chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days post ava #1 broke out in a rash in his axilliae.  No itching, or pain.  Photo's-confluent maculo-papular light pink rash, with few descrete distal lesions from central axillary confluent rash.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, 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 SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called to ask about insurance reimbursement. On an unknown date, the patient's body temperature was recorded as 102 degree F. The healthcare professional refused to answer any further questions and asked for insurance codes, when notified a transfer would need to occur to answer that question and asked if there were any other questions before that transfer asked for side effect information, VIS lack. Attempt was made to collect adverse events but the healthcare professional stated not having time and hung up. This case was 1 of the 2 cases, reported by the same reporter.
Spinal pain; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Spinal pain) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SPINAL PAIN (Spinal pain). At the time of the report, SPINAL PAIN (Spinal pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-116619, US-MODERNATX, INC.-MOD-2021-116654, US-MODERNATX, INC.-MOD-2021-116661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116619:Crosslinked with cluster case US-MODERNATX, INC.-MOD-2021-116654:Case for daughter US-MODERNATX, INC.-MOD-2021-116661:case daughter
feeling of pins and needles in their face; swollen and sore gums; swollen and sore gums; fever of 102F; heavy bleeding; A spontaneous report was received from consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heavy bleeding/ postmenopausal bleeding, and contained  large blood clots/postmenopausal bleeding, fever of 102F/ pyrexia,  swollen and sore gums/gum swelling, swollen and sore gums /gum pain.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided.   On 14 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection  On 18 Feb 2021 four days after the first dose of vaccination, patient began to bleed as if the menstrual cycle began. Patient reported that she was at a menopausal phase in life to typically do not bleed or if they do there was a light pink blood excreted, the last time this had occurred was in November. Patient had a bleeding that was very heavy and contained large blood clots. The event heavy bleeding/ post menopausal bleeding was a medically significant event.   Patient stated that this bleeding lasted 7 consecutive days until 25 Feb 2021. The bleeding then stopped 26 Feb 2021 for 2 days, and then heavy bleeding episode came back again on 28 Feb 2021 for 2 days lasting until 02 March 2021. On 03 March 2021 patient reported that she had a fever of 102F which lasted for 24 hours. Patient also reported that she had very very sore gums and swelling inside of mouth. Patient reported that she was not sure if these events were due to the vaccination.   Treatment activities for event was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, experienced heavy bleeding, bleeding was very heavy, and contained  large blood clots was resolved on 02-MAR-2021. The outcome of events,  swollen and sore gums were unknown  and fever of 102 F was  resolved on an unknown date.; 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.
This spontaneous report was received from a female patient of unknown age reporting on herself. On 26-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported). On an unknown date in 2015, after receiving ZOSTAVAX, the patient experienced burning red mark on arm at the injection site. The outcome of burning red mark on arm at the injection site was reported as not recovered/not resolved. Causality between burning red mark on arm at the injection site and ZOSTAVAX was not provided. Additional information is not expected as no patient's physician's contact details were provided.
pain at injection site; aches; fatigue; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2022, the patient received the 1st dose of Shingrix. On 6th February 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, pain, fatigue and fever. On an unknown date, the outcome of the injection site pain, pain, fatigue and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain, fatigue and fever to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in upper left non-dominant arm and experienced pain at injection site, aches, fatigue, fever. The symptoms were still ongoing. The reporter consented to follow-up and obtained consent to contact consumer and health care professional.
presented with c/o possible allergic reaction to MODERNA vaccine. pt reported that he left  Urgent care 10 mins after recieving first COVID vaccination.  pt reported feeling lightheaded while driving, decided to pull in to facility. pt had syncopal episode while filling out paperwork. pt was sitting, was immediately assisted and did not sustained injury, but did have LOC.  pt had syncopal episode, dizziness, nausea and hypotension
Suspected vaccination failure; Got the shingle shot a few yrs ago / shingles / said it was contagious / came back Its in my breast; Diagnose with a bad bladder infection; My back was itchy / wouldnt go away; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, bladder infection and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, bladder infection and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, bladder infection and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got the shingle shot a few years ago and now the patient suffering today went into the emergency thinking had a heart and patient's back was itchy. The patient was end up with diagnose with a bad bladder infection The itch wouldn't go away. The patient went to the doctor did not know what it was but the patient's neighbor told it was shingles and seek a dermatologist. The patient went to dermatologist and they said it was contagious. The patient stated that shingles came back in patient's breast and it feels like someone was standing patient and patient could not sleep. The patient was afraid of taking COVID vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation were not reported.
Petechia/Bruising began within a week,  July 14, 2021 labwork showed a platelet count of 7,000. Admitted to hospital through ER on July 15. ITP is likely diagnosis. No other contributing factors (No other illnesses, medication, health problems, etc)
Period came 5 days early and has lasted since 10/11 without stopping so far.
Breakthrough case admission after 2 vaccines PFizer x2; Pfizer 4/7/21 Lot# Ew0150;  Pfizer 4/28/21 LOT# Ew0158
Redness/swelling (L) deltoid (80mm x 110mm), fever 100.5 F, shivering, general malaise, muscle pain.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced rash, tenderness and touch sensitivity increased. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the rash, tenderness and touch sensitivity increased were unknown. It was unknown if the reporter considered the injection site pain, rash, tenderness and touch sensitivity increased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient received the dose of SHINGRIX in the left arm. The patient experienced soreness at injection site which lasted for a day. A day before the date of reporting, 2 days after receiving SHINGRIX, the patient developed a rash around the area of injection site, along with being tender and increased sensitivity to touch. This covered an area of 5 inches top to bottom and 3 inches left to right around the injection site. The reporter consented to follow-up. No further details were provided. This case was linked with US2019011825, reported by the same reporter.
Immediately after second vaccine (and likely first but 3 weeks was not enough time to say for certain) complete and total erectile dysfunction occurred. As opposed to several full spontaneous erections each month preceding vaccination, in the 8 months following vaccination not a single full erection was achieved, and the few occurring (<10) partial erections were extremely weak and nonfunctional. Only in mid-December was a full erection achieved, and only 2 other instances have occurred since that first instance.  No formal treatment has occurred due to personal nature of the condition especially at my age, personal attempts included periods of caffeine use cessation, higher amounts of L-Citrulline for vasodilation, and continued exercise. No porn use in any manner so that cannot be a cause.
Numbness in my left leg  thigh,  the area of the Rectus Femorus and  the Vastus Lateralis muscles, mild pain in that area and the pain  traveling to my left testicle,   constant sharp  tingling and burn like sensation to the touch of the skin
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L035283, expiration date:15-DEC-2016) for prophylaxis. There was no adverse event reported. The outcome of the event was unknown. Additional information has been requested.
Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021. Scheduled for her second dose on 27Jan2021. She asked that will it help or harm to get the second dose of the COVID vaccine with her history of a COVID positive test? She would like to know if she should get her second dose of the COVID vaccine after testing positive for the COVID infection, or not. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 31-JUL-2013 was vaccinated with a dose of ZOSTAVAX {strength, dose and route not reported, lot # H021459, expiration date: 30-APR-2013 (also reported as 03-APR-2014)}, that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to about 9 patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown date, about 9 patients were vaccinated with improperly stored ROTATEQ (lot # L044476, expiration date 07-SEP-2017; dose was unknown) orally. The vaccines were expose to 54.7 Fahrenheit degree for 39 hours, 27.7 Fahrenheit for 1 hours and 56 Fahrenheit degree for 3 hours and 3 minutes. No adverse effect reported. Additional information has been requested.
one day after injection of Varivax (L) arm red and swollen-area 3 cm x 35 cm-Ice applied-No further treatment.
Patient fully vaccinated and died of Covid related causes. According to patient's daughter,  her father was taken about 1 month ago with symptoms, waited 12 hours in the waiting room, was diagnosed with pneumonia, negative for Covid and returned. Symptoms worsened 1 to 2 weeks later on 08/24/2021. Was taken to ER and finally admitted to a room. Tested positive for Covid and isolated. Patient died about five days later.
Caller said that her arm was swollen after the first dose too.; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received first dose of bnt162b2 (Batch/Lot Number: EN9581, Pfizer BioNTech), via an unspecified route of administration, administered in left arm on 18Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm was swollen after the first dose on an unspecified date. Caller said that her arm was swollen after the first dose too, but she did not run a fever. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
For several weeks, patient experienced Bilateral Lower Extremity (BLE) swelling and a circulatory problem. Based on physician's assessment on 5/4/2021, events observed are temporally related with COVID vaccination.   During a hospital encounter on 5/4/2021, patient was diagnosed with IVC thrombosis.
received 1st dose in 2020 and more than a year later 2nd.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's Comments: The nurse reported that the patient just received second dose of Shingrix somewhere and also mentioned that it was more than a year from first dose. The reporter consented to follow up. The reporter did not want to answer any safety question. No further information available.  Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
SHORTNESS OF BREATH; MIGRAINES; CIRCULATION ISSUES; LETHARGY; BODY ACHING; NEUROPATHY PAIN; CHILLS; ARM SORENESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced migraines. On 2021, the subject experienced circulation issues. On 2021, the subject experienced lethargy. On 2021, the subject experienced body aching. On 2021, the subject experienced neuropathy pain. On 2021, the subject experienced chills. On an unspecified date, the subject experienced shortness of breath, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 2021, and arm soreness, and had not recovered from migraines, circulation issues, lethargy, body aching, neuropathy pain, and shortness of breath. This report was non-serious.
Six days after receiving the second vaccination, I had a night of non-stop heart arrhythmia which consists of the heart seemingly skipping a beat and then the next beat is very heavy.  It lasted throughout the night.  I have had an arrhythmia sporadically in my past, but I don't recall it ever being this pronounced or sustained.  I had the same exact thing happen 12 days after a positive COVID test in which I exhibited mild symptoms.
Dizziness; Headache; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 08-Mar-2021, HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            Relevant text: The patient post receiving the second dose of vaccine had a headache, developed fever, nausea, vomiting and dizziness. The patient reported that all these events subsided except for Dizziness.  No Concomitant product use was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medications for the events included paracetamol (Tylenol) and ibuprofen (Advil).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information was added
Within one month of receiving the vaccine, I began to have chronic headaches accompanied by dizziness (vertigo), as well as depression. These symptoms have remained chronic until the present, nearly seven years. I have tried many different treatments, including migraine medications (rizatriptan, topamax, beta blockers), supplements, psychiatric medications, Botox, acupuncture, chiropractic, massage, craniosacral, amino neurofrequency, and NSAIDs with limited success. My diagnoses are chronic migraine, new daily persistent headache or chronic daily headache, bipolar II and fibromyalgia. These conditions have caused significant and permanent disability.
No symptoms at this time. Received a Moderna booster when they should have received the Pfizer
Patient was in vaccine waiting area. Fell forward off the chair and hit his head on the floor after decent.  Patient was alert but groggy when I made my way over to him. Called EMT and continued to stay with the patient.  patient became alert and oriented x3 within 2 minutes.  Emt accessed patient and let patient go home.
FULL BODY FATIGUE; MILD HEADACHE; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 165 centimeters.  The patient's concurrent conditions included alcohol use, smoker, chronic pain, scoliosis of the 4 lower vertebrae, high anxiety, and marijuana addiction. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included fentanyl citrate for high anxiety, lorazepam for high anxiety, gabapentin for pain, and scoliosis, and cyanocobalamin for scoliosis, and back ache.  On 12-MAR-2021, the subject experienced mild headache. On 13-MAR-2021, the subject experienced full body fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild headache on 12-MAR-2021, and had not recovered from full body fatigue. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
pt was overdue for vaccination of DTAP and IPV at age 3 yrs and 8 months, pt was administered 1 dose of kinrix pre-filled syringe intramuscular injection to left thigh on 12/20/21 at approx. 1600 hrs to meet this requirement, no adverse effects reported at time of administration or to the time of this report