chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 year old female with penicillin allergy who on 29-MAY-2007 was vaccinated IM with 0.5 ml of the first dose of Gardasil (Lot #654702/0011U). There was no concomitant medication. On 30-MAY-2007 the patient experienced an all over body rash with itching. Prior to the injection, the patient complained of her eyes hurting, an upper respiratory infection, and fatigue. The patient did not have a fever. The physician performed an Epstein-Barr titer that came back with a result of "convalescencing". The patient was given Depo-Medrol on 30-MAY-2007 and Garamycin ointment for her eye. As of 01-JUN-2007, the patient was recovering. Medical attention was sought. Additional information has been requested.
Skin cysts developed, skin itchy, skin eczema, itching, dry and flaky skin. Skin hives, spontaneous burning sensation on the skin, infection with rash, skin discoloration.
felt it leak down her arm as needle was not tight; A spontaneous report was received from a physician concerning a 28-year old, female patient who experienced the event, felt it leak down her arm as needle was not tight.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT# U25J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient received her first dose of the COVID-19 vaccine and felt it leak down her arm as the needle was not tight. The pharmacist had no idea how much leaked or how much went in. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, felt it leak down her arm as needle was not tight, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 28 year old female patient. The patient's medical history is not provided. The patient experienced an unexpected event of vaccine leaking down her arm as needle was not tight. The event occurred on 28 Dec 2020 during administration of the first dose of the COVID-19 vaccine. The sponsor considered the event as not related to mRNA-1273.
chills; fever initially 100.6F/Fever returned at 101.1F by about 5pm; aches (injection site); aches (spine); aches (occiput); aches ( hips, knees); This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 13Feb2021 14:30 at single dose for COVID-19 immunisation .  The patient medical history was not reported. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 in left arm on 23Jan2021 at 12:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning approx 11 hours post (14Feb2021 01:00) was chills, aches (spine, occiput, hips, knees, injection site), and fever initially 100.6F. Fever reduced acetaminophen over time. Aches continued. Fever returned at 101.1F by about 5pm day after shot. The patient underwent lab tests and procedures which included body temperature: 100.6 fahrenheit (fever initially) on 14Feb2021, body temperature: 101.1 fahrenheit by about 5pm day after shot on 14Feb2021. Treatment received for the adverse event included acetaminophen, water, rest The outcome of events aches (spine, occiput, hips, knees, injection site) was not recovered, the outcome of other events was recovered on an unspecified date of Feb2021. This case was reported as non-serious. 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.
Sore arm where received injection; Feeling fatigued; A report was received from a Moderna employee concerning a male patient participating in the mRNA-1273 Program and experienced as sore arm and feeling fatigue.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   Sometime after the vaccine on 27 Dec 2020, the patient experienced a sore where he received the injection and was also feeling fatigued. Specific onset date is unknown. No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events, sore arm and feeling fatigue, was not reported.; Reporter's Comments: This case concerns a male patient of unknown age. The patient experienced non-serious expected events of Injection site pain and Fatigue at unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown).  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
local site reaction  and moved to elbow and then lower hand. Red and hard bump and it hurts a lot.
Left upper arm reddened tender to touch, and swollen at the area of pneumonia vaccine administration.
Red Patch on Skin at Injection Site on Left Arm; no pain, no itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 59-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 13:00 (Lot number: EN6204) at the age of 59 years as dose 1, single and administered in arm left, administration date 15Apr2021 13:00 (Lot number: EW0151) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1989 (ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 19Mar2021, described as "Red Patch on Skin at Injection Site on Left Arm; no pain, no itching". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: Caller states had her first vaccine on 18Mar2021 and immediately developed a red patch on her skin. Caller states he doesn't know how common this is. Caller clarifies the red patch is at the injection site and it didn't go away. Caller states she received the second injection in the same spot on 15Apr2021, and she still has the red patch, it has persisted. States it doesn't hurt, no rash, just red. Caller states, just to clarify, the skin is not broken up. Caller states he is calling to see if anything like this has been reported or if it is normal. Caller clarifies that the patient noticed the red patch the next day when she removed the band-aid. Caller clarifies the rash started after the first dose of the vaccine and persisted all the way to the second vaccine and continued to persist. Clarifies there is no pain, no itch, it is just different. Patient did not received any treatment.  No follow-up attempts are possible. No further information is expected.
racing heartbeat overnight; vertigo; exhaustion; foggy headedness; Headaches; Vision acuity lessened; Sore left underarm; extreme soreness in underarm area (lymph nodes she assumed)  Lymph node pain; ad the tightness in chest; Slight trouble breathing; There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2) at 51-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 20:00 (Batch/Lot Number: ER8736) as DOSE, 2 SINGLE for covid-19 immunisation. No pregnant. Medical history included Allergies, obesity, Exercise-induced asthma (diagnosed), Sensitive to Codeine product. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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. Concomitant medications included chlorpheniramine maleate; naproxen sodium (ALEVE). Historical Vaccine included BNT162B2 on 01Apr2021 at 51-years-old for COVID-19 Immunization (Dose Number : 1, Anatomical Location : Arm Left, Batch/lot number : ER8734, Start time: 08:00 PM) experienced Chills in the early evening first, fever overnight, Lethargic for approx a week. The second vaccine hit much, much harder. The patient experienced racing heartbeat overnight, vertigo, exhaustion, foggy headedness/ headaches, vision acuity lessened, extreme soreness in underarm area (lymph nodes she assumed). She still had the tightness in chest and also the sore left underarm, slight vertigo, and mild headaches, exhaustion, slight trouble breathing. The knots and soreness were still in left armpit. Right armpit was fine. There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R on 13May2021 15:00 with outcome of not recovered. The events were serious due to disability. Trying to get in to see a primary doctor for referral to a cardiologist, which is proving difficult. The patient hoped the symptoms can be lessened. She felt none of this prior to vaccines. The events resulted in Doctor or other healthcare professional office/clinic visit. Not resulted hospitalization prolonged, Treatment received: Unknown. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
8:15 PM headache, Next day fever 101 for next 4 days. Aching joints stabbing pains began on 4th day. Stiff neck started upper neck moved to mid back to lower back and down to 4 inches past elbows on 5th day, Fever lower 99 tingling right foot, chest pain, with severe stiff neck and difficulty breathing, headache returned and nausea very tired and sick.
CHILLS; LITTLE BIT OF NAUSEA; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced little bit of nausea. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from little bit of nausea, and had not recovered from chills, headache, and fever. This report was non-serious.
It was awful in the beginning; her face swelled up,Cheek swelling; her ears swelled up; her nose swelled up; a rash,her chest had the rash,her arms had the rash; hives; it's burning and itching; it's burning and itching; her hand feels the heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and FEELING ABNORMAL (It was awful in the beginning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included APIXABAN (ELIQUIS) for Blood pressure, URSODIOL for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and RASH (a rash,her chest had the rash,her arms had the rash). On an unknown date, the patient experienced FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up) and SWELLING (her nose swelled up). The patient was treated with PREDNISONE at an unspecified dose and frequency; MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency; DOXEPIN at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 180 mg. At the time of the report, URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat), FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up), SWELLING (her nose swelled up) and RASH (a rash,her chest had the rash,her arms had the rash) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications Steroid shot and Pepcid were reported.  Patient visited primary care,dermatologist, allergist, all of them gave her different medications.
Narrative:  The patient received one dose of Moderna COVID 19 Vaccine on 3 Jan 2022. The patient tested positive for COVID 19 on 7 Jan 22. The patient presented to the ED with weakness and rhabdomyolysis. The patient was admitted to the hospital and treated with fluids and statin on hold. The patient was discharged on 8 Jan 2022 in stable condition.
Information has been received from an office manager concerning a female nurse with a history of shingles who on 31-DEC-2008 was reconstituting ZOSTAVAX (Oka/Merck) to give to a patient. When she was injected the diluent into the vial, the pressure was so much that the vaccine sprayed back into face and eyes. Her face feels like it was burning but her eyes have no issues. It was reported that the nurse flushed her eyes and face with water. Additional information has been requested.
felt a little tired the next day after receiving the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (felt a little tired the next day after receiving the vaccine) in a 44-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (All previous doses were Pfizer COVID-19 vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.    On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Sep-2022,  after starting mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FATIGUE (felt a little tired the next day after receiving the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Tiredness, at an unspecified dose and frequency. At the time of the report, FATIGUE (felt a little tired the next day after receiving the vaccine) had resolved.            No concomitant drug was reported. It was reported that patient felt a little tired the next day after receiving the vaccine but felt fine after. Patient received Tylenol for symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2022-640766, US-MODERNATX, INC.-MOD-2022-640772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-640766:Wife case US-MODERNATX, INC.-MOD-2022-640772:daugter's case
15Dec97 recv pneumococcal vax 23 polyvalent.  Pt. exp. fever.  Pt. hosp 5Jan98.  Fever persisted month after vax.  Fever onset unknown.
Headache; fever (101.2); arthralgia; fatigue; This is a spontaneous report from a contactable consumer, the parent. A 23-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7534) via an unspecified route of administration on 23Mar2021 in the left arm (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and migraine. The patient had known allergies with avocado and strawberries. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number en6205) via an unspecified route of administration on 02Mar2021 in the left arm (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced headache, fever (101.2), arthralgia and fatigue. The patient lab test included body temperature which was measured on 24Mar2021 and the result was 101.2 (unspecified units). The patient received acetaminophen as treatment medication for the events headache, fever (101.2), arthralgia and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of headache, fever, arthralgia and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 6/21/99, the pt was seen by the physician who noted redness and swelling at the injection site. A dx of injection site abscess was made. The abscess was incised and drained; cultures were obtained and found to be negative. The pt was treated with Rocephin and Keflex. The abscess developed into an ulcer which was treated with packing that was changed every 2 days.
Multiple hospitalizations for pericarditis leading up up to a pericardectomy on May2021; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:30 (Batch/Lot Number: EL3246), age at vaccination of 64 years-old, as single dose, for covid-19 immunisation. Medical history included scarlet fever from an unknown date and unknown if ongoing, rheumatic fever from an unknown date and unknown if ongoing (as a child). The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medication included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis (hospitalization, medically significant) on 17Feb2021 19:30 with emergency room/department or urgent care visit as well as multiple hospitalizations leading up to a pericardectomy in May2021. Therapeutic measure was taken as a result of the event and included a course of Prednisone for 5 weeks/ followed by a co (as reported). Facility where the most recent COVID-19 vaccine was administered: Other.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included covid-19 negative on 19May2021. Outcome of the event was unknown.
both right and left arm became red, swollen and itchy approximately 6 hours after administration of seasonal and H1N1 vaccines; Mom was referred to ER. Discharged with benadryl and prednisone Return visit to ER 11/6/09 and admitted for: respiratory distress flu pneumonitis
Itching on chin, jawline and cheeks; cheeks would flush with the itching; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 27Mar2021 at 09:15(at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy(sulfonamide allergy). The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 27Mar2021 at 10:00 after 45 min of vaccination, the patient experienced itching on chin and itching continued mostly on chin, jawline and cheeks for 7 days. Occasionally her cheeks would flush with the itching. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included antihistamines. The clinical outcome of the event itching and flush were  recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
COVID(+) WITH SYMPTOMS HEADACHE, FATIGUE, BODY ACHES NASAL CONGESTION, NAUSEA Narrative:
Pt devel cellulitis, consisting of erythema & pain @ the inject site; pt seen in ER 5 days p/administration was treated w/Duricef; By 15NOV91, cellulitis had resolved;
Bells Palsy in her face; This is a spontaneous report from a Pfizer-sponsored program Support via a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included abatacept (ORENCIA) taken for an unspecified indication, start and stop date were not reported. The patient took first dose of Covid vaccine and experienced Bells Palsy in her face about 45 minutes after vaccine and it lasted for about a day. The outcome of the event was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Chills:started on day 1 lasted for 2 days low grade fever, started on day 2, last for 2 days 99.8-100.4 dull headache,  3 days, still a sympton breast/underarm tenderness, started on day 2 sour stomachs started on day 2, still a sympton
High Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had fever. The reporter asked was it normal to have high fever after the 2nd dose of Shingrix Vaccine. The reporter did not provide demographics or any additional information. The reporter did not consent to follow up. The reporter denied demographics.  The reporter provided name but did not confirm spelling and declined to offer any additional information.