chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6th day- got up nauseated, dizzy, feeling off. Went to lunch, by late afternoon was not better. At 830 pm had vomit and diahrea at same time. Continued til 1am- went to Bed. Back up showering at 2:30am. Fell in shower, got up, dizzy laid down till 11am. Didn't call ER til morning of day 18.
This spontaneous report was received from a physician regarding an approximately 4 month old male infant. No medical history was reported. On an unknown date approximately in 2011, the patient was vaccinated with measles virus vaccine (manufacturer unknown) (dose not provided) at 2 months of age, 3 months of age and 4 months of age. Other suspect therapies included DTaP. No concomitant therapy was reported. On an unknown date approximately in 2011, after 3rd dose of the suspect vaccine, the patient experienced thrombocytopenia and bloody stools. The patient was hospitalized for 7 days. The outcome of the events was reported as recovered (unknown date). The relatedness of the event to the therapy with measles virus vaccine was unknown. There was no product quality issue reported. Additional information has been requested.
got covid after first dose; got covid after first dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got covid after first dose". Clinical course: The patient first dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) on 31Aug2021 and then developed COVID-19. Patient did not receive second dose of the vaccine and caller is asking if patient needs to restart the series.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Hospitalization: 12/27/2022 - 12/28/2022 (31 hours) Presentation to the ED: slurred speech and hypoglycemia.  COVID + date: 12/27/2022 Treatment: no indication for medical treatment at this time.  Discharge to: home.   Moderna 012M20A 1/29/2021 Moderna 011A21A 2/26/2021 Moderna 033H21A 1/5/2022
Fever, headache, chills, body aches 4 hour duration, then fine.
Information has been received from a medical assistant concerning her daughter a 14 year old female with no medical history who received 2 doses of GARDASIL last summer in April 2009 and June 2009. In June 2009, after her second dose of GARDASIL the patient experienced fainted. The patient was treated in office. The same day of vaccination (in June 2009), the patient recovered from faint. The patient was fine with her initial dose. The patient's mother was considering not getting the third dose scheduled on 11-JAN-2010. This is one of several reports received from the same source. No further information is available.
PT'S THIGHS WERE RED AND IRRITATED AND SWOLLEN (BOTH THIGHS AT SITE ON INJECTION). PT WAS GIVEN BENADRYL, OUTCOME IS UNKNOWN YET.
Reported me on 9/22 6PM. Patient had flu like rxn, aching, chilling, severe weakness. Patient is a COPD patient that is on oxygen - had some increased shortness of breath. Refer patient to physician or ER room. Follow up with patient 9/23 and 9/25, still with SOB. Recommend see Dr. again. 9/23 - Recommend pt see Dr. 9/25 follow up done yet.
Arm soreness at injection site; Received the adjuvant portion only; Received the adjuvant portion only without the lyophilized antigen component; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) and (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix. On 29th October 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter asked for some guidance on a Shingrix first dose given to a patient who received only the adjuvant portion (without the lyophilized antigen component), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up by email.   Follow up information received from pharmacist on 1st December 2020: The patient's demographics were updated. The batch number and expiry details were updated. The patient received Shingrix via intramuscular. The patient experienced injection site pain.  It was reported that error occurred durring the administration. This was 1st shingrix shot to be administered and rporter failed to mix the adjuvant in to the antigen portion. The patient just received adjuvant, contributiing factor was that dose was given durring flu season where several flu shots had just been drawn from vial and injected. The outcome of injection site pain was unknown.  The reporter considered the injection site pain to be possibly related to Shingrix. The VAERS details were updated.
COULD NOT CONTROL HANDS OR FEET, HANDS WERE FORMING A FIST (NAILS INTO PALMS); COULD NOT MOVE HANDS OR FEET; COULD NOT WALK; TINGLING OF EXTREMITIES (UP TO KNEE, ARMS, FEET AND HAND) AND UPPER LIP AREA; NAUSEOUS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no history of drug abuse or illicit drug usage. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced nauseous. On 27-SEP-2021, the patient experienced fever. On 27-SEP-2021, the patient experienced headache. On 28-SEP-2021, the patient experienced could not control hands or feet, hands were forming a fist (nails into palms). On 28-SEP-2021, the patient experienced could not move hands or feet. On 28-SEP-2021, the patient experienced could not walk. On 28-SEP-2021, the patient experienced tingling of extremities (up to knee, arms, feet and hand) and upper lip area. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nauseous, fever, headache, could not control hands or feet, hands were forming a fist (nails into palms), tingling of extremities (up to knee, arms, feet and hand) and upper lip area, could not walk, and could not move hands or feet. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with low thyroid, heartburn and unknown reaction to prednisone (manufacturer unknown). On 04-JUL-2014 the patient was vaccinated with ZOSTAVAX (strength and dose not reported, frequency: single dose) (lot # reported as J016882, exp. date 04-JAN-2015), subcutaneous in the left arm. Concomitant medication included antacid medication and thyroid supplement. On 05-JUL-2014, 2 days after onset of therapy the patient experienced a 3 inch by 3 inch area of redness, itching and swelling at the injection site. No laboratory diagnostics studies were performed. The patient sought medical attention by coming to pharmacy. No treatment was given. No lab diagnostic was performed. The outcome of the event was unknown. The relatedness between the event and suspect drug was not reported. Lot number (J016882) is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Acute tenderness at injection site that worsened as time has gone on; chills approximately 12 hours after the injection was administered; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:45 (Lot number: EL3247) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: covid prior vaccination: Yes. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer Biontech, lot number: EL3248, lot unknown: False, administration date: 17Feb2021, administration time: 01:00 PM, vaccine location: Left arm, dose number: 1), administration date: 17Feb2021, when the patient was 32 years old, for COVID-19 immunization.  The following information was reported: INJECTION SITE PAIN (non-serious) with onset 11Mar2021 02:00, outcome "unknown", described as "Acute tenderness at injection site that worsened as time has gone on"; CHILLS (non-serious) with onset 11Mar2021 02:00, outcome "unknown", described as "chills approximately 12 hours after the injection was administered"; FATIGUE (non-serious) with onset 11Mar2021 02:00, outcome "unknown", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site pain, chills, fatigue.  Additional information: It was reported that, the patient did not take any other vaccine in four weeks of vaccination. It was reported that, the patient had no Known allergies. Reportedly, the patient had tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
0940 patient received vaccines and stated she felt dizzy. Member instructed patient to stay seated until she felt comfortable. Patient went into syncope and member alerted nurse. Two members and a nurse responded immediately, checking vitals elevating legs and offering water when patient became alert. Patient remained seated for about 5 minutes until she was moved to a table to lay down. Vitals taken four times . Once patient felt better she got up and left the clinic with mother.
Became deaphortic, dizzy and pallor within 1.25 hours after vaccination. VS normal 20 minutes after event.
Patient states that when she got home in the evening she developed a big lump in the neck she took some CLARITIN & in the morning following the vaccine, her eyelids were swollen. The injection site is red.
Approximately five minutes after receiving vaccinations patient, who was sitting in a chair, became rigid *for approximately equal to three seconds (*rigid limbs with some jerking present). Patient aroused; was oriented to person, place, time. States did not eat breakfast today.  Mom states patient was "nervous" about vaccinations. Vital signs monitored. Had pt rest on exam table. Pt. was given Sprite to drink/crackers to eat. Left clinic without difficulty at 10:05 AM - pt states feels "tired". Requested mom call this RN to inform of pt. status later today. Approximately equal to 4:30 PM - 8/4/10 - phone call to mom. Mom states pt. "doing fine" / "she's fine" but has some injection site soreness. 8/5/10 2:10P Phone call to parent of client - left voice msg. Re: follow up post injections. Requested call back from parent. 8/5/10 3:05P Return call from parent - States "she is fine and she is acting just like normal".
Fast heartbeat; shortness of breath; dizziness; weak; increased body temperature (no fever).
p/vax pt exp a rash w/approx 30 lesions on back, buttocks, & legs;
she has asthma and RA and on pred 2.5mg qd, advair 500 bid and ventolin 2 puffs qd, but over last few days increased ventolin to qid. cough is better today. cough nonproductive. exposed to friend over thankgiving. no fever or chills.. starting 12/6/21
Itching from the  2nd dose, Nausea from the 1st dose. Since recovered from the nausea. Not recovered from the itching.
Within first 48 hours, arm pain at site of injection as well as very sore lymph nodes under arm. Gross hematuria began 3 weeks later.
This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot # L024132 with expiry date 21-JAN-2017 (dose and route of administration were not reported) instead of PREVNAR 13. No adverse effects were reported. Additional information has been requested.
Rash the 1st night, lasting a couple of days (mild). No cold symptoms, more fatigue and paleness of skin last week. One episode of wheezing yesterday. Highest temp 103.8F (rectal) on 8/4/02. On 8/6/02, 3 chickenpox on chickenpox developed.
whole body hurts; Not sure if can smell; Not sure if can taste; Stomach is killing her, Has stomach pains; arm feels like a sledgehammer hit it where she was injected; Feels nausea; Headache; Body chills; Can't keep anything down she throws up everything; A spontaneous report was received from a healthcare professional concerning a 56 year  old, female patient who experienced her whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains.   The patient's medical history was in Mar-2020 the patient was positive for COVID-19. The patient's concomitant medications included omeprazole magnesium.  On 28 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced events, her whole body hurt, arm felt like a sledgehammer hit it where she was injected, couldn't keep anything down and she threw up everything, felt nauseous, and wasn't sure she could smell or taste, her head was pounding, body chills, and stomach pains.  Treatment for the event included ibuprofen.    Action taken with mRNA-1273 in response to the events was not provided.  .  The outcome of the events, whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains was unknown.; Reporter's Comments: This case concerns a 56-year-old female, with PMH of COVID-19, who had NS unexpected events of pain, anosmia, ageusia, abdominal pain upper and NS expected events of injection site pain, chills, nausea, vomiting, and headache. Event onset the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Starting fever of 102.5F raised up to 103.5f over night, with Motrin treatment.
Pt became dizzy immediately after receiving PCV23. Patient was given cold compresses while sitting in chair then began to shake. Patient was placed on floor 911 was called. After shaking stopped patient reported severe headache to back of her head. Pt. transported to hospital by EMS.
I tested positive for Covid 19 on September 12, 2022, I experienced sore throat, severe sinus infection, very fatigue, had on and off fever, difficulty breathing. wheezing, I was prescribed an inhaler and steroid for my symptoms. I have brain fog as well.
Pt had 2 month immunizations on 4-16-08. Came into office with fever of 103.5 next day (4-16-08). Was admitted to hosp for wk-up.  4/30/2008 MR received for DOS 4/16-19/2008 with DX: Fever of Unknown Origin, Prematurity, Flat occipital area, Feeding dysfunction. Infant presented with FUO. Temp 103'F in PMD office with flattened occipital area. Admitted for w/u.  PE (+) for tachycardia in the 200's. Initially thought to be meningitis, but r/o with 2nd LP. Improvement noted with abx.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 2016 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016 the patient was treated by a physician for blistering vesicular outbreaks that were diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a consumer concerning her 5 year old son with seasonal, milk, egg and house dust allergies who on 12Apr05 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included montelukast sodium and fexofenadine hydrochloride (Allegra). It was reported that on 12Apr05, the arm that the pt received the vaccination became swollen, red and hot. On 16Apr05 the pt developed a rash on his face. On 17Apr05 the rash appeared on his arms. On 18Apr05 the pt's rash was all over his body, and he started to developed coughing, runny nose and low grade fever. Unspecified medical attention was sought. At the time of the report, the pt had not recovered. The pt's arm that became swollen, red and hot, facial rash, generalized rash, coughing, runny nose, and low grade fever were considered to be immediately life threatening by his mother. Additional information has been requested.
Rapid, heavy heart beat - different from normal.  Woke up at 3:00 a.m. and it was still abnormal.
Hives to chest, back, arms, legs, groin, neck & face. Treated with BENADRYL & Hydrocortisone cream. Rxn occurred 5 hours after vaccine. Hives extremely itchy.
Moments after injection: light-headedness and sweating. On event date reported: baby discovered to have low heart rate during routine check up. Baby delivered via emergency c-section and put of 72 hour cooling protocol. Baby's birth weight was 7lbs 12oz and was at 39 weeks gestation. Baby found to have suffered stroke in utero. Baby had seizure shortly after birth. Baby diagnosed with Hypoxic Ischemic Encephalopathy and MRI confirmed significant brain damage.
Fever (99.3F); Body aches; Inability to lift up the arm where the injection was done; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170), via an unspecified route of administration in the left arm on 04May2021 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history included graves' disease and the patient had a history of peanut allergy. Concomitant medications taken within two weeks prior to the vaccination included thiamazole (METHIMAZOLE), rosuvastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN) and brimonidine tartrate (ALPHAGAN), all from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 16:00, the patient experienced fever (99.3-degree Fahrenheit), body aches and an inability to lift up the arm where the injection was done. On 04May2021, the patient underwent lab tests and procedures which included body temperature test and the result was reported as 99.3-degree Fahrenheit. The clinical outcome of the events fever (99.3-degree Fahrenheit), body aches and an inability to lift up the arm where the injection was done was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data unit updated and Treatment Received selected as No.
Feverish; It has been more than 6 months since they both received the first dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and incomplete course of vaccination. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of vaccine in November 2019 and experienced feverish symptoms.  Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2020085243, reported by same reporter.
Patient with pain in leg in area of Imm, getting worse in 48 hrs after imm, not wanting to bear wt. or bend leg with pain. Without erythema edema discharge fever or tenderness. Rx ibuprofen.
pt recv vax 23JUL96 & mom noticed a rash;the next day rash spread all over;pt seen in ER;mom told it was erythema multiforme or granuloma-a minor virus;t104 R, & cranky;dx erythema multiforme confirmed;
No Adverse event; Administration of an expired dose of M-M-R II vaccine; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. Patient's medical history, historical drug, concomitant therapies were not provided.  On 30-N0V-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status of rha (recombinant human albumin) (M-M-R II) (lot # S037499, Expiration date; 20-NOV-2021) (dose, route and site of administration not reported) and expired product administered and diluted in a sterile diluent (MERCK STERILE DILUENT) (lot # T032311, Expiration date; 05-MAY-2023) for prophylaxis.
Rt arm red & puffed to about an inch @ immun site; Fever 101-102 Wed night 23OCT91 + vomited; Feet & legs hurt, tingled; wants mom to rub; MD states no more DTP just DT; uncontrollable crying night p/vax;
redness and warmth at injection site/ fever of 103. Received Omnicif.