chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 08-AUG-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster and post herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered.  The events of multiple shingles outbreaks and postherpetic neuralgia were considered to be disabling.
Red bumpy, itchy rash developed a few hours after receiving vaccine (vaccine received at 1100, itching, redness, and rash began around 1330), localized to injection site, over course of 24 hours spread to face, entire trunk, and upper thighs. Notified physician, who order medrol-dose pack. Treatment started at 2130on Saturday, 1/16/21. Symptoms began to decrease within 3 hours, subsided within 48 hours.
Information has been received from a registered nurse (R.N.) concerning a 6-year-old white male with asthma and no known drug allergies who on 06/20/2000, was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication and there was no illness at the time of vaccination. On 12/07/2005, the patient was seen in the physician's office with lesions on his leg, some scabbed over. On 12/09/2005, he complained of abdominal pain, no fever. Subsequently, the patient recovered as of 12/12/2005. Additional information is not expected.
This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Eighteen hours post vax, the pt developed a local reaction. The following day, the pt presented to a physician with a swollen toe. Additional information has been requested.
No adverse effect; Improperly stored PROQUAD; This spontaneous report as received from a medical assistant refers to an 8 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 12-JUN-2019 the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection recombinant human albumin (rha) (lot # R030801, expiry date: 22-APR-2020) (dose, frequency and route were not reported) for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored in temperature of -14 degree Celsius (C) to -10 C (-14.4 C) for 15 minutes. There was previous temperature excursion reported -9 C to 8 C (-3.2 C, -7.6 C) for 4 hours. A digital data logger was not involved. No adverse effects were reported. No product quality complaint was involved.
I had dry cough.  I had severe headache.  I was extremity fatigue.  I had diarrhea for 3 days.  These symptoms lasted for about 3 to 4 days.  I contact my doctor about this.  I went to get a COVID-19 test on Dec 23rd, positive result.
Narrative:  COVID infection following COVID vaccine series 04/14, Moderna , dose #1 05/04, Moderna , dose #2 08/12 COVID swab, result: not detected 08/27 COVID swab, result: detected 08/27 pt cc: No symptoms exposure: unknown 08/27 SARS-COV-2 Variant Sequencing result: pending
18 months old received Boostrix/received Boostrix as Dtap 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included infection (suffered a cut on his feet with a gardening tool that created an infection).   On 21st July 2022, the patient received the 4th dose of Boostrix. On 21st July 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: An 18 months old male patient received a Boostrix vaccines as a Dtap 4th dose, due he suffered a cut on his feet with a gardening tool that created an infection.  The permission to storage personal information was not asked.  The email was sent to Safety. The reporter consented to follow up. Additional supportive information: The patient received a Boostrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Had to stay in bed - fatigue required bed rest x 2 days. Aches all over. Felt feverish - didn't check temperature. Headache. Small increase in nasal secretions. Takes EXCEDRIN regularly for arthritis. No extra taken.
Anaphylactic reaction w/o SOB. EpiPen 0.3mg administered to left thigh, 911 was called, pt transported to ER.
Patient presented to the vaccination site on 10/31/21. The client notified RN that he received first dose of the (Sputnik) COVID vaccine in another country in March 2021. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Janssen. Per CDC guidance, approval to proceed with COVID vaccine Janssen was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Janssen Lot# 1822809 on 10/31/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 1500.
Developed uticaria after 1 week+ from booster. Developed dermatographia 1 week+from booster. Uticaria and dermatographia have persisted for weeks. Could not work or sleep due to hives all over body,palms of hands etc. Sought urgent care twice to relieve symptoms with no improvement. (Given prednisone injection and 2 week course of 40mg prednisone and 25mg diphenhydramine). Sought allergy/immunology specialist and was instead prescribed pepcid twice daily, allegra twice daily, and hydroxazine to relive itching at night. Stopped all steroids. Instructed to follow up in 1 week, symptoms have improved but still present, able to work again, told can get any vaccines; not an allergic reaction but my body's immune system is releasing histamine in response to booster.
Subject in pneumococcal vaccine trial, with severe COPD hospitalized for uncontrolled hypertension. Vaccination took place on 11/14/07. According to physician, relationship is 'None'.
red spots on some toes which became like blisters.; red spots on some toes which became like blisters.; spot under her toe hurt upon walking; This is a spontaneous report from a contactable pharmacist (patient). A female adult patient of unspecified age received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization in Dec2020. No other medical history. No known allergies. No allergies to medications, food, or other products. Prior to vaccination, the patient did not diagnose with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Dec2020, 4 days after vaccination, the patient developed red spots on some toes which became like blisters. The spot under her toe hurt upon walking. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved.  Information on the lot/batch number has been requested.
During the administration of the vaccine the syringle seperate from the needle and the vaccine sprayed out of the side. The patient received an unknown amount of the vaccine but a significant amount of liquid was apparent on the patient's arm.
Flushing and facial rash immediately following vaccine administration; spontaneously resolved in a few hours; no anaphylactoid symptoms.
congested; she felt weird; Felt a little fatigued the next day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she felt weird), NASAL CONGESTION (congested) and FATIGUE (Felt a little fatigued the next day) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced FATIGUE (Felt a little fatigued the next day). In September 2021, the patient experienced FEELING ABNORMAL (she felt weird). On an unknown date, the patient experienced NASAL CONGESTION (congested). At the time of the report, FEELING ABNORMAL (she felt weird), NASAL CONGESTION (congested) and FATIGUE (Felt a little fatigued the next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive, negative (Negative) Negative and negative (Negative) Negative.         No concomitant drug details were reported. No treatment details were reported.  She did a home test and it came back positive, did additional tests and a pcr test that came back negative, did another pcr test and it came back negative, conducted an antibody test where it came back positive.   This case was linked to MOD-2021-345514 (Patient Link).
"Bones felt like truck ran over them".  Occurred after each injection. Also migraine headaches & breathing problems & now has chronic bronchitis. Also having a lot of food & environmental allergies.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date in March 2016 an unspecified number of patients were vaccinated with improperly stored (temperature excursion-55F) dose of GARDASIL 9 lot # L043213, expiry date-28-AUG-2017. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information is not expected as the reporter did not wish any further contact.
Patient (employee) experienced inflammation in bilateral legs, fever overnight Also had discoloration/rash of lower extremeties - per PA, consistent with livedo reticularis
Erythema, edema and induration of Lt arm. Body temperature 99.9 oral. Treated with Rest, Ice and Acetaminophen.
My hips, legs and feet have been really sore and making it hard to walk around since three days after receiving the booster
11/16/2022 I had a really bad cold. I had lots of mucous and coughing. I also had a low grade fever of 99. I tested positive on 11/18/22 with a home COVID test. I called the doctor's office on 11/21/22. She prescribed over the counter medication, MUCINEX and FLONASE and prescription cough syrup, promethazine. I took ibuprofen and TYLENOL. She told me I was past the period of having PAXLOVID. By 11/26/22, my symptoms were gone and I had recovered.
high heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced high heart rate on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Headaches after covid vaccine; Body aches after covid vaccine; stomach issues; This spontaneous case was reported by a patient and describes the occurrence of GASTRIC DISORDER (stomach issues), HEADACHE (Headaches after covid vaccine) and MYALGIA (Body aches after covid vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Ankylosing spondylitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe) and Ankylosing spondylitis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In 2021, the patient experienced GASTRIC DISORDER (stomach issues) and MYALGIA (Body aches after covid vaccine). On an unknown date, the patient experienced HEADACHE (Headaches after covid vaccine). At the time of the report, GASTRIC DISORDER (stomach issues) had not resolved and HEADACHE (Headaches after covid vaccine) and MYALGIA (Body aches after covid vaccine) had resolved.            No concomitant medications were reported.  On an unknown date, the patient experienced headaches. At the time of the report, headaches had not resolved. The reporter causality for the event of headaches was no reasonable possibility with Moderna COVID-19 vaccine.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of headaches was not provided. the reporter's causality for the events of body aches after covid vaccine and headaches after covid vaccine with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event of stomach issues with Humira(adalimumab) was reasonable possibility.  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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received, Event and dose information and narrative updated.
Sever nausea, high fever of 103, admittance to hospital emergency room with administration of intravenous fluids.
Symptoms were fatigue, muscle aches, and slight chills.  Symptoms dissipated the following morning after sleeping
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 11/18/2008 with CHF. Vaccination took place on 9/10/2007. According to the physician the relationship is 'None'. We would be happy to forward on the Study's SAE Reporting Form upon request.  5/14/09 Received SAE medical records of 11/19-11/26/2008. FINAL DX: CHF exacerbation and cardiomyopathy w/apical left ventricle akinesia & EF of 25%. Records reveal patient experienced lung heaviness x 1 day, DOE, chronic cough.  Responded well to meds & d/c to home.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-OCT-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash appearing on his left upper thigh and hip. In response to these complaints, on or about 14-OCT-2016, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events is unknown. Additional information has been requested.
Pt recv vax on 10/23/98; post vax pt exp vertigo lasting 5 min x 5 day w/nausea
At site of injection, itching, swelling, redness, warmth redness and warmth was in a 8 cm diameter continued and looked worse on day 8 (01/13/21) sought medical attention on 01/14/21 to rule out cellulitis, dr believes it to be localized adverse reaction to injection site area beginning to look better on day 9 (01/14/21)
diarrhea; vomiting; fever; 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 DIARRHOEA (diarrhea), VOMITING (vomiting) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043l20a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), VOMITING (vomiting) and PYREXIA (fever). At the time of the report, DIARRHOEA (diarrhea), VOMITING (vomiting) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Reporter'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.
We are patient's medical provider with (name) Medical Center.  We received the information regarding her vaccines through the Immunization Information System.  Per the Immunization Information System patient received her 1st dose of COVID 19 vaccine at the Health Department on 3/11/21 and this vaccine was the Moderna vaccine - Lot # 048A21A. Again per the Immunization Information System on 3/27/21 the patient received a 2nd dose of COVID 19 vaccine at the drugstore on 3/27/21 and this vaccine was the Pfizer vaccine - Lot #EN6202. Patient received 2nd dose too soon (not 28 days apart) and also received vaccine of 2 different products/manufacturers.
Pt. arrived for dose #2 04/27/2021.  We refused and informed that dose #2 can be given after 16th birthday.
Pt vaxed w/1st & 2nd dose of vax in JUN & JUL90 respectively; In NOV90 recd 3rd dose of vax instead of receiving it in DEC90; On 14DEC90 lab eval revealed positive results for Hep B surface antibody; There were no adverse rxn;
SEPTIC SHOCK; ACUTE HYPOXIC RESPIRATORY FAILURE; This spontaneous report was received from literature:  This report concerned an 88 year old male of unknown race and ethnic origin. The objective of this study was to describe fatal and non-fatal possible Adverse Events after COVID-19 vaccine administration. The patient's height, and weight were not reported. The patient's past medical history included: congestive heart failure, and cerebrovascular accident, and concurrent conditions included: hypertension, diabetes mellitus type 2, and multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, one total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced septic shock, and acute hypoxic respiratory failure and was hospitalized (date unspecified). Number of hospitalization days were not reported. On an unspecified date, the patient died from septic shock, and acute hypoxic respiratory failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The authors concluded that although reported adverse events (AEs) were not necessarily caused by the vaccination, this study provided further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. The study also supported prior data that serious AEs post vaccination were much lower than primary COVID-19 infections. Also, need for further studies to investigate causalities between vaccines and reported AEs across all age groups was highlighted. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211045466.; Sender's Comments: 20211048130-covid-19 vaccine ad26.cov2.s-septic shock, and acute hypoxic respiratory failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SEPTIC SHOCK; ACUTE HYPOXIC RESPIRATORY FAILURE
Pediatrics administered a flu vaccine to my 6 years old daughter last week. It is a Sanofi brand flue vaccine. She had adverse reaction first two days with severe pain on the location. Then 5 days later, we start seeing large hives covering her harm from shoulder to elbow. She said it hurts and itches so bad. Reported the incident to Sanofi but they are no table to provide any guidance on what to do. We honestly dont know what to do know? Which vaccine to give her next year for flue. Anyone in FDA can help us?
Patient with 3 COVID vaccines who admitted to hospital with positive COVID test.  Provider d/c note:  "86-year-old male with past medical history of hypothyroid, dementia, and neurogenic bladder s/p suprapubic catheter.  Patient was admitted 08/24 for sepsis secondary to urinary tract infection after presenting with symptoms of weakness.  He was also found to be COVID-19 positive, but with no hypoxia or chest x-ray findings of COVID-19 pneumonia.  He was started on IV Rocephin initially, but urine cultures grew MRSA, Enterococcus, and Corynebacerium, and so his antibiotics were switched to vancomycin.  His suprapubic catheter was exchanged 8/30.  He is stable for discharge home with home health and oral antibiotics."