chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 19-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Shingles/ which showed up after she had the 2nd vaccine dose; Shingles/ which showed up after she had the 2nd vaccine dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 26Mar2021 as 2nd dose, single for COVID-19 immunisation. Medical history included shingles (has a history of shingles even before taking any vaccine). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 05Mar2021 for COVID-19 immunization. Patient called because she was asking whether it was safe to take Acyclovir 400mg once a day for her pre-existing condition (Shingles) which showed up after she had the 2nd vaccine dose last 26Mar2021. Outcome of the event was unknown.   Information on lot/batch number has been requested.
10:25:10 minutes post receiving first dose of Pfizer vaccine pt reported having throat tightness and voice hoarseness "similar to when she has as asthma attack." HR 72, BP 180/60. Pt repeatedly apologizing stating "I'll be ok." 10:27:Ambulance service requested. 1030:Pt medicated w/ Benadryl 25 mg PO per standing order. 10:32 Ambulance arrived, report given to Paramedic. 1040: pt transferred to ambulance. 1045: Ambulance departs site.
Massive headache left temporal area; Vertigo; Fullness left ear with diminished hearing; Swollen lymph node behind left ear; Metallic taste; Fever; Fatigue; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, arteriovenous malformation (Surgical resection AVM), and penicillin allergy. Patient received other medications in two weeks, names were unspecified. The patient previously took phenytoin (DILANTIN), ceftriaxone sodium (ROCEPHIN) all from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 11:00, the patient experienced massive headache left temporal area, vertigo, fullness left ear with diminished hearing, swollen lymph node behind left ear, metallic taste, fever, fatigue, sore arm. Duration over 2 weeks and continuing.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Azithromax, Advil. The clinical outcome of the events massive headache left temporal area, vertigo, fullness left ear with diminished hearing, swollen lymph node behind left ear, metallic taste, fever, fatigue, sore arm was not recovered.  No follow-up attempts are needed. No further information is expected.
Varicella given subq R arm on 11/4/2008 and it starting turning red and swelling on 11/5/2008 around late PM. Return to RN on 11/06/08 at 4PM, injection site red and swollen.
Weakness in legs, and body, cold, weight loss, hair loss, muscle mass depleted, abdomen went through what is called a Metamorphosis, sound of ocean in right ear up to now, upper lip became white, and is still white. Pain here and there. And I often feel sadness, but with God, I am still standing.
arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 14:00 (Lot number: EN6199, Expiration Date: 30Jun2021) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "arm sore".  No follow-up attempts are possible. No further information is expected.
DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dull central chest pain and vague shortness of breath similar to her symptoms she had with her pericarditis. She is concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis and concern for rheumatologic etiology.  CT Chest showed Cardiomegaly and small pericardial effusion, similar to 1/4/2021.  Mild abnormality of CXR may be baseline.  Mild abnormality in ECG.  Elevated inflammatory markers and normal troponin.  As above this easily could be a flare of a prior diagnosis of pericarditis due to being on a prednisone taper.  She is under the care of a Rheumatologist. Concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis on a steroid taper and concern for rheumatologic etiology.    S/S: Dyspnea pn exertion, acute chest pain or pressure onset 05/03/2021
2:00 patient seated in observation area & RN noted she was holding herself, inquired if she was feeling ok and patient reported feeling dizzy and nauseated; RN provided waste basket & suggested that patient be moved to private observation area for some fresh air; patient declined 2:10 patient's symptoms did not improve & moved via wheel chair to private observation area accompanied by RN and EMT 2:14 water provided to patient who was encouraged to remove her hat, scarf, coat and mask; door opened for fresh air 2:16 VS: 116\90 | HR 72 | PO2 98% 2:22 patient provided with gatorade and  she stated her waves of nausea has improved; RN recommended that her husband accompany her for 2nd dose of vaccine; patient requested to sit in observation area longer rather than to call husband for ride because he would have to pack up kids; patient refused transport to hospital stating her sx improving 2:26 paramedic returned to vaccination table | RN present 2:30 355ml of gatorade PO intake by patient; patient reported getting dizzy & nauseated 1-2 times when receiving flu vaccine 2:34 patient reported feeling much better and self ambulated to car
Patient got second Moderna shot and was setting in waiting area.  About 10 minutes later the patient felt dizzy and laid down on the floor in the waiting area.  Her husband was in the waiting area with her.  The patient was given a cold compress and did not want emergency services.  Patient rested on floor for approximately 15 minutes then left store with her husband.
sore arm at the injection site; chills; subjective fever; fatigue; headache; This is a spontaneous report from a contactable physician (reporting for himself). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in left arm on 12Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included migraine, rosacea and overweight (not obese) from an unknown date and unknown if ongoing. Concomitant medication included doxycycline, magnesium, sulfamethoxazole, trimethoprim (BACTRIM) and Vitamin D. The patient was 59 years old when vaccinated with first dose of BNT162B2 (lot number: EL0140), intramuscular in left arm on 22Dec2020 11:00 at single for COVID-19 immunization and experienced a sore arm at the injection site. The facility where the most recent COVID-19 vaccine was administered was in the nursing home/senior living facility. 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, the patient has not been tested for COVID-19. For the first 24 hours, the patient simply had a sore arm at the injection site on 13Jan2021 09:00, similar to what he had with the first vaccination. Then for the next 12 hours had chills, subjective fever, fatigue, and headache on 13Jan2021 that did not respond simply to ibuprofen. The outcome of the events was recovered on unspecified date. The patient took ibuprofen, triptan as treatment for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.
Reports that two days post vaccine he developed a raised, red, itchy rash under his left armpit which progressed to right armpit, around beltline and into bilateral groin areas. Reports using over the counter Hydrocortisone cream. Has not seen a physician. Rash today noted under left armpit is pink 1" in length x 1/4" width; no drainage; reports small patch of rash in groin area but declines assessment of that rash. Reports no itching now and feels it is resolved.
could not breath; violent shaking in the right arm; could not walk; legs and knees were in a lot of pain/arms hurt; warm feeling over face; blurred vision in left eye; lost vision in the left eye, only had peripheral vision; sick to stomach; achy; Fever; upset stomach; legs and knees were in a lot of pain/pain in hip/knees, arms and hand joints both hurt; Hip and pelvic area had pain; feet burning; A spontaneous report was received from a consumer who was also a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced upset stomach, violent shaking in right arm, legs and knees in lot of pain, could not walk and breath, fever, hip and pelvic pain, feet burning, achy and sick to stomach, warm feeling over face, loss of vision, blurred vision, and hands hurt.  Medical history included hip prosthesis and COVID-19.  Concomitant medications included atorvastatin calcium.  On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lbatch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  By noon on 26 Feb 2021, he started getting minor side effects (not specified).  By that evening, he had an upset stomach.  A little after 11 pm, he experienced violent shaking in the right arm. His legs and knees were in a lot of pain and he could not walk.  His family called 911 because he could not breath and was admitted to the ER.  A thorough check up was done (not further specified) and he had documented leg and knee pain and fever. hip and pelvic area had pain, he could not walk, his feet were burning.  He also felt achy and sick to his stomach.  The patient said his adverse events were similar to when he had COVID-19 but said this was worse.    On 28 Feb 2021, the patient lost vison in his left eye, only had peripheral vision, along with blurred vision in his left eye.  His knees, arms, and hand joint both hurt.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events resolved on 01 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
lethargic; dizzy; his temperature was measured to be 99F; exhausted; nauseous; cold sweats; like having the flu; like having the flu; sore left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), the first episode of INFLUENZA (like having the flu), the second episode of INFLUENZA (like having the flu), LETHARGY (lethargic) and MYALGIA (sore left upper arm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (sore left upper arm). On 27-Apr-2021, the patient experienced COLD SWEAT (cold sweats), the first episode of INFLUENZA (like having the flu), the second episode of INFLUENZA (like having the flu), NAUSEA (nauseous) and FATIGUE (exhausted). On 28-Apr-2021, the patient experienced LETHARGY (lethargic), DIZZINESS (dizzy) and PYREXIA (his temperature was measured to be 99F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Apr-2021, MYALGIA (sore left upper arm) had resolved. On 29-Apr-2021, last episode of INFLUENZA (like having the flu), LETHARGY (lethargic), DIZZINESS (dizzy), NAUSEA (nauseous) and FATIGUE (exhausted) had resolved. At the time of the report, COLD SWEAT (cold sweats) and PYREXIA (his temperature was measured to be 99F) 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.   No concomitant medications were provided.
Post vax, this pt experienced stiffness in arm two days post vax 01/17. By 01/21, she experienced stiffness in neck. On 01/25, severe pain in arms wrists and knees. The pain continued to worsen and could not get relief from over the counter medications. Physician consulted and labs were conducted. Pt presented to the ER - pain caused difficulty breathing. The following day, she was seen by additional physicians who prescribed pain and inflammation reduction medication. Physicians thought there may be a causal relationship between vaxs and acute migratory polyarthritis.
After original vaccine, I began having high blood pressure. No known cause - stress test, ECG, EKG, chest xray, stress test, bloodwork all came back perfect. After the booster, my blood pressure dropped to 99/57 (heart rate -62) then 101/65 (heart rate - 67), then 100/59 (heart rate - 75). Did not take blood pressure meds that night due to being low. In the morning, 123/69 (heart rate -99), then 116/72 (heart rate 95) took 6.25 mg Metroporol then 7/68 (heart rate -81)
Chills; fatigue; fever over 99.6°C this morning; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (fever over 99.6°C this morning) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (fever over 99.6°C this morning). At the time of the report, CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (fever over 99.6°C this morning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Date of Admission: 12/30/2021   Date of Discharge: 1/1/2022   Issues to be Addressed at Follow-up: 1) COVID PNA. Isolation period will continue through 1/19/22. Patient does not require supplemental O2 on discharge.    2) HTN/HFpEF. Patient will continue PO HCTZ 12.5mg qd on discharge (hold for SBP <100). Her PTA lasix and metoprolol were held due to concern for low blood pressure on admission and HR in 50s-60s. Please follow up with primary care physician regarding when to restart lasix and metoprolol medications.     3) Diet. Patient was on mechanical soft diet with thin liquids by cup or straw. Medications whole with thin liquids or puree. 1:1 feeding for aspiration precautions.
About four or five hours following the vaccine I experienced rapid heart rate in the low 100's for two to three days.
103.2 fever for 3 days,  Nausea, vomiting, headache, body aches, rash all over body, swollen lymph node under left arm.
It was reported that a 4 year old female patient received an IPOL, a Tripedia and a MMR vaccination on 2/27/01. Reportedly that same day the patient developed a local reaction, site not specified, of redness and swelling. Doctor diagnosed as celulitis and treated with Augmentin.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. That was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021.  No treatment details were reported..
Started to feel itchy; Welts all over her body; This spontaneous case was received on 01-Nov-2022 from other healthcare professional via Med Communications (reference number: SEQW22-05304) and concerned a 67-year-old, female patient.  The patient's concurrent condition included possibly allergy to Fentanyl. The patient's concomitant medications were not reported.  On 22-Nov-2010, the patient was vaccinated with Fluvirin (influenza vaccine inact sag 3v; dose: reported as 0.5 ml; route of administration: intramuscular, and anatomical location: not reported) for prevention of influenza disease. The batch number reported was U3719AA and expiry date was 13-Jun-2011.  On the same date, at night, after receiving Fluvirin, the patient experienced itchy and welts all over body. The patient visited doctor and it was prescribed with some medications.  On an unspecified date in Nov-2010, the patient recovered from the events. As it was reported that symptoms disappeared after a few days.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The events of hives and welts are assessed as possibly related to Fluvirin due to plausible temporal relationship.; Sender's Comments: The events of hives and welts are assessed as possibly related to Fluvirin due to plausible temporal relationship.
ALMOST KILLED ME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 experienced almost killed me. Laboratory data (dates unspecified) included: Lab test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost killed me was not reported. This report was non-serious.
Fever; Pretty pronounced fatigue; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and FATIGUE (Pretty pronounced fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PYREXIA (Fever) and FATIGUE (Pretty pronounced fatigue). At the time of the report, PYREXIA (Fever) outcome was unknown and FATIGUE (Pretty pronounced fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
began 3PM high pitched cry 15 mins; fell asleep pt had high pitch cry for approx 5 hrs;