chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Provider d/c note:  "Patient brought to hospital with weakness, presyncope. Found to be COVID positive on 9/24, with mild hypoxia requiring small amount of supplemental O2. Also noted to have debility, dementia at baseline likely worsened by COVID. She was noted to be high fall risk, and PT/OT was ordered. CKD noted on chart, GFR improved during stay to be 80 by calculation.   Also found to have UTI, patient treated with five days of antibiotics. History of complete heart block with pacemaker placement, as well as afib. Continued home beta blocker, aspirin, Plavix. Hypertension controlled with lisinopril and beta blocker. Very hard of hearing at baseline, does well with hearing aids in.   Patient continued to recover from COVID, and worked with PT and OT, also with SLP evaluation. Therapy teams agreed patient likely to benefit from rehab. After ten days COVID isolation discontinued, as patient was no longer requiring oxygen and remained afebrile with minimal to no symptoms. Patient accepted for rehab, and discharged in stable and improved condition."
About 6 pm I got really fatigued. Went to be at 9. Shivered under the covers all night and body aches. Woke up at 6:30. My whole body hurt. Every joint, even my toes. Week. All day on Tuesday my heat rate was 95. Went to be at 8:30, took a night time Tylenol and slept pretty good. On Wednesday I felt better but still week. My heart rate was 88 all day.
chest pains, inj site red, warm, indurated-large red area @ inj site site 3" diameter, warm & indurated;pt adm to ER 6OT96 having chest pain;ER MD said rxn was totally unrelated to vax;pt had brownish mark @ inj site;allerg rxn
Erythema, edema to entire left upper extremity (vaccine site L deltoid) from shoulder to elbow. Also w fever. Required hospitalization due to concern for cellulitis vs vaccine reaction.
temporary delayed loss of taste; This is a spontaneous report from a contactable Physician. This Physician reported for similar events for 4 patients. This report is 1st of 4 reports. A male patient of an unspecified age received BNT162B2(Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: Unknown, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation . Patient's medical history included covid-19. The patient's concomitant medications were not reported. The patient experienced temporary delayed loss of taste. It was reported by physician that he heard of 4 other people at his employment who had previously had COVID-19 and developed this same reaction after the vaccine, temporary delayed loss of taste.Obviously this was not a serious reaction, just a peculiar one. Physician was unable to find this on the Internet. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient
This spontaneous report was received from a registered nurse referring to an approximately 8 month old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in 2017, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number: M044724 (expiration date: 13-JUN-2018), orally, for prophylaxis (strength and dosage schedule were not reported). The storage characteristics were the following: Temperature: 47 F to 77 F for 17 hours. Previous temperature excursion: No. No adverse effects were reported.
Received phone call from the patient. Complains pain on arm/shoulder on side immunization was given. Today 11/08//06 unable to lift arm above head. Takes Advil for the pain, which is persisting, hinders her dailly activities. Advised to see MD to assess and evaluate pain.
Fever; swollen lymph nodes; fatigue; This is a spontaneous report from a contactable consumer (patient herself) or other non HCP. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021, as a single dose for COVID-19 immunization. It was unknown if the patient was pregnant. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021, as a single dose for COVID-19 immunization. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021, the patient experienced Pyrexia, swollen lymph nodes and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events Pyrexia, swollen lymph nodes and fatigue was recovered on an unknown date in May2021.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
injection site pain; fev; chills; received her 2nd dose of Shingrix 9 day earlier than the 2 month mark; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance after 1st dose refer case US2020034256.).   On 22nd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fev, chills and drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fev and chills were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fev and chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms, but they were more intense and that lasted for 24 hours. The patient her 2nd dose of Shingrix 9 day earlier than the 2 month mark which led to drug dose administration interval too short.  Reporter did not consent to follow-up.  This case is linked to the case US2020AMR034881 and US2020AMR034882 husband's case.
Pt states L arm became red and swollen at 6 pm. Soreness and aching later on in evening. Pt applied ice pack and Darvocet, w/some relief. 5/7/08 Redness and induration > 120mm. Warm to touch with > redness increasing (per patient). Pt was seen by MD and tx'd w/celedrex 300 mg and pogel and OTC Benadryl.
mom stated 1SEP92 pt had german measles on 14AUG92 dx by MD;
Pt received second dose Pfizer COVID vaccine two weeks after first dose. Unknown reaction at this time.
Extreme itchiness in butt area, inner thighs, outer things, neck, hands.  Extreme itchiness in butt after itchiness subsided extreme pain replaced the itchiness sensation, with an intense pain, felt like it was bruised, deep purple painful bruises,  without signs of being bruise. lasted 24ish hours.  Pain in right arm, on and off, around vaccination site, feels like pain travels down to top of right hand.
pt recv vax 30OCT96 & sometime p/vax pt exp puffiness @ the inj site & a rash on the face & neck;since then pt thinks is developing asthma;pt is reportedly a smoker;
post vaccine myocarditis, symptoms 2 days after vaccination, came in the morning of 12/10. CXR and EKG normal, CRP 1.1 (mildly elevated) troponin 7.94 (elevated. Admitted to a local Hospital
sick; This is a spontaneous report received from contactable reporter(s) (Other HCP). A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Covid", start date: Jan2021 (unspecified if ongoing). Concomitant medication(s) included: XELJANZ XR taken for rheumatoid arthritis (ongoing). Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick".  Additional details: Patient reports being off medication Jan2021 due to having covid. Patient stated that she was advised to start when all symptoms resolved. After symptoms resolved, patient received covid vaccine which she "got sick" from, and then recommendation was to pause therapy until 1 week after vaccination. Re-started Xeljanz after second vaccine was received, a couple of weeks ago as per patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ten days after receiving her Covid vaccine Pt noticed a bumpy rash on her hands and fingers and toes which are itchy and sore. She saw her Dr. She said if it didn't improve she should see a dermatologist.
ringing in the ears (tinnitus) that started in July; headache that lasted for about 4 to 5 months; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (ringing in the ears (tinnitus) that started in July) and HEADACHE (headache that lasted for about 4 to 5 months) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in the ears (tinnitus) that started in July) and HEADACHE (headache that lasted for about 4 to 5 months). The patient was treated with PARACETAMOL (TYLENOL A) for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in the ears (tinnitus) that started in July) and HEADACHE (headache that lasted for about 4 to 5 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Approx 31 hours after the vaccine, I ran a 99.9 temp.  Ran than for about 30 hrs.  I also got diareah within 30 hours after shot.  That lasted about 24 hrs.  I had a slight headache for about 24 hrs
Adverse Event:  Death Treatment:  Rest & Cold Pack On Arm At Injection Site (Not Effective) Symptoms:  Arm Pain At Injection Site, Diarrhea, Fatigue, Dizziness, Low Appetite, Light Headedness, Fever & Chills
having allergies and took vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of ALLERGY TO VACCINE (having allergies and took vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy multiple.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (having allergies and took vaccine). At the time of the report, ALLERGY TO VACCINE (having allergies and took vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       He reports that the pharmacist noticed that people in general who had allergies at baseline and who had received any sort of vaccine were also coming in for more allergy support medications.
6/26/17 - vaccine (ZOSTAVAX given). 6/27/17 - injection site RXN approximately 3 inches by 3 inches. Pt. felt hot to touch and applied ice x 4 days. 6/30/17 - came into pharmacy. Redness at injection about 6" by 3" w/some heat.
Patient call on 4/2/09 stating that on Monday March 30 she received the Shingles vaccine.  She did not have any problems for greater than 24 hours.  On Tuesday late evening, she noticed a Red rasied area at the injection site that ran down her arm about 3-4 inches long and about 1 inch wide.  Today, Thursday, April 2nd there is a light pink circle around the red area that burns.  No treatment was done.  Instructed to use ice PRN and to contact her pCP for further directions.
Hardening, redness of the vaccine administration area when touching the area is hot and hurts when moving the arm.
One week after injection the right arm (place of injection) was painful to try to reach over the shoulder to the back. To lift anything; felt like a needle broke off in the injection area. Complained to Medical they said that was normal and that no needle broke off. Had xrays (twice taken - showed no foreign item in arm) still the same today.
The patient was given a Covid vaccine from a vial that had been opened the previous day Vial opened 8/8/2022 @ 9:30am patient received the vaccine 8/9/2022 @ 12:42pm. The patient and family were called 8/12/2022 when the error was discovered and the patient reported no adverse reactions or symptoms.
Swollen, red, hot to the touch 1.5 cm x 2 cm left thigh
pain in the arm as it have just received the shot today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm as it have just received the shot today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm as it have just received the shot today). At the time of the report, PAIN IN EXTREMITY (pain in the arm as it have just received the shot today) outcome was unknown.            No concomitant medication were provided.  Treatment medication was not provided
Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ligament tear and Gout. Concomitant products included MELOXICAM for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medication also include steroid shot and Meloxicam which are used for his knee No treatment medications were reported.  Patient reported that he is waiting on an MRI for his knee, which has a torn ligament, has gout, and is bone on bone. He received a steroid shot for the knee in the past but that only worked for about 24 hours.   This case was linked to MOD-2021-396001 (Patient Link).
Injection site (left thigh) edematous the size of an egg.  This area was warm to touch.  No redness at site.
headache; body aches; chills; 104 F. fever; Patient lost 9 pounds; congestion; cough; very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Impaired liver function and Kidney function abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Influenza virus test: Negative. In February 2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
5/22/2023 0955 Patient is 15 years old and was administered ProQuad(MMRV) SQ right arm on 5/17/2023. The patient should have been administered MMR and Varicella separately. ProQuad is not to be administered to patients 13 years or older. Patient tolerated the vaccines well and did not have any adverse reactions.
Pfizer vaccine, dose 1 12/17/20, dose 2 1/7/21.  Developed mild bells palsy 3/7/21. Unclear if related to vaccine but given no prior history of bells pallsy or other neurologic disease, reporting for safety monitoring. Saw primary care physician 3/16/21 who diagnosed bells palsy and started steroids.
Fever of 102, vomiting, pale complexion, sweating. Tylenol, normal dose given as required with age/weight, etc.
Cold symptom; Congestion; exposed to individual with COVID virus; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptom), NASAL CONGESTION (Congestion) and EXPOSURE TO SARS-COV-2 (exposed to individual with COVID virus) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold symptom), NASAL CONGESTION (Congestion) and EXPOSURE TO SARS-COV-2 (exposed to individual with COVID virus). At the time of the report, NASOPHARYNGITIS (Cold symptom), NASAL CONGESTION (Congestion) and EXPOSURE TO SARS-COV-2 (exposed to individual with COVID virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   It was reported that, patient woke up to cold symptoms and congestion. She found out that her son-in-law was diagnosed with Covid on 03-Mar-2021. She has been exposed to son-in-law over the last few days and a lot of people at her husband's employer have Covid. She had cold symptoms and congestion and was not sure if she herself had COVID.  No corrective treatment was provided.
This patient had immunization, 24 hours after she had a small bruise at the site of injection, with redness, swelling, and some burning in the arm; pain radiates to elbow. The patient had patches of red swollen areas; symptoms lasted about 36 hours.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported soreness in his arm with flu vaccine. This case has been linked to the US2018170064, reported by the same reporter.
Redness moving down the arm, patients states it started the day after receiving the shot and by the time she came to see me it was down to her elbow. she states no pain or discomfort.
Got shot Friday at noon, then while sleeping Saturday night gums bled in upper left back portion of mouth. Started after 9PM on friday and lasted until about 9AM Saturday
Heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FK9896) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression", start date: 2010 (ongoing). Concomitant medication(s) included: VENLAFAXINE taken for depression, start date: 2010 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: Noon, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Lot no: EN6203), administration date: 10Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Time: Noon, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Lot no: ER8730), administration date: 31Mar2021, for COVID-19 immunisation. The following information was reported: CARDIAC DISORDER (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Heart issues". Therapeutic measures were taken as a result of cardiac disorder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300066826 same patient/reporter, different drug/AE;US-PFIZER INC-202300066655 same patient/reporter, different drug/AE;
Bilateral pulmonary embolisms, R lower lobe lung infarct, mild R heart strain. Signs: Pleural chest pain radiating to shoulders, exacerbated with reclining, dyspnea
Wednesday - September 14, 2011 - Pt received flu shot - (R) deltoid. Later that night started to get some swelling, slight redness tenderness. Thursday - September 15, 2011 - called the office - Spoke to pt - she told pt monitor - TYLENOL for pain ice packs for swelling follow up if no better. Friday - September 16, 2011 - Pt advised to make dr pt came in.
6 chicken pox looking bumps on elbow and hand of the arm where the shot got in; 101 fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 19:00, the patient experienced 101 fever and headache about 6 hours after the shot for 24 hours. On 11Apr2021, 10 days after the shot the patient experienced 6 chicken pox looking bumps on elbow and hand of the arm where he got shot in. On 01Apr2021, the patient underwent body temperature test and the result was 101 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101 fever and headache were resolved on 02Apr2021 (reported as recovering). The clinical outcome of the event 6 chicken pox looking bumps on elbow and hand of the arm where he got shot in was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.