chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue and muscle soreness in upper legs lasting 10-14 days. Severe respiratory phlegm white mucus lasting 1 week. Next dose is Feb26 at 3pm. Wondering if I should proceed?; Fatigue and muscle soreness in upper legs lasting 10-14 days. Severe respiratory phlegm white mucus lasting 1 week. Next dose is Feb26 at 3pm. Wondering if I should proceed?; Fatigue and muscle soreness in upper legs lasting 10-14 days. Severe respiratory phlegm white mucus lasting 1 week. Next dose is Feb26 at 3pm. Wondering if I should proceed?; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 05Feb2021 at 15:30 (at the age of 65-year-old), in Arm Left, as dose 2, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Patient known allergies reported as NO'. Concomitant medication(s) included ALA ALC, vitamin D, magnesium, Vitamin C, Amlodipine taken for an unspecified indication, start and stop date were not reported. Historical vaccine of patient included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date (at the age of 65-year-old), as dose 1, single for COVID-19 immunization. Patient did not took any other vaccine within four weeks of COVID vaccine. Patient had not tested COVID prior vaccination and had been tested COVID test post vaccination. On 08Feb2021 08:00 the patient experienced fatigue and muscle soreness in upper legs lasting 10-14 days. severe respiratory phlegm white mucus lasting 1 week. next dose is feb26 at 3pm. wondering if i should proceed. On 21Jul2020 the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Patient visited Doctor or other healthcare professional office(or) clinic visit as a result of AE. Treatment was not received. The clinical outcome of events was recovering.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a pharmacist referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since 28-NOV-2015, an unspecified number of improperly stored doses of ZOSTAVAX (lot # L028280, expiration date: 28-OCT-2016) were inadvertently administered to the unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaints involved. Additional l information  has been requested.
This spontaneous report as received from a pharmacist regarding to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # R027993, 01-OCT-2020) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (-9 degree Celsius to 8 degree Celsius) (7C) for 6 days (144 hours). There was previous temperature excursion reported. No adverse symptoms were reported. No further information provided. No product quality complaint (PQC) was associated with this report.
High fever lasting several days (101-102). Headache, body aches, lethargy/very low energy levels. Slightly constrained breathing. Pain and inflammation at injection site.
AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE; Felt Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE) and SOMNOLENCE (Felt Sleepy) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-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, the patient experienced MOBILITY DECREASED (AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE) and SOMNOLENCE (Felt Sleepy). At the time of the report, MOBILITY DECREASED (AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE) and SOMNOLENCE (Felt Sleepy) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of mobility decreased was a reasonable possibility with HUMIRA (ADALIMUMAB) and reporter's causality for the event of somnolence was not provided with HUMIRA (ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
DIZZINESS, FATIGUE, NUMBNESS IN TONGUE, WEAKNESS, COUGH, NUMBNESS IN LEFT ARM, TACHYCARDIA, NAUSEA, MUSCLE ACHES AND PAINS, MILD FEVER, FEELINGS OF A HEAD COLD.
2 weeks after injection the area  2.5 x 1.5" just below the injection site is red, puffy, itchy & raised.  Up until now the only symptom was a sore arm  the day after injection.
Patient was administered a dose of Moderna that had been at room temperature for greater than 12 hrs after first puncture. Patient was due for a booster dose and was give 0.5mL dose -per chart review.  No known adverse reaction at this time.
Fever (103 per moms report) and rash on abd, back, and legs bilaterally). Fever lasted less than 24 hours rash started to clear on 10/15/2012.
headache, nausea, earache, swollen gland, sore, red (from top of shoulder to elbow and under arm, feverish swollen upper right arm, pain in back of neck, all joints ached, lower back pain, calves, pain outer side of thighs, pain in legs, low grade fever, body ache
Patient called after 2 days of receiving the vaccine and reported that she had fever and a knot on the arm that she had the covid shot. She is taking Benadryl and Tylenol and her symptoms are slowly going away.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned an adolescent male. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, and non alcoholic, and other pre-existing medical conditions included: The patient did not have known allergies and no history of drug abuse. 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 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 inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211140013.; Sender's Comments:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
rheumatoid arthritis; pain in his shoulders and elbow/pain in his hips and ankles; started to swell/The swelling in his upper body; pain in hand; pain in upper body; joint swelling; joints red; joint hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis) in a male patient of an unknown age 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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant), ARTHRALGIA (pain in his shoulders and elbow/pain in his hips and ankles), SWELLING (started to swell/The swelling in his upper body), PAIN IN EXTREMITY (pain in hand), PAIN (pain in upper body), JOINT SWELLING (joint swelling), ERYTHEMA (joints red) and FEELING HOT (joint hot to touch). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; MELOXICAM for Adverse event, at an unspecified dose and frequency and GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis), ARTHRALGIA (pain in his shoulders and elbow/pain in his hips and ankles), SWELLING (started to swell/The swelling in his upper body), PAIN IN EXTREMITY (pain in hand), PAIN (pain in upper body), JOINT SWELLING (joint swelling), ERYTHEMA (joints red) and FEELING HOT (joint hot to touch) outcome was unknown.            The another medication that started with an "Imm" for rheumatoid arthritis. Concomitant medications were not reported.  Company Comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis. The event occurred after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the information regarding the dose number is not specified. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis. The event occurred after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the information regarding the dose number is not specified. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
his skin all over feels like it's burning; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (his skin all over feels like it's burning) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (his skin all over feels like it's burning). At the time of the report, SKIN BURNING SENSATION (his skin all over feels like it's burning) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Patient got the Johnson and Johnson COVID19 Vaccine in March.
pain in right arm, difficult to lift & move arm, hot & cold chills, wiped out feeling, sick to stomach
COLLAPSING; EMERGENCY BRAIN SURGERY; BRAIN DEAD; CEREBRAL INFARCTION; DEATH; This spontaneous report received from a consumer (news article) via a company representative concerned a 57 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: heart valve surgery (33 years ago). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: unknown) dose was not reported, 01 total, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On 06-OCT-2021 the patient was collapsed and rushed to a hospital. He was diagnosed with a cerebral infarction there and underwent emergency brain surgery, but was eventually declared brain dead. Number of days hospitalized and discharge information was not reported. It was unknown if an autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death on 10-OCT-2021, and the outcome of brain dead, collapsing, cerebral infarction and emergency brain surgery was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211048955-COVID-19 VACCINE AD26.COV2.S-death, brain dead, cerebral infarction, collapsing, emergency brain surgery. 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: UNKNOWN CAUSE OF DEATH
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and in Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Sep2023, outcome "not recovered" and all described as "Tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299588 Same reporter, patient, product, different dose and events;
pt recv vax NOV96 & NOV97 pt devel a rash consisting of approx 100 lesions;MD inidcated that these lesions were not typical looking varicella & it was diffusely itchy;
After about 15 minutes of receiving the vaccine I became light headed and dizzy. I was hypertensive with my systolic blood pressure up to 160s. This event resolved after about 10 minutes. I was resting and about an hour later the light headedness came back along with an itchy throat. I was taken to the ED and given Benadryl. My symptoms then resolved.
Pt. has fever 100.5, chills, sore throat, vomiting. 10/31/09 started.
On 7-28-09 Patient received TDAP vaccine.  The patient circled no for pregnancy on the screening form. On 7-30-09 the patient reported and stated she had a positive pregnancy test done that morning. The patient stated that she was concerned about the TDAP vaccine because she had 2 previous miscarriages and a son with Cerebral Palsy.
Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid dermatopathy.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes: High blood pressure medication and thyroid medication   This case was linked to MOD21-028591 (E2B Linked Report).; Sender's Comments:  MOD21-028591:CROSS LINKED NO
The same day of vax, the pt developed an injection site reactions at the site of the vaccine.
2 months pregnant at the time of vaccine. Babies brain is not developing properly and miscarriage is expected.
R thigh hardened, red, swollen, hot, painful to touch-from hip to just above knee.
Patient called and said that she developed a red lump that was hot and is about 3/4 the size of her upper arm and it seems to be getting worse
Generalized rash to entire body.  Seen in Emergency Department.  Seen in Clinic. Given Medrol 4MG Taper Pack and Benadryl
received the Covid vaccine 19Dec2020/then became Covid positive; exposed to Covid/Covid positive; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on 19Dec2020 at single dose for Covid-19 immunisation .  The patient medical history  and concomitant medications were not reported.  The patient received the covid vaccine on 19Dec2020 /then became covid positive. The patient underwent lab tests and procedures which included Sars-Cov-2 test: positive on  unknown date.  Information on the Batch/Lot number has been requested.
The patient had excruciating, unremitting pain that began in her left arm and radiated to her left shoulder and neck shortly after the fourth dose of vaccine.
Pt recvd 1st dose of vax on 7JUL92 & immed following vax pt exp near syncope; the next day improved; It was also noted that pt recvd series of Hep B vax in 1986 & did not seroconvert;
Patient called pharmacy two days after getting vaccine. She reported swollen lymph nodes, swelling, and itchy/hurting eyes. Patient called PCP and took benadryl per PCP recommendation. She is being seen by doctor on 5/13/2022.
Vomited for 10 days. No diarrhea. No fever. No other problems. Pedialyte given.
has been diagnosed with MS; developed photophobia, the light sensitivity turned to double vision; light sensitivity turned to double visiondeveloped photophobia, the light sensitivity turned to double vision; Initial information received on 24-Aug-2022 regarding an unsolicited valid serious case from a patient sister.  This case involves a 49-year-old male patient who experienced has been diagnosed with multiple sclerosis (MS), developed photophobia, the light sensitivity turned to double vision while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date in Jun or Jul of this year 2022, the patient was doubted to received suspect Menactra vaccine at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization. Information regarding batch number requested.  On unknown date in 2022 within 24 to 48 hours of receiving the vaccine, patient developed photophobia and the light sensitivity turned to double vision (diplopia). Patient had developed other significant symptoms and after lots of testing.  On unknown date in 2022, the patient developed a serious has been diagnosed with MS (multiple sclerosis) at unknown latency. This event was assessed as medically significant.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for  the events.; Sender's Comments: Sanofi company comment 29-Aug-2022: This case involves a 49-year-old male patient who experienced has been diagnosed with multiple sclerosis (MS), developed photophobia, the light sensitivity turned to double vision after receiving Menactra vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Case number PHEH2014US003821, is an initial spontaneous report from a pharmacist received on 24 FEB 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: unknown) at a dose of 0.5 ml intramuscularly on 11 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of vaccination, lot # and expiration date not reported) as a shingles vaccination. On 04-JUL-2016, (reported as "week ago"), the patient had joint pain and their skin felt warm to touch. The outcome of the events were not reported. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Wife came in today and reports that "about 1 week ago, his arm started hurting and 4 days ago he ended up in the ER, then hospital for 4 days.  We suspect it was the shingle shot that gave him a major infection".
Erythema and induration around the site of injection. Patient reported the swelling began about an hour after the injection.
dry cough, sore throat, left eye schera injection (mild), left rhinnorhea within 15 minutes of vaccination.  Self resolve.  mild in nature
The patient had bad rash all over the body and fever; bad rash all over the body and fever; This spontaneous report was received from a medical assistant and refers to a currently 6-year-old female patient. The patient's medical history, concurrent conditions and concomitant medication were unknown to the reporter. The patient had previously experienced an unspecified allergy/drug reaction on measles, mumps and rubella virus vaccine (reported as MMR) (manufacturer unknown) (captured in case # 1907USA012574). On an unspecified date in 2014, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosing details, route of administration, lot number, and expiry date were not reported) for prophylaxis (reported as vaccine). On an unspecified date in 2014, the patient experienced bad rash all over body (rash generalised) and fever (pyrexia), which lasted for one week. The patient took diphenhydramine hydrochloride (BENADRYL) to treat the events. The patient visited the physician's office and sought medical attention. It was unknown to the reporter, if any lab diagnostics/studies were performed. The patient had recovered from rash generalised and pyrexia on an unspecified date in 2014 (reported as lasted for 1 week). The causality assessment was not reported. No product quality complaint was involved.; Sender's Comments:  US-009507513-1907USA012574: