sore and has a knot under it.
1st dose on March 5 and the 2nd dose on March 26 of this year; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) (batch number Abxb58aa, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 26th March 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 26th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 24-May-2022 Reporter's comment: Nurse reported that a patient received a dose of Bexsero inadvertently on 5th March and the second dose on right deltoid 26th March of this year. The expiration date was from agency.  The reporter was not able to provide additional information during the call, but consent was provided for follow-up via email. Additional Supportive Information: The patient received the second dose of Bexsero earlier than the recommended interval, which led to shortening of vaccination schedule.