chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 16-AUG-2017, at the age of 11, the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, route of administration, vaccination site, lot number and expiration date were not reported) for prophylaxis. On the same date, the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (formulation, dose, route of administration, lot number and expiration date were not reported) and MENACTRA (formulation, dose, route of administration, lot number and expiration date were not reported). On unspecified dates, the patient experienced abdominal pain and weight loss and was referred to multiple unspecified specialists. It was reported the abdominal pain and weight loss resolved on an unspecified date. On 05-MAR-2018, the patient was vaccinated with the second dose of GARDASIL 9 injection (dose, route of administration, vaccination site, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in 2018, the patient experienced exacerbation of abdominal pain and weight loss. It was stated that the symptoms were more severe on an unspecified date. On an unknown date in 2018, the patient was hospitalized (for five days) and on unspecified dates in 2018, upper gastrointestinal (GI) magnetic resonance enteroclysis (MRE), unspecified ultrasound and computerized tomography (CT) scan were performed, which all resulted negative. The patient was treated with omeprazole, nizatidine and "Contaza". The physician reported the patient might have irritable bowel syndrome. The outcome of the events was reported as resolving. It was stated the patient was gaining weight (further described as the patient was at the 38th percentile and dropped to 8th percentile in weight and he was currently at 11.27 percentile). The physician reported that she was not convinced that the patient's symptoms were vaccine related.
Administered 2nd Moderna booster from vial that was past its 12 hour expiration time.
vomiting and diarrhea on Friday night, afterward I have been feeling slight uncomfortable or pain in lower abdominal part
I have been in menopause since 11/26/2018( Date of my last menstrual period) . After second dose of maderna,  I got my menstrual Cycle on 4/12/2021. Had back pain, tender breast, just like when I use to menstruate. Mentrual period lasted 5 days and extremely heavy.
at 6pm on the 11th, his arm started to hurt, which lasted until when he woke up on the 13th. at 10am on the 12th, he got a headache and nausea, which lasted until when he woke up on the 13th. at 10:30 on the 12th, I gave him Tylenol and Zofran. at 9pm on the 12th, he got a pain in his underarm, which lasted until when he woke up on the 13th.
Patient seen in ED with COVID 19 symptoms and positive test. Treated with Regeneron antibodies. Vaccinated April 2021
arm was very sore upon vaccination.  10 days later got red, slightly swollen and hot.  friday, 2/26 had toothache - went to dentist - needs root canal.  The main concern is about the site of the vaccine and its reactions.n
I woke up feeling nauseous with a throbbing headache that would not go away. I also had brain fog, if I was walking I would lose my step. I reached out to my primary care physician, Dr.  and was advised to visit the ER if I didn't feel any better in a few days. Two days later, I went to the  Hospital ER in. I feel better but my energy levels are still low.
Patient's complaints of severe pain at injection site, asthenia, redness, we recommend to visit primary physician for evaluation. Treatment prednisone 5mg, cetirizine 10 mg, sulindac, Azithromycin.
On 12/25/2020 noted a lump in right breast and was then seen in the UT Breast Center 12/28/2020 and found to have enlarged lymph nodes as well as a tennis ball sized cyst. Returned to the UT Breast Center 1/4/2021 for cyst drainage & lymph node biopsy. Pathology reactionary.
Patient was administered the COVID-19 vaccine. Within a few minutes she began to experience pruritus, her throat itching, mild chest tightness, nausea. There are no visible hives, lungs were clear, no angioedema of the oral mucosa and blood pressure was 122/78. Patient denied any throat swelling or difficulty breathing. Patient was talking comfortably. She just kept itching her skin and then the skin would become slightly red. She reported having an allergic reaction to the flu vaccine that required an EpiPen injection. She also has a history of chronic idiopathic urticaria.  She takes Zyrtec daily. Administered Benadryl 50 mg orally Administered Solu-Medrol 40 mg IM Patient symptoms remain stable Patient was escorted to the ED for further observation and management.
Weakness & fatigue mainly in leg muscles & to a lesser extent in arm muscles-worse in am & with physical activity. Dx R/O Guillain Barre Syndrome. Pt experienced a poor appetite and nausea.  Follow-up: 02/15/00 - Consent form returned by pt - mailed with letter to hospital.
Hives (chest, injection site), flushing. Evaluated by EMS-Cleared
A physician reported that an 8 month old female received an injection of Prevnar on 10/17/00 and within 12 hours, post vax, the child experienced vomiting. Twenty-four hours, post vax, she developed a fever of 102F and erythema multiforme. The fever and vomiting resolved. This is 1 of 3 pts from this facility who had an adverse event following receipt of Prevnar. Follow up information received on 12/29/2000 the erythema multiforme resolved.
Tinitus beginning around time of COVID-19 vaccination series (4).  Tinitus seems to be in both ears, but is greatly exaggerated in right ear when chewing on left side of jaw.
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1: suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died due to unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211222777-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Heavier period Hot flashes the week after (that was the week prior to my period) Worse signs of PMS (breast sensitivity, cramps, nausea, body aches)
mom reports fever 104 w/high pitched crying x 4 days; called MD w/instructions to use cool compresses & APAP; mom states was effective for short period of time & then fever would shoot back up;
lost a friend; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100128 Same reporter/event/drug, different patient;US-PFIZER INC-202101100129 Same reporter/event/drug, different patient;US-PFIZER INC-202101100127 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend
Patient is an 11 week ex-35w6d di-di twin who presented on 9/4/2020 with 2 days of diarrhea and one day of altered mental status/sleepiness/decreased alertness found to be hyperglycemic, acidotic (non gap), and tachycardic to HR211 concerning for severe dehydration vs hypovolemic shock. Initial had hyperglycemia to 452 and reported somnolence concerning for DKA, however hyperglycemia resolved by report Glucose 78 in ED following 4 x 10ml/kg boluses. Her lactate downtrended to 3.3 from 8.5. She was transferred to hospital for management of her dehydration and metabolic acidosis secondary to diarrhea. To note, she has had household contact with diarrhea (twin with diarrhea as well) and recent 2 month vaccine shots including rotavirus.
Pt was given PNEUMOVAX 23 on Tuesday, October 28, 2014. Pt stated there was pain at the injection site later that evening. Pt's mother applied ice and gave Ibuprofen throughout the next day. Pt came to clinic Thursday, October 30, to report reaction.
wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis; shortness of breath; increased confusion; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the female patient who we sent out with shortness of breath and increased confusion, she wound up in the ER (emergency room) with hypoxia and sepsis and she passed away. The events were serious as hospitalization and death. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on the limited available information, the Company considered there was not a reasonable possibility that the reported events were related to the suspect product  BNT162B2 (COMIRNATY). 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.; Reported Cause(s) of Death: increased confusion; shortness of breath; wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis
The pt experienced a red rash on face and trunk. Denies any respiratory distress. The mother was questioned about hive like appearance and she was unsure. Advised to call MD. Treated with Benadryl.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, (booster)  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER: UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose : 2, MANUFACTURER: UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog". The lot number for bnt162b2 was not provided and will be requested during follow up.
Pain started 24 hours in to the vaccine/quite a bit of pain; Her epidural site area was tender about 24 hours after her second dose; her muscles are so tight in her thighs/if she walks quite a bit it has been going down to her butt, thighs, and calves and they are very tight; Muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back.; Muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back.; Muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back.; Feeling fatigued; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:30 (at the age of 34-year-old) (Lot Number: EW0165) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 15:30 (at the age of 34-year-old) (Lot Number: EW0150) as dose 1, single for COVID-19 immunization. On 28Apr2021, patient experienced feeling fatigued after the vaccine and the pain started 24 hours in to the vaccine. The patient reported it seemed to have triggered an area where she had an epidural on 30May2019 when she had her son. The patient stated that the epidural area was very tender, had muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back. The patient said it felt better with rest, and she would say it has gotten better since originally it was more spread out before, literally from her hips out, but now it was concentrated where she got the epidural. The patient said she had just finished her period cycle also, so she doesn't know if that was related. She said it was very tender, which she has never felt this before, and her muscles were so tight in her thighs, it was like the blood was not circulating or something, her butt was very tender and very sore. She said that the bottom half of her was not doing amazing. The patient received paracetamol (Tylenol) heating pad and even used a massager. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Booster shot. 4 days after normal arm pain and head ache  symptoms began to subside chest tightness developed associated with what appeared to be an anxiety attack from the symptoms despite no triggers for an anxiety attack. This shortness of breath lasted 1 week from the onset and appears to have subsided with sole time of shortness of breath in the morning.
BODY ACHES; HARD SPOT; ARM REDNESS; SORE/PAIN  ARM; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 2021421A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced hard spot. On 10-APR-2021, the subject experienced arm redness. On 10-APR-2021, the subject experienced sore/pain arm. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 11-APR-2021, and had not recovered from sore/pain arm, arm redness, fatigue, and hard spot. This report was non-serious.
Recurring, persistent Blister inside mouth and on the outside on lips, followed by pain in the eye and eye blisters. (2/2021 thru 12/2021 ). Dry mouth and dry eye ( 02/201 till current date )
Onset on 11/20/2021 (11 days after booster dose) of severe generalized urticaria. Can't sleep or work without round-the-clock cetirizine--which causes anticholinergic side effects. Double-dose loratadine and fexofenadine don't help.
headache; ringing in head; being sick; This is a spontaneous report from a contactable consumer(patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced a headache she went through a stage of being sick, there was ringing in head, all on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Child given PEDIARIX to complete 5th Dtap and 5th IPV, instead of INFANRIX and IPV. No adverse reaction occurred.
I have experienced soreness, swelling and itching at the injection site.  I broke out in hives about 2-2 1/2 hours after I received the vaccine.  The swelling and itching have not gone away and today (5/12/21) the injection site is very itchy and swollen.
no adverse effect reported; two year old received improperly stored Vaqta; This spontaneous report was received from a nurse and refers to a 2-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-AUG-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) injection, lot # S007770 and expiration date 24-JUL-2020 (dose and route of administration were not reported) for prophylaxis. The total time and the highest temperature was above 47°F (46.8F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Had a sore arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (Had a sore arm). At the time of the report, MYALGIA (Had a sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported..   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional initial information, outcome provided.
Employee received influenza vaccine (.5cc) into left deltoid and about 15 minutes later experienced injection site discomfort with a throbbing and numbing down back of arm to pinkie finger. Took EXCEDRIN w/o relief. Saw MD 3 days later. Dx: neuritis.
sick for 2 wks tickle in throat-cough seen by MD 16NOV; MD gave ATB & DPH for reaction to ATB; diarrhea & aches & pains;
I believe I began experiencing partial seizures in Aug 2021.  In Oct I went to the ER for a grand mal seizure.  I went to see my doctor in Nov and I was prescribed lamotrigine.  I experience several partial seizures between Oct and Feb.  I experienced another grand mal seizure in Feb.
She had not had menarche prior to first dose of COVID vaccine.  Had menarche following first dose and has not menstruated since.  Had extreme fatigue following second dose of vaccine.
trouble sleeping; very bad headache; nauseous; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty sleeping in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced difficulty sleeping, headache and nausea. On an unknown date, the outcome of the difficulty sleeping, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the difficulty sleeping, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first dose of Shingrix vaccine one day before reporting and had trouble sleeping, very bad headache and was nauseous.
I26.99 ACUTE PULMONARY EMBOLISM 2/18/2023 SHORTNESS OF BREATH J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/18/2023 SHORTNESS OF BREATH I26.99 ACUTE PULMONARY EMBOLISM 2/18/2023 HX OF HEPATITIS C J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/18/2023 HX OF HEPATITIS C I26.99 ACUTE PULMONARY EMBOLISM 2/18/2023 HOSPITAL ACQUIRED PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/18/2023 HOSPITAL ACQUIRED PNEUMONIA I26.99 ACUTE PULMONARY EMBOLISM 2/18/2023 CANCER METASTATIC TO UNSPECIFIED LUNG J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/18/2023 CANCER METASTATIC TO UNSPECIFIED LUNG I26.99 ACUTE PULMONARY EMBOLISM 2/18/2023 KIDNEY CANCER, RIGHT KIDNEY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/18/2023 KIDNEY CANCER, RIGHT KIDNEY
Approximately 1 week after vaccination developed burning chest pain, bilateral however greatest on L side.  Albeit the pain has improved, it has been 3 months since vaccination and continues with chest pain. Unable to exercise as pain worsens with activity.  History of covid + (mild illness without chest pain/SOB) approx 1 year with antibody production prior to vaccination.   Treatment includes NSAIDs with some relief.   Please investigate adverse events related to covid survivors with high antibody production prior to vaccine.
This spontaneous report was received from a nurse practitioner via a company representative, concerning her husband of unknown age with Diabetes. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, lot No and expiration date and route were not provided). On an unknown date, about 2 to 3 days after vaccination, the patient experienced pain at injection site. The patient did not seek medical attention and no treatment was given. No product quality complaint was involved. No laboratory tests were performed. At the time of this report, the outcome of pain at injection site was reported as recovered on an unspecified date. Additional information has been requested.
Per patient upon completing the 15 minute observation period, he experienced ringing in the ears. He said that he had this years (3-4) years ago but hasn't happened since then. He said that the ringing wasn't too loud in the ears but it was there. He left to go shopping and said he'd return if the ringing didn't stop. He came back about 20-30 minutes later and was still having the ringing. It was louder than before but he was still able to hear me talking to him. He said he was okay to go home and would call us if it got worse.