chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with an unspecified number of doses of M-M-R II (strength, dose, lot#, expiration date and route were unknown). On an unknown date the patient experienced an inflammatory bowel disease. The outcome of the event was unknown. Additional information has been requested.
12/23/2021-talking to neighbor, speech began to slur. neighbor told him to sit. alert and knew of his surroundings but my speech began to get worst.  speech had returned to normal within 3 min. legs felt a bit weak, between both legs--equally.
Immediately after initial shot I had a medicinal/metallic taste in my mouth and then my tongue felt like I had burnt it (like one would with hot coffee).  The scalded/burnt feeling has not gone away.  Immediately after my second shot (08/15/2021) the medicinal/metallic taste appeared again.  In both instances the medicinal/metallic taste dissipated within 2 hours, but the scalded feeling has remained constant.
had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice; had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300114776 same patient, different dose/event.;
14 y/o patient was administered a Menactra in January and accidentally received another one in August with no reported adverse event; Initial information received on 10-Aug-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 14 years old who experienced was administered Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] in january and accidentally received another one in august with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Aug-2023, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine Solution for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date in Aug-2023, the 14 y/o patient was administered a Meningococcal A-C-Y-W135 (D Conj) Vaccine in january and accidentally received another one in august with no reported adverse event (extra dose administered) (latency: same day).  It was reported, If a 14 y/o patient was administered a Menactra in January and accidentally received another one in August is there anything that needs to be done? Do they still need the booster at 16 y/o.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Large indurated, red, warm area at injection site. CIPRO BID taken for approx. 10 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE; LIVALO; ZETIA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course:  Anti-viral details: Product is COVID 19 treatment, Brand is Plaxlovid, Treatment start date is 11Jun2022, Treatment stop date is 16Jun2022, Indication was Treatment of COVID-19     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed symptoms of COVID 19 on 7/22,  Headache, runny nose, sinus pressure initial symptoms.  Home test positive that date. PCR on 7/23 positive result. Later, around day 4-5 developed slight cough, shortness of breath  in evenings, o2 sats decreasing at night causing anxiety, increased, bradycardia at night in low 40;s, runs of bigeminy - documented on EKG, pain in veins in legs.   Never had a fever. Prescribed medrol dosepack 7/27;  CDC representative contacted me on 8/12  in response to my completion of my 6 month VAERS questionaire and asked that I create an event report
Since 14 February he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy welts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affected his palms and soles, and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 3 February, 11 days prior to onset of symptoms. He has used oral antihistamines with benefit. He denies constitutional symptoms. UCT score today is 20 (2, 2, 3, 3, 1, 4, 2, 3). No history of adverse reactions to prior vaccines.
Intense headache with sharp pain behind right ear,  ibuprofen gave temporary relief, but pain recurred. Nerve block injection on 3/22 stopped the pain
This spontaneous report as received from a licensed practical nurse refers to a 12 month old patient. It was reported that on  16-MAY-2013 the patient received (merck) PROQUAD (lot number not provided) and (merck) VARIVAX (lot number not provided) at the same visit instead of M-M-R II (lot number not provided) and (merck) VARIVAX. No product confusion, just medication error. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
FEVER 102; CHILLS; LOSS OF APPETITE; MILD SWELLING AT INJECTION SITE
when exercising I am unable to recover my breath timely and it leads to panic attacks.  I also had episodes while sleeping were I was unable to breath normally causing panic attacks
Soar arm for the first 36 hours. 38 hours after shot woke up and couldn't go back to sleep. 40 hours after shot extreme weakness.  My wife had to help me get out of the recliner and get dressed for our trip. Also I was very confused. I was a bit nauseous and did not want to eat.  My blood sugar was 226.  For the next 6 hours as we traveled, I had to pee every 30-45 minutes. I needed help getting in and out of the rest stops and the vehicle.  As we traveled I mostly slept. I did drink a little diet soda, but did not eat.  After the 6 hours of travel I felt a stronger and was able to get out of the car and into the houses by myself.  For the next 24 hours I felt week, ate very little and sugers ran high.
Two hours post vax, the pt developed a large swollen, red, hard area at the injection site engaged whole leg, unconsolable crying for seven hours. Resolved in 48 hours. Seen in physicians office. From follow-up #1 correspondence received on 1-MAY-2001, the correct vaccination and adverse event onset dates (10-Nov-2000) as well as additional patient, vaccine and the reporter's phone number where provided.  -TS 23-Apr-2001. This case is closed.
arm pain Narrative: Employee states she is still experiencing pain at the injection site (today 1/22/2021) was vaccinated 1/6/2021 (she questions if the vaccine was administered too high in the shoulder and plans to follow up with her provider)
cant lift over 10 lbs are is sore from shot , went to pcp who gave medro dose pak for inflammation
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:
High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; headaches; fatigue; This is a spontaneous report from a contactable physician, the patient.  A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Dec2020 at 15:15 (at 49-years-old) as a single dose for COVID-19 immunization. Medical history included severe iron deficiency, hypothyroidism, osteoporosis, and low baseline IgM antibodies levels (unknown cause). The patient did not have any allergies to medications, food, or other products.  Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), and biotin (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Dec2020 at 18:00, the patient experienced high fevers (103/104 degrees Fahrenheit) with chills for five days followed by low fevers (up to 101 degrees Fahrenheit) for another six days, headaches, and fatigue; all reported as non-serious. On 24Dec2020, the patient had a post vaccination nasal swab rapid antigen test and SARS-CoV-2 PCR test with negative results. The patient took paracetamol (TYLENOL) and ibuprofen (ADVIL) for treatment for the events. The clinical outcomes of the fever, chills, headaches, and fatigue were recovering.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of high fevers with chills. 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.
PT administered Flu-Mist at 1050 and started c/o of loss of perpherial vision at 1100.  Pt examined by doctor and Field of Vision test performed.  Both test were WNL.  Pt c/o of minor photophobia and HA.  Neuro exam was normal.  After 30 min., symptoms decreased expect for HA.
pt recv vax & devel gen hives approx 30min later;pt was treated w/DPH & hives resolved;additional info 9JUN97  indicated that pt devel cold sx later that evening;pt recovered;
This report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 2 month old female participant in a post marketing evaluation of Prevnar. The child received the first dose on 11/28/00, at 2 months of age. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/28/00. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix vaccine, IPOL, vaccine, and Recombivax HB vaccine. On 12/1/00, four days post immunization, the patient experienced SIDS. According to the coroner's office, the cause of death was reported as SIDS. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related  to the study vaccine. On 2/2/04, additional documentation regarding this event has been requested by the investigator. Additional information received on 11-Feb-2004 provide autopysy results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) Injection) was received from an investigator regarding a 2 month old female participant in a surveillance trial. Safter of Prevnar administered concurrently with routing infant vaccinations at 2, 4, 6 and 12 to 15 months of age who died as a result of an unexpected sudden death. The child received the first dose on 28-Nov-2003, at 2 months of age.
pt recv vax 12SEP96 & 5hr p/vax pt broke out in hives over lower trunk, legs, feet, & ankles;MD visit was required;tx w/Medrol dosepak & then sx resolved;
Next day/continues today  - Hyperactivity. Next day/continues today - Fast speech. Next day/continues today - Shaking hands. Next day/continues today - Suicidal thoughts. Next day/continues today - Crying. One week later - Vomiting. One week later - Diarrhea.
Muscle soreness for 2 days, muscle spasms becoming more frequent for next days, pain in left deltoid severe grabbing.
Fatigue dizziness nausea vomiting severe bone and muscle pain Severe headache  sore arm swollen red  Symptoms increased from day of injection worse by 9:00am on 3-26, n/v with severe HA that evening and cont 3-27( no vomiting).  Medicated with acetaminophen, butalbital, rizitriptan. Stayed in bed until 3-28, symptoms milder. 3-30 Still fatigued with muscle ache and nausea. Med with zofran  and butalbital.. L arm red, swollen, sl rash, itching.
diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported), from a Pfizer-sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 11Feb2021, as single dose for COVID-19 immunisation. Patient's medical history included diarrhea. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), gabapentin, metformin, atorvastatin (LIPITOR) and trazodone. Historical vaccine included first dose of BNT162B2 for COVID-19 immunisation. Patient stated that he had his second dose of the COVID-19 Vaccine, today (11Feb2021), and had a question, that after his first dose he was able to take all of his regular medications and wanted to know if after the second dose, can he still continue his regular medications?. Patient said that he had a little bit of diarrhea, but he was feeling fine otherwise, but he was not sure that was related to the vaccine or not. He added he was already experienced prior. He wants to know if it is okay to take Tylenol or ibuprofen in case, he experiences some side effects (chills or fever). Patient wants to know if he can continue taking his regular medicine like metformin and trazodone, mentioned that he also took those medicine after his 1st dose of the vaccine. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
left arm still hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "left arm still hurts". The patient had complaints from the first two doses of the Pfizer Covid-19 vaccine (first dose time unknown, second dose in Jan2022 per Caller). Caller reported that she had complaints of sweats, fevers, left arm still hurts, arm numbness and tingling Caller reports that she was in the hospital back in Apr2022 due to the complaints with arm numbness and tingling due to concerns about a stroke but was told nothing is wrong with her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE reported; the patients that were administered the vaccines involved in the temperature excursion; This spontaneous report has been received from a pediatric office clinical coordinator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 10-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T030945 has been verified to be a valid lot number, expiration date reported and established as 09-MAR-2022) as prophylaxis.  The vaccine was exposed to a temperature excursion of 15.7 degrees Fahrenheit (F) during a time frame of 35 minutes; with no previous temperature excursion. No additional adverse events reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA004580: US-009507513-2108USA004581: US-009507513-2108USA003330:
Hearing loss in left ear. Has gone through treatment with cortisone injections but not effective.
Small red bumps on upper body; Excessive itching.; This is a spontaneous report from a contactable consumer, a patient. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration on the right arm on 03Feb2021 at 10:30 (age at vaccination at 74-year-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration on the right arm on 03Mar2021 at 10:30, as single dose for COVID-19 vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), omega 3 (MANUFACTURER UNKNOWN) and vitamin K2 with D3 (MANUFACTURER UNKNOWN) all for an unknown indication on an unknown date. The patient had no allergies to medication, food, or other products. Prior to 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 4 weeks prior to the vaccine. On 09Feb2021 at 09:00, the patient experienced small red bumps on upper body with excessive itching. The patient did not receive any therapeutic measure for the events blister and itching. The clinical outcome of the events blister and itching was not resolved at the time of reporting.   No follow-up attempts are possible. No further information is expected.
patient received two doses of adacel within 10 months /no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 17-Oct-2019 and then again on 17-Aug-2020 (batch number U6702AA; expiry date 20-Jun-2022 and dosing details 0.5 mL) via unknown route in unknown administration site for prophylactic vaccination (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was an actual medication error case due extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning a female (age not reported) who in December 2007, was vaccinated with the first dose of Gardasil (lot # not available).  In December 2007, after receiving her first dose of the vaccine, the patient fainted.  Subsequently, the patient recovered the same day.  Additional information has been requested.
Mom reported 3 days ago child received 4 y/o immunizations.  Started with small red spot on Saturday, since then is spreading and getting bigger, no pain, no fever, not painful to touch. Mom also states their has been a rash to the Left leg ,red, swollen, itchiness, and bruised looking per mom she states it looks better today she also states she gave the child benadryl  over the counter.  bruising noted today and she is scheduled to return for follow up later today per provider.