chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted to hospital through ER for suspected seizure episode without fever and no other symptoms/problems-EEG=WNL, Brain CT scan=WNL.  05/14/2007 MR received for an o/n ER admit (3/16/07) for parental report of a generalized shaking seizure-like episode which lasted ~ 1 min.  Pt's eyes were looking straight forward and child became sleepy after episode. Pt. (+) for diarrhea.   PE: (+) nasal congestion and perianal rash.  Temp 99.8'F. Otherwise WNL. Discharge DX:  Seizure 2' to immunization.
Rash which became itchy after using benadryl and moved to armpit; rash is more red; really hurt after bumping into the door; extremely sore arm, lift arm more than half way was more painful; uncomfortable for a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sore arm, lift arm more than half way was more painful), DISCOMFORT (uncomfortable for a week), PAIN (really hurt after bumping into the door), RASH PRURITIC (Rash which became itchy after using benadryl and moved to armpit) and RASH ERYTHEMATOUS (rash is more red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included SULFASALAZINE, VITAMIN D3 and MAGNESIUM for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (extremely sore arm, lift arm more than half way was more painful) and DISCOMFORT (uncomfortable for a week). On 27-Feb-2021, the patient experienced PAIN (really hurt after bumping into the door). On 10-Mar-2021, the patient experienced RASH PRURITIC (Rash which became itchy after using benadryl and moved to armpit) and RASH ERYTHEMATOUS (rash is more red). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 27-Feb-2021, PAIN (really hurt after bumping into the door) had resolved. At the time of the report, PAIN IN EXTREMITY (extremely sore arm, lift arm more than half way was more painful) and DISCOMFORT (uncomfortable for a week) outcome was unknown and RASH PRURITIC (Rash which became itchy after using benadryl and moved to armpit) and RASH ERYTHEMATOUS (rash is more red) had not resolved.            This case was linked.
Fever heavy sweating all night, malaise Narrative:  s/s lasted until 2/3/2021, took Tylenol and Ibuprofen alternately for symptoms
developed a myelitis, presenting and paresthesias and leg weakness, responsive to high dose steroids.
Patient received 2 month vaccines ROTATEQ, ENGERIX B 10 mcg/0.5 mL, PENTACEL, and PREVNAR 13 on 10/2/13. Pt had no adverse effects in office after vaccines. Per mom, pt developed seizures and infantile spasms 11 days after vaccines were given. Pt was admitted to hospital 12/17/13 with seizures.
sore at the injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at the injection site) and CHILLS (chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore at the injection site) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (sore at the injection site) and CHILLS (chills) outcome was unknown.
Immediately after the shot and for up to four days after:  Swelling, fever in the injection area, a hard knot at the injection site, pain in and around the injection site area  Seven days after the injection:  Increased swelling, itching, fever in the injection area, a very large hard knot at and around the injection site, pronounced pain in and around the injection site area
About two hours after getting vaccinated, Patient had her first ever migraine and the pain was so intense she passed out.  Paramedics transported her to ED where she had altered consciousness for about another 4 hours.
Mother called clinic approximately 15 min. after leaving clinic  (10:00 am) and reported child is not feeling well with symptoms including feeling clammy and vision is going black. Advised mother to seek medical treatment at nearest emergency room for child symptoms as we do not have a physician on staff.
Pt. states after receiving the Moderna shot 03/06/2021, a rash appeared 03/16/2021 throughout the body appearing lower legs then moving to the feet. Still continuing to appear on hands and now face. Physicians visit resulted in steroid shot. Allergist recommended but not seen.
No fever. Dad states within an hour after receiving the vaccines in Rt. thigh, pt began having a red area, the area kept enlarging every day since. Pt complained of pain at site. Refused to walk without holding Dad's hand.
Contact Dermatitis worsened, with hives.  Seen by Dermatologist, given steroids, patch testing done to determine allergy.  Patch test result in allergy to Thimerasol.
the second shot and gets a stroke; he lost his left foot; he can't see trough his left eye; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (the second shot and gets a stroke), LIMB INJURY (he lost his left foot) and BLINDNESS UNILATERAL (he can't see trough his left eye) in a 75-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (the second shot and gets a stroke) (seriousness criterion medically significant), LIMB INJURY (he lost his left foot) (seriousness criterion disability) and BLINDNESS UNILATERAL (he can't see trough his left eye) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (the second shot and gets a stroke), LIMB INJURY (he lost his left foot) and BLINDNESS UNILATERAL (he can't see trough his left eye) outcome was unknown.            No concomitant medication information was  provided. No treatment medication information was provided.  It was stated that the patient was  [PHI REMOVED], he can't work , he doesn't have a place to to live, he lives inside his truck.  Company Comment: This spontaneous case concerns a 75-year-old, male patient with no reported medical history, who experienced the unexpected, medically significant AESI of Cerebrovascular accident which resulted to the unexpected, serious events of Blindness unilateral (medically significant) and Limb injury (disability). The events occurred on an unspecified date after receiving the second dose of mRNA-1273 vaccine. The patient reportedly suffered from a stroke and eventually lost vision on his left eye and also lost his left foot. As a result, the patient was unable to work. Clinical course and treatment details were not reported in the case. At the time of reporting, the outcome was unknown. The elderly age of the patient remains a confounder for the cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient with no reported medical history, who experienced the unexpected, medically significant AESI of Cerebrovascular accident which resulted to the unexpected, serious events of Blindness unilateral (medically significant) and Limb injury (disability). The events occurred on an unspecified date after receiving the second dose of mRNA-1273 vaccine. The patient reportedly suffered from a stroke and eventually lost vision on his left eye and also lost his left foot. As a result, the patient was unable to work. Clinical course and treatment details were not reported in the case. At the time of reporting, the outcome was unknown. The elderly age of the patient remains a confounder for the cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have been vaccinated with improperly stored PNEUMOVAX23 injection, lot # M043424, expiration date: 06-JUN-2018 (dose and route of administration were not reported). Temperature excursion ranged from 47 to 77 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effect was reported. No product quality complaint was involved. This is one of three reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009340: US-009507513-1703USA012509:
Extreme fatigue started about 5 hours after innoculation, followed by chills (no fever), all over body aches, vise-like headache, and inability to sleep. Pulse and oxygen levels measured by fingertip oximeter were within normal range.  Symptoms peaked at 16-24 hours, and were mostly gone in 48 hours. Lingering headache for another 12 hours or so.
At approximately 9 AM the following day, it seem like all my joints are very achy and sore. All liquid ingredients that I tasted seem to taste very strange Seems to have cleared up by the third day. Other than taste buds.
Booster; Anaphylactic Shock; throat closure; rash; swelling; rapid heart rate; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 14:00 (Lot number: FF2590) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Rhuematoid Arth" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergy to Poultry" (unspecified if ongoing); "allergy to Eggs" (unspecified if ongoing); "allergy to gluten" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medications included: LANTUS; HUMALOG; ENBREL; SINGULAIR; LISINOPRIL. Past drug history included: Dimetapp, reaction(s): "Allergy"; Guaifenesin, reaction(s): "Allergy"; Erythromycin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 38 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 23Apr2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; ANAPHYLACTIC SHOCK (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "Anaphylactic Shock"; THROAT TIGHTNESS (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "throat closure"; RASH (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "rash"; SWELLING (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "swelling"; HEART RATE INCREASED (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "rapid heart rate". The events "anaphylactic shock", "throat closure", "rash", "swelling" and "rapid heart rate" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic shock, throat tightness, rash, swelling, heart rate increased included Epipen, Benadryl 75 mg, steroids, pepcid, fluids. She had Covid prior vaccination, no Covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Patient was shoveling snow and could not shut right eye, had jaw pain, was biting his tongue, and headache.  Went to ER and diagnosed him with Bell's Palsy and said it might take 6 months to go away.
Pt began having a rash approximately 2 weeks after the vaccination on left arm at vaccine site and it spread completely across his upper back with itching.  Rash continued until 7/26/21 when pt sought treatment in clinic and was given steroid injection, Vistaril oral med, and Triamcinolone Cream.
17 hrs. after receiving the injection, i woke up with my legs, arms and torso violently spasming. this lasted about 40 minutes.
This spontaneous report was received from a registered nurse via company representative refers to two patients of unknown age. On an unknown date in OCT-2013, the patients were vaccinated with a dose of PNEUMOVAX23 ( lot # J010332, expiry date 04-JAN-2015). On an unknown date in OCT-2013, the patients experienced swelling, pain and stiffness at the injection site after administration of PNEUMOVAX23. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were unknown. The patients sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Received Hepatitis B #2 on Friday 7/12/06. Joints ached on Saturday. Motrin helped. Tuesday 7/25/06 really bad body aches. Unable to come to work Wed/Thursday. Wednesday 7/26/06 (PM) noted itching all over. No rash. Friday 7/28/06 still taking Motrin but feels well enough to be at work.
tested positive for Covid-19; COVID-19; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), first dose on an unspecified date and second dose on 09Apr2021, both via an unspecified route of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she tested positive for COVID-19 on 12Apr2021 despite receiving second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412463 same patient/drug, different doses/events
Pt with constant tingling and heaviness into the arm she received the injection 12-16 hours post injection and continued symptoms at time of appointment
Two days after receiving the booster vaccine, I began experiencing intermittent chest pain on my left side. Pain is a 6/10, aching, throbbing, and sometimes sharp. I experienced this same quality and location of pain  after receiving my second Moderna dose in March 2021. The pain  lasted for 3 weeks intermittently, but I attributed the pain to anxiety/muscular pain.  I have been fatigued for the days following my booster vaccine, similarly to when I received my second dose. I have been resting when I can  and drinking fluids, but have not yet made an appointment with my physician due to my work schedule.
Severe, diffuse idiopathic urticaria lasting now > 6 days requiring multiple antihistamines, steroids, urgent care visit for steroid injection, leukotriene inhibitor.  Pending MD evaluation and allergy/immunology consult. Took day off of work for severe symptoms and urgent care.
chills; headache; tired; I was tired and weak; Hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2021 08:30 (Lot number: EL3246) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: has blood pressure problems, her blood pressure goes up and goes down; "COVID-19", start date: 09Nov2020 (unspecified if ongoing), notes: She reports she did have the Covid 19 virus. She was diagnosed with the Covid 19 virus on 09Nov2020. Concomitant medication(s) included: ASPIRIN (E.C.) (ongoing); LOVASTATIN taken for blood cholesterol (ongoing); METOPROLOL taken for blood pressure abnormal (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); LOSARTAN (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); ESTRADIOL (ongoing). The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ASTHENIA (non-serious), outcome "unknown", described as "I was tired and weak"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After first dose, Patient hair was coming out. Patient had chills, hair loss, headache and was tired and weak, but not real bad. Patient was 81 years old and her hair was thin anyway but it has gotten a lot thinner. The chills lasted up until this past month (at the time of report). She'd maybe have headaches off and on. Maybe a day she'd have a headache, then she'd be fine for a day or two, then she'd get a headache again. When probing medical history and concomitant medications, she reports she has blood pressure problems, her blood pressure goes up and goes down. She also reports she had a steroid injection in her right knee on 20Jan2021. Patient was having bad hair loss. So, that was the thing that she was concerned about was hair loss, will it comeback or will it continue going on or what. No additional vaccines administered on same date with the Pfizer vaccine. No Emergency Room and Physician Office due to events.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a consumer refers to herself as a 72 year old female patient. The patient pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 15-DEC-2014, the patient was vaccinated with ZOSTAVAX. On 31-OCT-2016, the patient experienced Shingles. The patient sought medical attention by contacting the physician and received unspecified treatment. The outcome of Herpes zoster was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the reporter does not want to be contacted.
A mother reported that her 4 month old daughter received a dose of Prevnar along with Engerix B, DTaP, Hib, and IPOL vaccines on 4/16/03. (The mother noted that the infant's third dose of Engerix B was inadvertently administered 4 months after the second dose instead of at the recommended 6 months interval because the second dose was not recorded in the infant's hospital records.) Reportedly, the infant had no relevant medical history. On 4/17/03, the infant became sleepy and cranky. She developed a slight fever, a cold sweat, and was jerky-twitching. She reportedly was not talking baby talk, and she was not herself, wouldn't play. Her pupils were small--just dots. According to the mother, she had to hold the infant for 3 days post-vaccination. On 4/20/03, the infant's symptoms reportedly resolved. Jerkiness and twitching were considered medically important (OMIC).
High fever from 11pm, then during 5am bathroom visit, experienced high-temperature, light-headedness, nausea and then fainted.
left arm soreness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID.  A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation; covid-19 vaccine (COVID-19 VACCINE), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "left arm soreness". Additional information: Patient reports left arm soreness over the past month but notes she had her vaccines (flu, COVID and RSV) all done in that arm in the last month. She sees her rheumatologist in one week and will discuss all this with her then.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Right lower extremity pain for the past 3 weeks after having Johnson Johnson vaccination on 4/5/2021
Tested positive for Covid months after getting the second dose; Tested positive for Covid months after getting the second dose; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history and concomitant medications was not reported. On an unspecified date, the patient had tested positive for Covid months after getting the second dose (medically significant).The patient underwent lab tests which included Sars-cov-2 test: positive.The outcome of the events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
On 09/28/2022, I woke up with mild head cold like symptoms and a cough. I tested positive for COVID-19 with an at home test. I called my physician who prescribed PAXLOVID which I began taking right away. My symptoms got a bit worse before they began to improve although they were only mild to begin with. On 10/06/2022, I had a rebound case of COVID-19. The symptoms were even more mild than before, and I recovered within a few days.
She received her flu shot yesterday in her primary care office. Returned to the walk in clinic this am with reports of her left arm being painful and swollen. No redness or swelling noted to injection area. She does have pain in her left arm and swelling in her left hand. Denies having any other injury to that arm.
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On 07-JUL-2016 the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot# M007728, L010598, expiry 06-AUG-2016; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.