chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild arm soreness; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable male consumer, the patient. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) , dose 1, single dose via unspecified route of administration on 22Jan2021  for COVID-19 vaccination. Medical history and concomitant medications were unknown. On an unknown date, the patient experienced mild arm soreness. It was unknown if the patient received treatment for the event. The clinical outcome of mild arm soreness was unknown.   No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing), notes: known allergies: Mango; "known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Nausea for 2 days; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not provided) via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Not tested for COVID post vaccination. On 23Jan2021 patient experienced Nausea for 2 days. The treatment was not received. The outcome of the event was recovered on 25Jan2021.  Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient appeared pale moments after receiving the vaccine. She said she felt nauseous, hot and sweaty.  I gave her a bottle of water, pretzels, and dum dum lollipop and she felt better and regained color by the time her 15 minute wait was up.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles/ severe vesicular rash, which was diagnosed as herpes zoster or shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 28-JAN-2011, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at the public health department, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 20-OCT-2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
fever to 104 10AUG93; fever to 100 w/poor appetite & diarrhea 11AUG93;
MISSED THE SECOND DOSE; This spontaneous case (PVX2019-1343) report was received from a consumer on 24-May-2019. It describes an adolescent female consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif about one week ago and forgot to take the second dose on time.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.
After injection of influenza vaccine into the left deltoid, imnmediate swelling occurred. Ice pack given
pt recv vax & pt devel 8 to 10 chickenpox;pt was afeb & subsequently recovered;
A report has been received from a Study Investigator concerning a 24 year old, female subject, Height: 64.0 inches,  Weight: 195.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date. The date of last menstrual period was 21-SEP-2013. The patient experienced pregnancy which started on 21-SEP-2013. The estimated date of delivery was 28-JUN-2014. The outcome of the pregnancy was reported to be a healthy baby  born on 26-JUN-2014. The number of weeks at outcome of pregnancy was 39.5. The report was considered to be non-serious. The study investigator considered that there was no casual relationship between pregnancy and study therapy.
severe Case of tinnitus; I felt a general weakness; patient didnt recieve the second dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (severe Case of tinnitus), ASTHENIA (I felt a general weakness) and PRODUCT DOSE OMISSION ISSUE (patient didnt recieve the second dose of Moderna COVID-19 Vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-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 TINNITUS (severe Case of tinnitus), ASTHENIA (I felt a general weakness) and PRODUCT DOSE OMISSION ISSUE (patient didnt recieve the second dose of Moderna COVID-19 Vaccine). At the time of the report, TINNITUS (severe Case of tinnitus), ASTHENIA (I felt a general weakness) and PRODUCT DOSE OMISSION ISSUE (patient didnt recieve the second dose of Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications was not provided.  Company Comment: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown,  with associated AEs (Tinnitus and Asthenia). Very limited information regarding this events has been provided at this time. The date of onset of events has not been reported. Further information has been requested.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown,  with associated AEs (Tinnitus and Asthenia). Very limited information regarding this events has been provided at this time. The date of onset of events has not been reported. Further information has been requested.
Migraines, tingling sensation in hands and feet, involuntary twitching in hands, diagnosed with visual snow syndrome.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender, who on 15-JUL-2013, was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported), and on 17-SEP-2013, the patient came into the office to receive her second dose of GARDASIL (dose, route and lot # not reported), but the vial unit malfunctioned and approximately half of the vaccine came out onto the patient's arm. No AE symptoms were reported. Therapy with GARDASIL continued. The reporter queried what to do for the patient. Additional information has been requested.
Local board of health nurse administered 0.25 of FLULAVAL QUADRIVALENT vaccine to a 2 year old patient. (Vaccine licensed for 3 and older). She contacted the State Department of Public Health, who let her know that most likely the patient would need to be contacted and revaccinated. The Local Board of Health nurse stated there were no adverse events noted in the patient. The nurse at the State DPH contacted GSK to ensure that this was indeed the case. A pharmacist at GSK stated that they do not have any data on the 0.25 dose, only on 0.5 dose and that they had recently filed papers to extend the age limit down to 6 months on FLULAVAL, but using a 0.5 dose. The GSK pharmacist confirmed that this patient should be revaccinated with the correct flu vaccine for her age. This was communicated to the Local Board of Health nurse by the State DPH nurse.
Diagnosed with Myocarditis. Severe chest pain began at 2:30am. Went to hospital ER at 4am. Was given an ekg and blood test which showed a potential heart attack and was treated with Nitroglycerin at 4:30 am. Was given a cardiac catheterization at 6am that showed no heart attack and no arterial obstructions but showed one wall of the heart was not functioning properly. Heart issue was confirmed later in the day by an echocardiogram study. Was admitted to the hospital. Had an additional attack of chest pains at approximately 2:30pm the next day which was treated with 3 tablets of Nitroglycerin. Blood tests showed markers for inflammation.
Client stated that he was 12 years old and was vaccinated. After further investigation, client was found to be only 11 years old (DOB 12/11/2009).
expired dose of Pediarix/ administered on 06/10/2021 / expired on 05/24/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 10th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 10th June 2021, patient received Pediarix, which was expired on 24th  May 2021. The reporter consented to follow up.
Approx 24 hours after 5th booster shot, (this is my 1st Pfizer Bivalent Booster),  I have a raised, very red, and painful somewhat circular spot on my arm that received the vaccine. It measures approximately 2" x 2".  I do have a photo available.
Started to feel chilly around 10 pm evening of 2/22/19. Woke up 7am on 2/23/19 feeling sore in all major joints and muscles, slight dull feeling head ache. Didn't feel like eating till around 2PM on 2/23/19. Had light lunch (chicken soup) and took one Advil liquid-gel 200MG. Started feeling back to normal on 2/24/19.
Information has been received from a medical assistant, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 syringes, lot number M023460 with expiration date on 12-NOV-2017 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported and no additional information was provided. The vaccines had a temperature excursion of 9 Celsius (C) to 25 C during 20 minutes,also was confirmed that the vaccines did not have previous temperature excursions and a digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA005670: US-009507513-1706USA005671: US-009507513-1706USA005672: US-009507513-1706USA004421:
hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse.  A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks.  Medical history included allergies to penicillin and shrimp.  There were no concomitant medications.  The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
S:self reported fever on 2nd night of 102 F and pain in LUE muscles, self administer tylenol for fever/pain  O:8x17cm erythemic induration w/ small areas of mild skin breakdown,
After receiving the second injection in my left arm on Thursday (4/1/21) afternoon, I noticed painful swelling had developed in my (L) armpit lymph node on Friday (4/2/21). Naproxen sodium taken orally (1-2x/day) & CBD oil lightly applied to area (2-3x/day) helped to lessen pain. Swelling began to dissipate daily & was undetectable by Sunday. On either Sunday (4/4/21) or Monday (4/5/21), I noticed some slight menstrual breakthrough bleeding. It was not the correct time in my cycle for menstruation and spotting is highly irregular - I have never experienced this. At first, I thought this was completely random & unattributed to receiving the vaccine but saw on social media that many other women had experienced these effects after their shot. They also spoke of increased pain and heavy bleeding. As I haven't yet had my period again, I cannot comment on my experience at this time, but I am still experiencing the light breakthrough bleeding. I also noticed some slight fatigue through Monday evening (4/5/21).
Medication error - given TDaP rather then DTaP. No AE reported to date 5/5/11.
Death; This is a spontaneous report from four non-contactable consumers via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms.    A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Dec2020 at a single dose for COVID-19 immunization.  Ongoing medical history included Alzheimer's Disease, encephalopathy, hypertension, acute kidney failure, urinary retention and recent urinary tract infection (UTI), all from an unspecified date.  Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN), bisacodyl (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), loperamide (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), senna alexandrina (SENNA PLUS), vitamin d3 (MANUFACTURER UNKNOWN).  The patient had no known drug allergies. The patient experienced death on 30Dec2020.  The vaccine was given on 28Dec2020 with no adverse events and no issues on 29Dec2020.  The patient died on 30Dec2020, at approximately 2:00 AM.   It was unknown if an autopsy was performed.  It was unknown if the event was related to the suspect drug, the administrator marked as natural causes.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death
Pt received dose of Fluzone 11/05/02, within 2 hours reported generalized rash and hives head to toe except for their face.  No difficulty breathing and no throat/lip swelling. No other events reported for this person.  There are a total of 3 similar reports from this facility.  A second person reported hives, generalized rash that occurred 4 days after vaccination, follow up with allergist. The third pt is employee in health center.
States hives started next morning on 10/01/2014. Took 1 Benadryl and hives resolved some. Next morning 10/02/2014 more hives on back, legs, chest, arms, face and torso. 1 Benadryl taken and did not resolve the hives. Hives are itchy and moderate and covering body at time of report. She is going to her doctor immediately.
The patient received the regular seasonal vaccine in her left arm, approximately 5 cm from the tip of the shoulder. She began experiencing pain down her entire left arm and a 5 mm red dot at the injection site the night after receiving her injection. There was no local swelling. She began to experience numbness in both legs, worse below her knees, particularly in her feet. She also complained of an upset stomach and diarrhea for 7-10 days following the vaccine as well as fatigue that still persists. The pain and numbness in her limbs resolved about one month after the vaccine. She did not seek medical care or receive any treatment for any of her symptoms.
Information has been received from a Nurse Practitioner (also reported as physician), concerning an adolescent female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown date, the patient was vaccinated with an unspecified dose of GARDASIL, via intramuscular route, (strength, dose, anatomical location, lot number and expiration date were not reported). No concomitant medications were provided. On unknown date, the patient began having seizures; she sought medical attention (unspecified) and was hospitalized on unknown dates. It was reported that the physician placed her on an unspecified medication. Then, the physician took her off the unspecified medication and she began to have seizures again, so she was placed back on the unspecified medication. It was unknown whether laboratory diagnostics studies were performed. At the time of reporting, the outcome of seizure was unknown. No product quality complaint was involved. The relatedness between the seizures and therapy with GARDASIL was not reported. Upon internal review, seizure was determined to be medically significant. Additional information has been requested.
FEVER; CHILLS; ACHY; VERY TIRED; MUSCLE PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination onleft deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced fever, chills, achy, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and muscle pain, and the outcome of fever, chills, achy and very tired was not reported. This report was non-serious.
Positive for COVID-19; severe fatigue; severe brain fog; hyperventilated and had trouble breathing; hyperventilated and had trouble breathing; abdominal pain; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19), HYPERVENTILATION (hyperventilated and had trouble breathing), DYSPNOEA (hyperventilated and had trouble breathing), ABDOMINAL PAIN (abdominal pain) and VACCINATION SITE PAIN (Pain in the arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HYPERVENTILATION (hyperventilated and had trouble breathing), DYSPNOEA (hyperventilated and had trouble breathing), ABDOMINAL PAIN (abdominal pain) and VACCINATION SITE PAIN (Pain in the arm). On 09-Jan-2021, the patient experienced FATIGUE (severe fatigue) and FEELING ABNORMAL (severe brain fog). On 20-Jan-2021, the patient experienced COVID-19 (Positive for COVID-19). At the time of the report, COVID-19 (Positive for COVID-19), HYPERVENTILATION (hyperventilated and had trouble breathing), DYSPNOEA (hyperventilated and had trouble breathing), ABDOMINAL PAIN (abdominal pain), VACCINATION SITE PAIN (Pain in the arm), FATIGUE (severe fatigue) and FEELING ABNORMAL (severe brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I started with a sore throat and developed a fever and body aches. I had sinus congestion, fatigue, and a cough. I took a rapid home COVID-19 test yesterday morning and it was positive. I called my primary care doctor to have a telehealth visit. They told me to do TYLENOL for fever and SUDAFED for sinus. I was also advised to stop taking the simvastatin until they can determine whether an anti-viral. My symptoms have improved. I do not have as much sinus pressure now and the sore throat. I do still have a fever of about 101.