chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was hospitalized due to breakthrough infection. Patient received the Pfizer vaccine (2nd dose in series) on 04/17/2021. Patient was hospitalized from 10/15/2021 - 10/21/21. Below is copied from discharge summary:   Patient is a 72 y.o. male patient who is being discharged today.   Hospital Course: Case of 72-year-old male recently diagnosed with COVID-19 infection comes with progressively worsening fatigue shortness of breath and loss of appetite.   Acute Hypoxic respiratory failure due to COVID-19 pneumonia Patient tolerated well overnight Now weaned to Nasal canula 4lts, osat 93% Continue po decadron 3 more days, continue wean off oxygen  Isolation precatuions Procalcitonin 0.18- 0.9, CRP 205- 33, D-dimer 12,041, BNP 371 CTA Pe protocol: Negative for PE Recent echo showed normal LVEF No need for Anibiotics at this point Patient outside window for receiving remdesivir. Home Oxygen qual test done pateitn qualified Department consulted for Home oxygen now arrived   Esophageal cancer with Mets to liver -Outpatient Oncology follow-up and resume chemotherapy when stable.   CAD-continue DAPT, statin, ACE-inhibitor    CKD stage 3-continue to monitor and avoid nephrotoxins   Dyslipidemia-continue statin   BPH-continue Flomax   DM:  Hba1c 6.8 Resume home metformin 1000mg bid Encourage to monitor bs while on steroids   Vitals and labs personally reviewed.   Dispo:Dc home today with above recs.    Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
That evening, she developed an injection site reaction characterized by swelling, redness, and warmth. She was treated with Benadryl and applications of warm compresses and recovered. This is 1 of 4 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune.
Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.
Information has been received from a LPN concerning a 19 month old white female with no pre-existing allergies, birth defects, or medical conditions who on 09/18/03 was vaccinated with a 1st dose of varicella virus vaccine, live. Concomitant therapy that day included a first dose of MMR. There was no illness at the time of vaccination. On 05/12/04, the pt came down with chickenpox after being exposed to the virus at day care. Follow up information indicated that the pt recovered. There were no relevant diagnostic tests or lab data. No further information is expected.
Unable to function for 24 hours, difficulty walking, Severe upper left back and chest pain, dizziness, arm/shoulder  pain all the way down to fingers(still have that adverse reaction), brain fog, severe nausea, difficulty swallowing, pain and cramps in both feet, horrible all over feeling.  Not able to fully function for 2 days.
fever, chills, body aches, dizzy, nausea for 2 days and achy for 4 days 3/17-fever and body aches for 2 days  3/30-sinus infection treated with antibiotics 4/3-lost taste and smell, fever, chills, exhausted, could not wake up, dizzy for 3 days 4/5-tested positive for Covid and still not feeling better
Janssen COVID-19 Vaccine EUA.  Symptoms: fever of 103.4, chills, headache, ringing in ears, nausea, sore arm, dizziness (started same day as shot approximately 8 hours after shot)  Still felt sick next day with fever of 100 with all the same symptoms that I listed above  1 week later my arm is still sore from injection site
pt slept 2hr p/vax & upon waking mom gave pt APAP & something to drink;mom stated pt started vomiting 10PM non-stop for 1 1/2hr;mom called ER & talked to ped nurse who stated milk might be upsetting pt stomach;pt vomited while sleep;
CHIEF COMPLAINT:   Pt tested Covid+ 8 days ago, now out of quarantine. Today pt c/o feeling his heart race and complete weakness. Hx of A.fib. Denies CP or SOB. No fever.   HISTORY OF PRESENT ILLNESS:     73 yo M c Parkinson's disease, HTN, edema, CKD, BPH who comes to the hospital with complaints of palpitations.  Patient reports that he is having worsening weakness since the past 8 days.  He was diagnosed with Covid 8 days ago and has recently completed quarantine.  He states that he has no energy.  Today he noted his heart racing and some minor chest pain.  In the ED the patient was found to have mildly elevated troponins.
pt recv vax 20AUG97 & 3SEP97 pt exp a rash over stomach, legs & trunk, which later resolved;p/initial rash resolved pt exp an eczema-type rash on lt thigh;10SEP97 pt was examined @ a MD office for URI;rash looked like a hard chickenpox;
pt recv vax 3JAN97 & 3JAN98 pt exp chickenpox w/more than 100 lesions;
so far, the child had not experience any of those effects or other effects.; GARDASIL 9 injection was given to 4 year old child; This spontaneous report was received from a nurse, referring to a 4 years old patient of unknown gender. Information about historical conditions, concurrent conditions and concomitant medications were unknown.  On 08-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621931, expiration date 26-JAN-2022; strength, dose and route were unknown) for prophylaxis (product administered to patient of inappropriate age). The nurse stated this was unintentional. The office had called Poison Control but was not provided with any guidance on what to look for in children younger than 9 years old. Nurse said the parent of the child had been advised of the side effects listed in the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) product information (PI) and that so far, the child had not experience any of those effects or other effects. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
feels like they're itching all over the body; irritation; rash in the arm where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (feels like they're itching all over the body), SKIN IRRITATION (irritation) and VACCINATION SITE RASH (rash in the arm where the shot was given) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE RASH (rash in the arm where the shot was given). On 17-Mar-2021, the patient experienced PRURITUS (feels like they're itching all over the body) and SKIN IRRITATION (irritation). At the time of the report, PRURITUS (feels like they're itching all over the body), SKIN IRRITATION (irritation) and VACCINATION SITE RASH (rash in the arm where the shot was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
shortness of breath; sometimes a rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and HEART RATE INCREASED (sometimes a rapid heartbeat) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced DYSPNOEA (shortness of breath) and HEART RATE INCREASED (sometimes a rapid heartbeat). At the time of the report, DYSPNOEA (shortness of breath) and HEART RATE INCREASED (sometimes a rapid heartbeat) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.
I had a wonderful reaction I have severe arthritis in my left shoulder due to have a shoulder replacement after the vaccine the pain in my left shoulder was completely gone slight pain has returned one week later a wonderfully blessed side effect of this vaccine
got pos COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got pos COVID) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (got pos COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in August 2022 at a dose of Approx 5-7 days. At the time of the report, COVID-19 (got pos COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Positive, three weeks ago and (Negative) Negative, day 5.         No concomitant medication was reported.  Company comment.  This spontaneous case concerns a 56  year  old, female patient, with no medical history reported, who received a booster dose of mRNA-1273 vaccine (considered as fourth dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and exact onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir) and tested negative for COVID  19 on day 5. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56  year  old, female patient, with no medical history reported, who received a booster dose of mRNA-1273 vaccine (considered as fourth dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and exact onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir) and tested negative for COVID  19 on day 5. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
headache/Headache intensified; feeling very sore/weak; feeling very sore/weak/unable to gather the strength to move or stop puking; nauseous; vomiting; I felt incredibly dizzy; I hadn't been able to eat or drink very much; full blown migraine; I was dry heaving; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 14:30 (Lot number: FF8841) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 11Oct2021. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicilin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 02Feb2021, when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 23Feb2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Nov2021 07:00, outcome "recovered with sequelae", described as "headache/Headache intensified"; PAIN (non-serious) with onset 04Nov2021 07:00, outcome "recovered with sequelae", described as "feeling very sore/weak"; ASTHENIA (non-serious) with onset 04Nov2021 07:00, outcome "recovered with sequelae", described as "feeling very sore/weak/unable to gather the strength to move or stop puking"; NAUSEA (non-serious) with onset 04Nov2021 07:00, outcome "recovered with sequelae", described as "nauseous"; MIGRAINE (non-serious) with onset 04Nov2021, outcome "recovered with sequelae", described as "full blown migraine"; RETCHING (non-serious) with onset 04Nov2021, outcome "recovered with sequelae", described as "I was dry heaving"; VOMITING (non-serious) with onset 04Nov2021 07:00, outcome "recovered with sequelae", described as "vomiting"; EATING DISORDER (non-serious) with onset 04Nov2021, outcome "recovered with sequelae", described as "I hadn't been able to eat or drink very much"; DIZZINESS (non-serious) with onset 04Nov2021 07:00, outcome "recovered with sequelae", described as "I felt incredibly dizzy". Therapeutic measures were not taken as a result of headache, pain, asthenia, nausea, migraine, retching, vomiting, eating disorder, dizziness.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Other medications the patient received within 2 weeks of vaccination was Birth Control Oral Pill. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 60 year old female with hypertension, hypothyroidism, elevated cholesterol, allergies to penicillin and diphenhydramine (BENADRYL) with a childhood history of chicken pox, who on 17-SEP-2007, received a dose in her left arm of zoster vaccine live (Oka/Merck) (lot# 685083/0855U).  Concurrent medications included: atorvastatin calcium (LIPITOR), gabapentin (NEUROTIN), hydrochlorothiazide (+) losartan potassium (MSD), levothyroxine sodium (LEVOXINE), and nabumetone (RELAFEN). One week post vaccination on 22-SEP-2002, the patient developed less than or equal to 5 patchy lesions of a vesculiar puritic rash described as a disseminated zoster like rash on her neck, right arm and hand, left wrist and abdomen. She complained of significant itching. Her maximum temperature was 98.4 degrees. She was seen by her physician, who believe it was zoster. The patient was kept home from work due to transmission concerns. On 24-SEP-2007, a culture for herpes viral screen was obtained and sent it to a local lab. The lab results reported on 30-SEP-2007, were positive for herpes simplex and not zoster. At the time of the report the patient was recovering. No product quality complaint was reported. No further information was available. Additional information has been requested.
Patient requested Moderna; Previously had Pfizer, told Pfizer would be dose but vaccinator delivered Moderna to patient. No adverse event.
Hepatitis A vaccine was administered to the patient by mistake, 7 months earlier than the recommended age.
Information has been received from a nurse concerning an 18 year old female patient with asthma nos who on 07/02/1985 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and subsequent dose on 08/16/1995.  The patient was not ill at the time of vaccination per the reporter.  The lot number was not available, as it was not written down in the patient's chart.  Concomitant therapy included ...ophylline (SLO-BID), inhaler (prn) [therapy unspecified], ethinyl estradiol/norgestimate (ortho-tri-cyclen) and amoxicillin.  On 01/06/2003 the patient's titer was 0.5 for measles and positive for rubella.  Follow up information has been received from a nurse indicating that the "patient did not have an adverse event."  The reporter stated that the patient was antibody negative for rubella (previously reported as positive).  The patient only needed rubella "re-shot" per the reporter.  It was reported that "this was interpreted wrongly" and that "this is not an adverse incident."  The titers were drawn as required for nursing school physical.  The reporter indicated that contact on this "closed case" should be discontinued.  Unspecified medical attention was sought.  Additional information is not expected.
Patient anxious prior to coming to vaccine site. His anxiety worsened before shot was given. He was still anxious after the shot and could not calm down. Patient taken to observation unit. Became calm in observation unit, and exam showed no light headedness or nystagmus. Was given one bottle of water to drink and was feeling fine. Ready to go. 5:27pm discharged with no symptoms.
Red itchy rash, swelling on both  arm from wrist to shoulders., facial rash as well with blotchyness and red pimple  like bumps. Itching was extreme and long term. Doctor prescribed steroids to help. Still happening although not as severe. However face still retains blotches and redness, as well as itching in both arms.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male of an unspecified race. Initial information was processed along with the additional information received from department on 28-OCT-2022. The patient's weight, height and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 18-FEB-2022) dose was not reported, 1 total administered to the left arm on 05-MAY-2021 for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with primary dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 08-SEP-2022) dose was not reported, 1 total administered to the left arm on 01-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 52 years old. No concomitant medications were reported. The patient stated that on the previous day of report, on 26-OCT-2022, at morning he coughed and was feeling rundown with a headache, chills and was just tired (coded as confirmed covid-19 infection which led to confirmed clinical vaccination failure). It was also reported that on the day of reporting, on 27-OCT-2022 , the patient got covid and was tested positive with a take home test (Binax Now from Abbott) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000257104.; Sender's Comments: V0: 20221057885- Confirmed clinical vaccination failure- The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration
stomach cramps, vomiting, fever, cold chills, slept all day 16JUL93; began 24 hrs p/vax recvd; lasted 48 hrs;
Sweating, paleness, cold extremities, increased HR, reported temporary numbness in arms and legs