chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Monkeypox; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Lot number: EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endocrine disorder" (unspecified if ongoing), notes: Caller said she has an endocrine disorder and is undiagnosed and she treats herself; "hormonal disorder" (unspecified if ongoing); "delta", start date: Apr2020 (unspecified if ongoing); "Long COVID" (unspecified if ongoing), notes: she had long Covid and lost sense of smell and all the symptoms; "COVID-19", start date: Jan2020 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: They had Covid several times. There were no concomitant medications. Past drug history included: Tylenol, reaction(s): "severe hormonal reaction". Vaccination history included: BNT162b2 (1st dose, NDC: Unknown), administration date: 21Apr2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "Sick", "diarrhea". The following information was reported: MONKEYPOX (medically significant), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: Body temperature: 103 Fahrenheit, notes: Caller said she had a 103 fever. The clinical course was reported as follows: caller said is home sick and very increasingly bothered and when statistics come out, they don't include people that have every time and in the beginning.  Got in this Jun and had monkey pox and felt like getting better after 3 weeks and went out and caught whichever variate in early July.  All symptoms of monkey pox and they have friends who are homosexual, and they are not homosexual and are in a heterosexual relationship and they hug there friends and yet when she called the department in (city withheld) City for monkey pox testing in Jul they asked if they were a homosexual male and she said no and they could not get test.  Caller said she is a heterosexual female and the only reason showing up homosexual male because cannot get test.
Initially headache and body aches. Within 24 hours developed chest pain, dyspnea on exertion and shortness of breath.   Patient still currently hospitalized.
A few weeks after the vaccine I woke up to a super sore left arm. The pain was so terrible I couldn't lift it or anything. I suffered for about a month with this pain and on 7/19 I went to my Orthopedic Dr. who took an X-ray but saw nothing but gave me a shot of Cortisone in the arm. The pain slowly diminished after about 2 weeks later along with exercises and hasn't come back since.
runny nose, headache, fatigue, 101.4 temperature, body ache.  Treated with 500mg of acetaminophen and rest.  Symptoms ceased in 24 hours.
No adverse event. Patient was 17 years old at the time of vaccination and it's indicated for age 18 and older.
The patient was given a Kinrix in lieu of Dtap.  The patient DID NOT have any adverse reactions to this immunization.
Guillain-Barré, was in the hospital for a long time; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.  Age at vaccination was not reported. The reporter is a neighbor of the patient. The patient received a flu shot (year unknown) and later was diagnosed with Guillain-Barre, she was moved from her local hospital to a more specialized hospital and was in the hospital for a long time. The patient was recovered. The reporter has no other information. The reporter did not consented to follow-up. The case was linked with case US2021194306, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021194306:Same reporter.
feels like something is crawling on her skin; forming a crust; fluid filled vesicles began to pop up; very tired; vesicles as extremely itchy and forming a crust on the top very much like chickenpox; This non-serious case was reported by a consumer via call center representative and described the occurrence of vesicle in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (when she was a child).   On 22-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 27-JUL-2023, 35 days after receiving Shingrix, the patient experienced vesicle (Verbatim: fluid filled vesicles began to pop up), tiredness (Verbatim: very tired), pruritus (Verbatim: vesicles as extremely itchy and forming a crust on the top very much like chickenpox) and crust (Verbatim: forming a crust). On an unknown date, the patient experienced crawling sensation (Verbatim: feels like something is crawling on her skin). The outcome of the vesicle, tiredness, pruritus and crust were not resolved and the outcome of the crawling sensation was not reported.   It was unknown if the reporter considered the vesicle, tiredness, pruritus, crawling sensation and crust to be related to Shingrix.     It was unknown if the company considered the vesicle, tiredness, pruritus, crawling sensation and crust to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter was the patient who reported she received her first Shingrix vaccine on 22 jun 2023, in the left arm. After 5 weeks little fluid filled vesicles began to pop up all over her body. The reporter described the vesicles as extremely itchy and forming a crust on the top very much like chickenpox and new ones were popping up each day.  The reporter was very tired.  She felt like something was crawling on her skin and when she looked down ,nothing was there. The reporter had a severe case of chickenpox when she was a child. The reporter consented to follow up.
Patient felt dizzy. Laid patient on exam table. BP 90/54. Patient stated he felt better. Sat patient up BP 92/58. Patient stated he felt better. Patient stood up BP 92/58 and patient felt fine to walk. Walked patient to car and instructed to lay down if dizzy again.
none yet.  Plan to see doctor if does not clear up / stop itching by end of week.  Large red, raised, hard bump at injection site.  Uncomfortable to touch and itches very much.  Arm is still very sore after almost one week.  Diameter of bump is approximately 3 inches.
Similar pain in opposite (right) arm lasting from day AFTER injection through today (2 days after). Remains at similar intensity, which is decreasing as expected. NOT SEVERE PAIN IN EITHER ARM..
patient states she developed a rash the next day after receiving Shingrix and Flublok vaccinations Advised patient to proceed to ER for further evaluation
Chills overnight starting 6:00 pm 26 February 2021 and lasting until midday on 27 February 2021.  I put on extra blankets and slept okay in my own bed.  Appetite remained good.
Received her 2nd dose / on 01Jul2021 and the needle leaked; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 1st July 2021, the patient received the 2nd dose of Shingrix. On 1st July 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The pharmacy student reported that a patient received her dose of Shingrix and the needle leaked, which led to incomplete dose administered. The reporter did not mention if the leakage touched the patient or the health care professional. The health care professional did not have the lot number or expiry date at the time of reporting. The reporter consented to follow up.
Patient had syncopal episode within 15 minutes of vaccination.  Felt better after resting and drinking some juice, and was released to home.
soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse.   A 56-year-old female nurse received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization on right arm.Relevant medical history included ongoing osteoarthritis and high cholesterol. Concomitant medications included  atorvastatin calcium (LIPITOR ORIFARM), escitalopram oxalate (LEXAPRO) and pantoprazole. On 28Dec2020 at 07:00 PM patient started experiencing soreness in arm when using arm or to touch. At the time of the reporting the patient was recovering from the event.
PAIN IN SHOULDER; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (PAIN IN SHOULDER) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (The patient is scheduled PET scan 13 days later of  1st dose vaccine. The doctors found another spot of his lung.).    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 ARTHRALGIA (PAIN IN SHOULDER). At the time of the report, ARTHRALGIA (PAIN IN SHOULDER) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       His second dose of the Moderna vaccine was scheduled for 25-Feb-2021,13 days later he was scheduled for a was due for petscan.  He had no reaction to the second dose   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Event outcome and narrative was updated.
This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown age and demographics. Current conditions and medical history was not reported. On 16-SEP-2014, the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 16-SEP-2014, it was reported that the patient received ROTATEQ that was exposed to temperature outside of the proper storage range. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
brought about a terrible case shingles for me; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported as taking our 2 vaccine shots has brought about a terrible case shingles for the patient. Not enough testing and warnings.Outcome of the event was unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
After 2 day I had a hard red raised bump on the site of the vaccine. It went away after 2 days. Today 03/24/21 I woke to a severely itchy and red arm on the shot site. Now I have tiny red bumps around the red swollen area. There is no pain with it only itchiness
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs.  No symptoms after 24 hrs except sore arm for 2 days.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 10:53, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
Sore, inflamed, "warm" and tender to touch, red mark about 2.5" diameter.
After vaccination with Pfizer vaccine at our clinic, the patient presented her vaccine card to the nurse and it showed that she had previously received the Moderna vaccine.  The patient stated that someone at her workplace had scheduled the appointment for her.  Our clinic records showed that she had registered to receive a 1st dose and 2nd dose of Pfizer vaccine with us through .  The patient was monitored for 15 minutes and did not experience any adverse reactions.  She was discharged with instructions that she had completed her Covid vaccine series.
Case number PHEH2014US016593, is an initial spontaneous report received from a medical assistant on 18 Aug 2014. This report refers to a 19 year old male patient. Past medical history and concomitant medications were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13066), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 18 Aug 2014. No adverse event was reported following this administration error.
Nausea/vomit/fatigue (extreme)   Something happens if I try to exert any energy, there is a heavy feeling, then chills, followed by profuse sweating followed by nausea/vomiting.   Basically feel like my endocrine system is confused.
Day 2  muscle pain and fatigue, low grade fever, fatigue, at injection site: edema erythema pain, limited range of motion and strength Day 3  muscle soreness, fatigue I jerk tion site pain swelling and strength with poor range of motion.  Day 4:  fatigue arm pain swelling and strength with limited range of motion.
A bad reaction to PNEUMOVAX 23 25 MCG/0.5ml inj Swelling upper left arm, severe. Pain, Redness, severe. Symptoms did not reduce until 2/24/18. I have never had a reaction nor allergy to any immunizations.
Even 1 month later inject site is still very sore. Left hand and arm gets pins and needles feeling several times throughout the day which sometimes leads to numbness.
Chest pain, trouble breathing, rapid heart beat, abdominal pain, numbness in leg, numbness in jaw, sweating, paleness, headaches, numbness in arm/hand, hives. 12/4/2009 PCP records for visits 5/2009-11/2009. Patient with c/o's headaches, eye pain, per patient went to ED 9/2009 with same c/o's and a neg w/up, no tx noted
Loss of memory, time, place, reason; Loss of memory, time, place, reason; Several asthma attacks; involuntary body shake; headaches; muscle pain from left shoulder to left side of the head; coughing; small bumps in the face and back of the ears; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9266), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (age at the vaccination 38-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The Patient experienced loss of memory, time, place, reason, involuntary body shake, headaches, muscle pain from left shoulder to left side of the head, coughing and small bumps in the face and back of the ears and several asthma attacks on 16Feb2021. Patient visited physician office. Therapeutic measures were taken as a result of loss of memory, time, place, reason, involuntary body shake, headaches, muscle pain from left shoulder to left side of the head, coughing and small bumps in the face and back of the ears and several asthma attacks. The outcome of the events was resolved with Sequel.
patient came in to receive a tetanus booster for school. Highly anxious at time of shot but tolerated procedure well. left facility and came back complained of double vision. Pulse of 72 noted and regular. Given Zyrtec 10mg per. Went home and found that pt went to ER via ambulance and found to have had allergic reaction to tetanus, Benadryl given pt released to home after treatment at ER.
MUSCLE ACHE; FEVER; HEADACHE; FEELING OUT OF IT; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry date: unknown) dose was not reported, administered on 23-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced feeling out of it. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 25-MAR-2021 and feeling out of it on 24-MAR-2021, and had not recovered from muscle ache. This report was non-serious.  Additional information was received from the patient on 25-Mar-2021. The following information was updated and incorporated into case narrative: Additional event added; outcome updated.
pt recv vax;acetaminophen given 15 mins later;almost cont crying for approx 9 hr; T 103 w/ "fever scan" at 3 hr p/ started acetaminophen; "quivered" all over, used warm water bath to stabilize T;
Hives on left arm between wrist and elbow, 1 hive on upper arm and 1 hive on neck within few hours of receiving HPV vaccine (Gardasil).  Treated with Benadryl PO.
Fatigue Extreme; Rash; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue Extreme) and RASH (Rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue Extreme) and RASH (Rash). At the time of the report, FATIGUE (Fatigue Extreme) and RASH (Rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no reported medical history. The patient stopped Rinvoq for seven weeks to take the Covid Moderna Vaccine. She was noticing extreme fatigue and got a rash after the first injection that lasted until two weeks after the second vaccine dose. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant and treatment medications were reported.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 18-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBD" (unspecified if ongoing), notes: Was diagnosed with IBD but was totally symptom free at the time of taking the Pfizer vaccine. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left), administration date: 24Mar2021, when the patient was 18-year-old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "6 lymph nodes under the left armpit and neck region"; IRRITABLE BOWEL SYNDROME (non-serious), outcome "unknown", described as "IBD flare". The events "ibd flare" and "6 lymph nodes under the left armpit and neck region" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of irritable bowel syndrome, lymph node pain. Additional information: The patient did not receive any prior vaccination. The patient was tested for covid post vaccination. It also triggered an approx. 6-week long IBD flare. Symptoms included loss of appetite, weight loss, and change in bowels. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Congested nose; Developed a Sneezing episode; When moved head over and water was coming out of my nose; Felt excessively tired and all they wanted to do was lay down; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congested nose), RHINORRHOEA (When moved head over and water was coming out of my nose), SNEEZING (Developed a Sneezing episode) and FATIGUE (Felt excessively tired and all they wanted to do was lay down) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lacunar stroke (Affected their right side) since 01-Dec-2018. Concomitant products included APIXABAN (ELIQUIS) from 01-Dec-2018 to an unknown date for Lacunar stroke.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 2:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt excessively tired and all they wanted to do was lay down). On 17-Apr-2021, the patient experienced RHINORRHOEA (When moved head over and water was coming out of my nose). On 17-Apr-2021 at 6:00 AM, the patient experienced SNEEZING (Developed a Sneezing episode). On an unknown date, the patient experienced NASAL CONGESTION (Congested nose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 17-Apr-2021 at 8:30 PM, FATIGUE (Felt excessively tired and all they wanted to do was lay down) had resolved. At the time of the report, NASAL CONGESTION (Congested nose), RHINORRHOEA (When moved head over and water was coming out of my nose) and SNEEZING (Developed a Sneezing episode) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: (Inconclusive) 98.6F. On 02-May-2021, Body temperature: (Low) 94.6F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-100481, MOD-2021-101106 (Patient Link).