chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The rash developed and there was a lot of pain with the rash. I went into the clinic the next day and was told it was shingles I was given anti-viral. I came home it never blistered bad and open, but it was uncomfortable I got a rash in my mouth and the fatigue was intense. I stayed home and rested I started to lose the fatigue. When I was resting my husband gave me a upper respiratory virus and ended up with an ear infection and my ear drum busted and lost my hearing temporarily. I have been dealing with fluid in the ear and they think that they are allergy related. I just started back with getting the allergy shots. When I would go outside the sun would bother me even through clothing and that lasted 5 weeks.
This non-serious medically confirmed spontaneous report (initial receipt 19-Nov-2014) concerns a 7 year-old female patient who had no known allergies or sensitivities to latex or eggs. On 16-Nov-2014 at 17:00 hours, the patient received intramuscular AFLURIA (batch number T52908) 0.5mL. AFLURIA was stored correctly. On 17-Nov-2014 in the morning, the patient started to have a fever which was 99 Fahrenheit and caused her to miss her school. On 18-Nov-2014, she developed warmth and pinkness at the injection site, which widened to an area of the size of a golf ball. The injection site was not painful, it was only warm to touch. The patient recovered from the fever on 19-Nov-2014 and went to school, but the injection site reaction remains. Patient's mother did not seek medical attention or administer any medications to her daughter. Outcome was reported recovered for fever and not yet recovered for injection site reactions.
pt reported she had the rash around the injection site , the rash last for 1 week then gone
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles (date unspecified), was treated by a physician and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation). At the time of the report, INCORRECT DOSE ADMINISTERED (6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that a 6 years old patient received first dose of Moderna COVID-19 vaccine from 6 month - 5 year old vial presentation and patient did not reported any adverse reactions.  No treatment medication information was provided.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: The outcome of the event has been updated from unknown to resolved.
Had my first Pfizer vaccine and few days later I tested positive for COVID; Had my first Pfizer vaccine and few days later I tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration, administered. The patient medical history and concomitant medications were not reported. Caller received her first dose of Pfizer's COVID vaccine and a few days later, she tested positive for COVID. She will have gone through her isolation of quarantine period and will be symptom free by the time she gets her second dose. Caller is wondering if she should be receiving her second dose. At the time of reporting the outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Bad aches in my joints. Even my feet and hands hurt. No fever but felt like a fever.  I took ibuprofen and Tylenol throughout the day. I felt much better the next morning.
pt recvd vax;was noted that T 101.9 2 days earlier but afebrile the day of vax;16aug95 exp soreness at inject site, tiredness & abd pain;next day productive cough composed of phlegm
Right after the first dose, he felt it was hard to breathe but went away after 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Right after the first dose, he felt it was hard to breathe but went away after 15 minutes) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 638C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Codeine), Drug allergy (Tramadol), Drug allergy (Toradol), Drug allergy (Gabapentin) and Fruit allergy (mangoes).    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced DYSPNOEA (Right after the first dose, he felt it was hard to breathe but went away after 15 minutes). On 09-Jul-2021, DYSPNOEA (Right after the first dose, he felt it was hard to breathe but went away after 15 minutes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  It was reported that patient did not take any medication with the symptoms, just increased his water intake and also confirms that patient was not taking any regular prescribed medications or any supplements.   This case was linked to MOD-2021-284335 (Patient Link).
Not comfortable; a bit sore; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort and pain. On an unknown date, the outcome of the discomfort was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the discomfort and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter hoped that both doses were included in 190 dollars. The patient received dose of Shingles vaccine and felt not comfortable and stays a bit sore. The patient stated that only have to do it once in a lifetime. The follow-up would not possible as no contact details were available.
HAD A N ITCHY RAISED RASH ON MY  BODY (EVERYWHERE BUT MY  FACE)  TOOK ORAL BENADRYL 50 MG THE FIRST EVENING.  WHEN I AWOKE THE RASH WAS STILL PRESENT TOOK TWO MORE DOSES OF ORAL BENADRYL 50 MG ALONG WITH A CORTISONE SPRAY FOR THE ITCHING, THROUGHOUT THE DAY.  THE RASH WAS GONE BY SATURDAY 1/9/2021 LATE EVENING.  DID NOT CONSULT OR GO TO THE DOCTOR
Long-term tinnitus, left ear. Began December 22, 2021 --  unsuccessfully attempted to treat with oral steroid, klonopin, gingko biloba, and over the counter Lipo Flavonoid.
Numbness of pad of right thumb (vaccine was in left arm) starting 1 he after vaccine and persisting 48 hrs after.
Post vaccination Pt. stated that sh e felt lightheaded and did not take her BP meds this am is nervous and anxious about getting the vaccine today.  Vitals taken and around 10:22am BP 225/ 80 patient escorted to ED and 10:04 Am
This spontaneous report has been received from a pharmacist referring to a 81 year old male patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions was not reported. Concomitant therapies included FLUVIRIN. On 21-NOV-2017, the patient was vaccinated in the left arm with an expired dose of VARIVAX first dose, lot # L035127 (also reported as L025127) and expiration date 14-SEP-2017 (strength and route were not provided) for prophylaxis. The patient did not have any illness at the time of vaccination.  The reporter stated that after administered the vaccine, she realized it was expired by a couple of months. She called the manufacturer and was told the vaccine's potency was still the same. No adverse effects were reported.
Pain radiating up and down arm, "bit red patches" on shoulder, axilla. Unable to come to clinic for evaluation and tx.
Narrative: COVID infection following COVID vaccine series 03/04, Pfizer, dose #1 03/25, Pfizer, dose #2 08/04 COVID swab, result: detected 08/05 pt cc: cough, rhinorrhea, loss of taste or smell exposure; unknow 08/08 clinically resolved.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported from the patient's friend. The age at vaccination was not reported. The patient experienced flu-like symptoms after her 2nd dose of Shingrix, but she not experienced after her first.  The reporter declined to provide additional information.
Blacked out; Stomach started to mumble; Stomach started to hurt; Feeling sick; Wanted to throw up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Stomach started to mumble), ABDOMINAL PAIN UPPER (Stomach started to hurt), MALAISE (Feeling sick) and NAUSEA (Wanted to throw up). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out), ABDOMINAL DISCOMFORT (Stomach started to mumble), ABDOMINAL PAIN UPPER (Stomach started to hurt), MALAISE (Feeling sick) and NAUSEA (Wanted to throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Blood test: normal (normal) everything was fine.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient got the first dose of the Moderna vaccine and minutes after, patient's stomach started to mumble and hurt and felt sick, like wanted to throw up and then blacked out.  When patient woke up, run over to the pharmacist and told what happened and they told to sit down and called an ambulance and when patient got into the hospital it was so busy that patient was sitting in the ER with the ambulance bed for a long time.  The hospital did a blood test and told that everything was fine, so patient went home. One of the doctors told that reaction to the second dose would be worse, so patient decided not to get it.  Concomitant medications were not provided.Treatment information was not provided.  This case concerns a 19-year-old, male subject with a history of asthma, who experienced the unexpected events of loss of consciousness, abdominal discomfort, abdominal pain upper malaise and nausea. The event occurred the same day the first dose of the Moderna Covid-19 vaccine was given. The rechallenge is not applicable in this case. The reporter's assessment  is not provided. The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 19-year-old, male subject with a history of asthma, who experienced the unexpected events of loss of consciousness, abdominal discomfort, abdominal pain upper malaise and nausea. The event occurred the same day the first dose of the Moderna Covid-19 vaccine was given. The rechallenge is not applicable in this case. The reporter's assessment  is not provided. The benefit-risk relationship of the vaccine is not affected by this report
Customer had seizures   couple of minutes after administration of vaccine, she was not unconscious, breathing normal but not responded when we talk  and had frequent jerking movements. Paramedical arrived and took her to the hospital
One day after the shot, I had menstrual spotting for the first time in 7 years. I use the Nexplanon birth control implant and I have not had bleeding or spotting since 2014. It was dark red and dry. It lasted for a day. It was shocking because I have not had anything that would cause it except for the vaccine. My body feels healthy otherwise.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 10-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # L040459, expiration date 06-APR-2017) (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Immediately after the vaccine I had a sore arm. Within a week I had developed a hard lump under it, and a red ring near the injection site which was hot to the touch and extremely itchy. The rash went away after a few days, but ever since then I've suffered from extreme brain fog, dehydration, exhaustion, and just felt overall unwell.
eyes became swollen feeling and a bit itchy as I was driving home (approximately 15 mins after the shot).  It resolved about 20 minutes later by itself.
preg pt was noted to have toxoplasmosis antibody titer present on routine testing p/recvd flu vax; antibody titers were confirmed on 2 subsequent occasions; however no inc was noted; pt is asymptomatic & the reporter felt these titers  low;
Information has been received from a physician assistant concerning a 65 year old male with aspirin allergy and glaucoma and a history of skin cancer and kidney stones who on 15-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Lipitor, Flomax and Xalatan. On 11-SEP-2007, the patient developed chicken pox. The patient first noticed a rash on his ankles. The chicken pox lesions have been progressively moving up the patient's body and are no on his legs and trunk. Unspecified medical attention was sought. No lab studies were preformed. At the time of this report the patient had not recovered. There was no further information provided. There was no product quality complaint involved. Additional information has been requested.
Initial case report received from a health care professional on 04 NOV 2009. A 67-year-old male patient was vaccinated with FLUVIRIN 2009/2010 (batch no. 960356) into the left deltoid on 02 OCT 2009 or 03 OCT 2009. The reporter stated that the patient "later that evening" was experiencing numbness in his arm and began to feel a headache. He went to emergency room and had "swelling in his brain". Numbness had extended to his face. He did not experience a stroke. Patient had not recovered at date of the initial report. Company assessment: Seriousness criterion: hospitalization. Causality: insufficient data. The amount of data is insufficient to finally assess the causality. Need to get all available hospital reports from the reporter. Expectedness assessment according to agency and label; Brain swelling is unexpected, headache and numbness are expected after vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.; NA09-007566
Within 4 hours of the injection patient developed a red, hot, circular rash measuring 10 cm x 13 cm lasting 48 hours and patient used ice packs and ibuprofen.
Pt phoned our office on 04/19/21 with complaints of abdominal pain and bilateral leg pain.  Pt was instructed to seek immediate health care for evaluation.  He refused.  Pt was very agitated and concerned about covering costs of medical care despite having health care insurance.  Pt again instructed to seek health care and he refused.
Fever of 102,  Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms heavy; dizzy; fatigued; unwell feeling; bright lights bother my eyes; achy bones; a little difficult breathing; I feel hot then cold back & forth; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via intramuscular route of administration in right arm on 14Apr2021 at 7:45 am (at the age of 56 years old) as single dose, for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6207), via intramuscular route of administration in right arm on 24Mar2021 at 07:30 (at the age of 56 years old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks. It was reported that on 24Apr2021 at 07:30 AM patient experienced arm sore (could not lift), tight shoulders, tight neck, fingers numb, fingers feel swollen, forearms heavy, dizzy fatigued, unwell feeling, bright lights bother his eyes, achy bones, a little difficult breathing, he was feeling hot then cold back & forth. The patient did not receive any treatment for the events. Outcome of the events was resolved on unspecified date.   Follow up attempts are needed. Further information is expected.  Follow-up (14Jun2021): New information reported from a contactable consumer includes: Aanatomical site of first and second dose injection updated from left arm to right arm, route of administration for both doses, date of the second vaccine dose and first dose changed from suspect dose to historical vaccine.  Follow-up attempts are completed. No further information is expected.
I gradually had an increasing fever of 101.  Felt like flu symptoms.  Aches and pain in joints.  Chills, and thirsty. After 8 hours, fever subsided, and then a headache for about 2 hours.
Patient began experiencing pain in right deltoid evening of vaccination 2/4/2019. Patient became febrile through the night and temp continued to rise. Patient was given ibuprofen when temp was 100.2. Pain continued to increase at injection site without erythema.Temp increased to 102.9 and was directly admitted to hospital d/t sickle cell diagnosis for monitoring /pain control/hydration.