chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration, administered in the left arm on 24Apr2021 12:30 (at the age of 56-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included very low iron, asthma, and COVID-19. Patient reported she is taking "too many to name" unspecified medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea on 25Apr2021 00:00. Patient reported she had diarrhea since her first dose. She had COVID so she expected to be ill after the first vaccine. Patient took unspecified diarrhea medication as a result of the event reported. The outcome of event was recovering.  Information on the Lot/Batch number has been requested.
Patient called and stated she received Moderna vaccine on 4/22. She stated on Saturday she had a pain in her temple that she still has though it is better, only feeling like a dull ache. She stated she has a hx of Migraines but that this did not feel like one. She denies any fever, no other sx.
Patient given first dose of COVID vaccine today. After being vaccinated patient walked over where his brother was sitting. Soon after siting he felt weak and fell to the floor, patient appeared to be shaking for 2 seconds, generalized, witnesses unsure if he hit his head. No eye rolling, no foaming of the mouth, no incontinence noted. Patient was monitored and assisted off the floor to a wheelchair. While being assessed at a nearby cot, while siting, the patient's eyes rolled back, upper limb shaking for 2 seconds. Patient does not remember either episode. Vitals: 120/70, HR 88, RR14, Oxygen 100%, Glucose 113, exam: patient alert and oriented x3, PERRLA, heart RRR, normal S1 and S2, no murmur, lungs cleared. Due to second episode occuring, 911 was called. Mother was on site and full report given to her. Patient was getting up and heart rated noted to drop to 56, he felt dizzy at this point and sat down, then laid down. The patient was evaluated by EMT and was taken to hospital for further evaluation.
Information has been received from a physician concerning a 21 month old male who, at 12 months of age, was vaccinated with a dose of VARIVAX (Oka/Merck). Subsequently, the patient developed shingles. The physician was "positive" that it was shingles and it was noted to be around his trunk area nerve track. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears. Concurrent medical conditions included Hearing loss.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-324268 (Patient Link).
Client stated she noticed a headache, chills, fever 100.2, sleepy, legs twitching,  restless and unable to sleep, Client stated she had 2 glasses of wine and had stopped taking antidepressants Sunday 9/15/19 and Monday 9/16/19.  Client stated fever is gone but is unable to sleep. after not sleeping the night before.
Information has been received from a physician concerning a patient who was vaccinated with a "booster" dose of PNEUMOVAX 23 (Lot # not provided). After patient received PNEUMOVAX 23, the patient experienced blood clots at the injection site and phlebitis of the extremities. This is one of two reports from the same source. Additional information has been received from Health Care worker concerning a 82 year old male patient who was vaccinated with PNEUMOVAX 23 (Lot # not provided). Concomitant therapy included FLUOGEN on 15-NOV-2008. On 15-NOV-2008 he developed deep vein thrombosis in right arm. Patient was hospitalized for 5 days. Additional information is not expected.
Swollen lymph lymph node on collarbone on the same side as the vaccine injection.
pt recv vax & w/in 24hr of vax pt devel a welt @ the inj site, diarrhea & flu-like sx;this is 1 of 2 pt from this site to have an adverse rxn p/vax;
One week after injection, symptoms started. At the site of injection, swollen, redness, pain  for one week.  Size of swelling:5cmx 10 cm . Symptoms resolved  after 8 days
Headache, CoughWheeze, shortness of breath Narrative:  THree weeks after vaccine first dose employee experienced migraines and 4 nights of cold like symptoms, shortness of breath, cough and soreness at injection site.
Violent shaking & shivering, fever, unable to sleep, exhaustion, body aches
patient states that he began to experience the following at approx 12:40, itchy, runny nose Drove to office the following symptoms began at approx 12:58, itching chills, swelling hives on arms, trunk, his legs. Minimal anxiety with minimal shortness of breath, Took Benadryl liquid, offered by co worker. Symptoms began to resolve only few hives present on legs approx 30 mins later.
Fever 101 degrees; Headache; Severe muscle aches/pain; Nausea; Tiredness; Injection site pain; Chills; Severe muscle aches/pain; After my first and second vaccinations my sinus congestion and seasonal allergies completely disappeared; This is a spontaneous report from a contactable consumer (patient). A 61 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) via an unspecified route, administered in Right arm on 24Mar2021 at 09:45 (61-year-old at vaccination) at a Dose 2, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient's medical history included Hashimotos thyroiditis, high cholesterol, dry eye, Seasonal allergies, Nasal polyps. The patient had known allergies to sulfur antibiotics. The patient had experienced rash while on sulfur antibiotics. The patient's concomitant medication(s) included levothyroxine sodium (SYNTHROID); liothyronine; pravastatin; ciclosporin (RESTASIS) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198) via an unspecified route, administered in Right arm on 03Mar2021 at 08:30 (61-year-old at vaccination) at a Dose 1, Single for Covid-19 immunization. No adverse effect but a positive outcome. After her first and second vaccinations her sinus congestion and seasonal allergies completely disappeared. After first dose she noticed complete clearing of nasal passages (she had nasal polyps) and she have not needed any seasonal allergy medicine this spring. Felt absolutely fantastic. On 24Mar2021 at 23:00, the patient had experienced fever 101 degrees, headache, severe muscle aches/pain, nausea, tiredness, injection site pain, chills. Lasted 6 hours only. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 24Mar2021. o treatment received for the resulted events. The reporter consider seriousness of events as non-serious. The outcome of the events was recovered on 25Mar2021.  No follow-up attempts are needed. No further information was expected.
Severe burning pain in shoulder where the injection was administered for 2 days. Right arm was mostly immobile during this time and had to use the left arm to lift/move the right arm. That pain changed to a continuous aching pain that lasted for several months.
There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medications were reported. No Treatment medications were reported.
optic neuritis 12/10/2009 PCP visit 11/12/2009 f/up visit for rt optic neuritis, taking steroids for tx, c/o's not sleeping well otherwise no problems, scheduled for further dx tests 11/19/2009  12/29/09 Medical records received for dates 10/7/09 to 12/4/09. DX:optic papilitis, optic neuritis OD, s/p recent IV solumedrol now w/ disc edema OS amaurosis sx decreased vision, Central scotoma, optic neuritis, venous thrombosis, eye problems, disk edema. CC: vision changes, eye pain. Multiple ophthalmology visits.
HCP unknowingly administered GARDASIL 9 to a patient who was already fully vaccinated; No additional AE details; This spontaneous report was received from a company representative and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient, who was already fully vaccinated, was unknowingly administered another extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot #, expiration date and route of administration were not provided) for prophylaxis (extra dose administered). No additional adverse events were reported (no adverse event).
Information has been received from a nurse concerning a 33 year old white female with a history of yeast and "RECOMBIVAX" who in September 2002, was vaccinated with the first 1ml IM dose in a series of hepatitis B. Subsequently the patient experienced a mild allergic reaction. She became severely itchy for 2 days and the rest of the series was discontinued. It was reported that the symptoms lasted for 2 days and then resolved. The reporter felt the patient's experience was disabling. Additional information is not expected.
died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047644 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047643 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047642 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047646 as same reporter/drug, different patient/event;;US-PFIZER INC-202300047640 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047645 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047636 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047639 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047641 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047638 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047637 as same reporter/drug/event, different patient.;; Reported Cause(s) of Death: died since taking your COVID vaccine
as vaccine was being given, vaccine leaked out from between syringe and needle and leaked down patient arm
pt says he developed fatigue, loss of taste and smell, headache, chills, joint pain, nausea, vomiting, fever, muscle aches and pains.  These symptoms lasted a couple of day and have since subsided.
Localized redness 3 inches below injection site in circular pattern. Patient denies soreness, itching, irritation at affected area. She went for a routine blood draw for INR monitoring and MD prescribed dicloxacillin for possible cellulitis. We will f/u with patient in a few days to track progress.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 06-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS-LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified dates, the vaccine experienced two temperature excursions one of 48 hours and other of 40 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 47 F (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several received from the same reporter. Additional information has been requested.
H1N1 vaccine received 11/16/09. 11/17/09 @ 0100 awakened to rash on (L) deltoid where shot given. Rash with wheals, hives, papules spread to entirely body 11/17/09- Lasting up to 12/3/09.
pt. recvd M-M-R II & exp. "Mumps-like synd" w/ testicular pain & epididymitis.
the patient did not receive the full dose as she noted that some leaked out of the syringe when the patient moved; the patient did not receive the full dose as she noted that some leaked out of the syringe when the patient moved; No additional AE reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W004026, expiration date 02-AUG-2023 (dose, route and frequency were not reported) along with sterile diluent, for prophylaxis.   The reporter mentioned that, on an unknown date, the patient moved when she was administering a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), and stated that the patient did not receive the full dose as she noted that some leaked out of the syringe when the patient moved. No additional adverse event was reported.
Dosed outside recomended time frame, >12 hours post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dosed outside recomended time frame, >12 hours post vial puncture) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Advil), Fruit allergy (Kiwi), Seafood allergy (Lobster) and Seafood allergy (Shrimp).   On 24-Aug-2021 at 9:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dosed outside recomended time frame, >12 hours post vial puncture). On 24-Aug-2021 at 9:15 AM, EXPIRED PRODUCT ADMINISTERED (Dosed outside recomended time frame, >12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vial with lot number: 022C21A was punctured on 23-Sep-2021 at 9 am, after puncture at 9 pm vial was properly labeled and was kept at recommended temp of 2-8 Celsius.  No treatment information was provided by the reporter.  No adverse events noted since vaccine given.   This case was linked to MOD-2021-331573 (Patient Link).
dizziness with passing out and vomiting. not a vagal response, out of the blue, just happened, nothing new, 3 weeks later and then again 3 weeks later x 2 more times.
got shingles after he had two doses/Suspected Vaccination Failure; got shingles after he had two doses; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles after he had two doses/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles after he had two doses). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that apparently, just because we got the shingles vaccine and it did not mean that we could not still get shingles.  The reporter further stated that his/her boss (patient) just got shingles after he had two doses of the shingles vaccine and it was very mild but it was still shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Information has been received from a medical assistant concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL injection. Subsequently on an unspecified date the patient fainted after receiving GARDASIL. It was unknown if the patient recovered. Additional information has been requested.
Injection site reaction - redness, pain, and swelling at injection site. Started 1 day after vaccination and worsened on day 2 (date of this report). Administered ibuprofen.
Narrative:  Patient noted he experienced weakness and chills for 2 days after his initial COVID-19 vaccine on 01/15/2021. Reactions self-resolved with no further complaints. Weakness, chills
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 26-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
The day following the vaccine I had redness around the injection site and a bump. After a few days it felt like the bump had gone down and the redness was totally gone. On 2/23/21, the redness was back and the bump was expanding and very itchy. I took an Allegra tablet and put Benadryl ointment in it and went to bed. 24 hour later it has now expanded in circumference.
J96.00 ACUTE RESPIRATORY FAILURE 1/9/2023 LEUKOCYTOSIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/9/2023 LEUKOCYTOSIS
This is a spontaneous report received from a contactable consumer or other non-HCP. A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced muscular weakness/arm weakness, with outcome of unknown. Additional information: Patient experienced arm weakness within 24 hours of 1st shot of Pfizer vaccine. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
On Monday 9/24/18 child received immunization for flu at recheck appointment. As documented and recalled by person who administered, it was given in left thigh intramuscularly. Mom called triage nurse on 9/25/18 with concerns regarding redness, heat to right upper thigh. Mom stated this was the site of injection. Child brought into provider on 9/16/18. Redness and heat to right upper thigh. No injection site notable at visit.
2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.