chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 75 year old female with allergic reaction to penicillin and LEVAQUIN and aspirin and naproxen hypersensitivity who on 09-JAN-2009 was vaccinated with a dose of PNEUMOVAX (lot no. 662599/1076X) 0.5 ml, IM into the right arm.  Concomitant therapy included chondroitin sulfate sodium (+) glucosamine sulfate, ramipril, lovastatin, vitamins (unspecified) and calcium (unspecified).  On 09-JAN-2009 the patient experienced erythema, swelling and soreness in right arm.  The patient also experienced fatigue and weakness.  On an unknown date, the patient recovered.  Follow up information was received from a health professional which reported that the patient experienced erythema, swelling, soreness, bruising in right arm, fatigue and weakness on 10-JAN-2009 at 9:00 am.  On 15-JAN-2009 the patient recovered from the events.  The patient weight was 164 pounds and height 63 inches.  The patient had no illness at the time of vaccination.  Additional information is not expected.  This is one of several reports from the same source.
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: I gave flucelvax on left arm then preceeded to give moderna bivalent on right arm. After applyingbandaid pt told me she felt like she was going to faint. He face looked pale. I asked her to lay on the ground. As i was moving her she fainted in my arms. about 5 second later she regained consciousness. and I slowly moved her to ground with her legs on top of the chair. Her father came to watch her and I asked if she wanted water and proceeded to dial 911. she was smiling and using her phone after
This started with joint pains in Hips, knee, and ankle.  The next day, all joints hurt.  The next day, I awoke with a bad headache, I had body pain everywhere. I also had fever and night sweats. At Home COVID-19 test positive on 4/6.  Televisit with doctor, who proscribed Paxlovid.  Joint pain significantly decreased by 4/8, but I slept poorly due to horrible taste from Paxlovid.  4/6 had difficulty passing urine, but no trouble since then. Symptoms diminishing over time with the night of 4/11-12 being the first night with no night sweats and slept through the night.  I am still recovering at time of reporting.
When woke up, he felt nauseated. Within a few minutes, he got out of bed and walked to the bathroom, where he fainted. He ?came to? within a minute or two, but as soon as he did, he vomited. He vomited again later on in the day, and then one more time in the early evening.
At birth, received hepatitis vaccine. Child came down with case of yeast infection oral/intestinal for 6 weeks; was very sick and remained very colicky. Child taken off all dairy and wheat 1 year ago; colic better. Diagnosis: PPD NOS/ASD (autism). Received all routine vaccines to year 3.5. Diagnosed 03/03.
Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from an office medical assistant and nurse practitioner concerning a 23 year old female with a history of migraine headaches and HPV and no previous pregnancies who on 11-JUN-2007 was vaccinated with her first dose of GARDASIL (lot #657868/0523U). On 07-AUG-2007 the patient received her second dose of GARDASIL (lot# 658554/0928U). On 20-DEC-2007 the patient came in the office for her third dose of GARDASIL (lot# 659441/1446U). The patient did receive the third dose that day, but during conversation she mentioned she had been spotting and had stopped taking her birth control. The office medical assistant reported that later on that day, they had found out that the patient was pregnant. The patient's last menstrual period was 01-NOV-2007 (previously reported as 03-DEC-2007) and estimated date of delivery by ultrasound was 20-AUG-2008. An ultrasound was performed that showed 5 weeks gestation. No adverse event was involved that time. Medical attention was sought, by a physician. Follow-up information was received. On 14-JUL-2008 the patient experienced premature rupture of membranes and delivered a normal, healthy male baby weighing 5 pounds 10 ounces at 34 weeks. There were no congenital anomalies. The infant with apgar scores of 6.8 was in NICU for breathing. Meconium stained membranes were noted on placenta pathology. Concomitant therapy included UNISOM for insomnia and ZANTAC for heartburn. The patient also noticed decreased milk production during breast feeding. Upon internal review, in NICU for breathing was determined to be an other important medical event. Follow-up information was received from a physician who reported that the mother was not a patient of his and the baby's name was a name unknown to him. Additional information has been requested.
I95.9 HYPOTENSION 10/26/2022 ESRD (END STAGE RENAL DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 10/26/2022 ESRD (END STAGE RENAL DISEASE) I95.9 HYPOTENSION 10/26/2022 ATHEROSCLEROSIS OF LEFT LEG W PAIN AT REST J96.00 ACUTE RESPIRATORY FAILURE 10/26/2022 ATHEROSCLEROSIS OF LEFT LEG W PAIN AT REST
consumer was given Rotarix for the second dose; consumer was given Rotarix for the second dose; Caller did not report any additional adverse event; This spontaneous report was received from a patient's father and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, instead of being vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) the patient received rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (dose, route of administration, lot # and expiration date were not reported) for the second dose for prophylaxis. No additional adverse events were reported.
Patient required hospitalization due to breakthrough infection. Patient received Moderna vaccine (2nd dose in series) on 03/11/21. Hospitalized from 07/27/21 - 09/09/21. Below is copied from discharge summary:   PATIENT is  a 57 year old with PMH of early Alzheimer's dementia, type 2 diabetes mellitus. ESRD, hypertension, bullous pemphigoid 12/2020, multiple prolonged hospitalizations at University Health due to dementia related issues. Patient was recently presented from nursing home due to altered mental status-more confused than baseline less energetic and this lasts hemodialysis. In ED, patient was talking nonsense, hypertensive with fluid overload, severely required nicardipine drip in hemodialysis. .Patient developed fever on hospital day two and was COVID positive. She became hypoxic and required corticosteroids, that she became hypothyroid and lethargic bradycardia and 32. Patient transferred to MICU unit requiring BiPAP and high flow nasal cannula and 88 neurology was also consulted, patient had negative EEG and LP 08/06/2021. Infectious workup was negative and patient was transferred to hospital medicine. Patient completed steroids. Patient has been on isolation since 08/17/21. (negative COVID test)
Within 30 min, throat swelled and I could no longer swallow easily. Swelling went down after 25 min without any additional meds administered.  Left side of my face swelled 45min after shot and I experienced bell's palsy for 3-4 hours.
The day after the vaccine, I started developing a red rash on my right thigh. I dismissed it initially but the rash kept developing further into sores, which turned out to be shingles.; The day after the vaccine, I started developing a red rash on my right thigh. I dismissed it initially but the rash kept developing further into sores, which turned out to be shingles.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ew0177, Expiration Date: not reported) via an unspecified route of administration in left arm on 15Aug2021 16:00 as dose 1, single for COVID-19 immunization (at the age of 45-year-old, non-pregnant). Medical history patient had covid prior vaccination from an unknown date and known allergies was none. There were no concomitant medications. Patient did not receive other vaccine in four weeks and other medications in two weeks was none. COVID was not tested post vaccination. The patient experienced the day after the vaccine, she started developing a red rash on her right thigh. She dismissed it initially but the rash kept developing further into sores, which turned out to be shingles on 16Aug2021 13:00. AE resulted in doctor or other healthcare professional office/clinic visit. Patient was prescribed anti-viral medication for shingle. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Shots given on 11/30/09 - came to clinic on 12/3/09 - noted lg. red, swollen area on L upper thigh where Dtap and polio were given.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female non-pregnant patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration on 13Apr2021 (at the age of 50-year-old) as a dose 2, single and the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration on 23Mar2021 (at the age of 50-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was not pregnant at the time 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 diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. On 07Nov2021, the patient was tested positive for COVID-19. Hospitalization prolonged was reported as no. Treatment was not received for the events. On 07Nov2021, the patient underwent lab tests and procedures which included Bionix Now (SARS-CoV-2 test), resulted as positive, Nasal swab. The device date was on 08Nov2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt recv vax 16SEP97 & 1hr p/vax pt presented to an ER w/severe dizziness;it was reported that no rxn occurred p/1st inj;
The patient passed away today, 1/13/2021.  She was a hospice patient.  She showed no adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went limp and was non-responsive.  The patient passed away at 7:45 am.
pt recv vax 6SEP96 & exp a rash which was more urticarial this time & which itched;there was no swelling or SOB;
Myalgia, Arthralgia, body aches, fatigue, sore at injection site Narrative: The day after receiving the first dose of the Pfizer COVID-19 vaccine, she reported experiencing fatigue, body aches, and pain at the injection site. She treated herself by resting, drinking lot of fluids, and taking acetaminophen (dosing unknown).
Client called office on 2/22/2021 to report chills with COVID vaccine given on 2/1/2021. On 2/3/2021 she experienced extreme exhaustion. From 2/6/2021 to 2/8/2021 her legs were weak and shakey. On about 2/15/2021 she developed a large patch of redness to her arm where the injection was given that measured about 6" x 3" and still has this as of 2/22/2021. No symptoms within 4hrs. of shot per client. These reactions were reported to our county health officer Dr
SOB/wheezing began 7 days after Janssen Covid vaccine.  Patient found to have a PE and COPD exacerbation.
Information has been received from a pharmacist referring to a 57 year old patient of unknown gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. In November 2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # L026037, expiry date 17-JAN-2018, dose and route were unspecified). On 23-MAR-2016 the patient got the second dose of RECOMBIVAX HB (lot # L026037, expiry date 17-JAN-2018), which was 4 months after the first dose was administered. No adverse effect was reported. Additional information is not expected because there was no consent to contact physician.
it was rpt pt recv 1st dose varivax 11/96 & in 5/98 pt devel chickenpox. had 3 lesions.
they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-365274 (Patient Link).
Localized irritation to Pneumovax..."Inflammation of puncture site and tissue distal to it." Given Clindamycin for 10 days.
p/vax pt exp soreness @ the inj site;the next day pt exp severe pain @ the inj site & was unable to move arm;no tx given;
Pap/Vesic lesions 2 mm lesion right ankle, abd, fever on back. Itchy scalp.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 21-MAR-2017 at 15:03, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000403: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457: US-009507513-1704USA000458
On 11/9/16 (L) arm hurting with sharp pains. Swollen area and warm to touch. Pt took BENADRYL and TYLENOL. On 11/10/16 (L) arm with 1 1/2" x 2" swollen warm area, very tender to touch. Going to Primary Care doctor.
Narrative:  76yo male Pt died on 11/20/2021 where he lived . No information given about pt's death. Hospital problem list: 13 Active Problems PROBLEM LAST MOD PROVIDER - Coronary artery disease  09/27/2018 (ICD-10-CM I25.10) Polyp colon (ICD-10-CM K63.5) 09/27/2018 HTN- Hypertension (ICD-10-CM 09/27/2018 I10.) Hyperlipidemia (ICD-10-CM E78.5) 09/27/2018 Obesity (ICD-10-CM E66.9) 09/27/2018 Sleep apnea (ICD-10-CM G47.30) 09/27/2018 GERD - Gastro-esophageal reflux disease  09/27/2018 (ICD-10-CM K21.9) Closed fracture of base of thumb 09/23/2015 (ICD-9-CM 815.01) Gout (ICD-10-CM M1A.00X0) 08/25/2020 (ICD-9-CM 788.41); Frequency of Urination 05/12/2009 (ICD-9-CM 788.41) (ICD-9-CM 715.90); Osteoarthritis * (ICD-9-CM 05/12/2009 715.90) Alcohol Dependence (ICD- 9-CM 303.90) 05/20/1997 Other specified diseases of the salivary glands 05/27/1997 (ICD-9-CM 527.8) Pt had received  only one covid vaccine at hospital on 4/5/2021. Unable to assess if this death is related to the covid vaccine, likely is not given pt's age and long time frame between date of covid vaccine administration and date of death.
Herpes; Rash; This case was reported by a other health professional via sales rep and described the occurrence of herpes virus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced herpes virus infection and rash. On an unknown date, the outcome of the herpes virus infection and rash were unknown.   It was unknown if the reporter considered the herpes virus infection and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by physician assistant (PA) to the field representative. The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced a rash or herpes after receiving Shingrix.  No additional details were provided. The reporter consented to follow up. This case is 1 of the 4 cases reported by the same reporter.
This spontaneous report was received from field representative on behalf of patient's mother refers to a 13 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. Approximately in 2017 (reported as when patient was 12 years old), the patient was vaccinated with first dose of GARDASIL 9 in the thigh (lot#, expiry date and dose not reported), intramuscularly as human papillomavirus (HPV) vaccination. Approximately in December-2017 (reported as "over Christmas break"), the patient was vaccinated with second dose of GARDASIL 9 in the thigh. It was unspecified if patient received both doses in the same thigh. On an unknown date, a few days after vaccination with the 2nd dose of GARDASIL 9, the patient developed a baseball sized lump, which was extremely painful. The patient sought medical attention, she returned to physician, who informed patient that she had a bad response to the GARDASIL 9, and informed patient to take an unspecified dose of unspecified analgesics (also reported as no treatment was given for events). None lab diagnostics/ studies were performed. No product quality complaint (PQC) was involved. It was reported that patient continued to feel an unspecified amount of pain in the injection site. The outcome of the events was reported as not recovered. The reporter did not provide any causality assessment.
Pediatric dose 0.2ml of Pfizer-BioNTech given to 12 year old girl who should have received adolescent/adult dose of 0.3ml Pfizer-BioNTech. Phone call to mom, on 11/05/2021 at 12pm to report error. Mom states patient has a little bit of injection site pain but feels fine otherwise. Mom appreciates the notice and questioned what dose she will get when she returns for second dose. Writer informed mom that patient will received the adolescent/adult 0.3ml dose of Pfizer-BioNTech. No other questions from om and patient is scheduled for second dose administration on 11/23/2021.
After administering vaccine to patient, it was realized the syringe had likely only been drawn up with air and no vaccine. The pharmacist drew up remaining doses from vial and confirmed there was ~0.56mls remaining in the vial, which further confirmed the patient likely did not receive vaccine. The pharmacist immediately let the patient know of the error and re-administered the proper amount of vaccine to the patient.
Pt. called clinic stating that ~ 2 hours after receiving her vaccine her head felt like it was being squeezed. Pt reports eating and feeling better but symptoms returning. Pt also reports feeling hot. Pt instructed to take Tylenol or Ibuprofen and go to ED with worsening or concerning symptoms.
Due date 4/18/2021.  Pt presented in labor on 4/10/21.  Her labor was uncomplicated and progressing appropriately.  She had sudden onset of coughing following by loss of consciousness.  Code blue was called.  Emergency bedside C/S was performed.  Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired.
pt recv vax 1DEC96 & learned that was pregnant (LMP 25NOV96);pregnancy was confirmed by a home pregnancy test;estimated delivery date was 2SEP97;FEB97, 12 wk from LMP, pt exp 2 blighted ova & a miscarriage;
Sore arm; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Red at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 24-Mar-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) and INJECTION SITE ERYTHEMA (Red at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications also included high blood pressure medication and cholesterol medication. The patient did not take any treatment medication.