chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; DECREASED APPETITE; 106 DEGREE FAHRENHEIT (F) FEVER; FATIGUE; STOOL ODOUR ABNORMAL; REDNESS OF LEGS; BRUISING OF LEG; PYLORIC SPHINCTER INSUFFICIENCY; PSORIASIS; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1139170) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported.  On APR-2021, the subject experienced stool odour abnormal. On APR-2021, the subject experienced redness of legs. On APR-2021, the subject experienced bruising of leg. On APR-2021, the subject experienced pyloric sphincter insufficiency. On APR-2021, the subject experienced psoriasis. On APR-2021, the subject experienced 106 degree fahrenheit (f) fever. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 106 F. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced decreased appetite.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from stool odour abnormal, redness of legs, bruising of leg, pyloric sphincter insufficiency, and psoriasis, and the outcome of 106 degree fever, vomiting and decreased appetite was not reported. This report was non-serious.
Shortness of Breath, Unable to fully lift left arm for a week, Rash spread, Chest pain, Heart racing
Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headache and nausea. Took Tylenol. Rested 2 hours, still some dizziness, headache, nausea. Improved by 2:30 pm after more rest.  I had arm and neck pain , nausea and fatigue for 4 days after the vaccination.
Fever, wheezing, paleness, weakness, dizziness, breathing, redness, hot on muscle, heart fast.
Post-immunization, within a few minutes of administration, client fell forward out of chair, hit head, and had a tonic-clonic seizure lasting approximately 5 seconds. He resumed consciousness, and remained in confused, lethargic postictal state, with stable vital signs, until EMS arrived and transported him to the emergency room. Mother called later that afternoon to report that client was discharged from the ER, remained lethargic, but had not had any subsequent seizure activity at the time of the phone call.
No additional AE details; patient was vaccinated with VARIVAX after temperature excursion; This spontaneous report was received from a customer and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapy was sterile diluent (manufacturer: Merck).  On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot #U039949 with expiration date: 16-DEC-2023; dose, and route of administration were not provided) for prophylaxis after temperature excursion -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; and -10 Celsius degrees up to 8 Celsius degrees (-0.4 Celsius degrees) for 1 hour 25 minutes 0 seconds (Product storage error). 1 week ago, this vaccine had another temperature excursion with -14 Celsius degrees up to-10 Celsius degrees (-12 Celsius degrees) for 0 hours 50 minutes 0 seconds. There were no additional adverse event details (no adverse event).  This is one of 13 reports received from the same reporter.
sore underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9262) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nightmares" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE taken for blood pressure abnormal (ongoing); CLONAZEPAM taken for anxiety, start date: 2016 (ongoing). The following information was reported: AXILLARY PAIN (non-serious) with onset 24Jan2021, outcome "unknown", described as "sore underarm".  Additional information: Caller mentioned that she had no other side effects from the first three doses of the vaccine other than a sore underarm the next day and  stated that she kept moving her arm and it cleared up and was better.
20min p/vax  episode of apparent sz activity last 3min;pt w/no prior sz;
Patient had a grand mal seizure 2 mos. after receiving the Gardasil shot received at Dr's Office.  The seizure last a full 5 minutes with tonic clonic episode and unconsciousness.  The episode happened at the high school and taken to Hospital on June 6, 2008.  8/11/2008 MR received for ER visit 06/06/2008 with DX: Closed head injury, loss of consciousness <1 hour.  Seizure, generalized. Pt presented to ER after witnessed tonic-clonic seizure at school. (+) vomiting. PE WNL except 2 cm L forehead contusion. D/c to f/u as out pt.  5/22/09 Medical records (neurology consult) received DOS 6/6/08 to 6/12/08. FINAL DIAGNOSIS: Single major convulsive seizure without aura. Presented with major convulsive seizure, tenderness over left eyebrow, bit  tongue - small hemorrhagic area.
pt recv vax 10NOV95 & 13DEC96 pt to MD w/classic case of chickenpox w/lesions all over body including throat;MD stated it was one of the worst cases of chickenpox seen in a long time even in un-immunized children;devel fever & sore th
Rash at vaccine site within approximately 30 min of administration. Erythematous maculo papular no systemic spread. No urticaria. No wheezing. Resolved in 2 days. Associated fever for 2 days.
PAIN & HOT TO TOUCH AT INJECTION SITE, FEVER, HOT/COLD, FATIGUE, LETHARGIC, NAUSEA, ALOOF Narrative:
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, improperly stored doses of GARDASIL 9 lot # K026246 exp. 28-JAN-2017 (route of administration, dose were not reported) were administered to unspecified patients. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via an other company and refers to a patient of unknown age and gender. Relevant medical history, drug history and concomitant medication information was unknown. On an unknown date, the patient was given with GARDASIL 9 lot # reported as 36301, expiration date December 2017 (strength, dose, dose number and route of administration were not provided) that underwent a temperature excursion and had been exposed to a temperature of 32.1 Fahrenheit degrees for 7 hours on an unknown date. The patient did not experience any adverse events. It was unknown if any relevant tests were done. This is one of several reports received from the same reporter. Additional information has been requested.
Weakness Narrative:  Patient is a 61 year-old female with PMH of multiple sclerosis. She received her first COVID vaccine on 1/14/21 and her second dose on 2/4/21. Denied any serious reaction to first dose of vaccine. She had a visit with her spinal cord injury reaction to first dose of vaccine. She had a visit with her spinal cord injury psychiatrist via VVC on 2/24 following a fall that day due to extreme weakness and edema in her legs. On 3/9 she called her primary care provider office with continued symptoms, reporting extreme weakness and inability to ambulate beyond a couple steps since receiving COVID vaccine on 2/4. She additionally reported believing these issues to be related to her MS. It was noted by her provider that her symptoms did not appear to be different than prior symptoms and that she was treated for UTI at her last hospital admission (which can cause pseudoexacerbation of her MS). Patient was instructed to report to the ER for evaluation and was admitted to the medical facility 3/15. As a diagnosis, she was noted to have lower extremity weakness secondary progressive MS vs chronic deconditioning and lower extremity lymphedema. She was treated for her MS and discharged 3/18.
Per hospital pharmacist, patient was admitted on 6/21/15.  Hospital physician had a differential diagnosis of disseminated herpes zoster infection.  Patient started on IV Acyclovir and discharge on 6/26/15 with oral Acyclovir 200mg and Potassium 20 MEQ.
I received the vaccination at 9:30 am. I developed mild-moderate pain in my left arm around 10:30 am. I developed nausea around 10:30 am. I ate normally throughout the day and began feeling faint and severely nauseous at 7:30 pm and vomited immediately after. Vomiting persisted for approx. 5 minutes and was the peak of my adverse event.
Blanching erythematous rash from upper chest to neck, back of neck to ears.  Slight rash on upper and lower back.  Not pruritic.   Slowly resolved over two days.  Took a small dose of Benadryl for two nights.  25 mg the first night and 12.5 mg the second night.
Redness, warmth and swelling below the injection site to level of elbow. Since then, erythema, and swelling have increased and now spread beyond level of elbow. Itchy and tender at site and all over body and joint aches.
A tickle in her leg; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced a tickle in her leg. Outcome of the event was unknown.   PSCC Communication: Caller disconnected prior to completion of transfer. Full details not obtained.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Narrative: COVID infection following COVID vaccine series 03/31, Pfizer, dose #1 04/21, Pfizer, dose #2 09/13 COVID swab, result: detected 09/13 pt cc: SOB and productive cough exposure: unknown
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented mild pain at injection site.
Patient developed hives soon after getting the flu shot. He had the same reaction last year but was worse this year. Dad gave him benadryl. Didn't have breathing issues. Patient was seen that night by dr. at which time he felt bad all day. He also threw up twice this afternoon. We did a strep test which was positive. Patient is being treated for strep.
Information has been received from a physician concerning a 4 month old female with a history of premature baby 34 weeks and bronchopulmonary dysplasia who on approximately 11-AUG-2008 was vaccinated PO with the second dose of ROTATEQ vaccine live (human-bovine). The physician reported that on approximately 12-AUG-2008 (the day after vaccine administration) the patient's mother complained the child lost her appetite. Unspecified medical attention was sought. Subsequently, the patient recovered from loss of appetite (date unspecified). A product quality complaint was not involved. Additional information has been requested.
No adverse event; Primary 1 22JAN2021 and Primary 2 27FEB2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 22JAN2021 and Primary 2 27FEB2021) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 22JAN2021 and Primary 2 27FEB2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 22JAN2021 and Primary 2 27FEB2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 22JAN2021 and Primary 2 27FEB2021). No concomitant medication were reported.             No treatment information was provided by the reporter. This case was linked to MOD-2022-630791 (Patient Link).
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 22-OCT-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated by a physician for a  painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) and topical shingles cream for management of her painful condition. 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, pain and suffering, and other damages. Additional information has been requested.
I first noticed mental and memory fogginess, significant joint and hip pain. I had a burning in my legs that was significant, sinus problems, fatigue and lethargy. Runny nose, cough. sore throat, minor shortness of breath, I also had right upper abdominal pain. I now become winded easily.
Pt. c/o lightheaded/dizzy. Pt. moved To private Treatment area. History and Vitals obtained. Pt. monitored  for 30 mins, Pt. stated this happens whenever she gets any type of shot. Pt. stated she felt better and was released with advice to call 911 w/any further problems.
Diffuse maculopapular rash to trunk, BUE and BLE. No fever, pharyngitis, testicular pain. Severe itching.
He reports to having bleeding of the gums, bleeding from the nose a week or so after receiving the COVID vaccine.  He had bleeding from the right ear on 9/13/2021.  He lost hearing in the right ear since then.  He was hospitalized from 9/24/2021 to 9/26/2021 for low platelets.  Platelet count in the hospital was less than 2000. He was treated with steroids.  Platelet count 39000. Again he was hospitalized from 10/8/2021 to 10/11/2021 for low platelets.  He was hospitalized from 10/28/2021 to 10/30/2021 for low platelets.   He received platelet transfusion, IVIG ,steroids and Rituxan.  He is followed by hematologist.
High fever all day 102 F  Eat Tylenol, but another high fever after 5 hours Diarrhea Severe headache Severe Joint ache Severe chill
Pt states the flu vaccine site became sore almost immediately. She stated the injection "felt different" from other flu injections she had gotten previously. Soreness radiated from the injection site. Pt calls our office complaining that the L arm from the shoulder to upper arm is still sore. She states there was no ? redness, swelling or bruising. Advised to see MD 1/6/03. The follow up states pt was advised to see her doctor.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (received 1st dose in August 2018 and experienced pain in arm and swelling, refer case US2019GSK032752). Concurrent medical conditions included intervertebral disc disorder. Concomitant products included MEDROL and meloxicam. On 11th February 2019, the patient received the 2nd dose of SHINGRIX. On 11th February 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 14th February 2019, the patient experienced allergic reaction and erythromacular rash. In February 2019, the patient experienced pain in arm, swelling arm and skin discoloration. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the swelling arm, allergic reaction and erythromacular rash were not recovered/not resolved and the outcome of the skin discoloration and drug dose administration interval too long were unknown. It was unknown if the reporter considered the pain in arm, swelling arm, skin discoloration, allergic reaction and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on an unknown arm. The patient's arm was swollen pretty quickly than after the 1st dose and experienced swelling that was purple in color. At the time of reporting the patient's arm was tender. The patient experienced allergic reaction to her face and had two big spots on her left and right cheek. The patient received 2nd dose of SHINGRIX late than the recommended schedule, which led to lengthening of vaccination schedule. The patient had a back disk problem for the past couple of years which flared badly on 10th February 2019, so she received MEDROL pack (4 mg) one tablet before breakfast and  Meloxicam (50 mcg). The reporter consented to follow up. This case has been linked with case US2019GSK032752 reported for the same patient by the same reporter.
A 2" x 2" induration immediately developed at injection site. Mild bruising immediately which became more extensive over the next 1-2 days.
I had a pneumonia vaccine on 06/14 appt was at 2 pm. I had to wait for nurse. The next day my right arm was swollen and had red blotches all around the area my forehead had red blotches and my eyes got blood shot. Resolved in about a week.  A follow up report received 9/18/2002 adds: I can't sleep on the right side as my arm hurts when I do that to this day. I had no treatment.
Pt's family reports was diagnosed with chickepox 12/2002. Normal cause of disease.
Patient was given a Moderna Booster shot at the age of 15 years old by mistake through confusion with Pfizer age eligibility. At this time, no adverse symptoms/signs/etc.
The evening of immun pt had a high pitched cry & mom noticed jerking movements of legs spoke w/family MD 25FEB94 & felt it was a vax react;
08/24/22 presents to EC ED for "abdominal pain, shortness of breath". PMHx of "MS, CVA, recent fall and left rib fracture"
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
feeling numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (feeling numb) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (feeling numb). At the time of the report, HYPOAESTHESIA (feeling numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
1 WEEK AFTER VACCINATION PATIENT DEVELOPED AXILLARY TENDERNESS AND SUBJECTIVE FEVER AND SWELLING >5CM. TODAY HAS 6CM DIA ERYTHEMA AND MILD INDURATION BUT TENDER TO PALPATION. LEFT AXILLARY NODE IS SWOLLEN AND TENDER 1 CM ULCER CRATER AT LEFT DELTOID INJECTION SITE. T=37.4C
Hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR024175   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the physician recommended to receive Shingles vaccine for all the peoples 50 years of age and older. There was two doses and we are protected against that painful disease. The patient stated that he/she received first dose of shingles vaccine in December 2022 and he/she shall receive 2nd dose in March 2022. The patient asked about vaccine insurance covers and it was hurts like any vaccine. Additional supportive information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR024175:Same reporter