chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received tetanus vaccine around 6 pm.  Same night,arm became very swollen (3 to 4 times normal size) and hot.  Patient ran high fever for 2 days,
Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient did not took other medication in 2 weeks and took Plaxovid as covid-19 Treatment from 25Jun2022 to 30Jun2022.
This case was reported by a nurse and described a 42 year old female subject who did not respond to immunization with Engerix-B for prophylaxis. Medical history included "moderate tobacco use." On 07 November 2003 and 12 December 2003 the subject received the 1st and 2nd doses of Engerix-B (lot ENG5305B6). On 14 May 2004, the subject received the 3rd dose of Engerix-B (lot ENG5562B6). On an unspecified date in 2005, on or before 20 May 2005, approximately 1 year after vaccination with the 3rd dose of Engerix-B, a hepatitis B surface antibody titer indicated "no measurable titer level." The nurse considered the non-response to therapy to be related to vaccination with Engerix-B.
fever; woke up shivering during the night; just feel a bit sensitive on my left hand where I had seen blisters; sensitive on my left hand; This non-serious case was reported by a consumer and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at age 59). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 13-OCT-2023 11:00, the patient received the 2nd dose of Shingrix. On 13-OCT-2023, 12 hrs after receiving Shingrix, the patient experienced fever (Verbatim: fever) and shivering (Verbatim: woke up shivering during the night). In OCT-2023, the patient experienced blister (Verbatim: just feel a bit sensitive on my left hand where I had seen blisters) and sensitive skin (Verbatim: sensitive on my left hand). The outcome of the fever, shivering, blister and sensitive skin were not reported.   It was unknown if the reporter considered the fever, shivering, blister and sensitive skin to be related to Shingrix.     It was unknown if the company considered the fever, shivering, blister and sensitive skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-OCT-2023 The reporter reported the case for herself, she reported that she had first dose of Shingrix and did not recall side effects. She reported that after the second dose about 12 hours later, she had 99.2 fever, and woke up shivering during night. Reporter thought it was just the cooler weather in their City, but she just looked up side effects on website, and it mentioned that fever and shivering. Reporter had shingles at age of 59. Reporter looked up symptoms and went to physician, who gave her shot. The physician said that patient was diagnosed the problem, but he still had to bill the insurance company for the visit. Reporter said that she was very luck she just felt a bit sensitive on her left had where she had seen blisters. The reporter requested to consent the follow up.
Patient C/O palpations, hot, dizzy, slightly nauseated.  No SOB   Patient observed x 40 minutes   B/P 126/86  HR 76  Sat 96%   Patient did elect to call her husband to pick her up
Case number PHEH2012US021954 is an initial spontaneous report received from a consumer on 06 Nov 2012. This report refers to a 72-years-old male patient. His medical history included cardio vascular symptom of heaviness on 23 Oct 2012. On 24 Oct 2012, he went for a routine checkup and was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on to unspecified site. The physician asked him to do an EKG as the patient had cardiovascular symptom of heaviness before vaccination. He did an electrocardiogram in physician's office and "had changes'. He was sent to hospital for blood test. About an hour after blood tests, he was instructed to get back to hospital immediately and his enzymes were elevated. He was transferred to hospital by an ambulance. A second electrocardiogram was performed. He also had enzymes test and heart catheterization and it was report that from heart catheter, they did not find blockage, but he just had weakness. On 26 Oct 2012, his enzyme levels started going down. It was reported that initially doctor stated that it could have been a heart attack or broken heart syndrome, but later it was confirmed as a heart attack. He was hospitalized on an unknown date (duration of hospitalization was not reported). The patient's wife reported that he did not have any pain during any of the event. The reporter believed that the event was a reaction to the flu vaccine. The outcome of the event was not reported. No further information was available.
This is a spontaneous report from a contactable consumer. This report was received via a Pfizer sales representative. A female patient of an unspecified age (reported as at least 65) received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization and SHINGRIX, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received both the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and varicella zoster vaccine rge (cho) vaccine together and said it hurt, was sore on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
Anaphylaxis & Rash Narrative: Employee with h/o prolonged laryngitis following illnesses who was returned to work earlier this week following an extended absence for the same, developed laryngitis following vaccination with Moderna. Additionally she developed a rash on the lateral aspects of her neck, down to her clavicles that was warm to the touch. Rash was not raised. She developed the same type of erythema above and below where the BP cuff had been placed. Sats were 100%, HR 98, BP in the 150s/90. she was given 25 mg of PO Benadryl. When she felt her throat tightening, she was escorted to the ED. In ED symptoms had expanded to include: "chest tightness, hoarseness, palpitations, " In the ED, she was given: 25mg IV benadryl, 60 prednisone. Laryngoscopy was performed with following results; "post cricoid edema which is nonspecific and no evidence of laryngeal edema." The ED concluded that because multiple organ systems were not involved this is "suspicious for an adverse reaction" but unlikely to be anaphylaxis. Employee discharged on PO prednisone and given a steroid dose pack.
Near total loss of use of her left arm. No ability to raise her arm, severely limited grip. Neurologist recommended prednisone and physical therapy. Also had pediatric chiro.
pt recvd flu shot 6NOV92; 7NOV92 pneumonia shot; 7NOV92 entire body aches, inc temp & chills, arm blotchy, red, sl swollen & inc gas;
Flu-like symptoms and red raised whelp on my left arm and my lymph nodes swelled under both armpits left arm[pit worse than the right.
Pt w/ history of severe allergy to "antibiotics and dyes". Pt c/o difficulty swallowing and numb tongue.  BP 138/97, HR 103 -- > 160/100, 81 -- > 140/90.  Pt administered 50mg IM Benadryl 20mins post vaccination.  Pt reports symptoms resolved w/ benadryl.  Referred to PMD for 2nd dose.  Pt stable and released from the vaccination site.
feels heart beating faster, numb lips, rash on chest, EMT evaluated, self-resolved, pt. refused transport.
Pt c/o inability to speak with lips tingling 30-35 minutes after receiving Tdap vaccine. Inability to speak lasted a few seconds.
4/22/2023 - 5/3/2023 (11 days) HEART CENTER  CAD COVID-19 Severe aortic stenosis Combined cardiomyopathy Acute on chronic combined CHF Normocytic anemia HTN Dyslipidemia LBBB Mitral insufficiency DM type II Carotid stenosis HOSPITAL COURSE: Patient is a 93 year old with known CAD and severe aortic stenosis who had previously undergone work up for TAVR.  She had been scheduled for PCI in December however unfortunately her husband passed away and she had to cancel.  She was then scheduled for outpt PCI of the LAD 4/26/23 but presented to the local ED with chest pain and was positive for COVID-19.  She was transferred to another facility and underwent DES to LAD 4/25/23.  Pt developed worsened respiratory status on 4/26/23 requiring bipap and was treated with IV lasix for CHF and also secondary to COVID-19.  Pulmonary was consulted and started decadron.  Pt had worsening renal function 4/28/23 with early signs of shock with elevated LFTs and borderline lactic acid.  BAV was offered but family ultimately preferred comfort approach and did not want any further procedure.  Palliative was consulted.  Pt continued to decline with worsened renal function, poor oral intake, and hypotension due to cardiogenic shock/severe aortic stenosis and cardiorenal.  Hospice was consulted and ultimately decided to transfer to hospice facility.
Covid hit, didn't receive second dose / doctor says that i need to start over; This case was reported by a consumer via (Shingrix GSK and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 20 months ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had received first dose of Shingrix just before Covid hit.  The patient did not receive second dose and it had been about 20 months since the first shot, which led to social problem. The patient's doctor said that the patient needed to start over-get two doses. The patient stated that the site said that there was no need to start over.
Vials stored briefly at <2 degrees C during transport to facility. No s/sx of adverse event
An adult patient received two pediatric doses of VAQTA; no adverse event; This spontaneous report has been received from a Registered nurse concerning an adult patient of unknown gender.  The patient's concurrent conditions, medical history, historical drugs or concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) (anatomical location, route of administration, lot#, and expiration date were not reported) for prophylaxis. On an unknown date, two additional pediatric doses were administered to the patient as second dose (Product use issue).  No additional adverse events were reported.
NA - vaccine was punctured 8/23 1410. Vaccine was administered 8/24 around 1404
Low grade fever 100.2  , Headache, Chills, body aches  Took Tylenol once effects lasted about 12 hours
After patient received MENACTRA vaccine, about 2 minute she felt dizzy and almost passed out. After 2-3 minutes she recovered.
Per recovery RN notes:  Patient: DOB 10/22/1961, Female 05/10/21 at 1025am   Vaccine Time: 1013 Symptoms: Patient stated, "I am not feeling well, I want to lay down". Intervention: RN took vital signs  157/94 in R arm sitting. Pulse 99. 02sat on room air 98%. RR 16. Patient placed on stretcher and in recumbent position, given some water, and a cold compress to the forehead and neck. BP rechecked at 1002am. BP 145/86, HR 77, 02 sat 99% RR14. Recheked VS at 1122am BP 125/82. HR 67 and 02 sat 99%. Response: Patient felt better at 1124 and verbalized feeling well to go home.
She got pregnant way after she received the 2 doses but experienced miscarriage; This is a spontaneous report received from a contactable reporter (nurse, a retired licensed vocational nurse) from Medical Information team.  A 31 year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown," described as "she got pregnant way after she received the 2 doses, but experienced miscarriage." The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient was the reporter's daughter-in-law and wanted to know if this might be related to the vaccine.  The batch/lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the causal association between the event miscarriage and the suspect drug BNT162B2 is assessed possibly unrelated  The case will be reassessed once new information is available.
injection site reaction Narrative:  Patient states some itchiness and red spot at injection site. Symptom has resolved.
expired dose of pentacel was administered to a 13 month old patient with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 month old male patient and reporter reported that expired dose of diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib (PRP/T) Vaccine [Pentacel (Vero)] was administered to a 13 month old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad)  On 16-Oct-2023, the patient received a expired dose 4 at a dose of 0.5 ml of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib (PRP/T) Vaccine Suspension for injection (strength: unknown, expiry date: 01-Oct-2023 and lot UJ807AA) via intramuscular route in the right thigh (Vastus Lateralis) as immunization (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Funny feeling; heart palpitations; The place patient got the shot was all red; Started scratching the place patient got the shot; little bit of a fever; whole arm was red; Sometimes patient had the shingles in the left eye and the numbness is on that side; affected whole left side of the face, felt a little numb; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (whole arm was red), HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), FEELING ABNORMAL (Funny feeling) and PALPITATIONS (heart palpitations) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ERYTHEMA (whole arm was red), HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), VACCINATION SITE ERYTHEMA (The place patient got the shot was all red), VACCINATION SITE PRURITUS (Started scratching the place patient got the shot) and PYREXIA (little bit of a fever). October 2021, the patient experienced PALPITATIONS (heart palpitations). On 28-Oct-2021, the patient experienced FEELING ABNORMAL (Funny feeling). In October 2021, PALPITATIONS (heart palpitations) had resolved. At the time of the report, ERYTHEMA (whole arm was red), VACCINATION SITE ERYTHEMA (The place patient got the shot was all red) and VACCINATION SITE PRURITUS (Started scratching the place patient got the shot) had not resolved and HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), FEELING ABNORMAL (Funny feeling) and PYREXIA (little bit of a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.    Patient experienced palpitations started at 3 in the afternoon, and by 6 pm it slow down and went away. Patient went to the emergency room. After the vaccination, patient was for an hour and it was all calm.   Reporter did not allow further contact
metallic taste and severe loer abd and back pain, llasted 4 days, still having some low back pain Narrative:
Very sore arm at injection site, felt light headed about an hour after but that went away within a few hours.  Next day, developed canker sore in mouth but I am prone to them.  Otherwise, no other effects.
no energy; Headaches; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 12Apr2021, outcome "unknown", described as "no energy"; HEADACHE (non-serious) with onset 12Apr2021, outcome "unknown", described as "Headaches"; CHILLS (non-serious) with onset 12Apr2021, outcome "unknown", described as "chills".  Additional Information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Treatment for AE was unknown. Covid prior vaccination was unknown. Covid tested post vaccination was unknown. List of any other medications the patient received within 2 weeks of vaccination was unknown. Treatment received for the adverse event was unknown. Prior to vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headaches on a regular basis since getting the flu shot, at least every other day. OTCs useless in treating the pain and migraine meds not recommended by PCP.
Patient b/c diaphoretic, pale w/ facial flushing w/in 3 min of injection.  He then c/o feeling dizzy and nauseous.  Vitals were stable other than his BP being slightly low at 97/58.  After ~10 min he c/o feeling his throat getting  a little tight, at which time he was injected w/ 0.3 mg of Epinephrine w/ an auto-injector.  His throat started to feel better shortly after, but still felt sick.  He was given Cetirizine 10mg along w/ Pepcid 10 mg , but avoided benadryl d/t h/o severe sedation and wanted to keep him alert during the observation period.   After 2 hrs of observation, he was feeling much better and all vitals were normal.  However, he still c/o some discomfort w/ his throat, so another 0.3mg of Epinephrine was injected using an auto injector.   He continued to recover and after another 2 hrs of observation, he was allowed to go home w/ his wife for close monitoring.  He was called 1 hr later and confirmed that he continue to do well.  He was advised to take 25 mg of Benadryl before going to bed.  He was seen the following day and was back to normal.
10 hours post vaccination: onset of fever (100.4)?, chills, nausea, headache, neck pain, muscle aches. Continued for total of 24 hours but decreased appetite, injection site swelling and pain, along with swelling and pain under injection side arm
Still feeling weak; Tunneling vision (she lost peripheral vision),; She blacked out and fell from the chair; Veritgo; Tingling throughout the body (up and down the spine),; Ear pitching sound; Severe hypotension; Dizziness; lightheadedness; Unsteadiness; Back Soreness; Tired; Arm soreness; Unable to walk 4 miles every other day like she normally does; A spontaneous report was received from a consumer concerning about a 59 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tunneling vision/tunnel vision, blacked out/loss of consciousness, tired/fatigue, pain in arm/vaccination site pain, back soreness/back pain, dizziness/dizziness, lightheadedness/dizziness, unsteadiness/balance disorder, vertigo/vertigo, tingling/paraesthesia, ear buzzing/tinnitus, hypotension/hypotension, weakness/asthenia and unable to walk/gait inability.  The patient's medical history was not reported. Concomitant medications were not reported.  On 09 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in upper left arm for the prophylaxis of COVID-19 infection.  On 09 Mar 2021, the patient was tired and her arm and back was sore. On 10 Mar 2021, the patient experienced dizziness, light headness and unsteadiness. On 11 Mar 2021, while sitting in a chair she began to experience vertigo, tingling throughout the body (up and down the spine), ear pitching sound, tunneling vision (she lost peripheral vision). The patient then blacked out and fell from the chair. The patient also reports having severe hypotension. She was unable to perform her normal 4 mile walk due to symptoms.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcome of the events,  tunneling vision, blacked out, tired, pain in arm, back soreness, dizziness, lightheadedness, unsteadiness, vertigo, tingling, ear buzzing, hypotension, weakness and unable to walk, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.