chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms after receiving SHINGRIX, had to stay in bed for two days to recover.
Face became red and flushed at 10:00 the next morning (1/8/21) and symptoms subsided by 12:45 pm.  A second, milder flush of the face (pink) occurred at 5:15 pm and was resolved by 6:30 pm.  Called health care provider, monitored symptoms, but no treatment needed or sought. No additional reoccurrences.
No symptoms until approx 2 months after receiving my 2nd shotgun 4/30/21. At first, I noticed soreness and stiffness in my left arm. The pain and soreness continued to get worse. Approx a week after my initial symptoms, I was no longer able to lift my left arm. Any attempt to raise my arm would result in great pain and screams. My left shoulder is tender to palpation and hurts like all heck.
Increased heart rate, syncope at 11:30pm. about 6 hours after vaccination.
Around 9:30 pm on Sunday 10/03 I had a low-grade temp 99.1ºF. Three hours later I awoke with bone pain that felt like someone was crushing all my bones in my body. I developed shooting pains in my finger tips as well as random shooting pains all over my body (chest, stomach, shins). Took my temperature at 2:30 am  on 10/4 and temp was 100.2ºF, 3:44 am 100.3ºF, 7:30 am 100.7ºF. My temp stayed at 100.7ºF until 10/4 at 3:26 pm where it is now 101.0ºF. Still dealing with throbbing headaches, stomach pain, sore joints and muscles.
pt recvd vax; exp profound muscle weakness w/ low grade & elevated WBC = 13,000; URI w/ sore throat & t of 100; cont w/ muscles weakness as of 22oct93; 2dec93 no response to f/u request;
Patient had swelling, redness, hot to the touch and painful on his right arm where the injection was given. The reaction was noticed the morning after he got the vaccine.
one day after vaccination 11/3/2022 developed right anterior chest swelling directly below clavicle and small mobile nodule on top of clavicle approximately 3mm ( both areas tender to touch). When seen  11/8/22 anterior chest swelling and tenderness resolved, but nodule still present and tender.
Chest pain, sob, swelling of extremities, numbness in extremities,  severe migrain, couldn't get out of bed for 3 days, couldn't walk,  fever, and general body pain. I refused to have my wife call EMS and be admitted to the hospital. I was told afterwards it wost likely myocarditis.
Localized skin reaction immediately after MMR and DTaP.  No hives nor systemic effects.
Patient states that on 10/9/11 after taking 3rd pill of oral typhoid she developed hives all over her body, abdominal discomfort & slight sensation in her throat. Pt. went to ER where she received IV BENADRYL, SOLU-CORTEF & PEPCID. Discharged from ER on Prednisone, BENADRYL & PEPCID. As of 10/11/11, pt. is feeling better.
This case was reported by a healthcare professional and described the occurrence of worsening elevated GGT in a 60-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline). Concurrent medical conditions included aspirin allergy and elevated gamma glutamyl transferase. On 14 February 2008 at 09:00 the subject received 2nd dose of Havrix at 1.0 ml (1440 eliza units) in the left arm. Between 15 February 2008 and 19 February 2008, following vaccination with 2nd dose of Havrix, the subject experienced worsening elevated GGT, a systemic reaction. A GGT level was drawn (date thought to be 15 February 2008, but reporter not sure) and the result was 226. The subject received the GGT results on 19 February 2008. This event was considered to be medically serious by GSK. The reporter stated that the subject had not had any symptoms or required medical treatment. At the time of reporting the events were unresolved.
Temp. 99.3. Pt. came in w/ red, very swollen, hot, itchy reaction on left deltoid. Started 2 days after injection. Doctor advised Benadryl and IBU, w/ cold packs.
At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia which was treated 07-03-2020. She has history of neurological problems from chemotherapy. She also has down syndrome. She has headaches since the vaccine. She is non speaking, non-verbal. After her Pfizer vaccine, my daughter repeat things over and over, at night she cries, moves her hands a lot, yells when she is at school. My daughter did not have a fever, body aches after her vaccine. I feed her, bathe her and take care of her and since receiving the Pfizer vaccine she is not the same person. Before the vaccine, my daughter was sociable, respected, educated but since the vaccine she has been out of control and acting crazy.   My daughter received the Pfizer vaccine at a clinic and the doctors there said that she should not get the second dose. At this time, my daughter is scheduled for an MRI appointment on 06-18-2021.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022) dose was not reported, frequency 1 total, administered on 06-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included azathioprine for Crohn's disease, and ustekinumab for Crohn's disease.  It was reported that the patient took covid-19 vaccine ad26.cov2.s on 06-MAR-2021. On 30-MAR-2021, the patient experienced suspected immunological vaccine failure and took antibody test on 30-MAR-2021 and test results on 31-MAR-2021, stated that the patient did not had any detectable antibodies in the test. Laboratory data included: Antibody test (NR: not provided) No detectable antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407542-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
feel nauseated; I felt a heavy arm; Muscle discomfort; discomfort that went to neck in same left side, discomfort it's been coming and going; tired after the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired after the shot), LIMB DISCOMFORT (I felt a heavy arm), MUSCLE DISCOMFORT (Muscle discomfort), MUSCULOSKELETAL DISCOMFORT (discomfort that went to neck in same left side, discomfort it's been coming and going) and NAUSEA (feel nauseated) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced FATIGUE (tired after the shot). On 15-May-2021, the patient experienced LIMB DISCOMFORT (I felt a heavy arm), MUSCLE DISCOMFORT (Muscle discomfort) and MUSCULOSKELETAL DISCOMFORT (discomfort that went to neck in same left side, discomfort it's been coming and going). On 03-Jun-2021, the patient experienced NAUSEA (feel nauseated). The patient was treated with PARACETAMOL (PANADOL) (oral) at a dose of 500 milligram as required. On 17-May-2021, LIMB DISCOMFORT (I felt a heavy arm), MUSCLE DISCOMFORT (Muscle discomfort) and MUSCULOSKELETAL DISCOMFORT (discomfort that went to neck in same left side, discomfort it's been coming and going) had resolved. At the time of the report, FATIGUE (tired after the shot) and NAUSEA (feel nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Got so sick from the flu shot that it almost killed her / came to see her; Got so sick from the flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of near death experience in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2016-2017 season) (batch number 7K45B, expiry date unknown) for prophylaxis.   The patient's past medical history included mumps (experienced mumps after mumps vaccine) and measles (experienced measles after measles vaccine). Previously administered products included Mumps vaccine with an associated reaction of mumps and Measles vaccine with an associated reaction of measles.   On 8th December 2016, the patient received Fluarix Quadrivalent 2016-2017 season .5 ml. On an unknown date, unknown after receiving Fluarix Quadrivalent 2016-2017 season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and sickness. On an unknown date, the outcome of the near death experience and sickness were unknown.   The reporter considered the near death experience and sickness to be related to Fluarix Quadrivalent 2016-2017 season.  Additional details were provided as follows: It was reported that as a child the patient got Mumps after the Mumps vaccine and measles after the measles vaccine. She had no further information on the dates or lot numbers of these vaccines.  The patient did not have history including any illness at time of vaccination. The patient did not have medical history relevant to adverse event. The patient got so sick from the flu shot that it almost killed her. The reporter consented to follow up.
Rapid onset of sever headache. Second day post injection visible joint swelling of left elbow and wrist. As swelling in wrist subsided the nerve was in-trapped causing constant radiating pain from wrist to elbow. As well,  numbness of fingers and loss of grip strength.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient called this morning to report that the area of the vaccination injection was hard "like a knot" and red
Cancer; fat brain/ Lipoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in Jul2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Patient is allergic to not having crystal methamphetamines" (unspecified if ongoing). Concomitant medication(s) included: METHAMPHETAMINE [METAMFETAMINE], start date: 01Sep1996. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "not recovered", described as "Cancer"; LIPOMA (medically significant), outcome "not recovered", described as "fat brain/ Lipoma". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging head: fat brain; Protein total: Inconclusive; SARS-CoV-2 test: Inconclusive. Therapeutic measures were not taken as a result of neoplasm malignant, lipoma. Clinical course: Patient was reporting for himself. Facility type vaccine unknown. He received Other vaccine in four weeks and Other medications in two weeks. Administration time: 12:00 AM. Adverse event: Unable to receive more methamphetamines he did need that to go along with his secured medicines. Unable to receive his original documents of MRI (Magnetic resonance imaging) fat brain and he wanted see his back brain back intact and he need his methamphetamines to go along with his cancer treatment, he thought that's what's going on was he wrong get back to him come back. No COVID prior vaccination. COVID was tested post vaccination. Other medical history: Patient was very concerned he cannot get his original MRI documents around the 2000 and 3 area in (Withheld).  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Tested NAAT positive for COVID 8/28/21 after being fully vaccinated.
feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients
received his second dose of SHINGRIX 10 months after his first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 10 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received his second dose of SHINGRIX 10 months after his first dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 05-OCT-2023 This case was reported by patient's wife. The patient received his second dose of SHINGRIX 10 months after his first dose. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
sweats, possible fever, rigors, severe headache, nausea, severe full body myalgias and arthralgias, extreme fatigue.    Had to take Nyquil a couple times for symptoms and slept off and on for nearly 24 hours.  Symptoms have now almost totally resolved after 24 hours.
It was reported that a 3 year old male pt received vaccines on 8/26/99. Reportedly, about 20 minutes, post vax, the pt became irritable, began digging at ears, developed congested eyes and spitting. The pt also developed hives on trunk and back, no wheezing. The pt was sent to the ER where he received SC epi and Benadryl. The pt was hospitalized in he ER "short-stay unit" for 6 hours. Reportedly, the pt recovered from this experience. From correspondence received on 1/28/00, amendments in the reporter's address and in the amount of time the pt was in the "short-stay unit"  was provided.
First dose of Pfizer COVID-19 vaccine administered to this individual.  She reported dizziness and head feeling "fuzzy".  Had patient drink water and juice.  VS were BP 137/90 HR 91.  She stated her HR routinely runs in the 90s.  Observed her for greater than 30 minutes.  Symptoms didn't worsen.  She was awake, alert with a steady gait. Patient was released to home.
vasovagal symptoms: low bp 87/71 sweating, nausea, but alert and awake stayed with patient until EMS arrived
Case number PHEH2014US014303, is an initial spontaneous report received from a medical assistant on 15 Jul 2014 with a follow up information received from health care professional on 04 Aug 2014. This report refers to a patient of unknown age and gender. It was reported that the patient received Men a component of MENVEO (batch number: A14040) reconstituted with a sterile diluent intramuscularly on 14 Jul 2014. The patient did not receive the Men CYW-135 liquid component of MENVEO. No adverse event was reported following the maladministration. Upon follow up information received on 04 Aug 2014, the reporter stated that the patient came back on an unknown date and was re-vaccinated with a full dose of MENVEO. No further information was provided.
Client reported having had itchy, painless rash on face, arms, hands, legs, and back for about 10 days, starting a couple days after vaccinations were given. Denies fever at time of rash. States that rash has resolved.
This case was reported by a consumer via call center representative and described the occurrence of flu in a female patient who received BREO ELLIPTA inhalation powder (batch number R713704, expiry date 31st October 2016) for emphysema and shortness of breath. Co-suspect products included Influenza vaccine. The patient's past medical history included lost weight. Concurrent medical conditions included increased blood pressure, low thyroid and high cholesterol. Additional patient notes included concomitant medications of baby aspirin and unspecified cholesterol medication. Concomitant products included atenolol, levothyroxine and lisinopril. In May 2014, the patient started BREO ELLIPTA (inhaled) 1 puff(s) once daily. In October 2014, the patient received Influenza vaccine. In October 2014, an unknown time after receiving BREO ELLIPTA and Influenza vaccine, the patient experienced lack of drug effect. In March 2015, the patient experienced flu. BREO ELLIPTA was continued with no change. The action taken with Influenza vaccine was unknown. On an unknown date, the outcome of the flu and lack of drug effect were recovered/resolved. The reporter considered the flu to be unrelated to BREO ELLIPTA. It was unknown if the reporter considered the lack of drug effect to be related to BREO ELLIPTA and Influenza vaccine. It was unknown if the reporter considered the flu to be related to Influenza vaccine. Additional Details: A female patient reports that she came down with the flu in March 2015. The patient also noted that she received an unknown manufacturer's brand of influenza vaccine but still came down with the flu. Caller was transferred from another location.
(1) Flashing & feeling warm (2) Palpitation (4) Fainting (5) Moderate Shortness of Breath RX: (1) IV Fluids (2) Monitoring in The ED (3) Blood work & ErG
Received the J&J COVID vaccine at a state-run site. Chills and fever on day 1 post-vaccine. Vomiting and epigastric abdominal pain on day 3 post-vaccine.  Continues with decreased appetite. Symptomatic care only at this time.
Onset of generalized vaccinia on Mar 03. Erythemous/ vesicular rash spreading over lower abdomen, legs, and back. Generalized vaccinia.
Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm.  Has body aches, joint pain, muscle ache, head ache, fatigue, and arm pain.
Major changes in menstrual cycle including, but not limited to , severe cramping, extreme breast tenderness to the point where wearing clothing and taking showers were painful, increased flow, longer cycle
I had one episode  of  syncope in the morning  on 1/22/2021 after waking up in the morning, two days after the 2nd shot but within 48 hrs.  Other than that, I just had a moderate left arm pain (starting  on 1/21/2021).  Also generalized low energy level (starting  on 1/21/2021) and very mild muscle soreness especially with both legs (starting  on 1/22/2021) .
Pt is a 60 y.o. female presenting to clinic with L arm pain. She states Tuesday was her booster shot- Moderna. Yesterday and today she is having L shoulder and under arm swelling. Pt did not call and report reaction. Pt states she has not had any reactions to the other injections. Pt states Wednesday night she had fatigue and fever (100F). Pt denies taking OTC medications. She is currently taking blood thinners and cannot take NSAIDs and she is allergic to Tylenol. Pt has pending appt with PCP on 10/8/21.
pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 29-Mar-2021.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-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 PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medicines were not reported Action taken with mRNA-1273 in response to the event was not applicable.
Light case of varicella. Sib with obvious case of C-pox. Dx: varicella. Tx: acyclovir.
PT STOPPED BY PHARMACY AND SAID THAT SHORTLY AFTER LEAVING THAT SHE STARTED HAVING PAIN IN HER RIGHT ARM. VACCINE ADMIN IN LEFT ARM. SHE STATES THAT SHE BECAME THIRSTY, HAD FEVER BLISTERS, HER CHEST BONE HURT AND HER CHEST WAS HEAVY. SHE HAD SPASMS IN HER BACK AND DOWN HER LEGS. SHE SAID SHE DROVE TO HER SONS AND THIS LASTED APPROXIMATELY 15 MINUTES. SHE SAID LATER SHE HAD FLU-LIKE SX THAT LASTED 11-12 HRS. I TOLD HER I WOULD REPORT AS THESE WERE RATHER UNUSUAL SX.
Erythema of upper arm at site of injection DTaP, Edema and  pain as well.
My husband heard a barking cough. Nurse told me it is croup. It was only a few times. It has gotten worse over these last few days. My 4 year old is now sick as well.