chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable other HCP via Pfizer sales representative. A 19-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, at single dose and the first dose of tuberculin PPD, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced not being able to see with outcome of unknown, could not breath with outcome of recovered. Therapeutic measures were taken as a result of could not breath included an EPIPEN. The events were described as follows: Upon leaving the office while she was scheduling her week later follow up for PPD, at the checkout desk she complained of not being able to see. The doctor took her to the back exam room then she said she could not breathe. They called number but in the meantime the doctor administered an EPIPEN. She was OK after that. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Patient felt warm. Patient's face + chest became pink and blotchy 15 minutes after administration. Patient received 2 25 mg oral capsules of Benadryl.  Oxygen level 99.1. -Pulse 90.  Monitored patient for 30 more minutes + she felt improved. She then discharged.
Information was received from a nurse practitioner referring to a 19 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 16-AUG-2016, the patient was administered an adult dose of RECOMBIVAX HB injection (lot # L035881, expired date 26-JUN-2017, the 2nd dose of 3 doses series, dose and route unknown) by the nurse practitioner (unapproved dose administered). No adverse effect was reported. Additional information has been requested.
pain/sore in the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 (Batch/Lot number: unknown) at the age of 69 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: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain/sore in the injection site". Additional information: The patient reported that her arm was sore after the first dose, clarified that it lasted for days and now her arm is sore again at the injection site of the first dose and felt like she has taken it again. The patient wanted to know if it feels that way for her to be able to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Erythema and Induration measured 2 and 3/4 inches x 1 and 3/4 inches for 5 days. No joint involment. No activity impairment. Easily tolerated.
Spoke with the parent and she stated the child had a seizure.  She was seen by a physician who indicated to the parent it was a vasovagal reaction.
Patient admitted  for severe hyponatremia with sodium of 111 with associated confusion.  He was admitted in the ICU and started on 3% saline and DDAVP.  IV ceftriaxone and azithromycin were started for possible pneumonia. CXR revealed pulmonary vascular congestion.  He completed a course of azithromycin and ceftriaxone for CAP coverage.   He made good progress and O2 was weaned down to about 2-3L. He was discharged to SNF, where O2 will be attempted to be weaned off.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Sleeping and lethargic and poor feeding.  Hospitalized - Hydrated.  1/17/09 MR received for DOS 1/29-30/2009 with D/C Dx: Sleepiness after immunizations. VP shunt for congenital hydrocephalus. Pt presented with 2 day hx of sleepiness and eating poorly. PE (+) for sleepiness otherwise WNL. Admitted to r/o shunt malfunction. Remained intermittantly somnolent with periods of activity, but improving. D/C home.
Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19; Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 93-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive from COVID 19.  Clinical information: Caller stated that she tested positive from COVID 19 yesterday. And she is very confused about the dosage of Paxlovid, she doesn´t know if she has to take it every 12 hours or for how many hours she needs to wait between doses. She wants a clarification on this. She also recommended to write this information as an instruction in the package of Paxlovid. She also stated that she has COPD (Chronic obstructive pulmonary disease), but she was told that it should be no problem for her to take Paxlovid. Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19. she received her first booster shot on Nov2021 and she wants to know how long she needs to wait until she can receive her second booster shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt states 2-3 day p/inject became nauseated & vomited several times w/diarrhea; 25MAR low back pain which inc to most major joints; pt adm to ER & observed; given med for pain, nausea, diarrhea;
Severe bilateral hip pain that started less than a week post injection. Now requiring 2 anti-inflammatory meds that temporarily relieve symptoms. Work and exercise routine have not changed. Difficult to walk without a limp at times. Other symptoms are fatigue and weakness. Also had tooth pain develop about a week after vaccination. Saw a dentist on 10/02/2023 and x-rays looked OK. Dentist stated it was probably inflammation.
heavy periods; earaches; I got my period on July 30th and then I got the vaccine and it started again; This is a spontaneous report from a contactable consumer (patient herself). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced heavy periods, earaches, got her period on 30Jul2021 and then got the vaccine and it started again. The reporter wanted to know if these were side effects from the vaccine. The outcome of all the events was unknown. There was no product quality complaint (PQC) present.   The lot number for the vaccine was not provided and will be requested during follow up.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a family practice office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated at a primary care office for a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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.
cough; chills,shiverings; fever; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot number: EN6204, Route: Intramuscular) on 02-Mar-2021, Pfizer (2nd dose, Lot number: ET6955 and Expiration date: 30Jun2021) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Cholesterol, Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to Lipitor), Drug allergy (Allergy to Morphine), Heart failure (all her life, Recent change in status such as improvement or worsening: she feels very sick), Renal failure (since 3 years ago, Recent change in status such as improvement or worsening: she feels very sick), COPD (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Polyneuropathy (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Diabetes (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick) and Sleep disorder NOS. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Heart disease, unspecified, METOPROLOL for Heart disorder, TRAZODONE for Sleep disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID], ISOSORBIDE and HYDROCODONE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever). On 21-Nov-2021, COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) had resolved.            No treatment medication was provided. Patient did not experienced a similar event in the past. Patient symptoms did not got any better.   This case was linked to MOD-2022-630425 (Patient Link).
fever, chills, nausea, fatigue, lighthead, lasted for several hours went away by the morning. Took ibuprofen for the arm pain and the fever.
Red, swollen, hot, itchy, painful, feverish, sore, extremely tired Monday night and today. Antibiotics: cephalexin, hydroxyzine tablets.
03/15/2021: Presented to the emergency department after losing his balance and falling down five stairs. The patient hit the back of his head, but didn't lose consciousness and currently takes a blood thinner. The patient was admitted with a pubic rami fracture and T12 fracture. The patient remains admitted and may undergo surgical repair.
pt recv vax 14AUG97 & devel fever of unspecified degree;16AUG97 pt was still febrile & was taken to ER:ER MD dx OM & prescribed Zithromax;pt remained febrile until 18AUG97 @ which time devel gen maculopapular rash;
Severe chills, nausea and vomiting. Patient got immunization at 5p.m. Started having chills after about 10 minutes and within 1/2 hour was vomiting. Chills, nausea and vomiting throughout night. Pharmacist called at 10:45 a.m. the next morning and she was feeling slightly better. Had not vomited for 4 hours. Will follow up tomorrow morning.
itchy, hives on left leg on inside of upper groin on sunday around lunch patient says now getting on right leg
Patient reported one side of the mouth twitching but it was fine a few hours later by end of shift.
HA, bodyache and chills since he got a J&J 10am this morning. Also having some left side pain without urinary issues or trauma. Has not taken any meds. Denies chest pain, difficult breathing.
This spontaneous case reported by a patient, describes the occurrence of dysgeusia (metallic taste in mouth), oropharyngeal pain (sore throat), dyspnea (slight labored breathing), pain in extremity (pain in the right heel) and headache in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 032B21A) for COVID-19 immunization. No medical history reported. Concomitant products included Lipitor (atorvastatin calcium) for an unknown indication. On Apr 7, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 7, 2021, patient experienced dysgeusia (metallic taste in mouth), oropharyngeal pain (sore throat) and headache. On Apr 17, 2021, patient experienced dyspnea (slight labored breathing). On Apr 30, 2021, patient experienced pain in extremity (pain in the right heel). On Apr 9, 2021, dysgeusia (metallic taste in mouth), oropharyngeal pain (sore throat) and headache resolved. On Apr 28, 2021, dyspnea (slight labored breathing) resolved. At the time of the report, pain in extremity (pain in the right heel) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided.
Approximately 20 minutes after injection, I experienced tingling sensation of tongue with mild swelling, pharyngeal pruritis, increased mucus production causing coughing, nasal congestion, and constant throat clearing, globular sensation when swallowing, voice became hoarse. I reported to nurse monitoring patients post injection. Was asked regarding symptoms and told to take medications that I had brought with me. Medications were Pepcid 20 mg, Benadryl 50 mg, Prednisone 10 mg. I was  monitored for another 90 minutes. Symptoms began to resolve approximately 30 minutes after taking medications. Full resolution of symptoms occurred approximately 8 hours after taking medications. Followed nurse's instructions and immediately notified PCPs office upon returning home. PCP recommends to not receive 2nd Pfizer vaccine.
Shingles-like breakout on right side of neck within 5 hours after injection. Next day light fever, chills. Non-filled pustules around entire neck, behind ears, and chest. Extremely itchy with no pain. Non-filled pustules are similar to chicken pox. 13 days after vaccine injection resulted in some affected areas clear of reaction event but still reacting in new areas. Treated with Naproxen OTC, Benadryl tablets @ 25 mg each/ 2 every 4 hours daily and Benadryl gel to prevent topical itching.
Broke out into hives all over her body. They became big red patches that was very itchy. Contacted doctor and he called her in some meds. Her tenders on her arms started swelling then down to her hands.
My 4 month old passed out soon after we got home from the shot (an hour after the injection). He was unresponsive, he wouldn't wake up even as I moved him and tried to wake him. His breathing was slow and he looked a bit pale. He slept like this for an hour and I called the nurse who advised me to monitor him closely. Later that evening he woke up screaming a high pitched scream and wouldn't open his eyes all night. When he would start to calm down his arms would jerk, his body would tense up and he would scream like he was in pain. This happened three times throughout the  night. The next day and evening his temp remained at 101.8 even after giving Tylenol and he was lethargic. His left eye got swollen that evening and He also developed three red inflamed bumps on his testicles over the course of the day.
On 9/19/07 between 11:30-12N child received 4 vaccinations (see below). Dr saw infant 3 hrs later and he appeared well. Parents state between 6p-8p infant fussy. In AM of 9/20/07 child found "blue" 911 called but infant died.
About 12 hours (at midnight) after my second Moderna vaccination, I lost all bladder control and the use of both legs.  I didn't have much pain but was very tired.  Trying to get out of bed I fell, and my wife had to get me up.  I decided not to call 911 but to wait until the following morning to go to the ER, which I now know was a mistake.  By the morning the use of my legs was starting to return.  I have been told by medical professionals (my wife being one, an RN) that it was the symptoms of either Transverse Myelitis or Gillian-Barre Syndrome.  If it reoccurs, I am told to get to the ER immediately for a spinal tap.  I had no adverse effects from the first vaccination, nor have I ever had any reactions from any other vaccinations or medications.  I am not sure if this is the right place to report this.  If not, please forward that info to me.  Thank you.
Ten minutes after receiving the Meningitis vaccination, I began to feel intense, unnatural perspiration, dizziness, nausea,  as well as blurry vision. Additionally, I turned pale and experienced extremely low blood pressure (98 / 70), as measured by a nurse, which returned to normal after approximately ten minutes (113 / ?). Had I not squatted down once I began to experience symptoms, I would have fallen or possibly lost consciousness. I do not experience this after blood work or dental work, nor have I ever experienced this after receiving any vaccination apart from the Meningococcal immunization. Throughout the remainder of the day, I felt weak and tired.
Severely swollen, red/hot, itchy area around injection site. Site first the size of a lime eventually growing to the size of a small apple. Continues to be swollen and itch 6 days after injection
Headache - moderate - 18 hours  Chills - moderate - 18 hours Muscle aches - low - 18 hours Tiredness/sleepiness - high - 18 hours Soreness at injection site - moderate - 24 hours  Treated with 2 extra strength Tylenol every 6 hours beginning at 6:45 AM Feb 23, 2021. Last dose 9:30PM Feb 23, 2021
patient is 15 years old and received a vaccine indicated for 18+ only. patient didnt experience any side effects
woke up from afternoon nap, top lip swollen;called clinic advised to take to ER;
COVID-19 symptoms started around 1:30/2 AM 05/16/22; tested positive on 05/17/22. I felt achy, had fever, sore throat, headache, flu-like symptoms, strep-like symptoms, and COVID-19 symptoms. I called my PCP and they said I needed to come in and be tested for all 3 (Covid, strep, flu) and all came back negative except COVID-19. I had a fever that went up to 103 and didn't break until that Thursday 05/19/22. It started at 101 and the highest was 103. They put me on medication PAXLOVID for twice a day and I started that on 05/17/22 and I was on it the whole time but fever still went up. I had a cough and the cough was a wet cough and that lingered for another week and I had coughing fits. I had no difficulty breathing, and I was checking pulse ox and that was OK but I became tachycardic. Pulse was in the 90s and usually it's in the 60s or 70s and it was very rapid. I had fever, chills, and cough, but the cough took the longest to go away. I was bed ridden and couldn't go to work like that.
Called in reporting generalized tingling over entire body which started about 3 hours after injection.  No redness or swelling.  Referred to ER.
COVID-19; feeling hot and then cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold) and COVID-19 (COVID-19 ) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold). On 29-Apr-2021, the patient experienced COVID-19 (COVID-19 ). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 27-Apr-2021, FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold) had resolved. On 03-May-2021, COVID-19 (COVID-19 ) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 02-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
APPETITE LOST; DIMINISHED SENSE OF TASTE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced appetite lost. On 21-MAR-2021, the subject experienced diminished sense of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from appetite lost and diminished sense of taste. This report was non-serious.
Diagnosed with covid after the 1st dose, asymptomatic; This spontaneous case was reported by a pharmacist and describes the occurrence of ASYMPTOMATIC COVID-19 (Diagnosed with covid after the 1st dose, asymptomatic) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asymptomatic COVID-19.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (Diagnosed with covid after the 1st dose, asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (Diagnosed with covid after the 1st dose, asymptomatic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient subsequently was diagnosed with COVID after the 1st dose however the patient was asymptomatic but had a little bit of the virus ( viral load). Since then, the patient has now tested negative but never received the 2nd dose of Moderna COVID vaccine as he was advised by the doctors to wait 90 days after being diagnosed with COVID initially.