chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A Fib; irregular heartbeat; dizziness; This is a spontaneous report received from a contactable consumer (patient) from Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via an unspecified route of administration on 16Feb2021, at a single dose for COVID-19 immunisation. The patient's medical history included pre-existing condition related to her heart. Concomitant medications was not reported. On 16Feb2021, the patient experienced an irregular heartbeat and dizziness after the 1st shot, she was not sure if that was related to the vaccine as she mentioned she has a pre-existing condition related to her heart. She wants to check if she can take the vaccine on 09Mar2021 since she has AFib after going to her heart doctor. The patient underwent lab tests and procedures which includes heartbeat irregular. Outcome of the events were reported as unknown.
No other adverse event reported; MMR II and VARIVAX administered during a temperature excursion; This spontaneous report was received from an "HBP", referring to to a patient of unknown age and gender.The patient's pertinent medical history,  concomitant medications, previous drug reactions, or allergies were not provided.  On 23-SEP-2020 the patient was vaccinated with improperly stored dose of measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+)  live rHA (M-M-R II) at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection, and route of administration were not reported; lot number s006051, expiration date: 27-FEB-2021); and lot number S015427, that has been verified to be a valid lot number for measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+)  live rHA (M-M-R II), expiration date reported and stablished as as 20-MAY-2021, as prophylaxis (product storage error); and with  improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection, and route of administration were not reported; lot number S002740 has been verified to be a valid lot number, expiration date reported and stablished as 28-JAN-2021); and lot number 031494,  which is an invalid lot number for varicella virus vaccine live (Oka/Merck)(VARIVAX). Lot number 031494, does not match any Company product as confirmed by Lot Verification team, expiration date reported as 07-OCT-2021) as prophylaxis (product storage error). No other adverse event (AE) reported.  The vaccines that were administered, underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 14 hours, as recorded by a data logger. There was no previous temperature excursion.
On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired.
lightheadedness; pain in arm; dizzy; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in arm), DIZZINESS (dizzy) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in arm), DIZZINESS (dizzy) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and Manual therapy (hot and cold compress) for Pain in extremity. On 20-Mar-2021, DIZZINESS (lightheadedness), DIZZINESS (dizzy) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.
- Hot and burning internally immediately - Face redness and swelling and all below within the first 30-60 minutes - Rash on both arms, chest, legs - Lips bright red - Itchy  - Sweating  - Flush  - Throat pain and mild swelling
Fever  100.4-101 lasting for about 30 hours, chills, fatigue, perspiration, had to stay in bed for the whole day
That evening I felt like my abdomen/GI was on fire, inside. I experienced residual feelings of the inflammation (? I am calling it a "fire" to approximate what it made my abdomen feel like) for the rest of the week. Since the perception of abdominal irritation/inflammation wasn't on my handout of possible adverse reactions I did not report. I had muscle ache and ache that I treated with advil. Those aches only lasted 2 days, but the abdominal symptoms continued until the weekend. I read last eve an article online and am reporting because I saw that abdominal pain was listed as an adverse effect that was to be reported.
Presented after sycnope in personal car, c/o weakness. Reported testing Covid +. Tx w/ Decadron, Remdesivir
Tenderness, firmness over injection site. No redness. Hurts when she moves extremity.
IMMUNOCOMPROMIZED BOOSTER, MIXED MRNA 3RD DOSE
Very active pt, no distress whatsoever. L arm-deltoid area with 12cm x 12cm area of blotchy erythema; warmth, no tenderness apparent. Parent advised to RTC PRN increase or persist sx. Rx: Ibuprofen Q6 x 24, cool compress, Benadryl give slightly urticarial appearance.
Pt experienced redness warmth to injection site right deltoid; suspected allergy to tetanus (Mother allergic to tetanus)
He was seen at his PCP on 10/25 with complaints of fatigue, chills since 10/20. Tested positive for COVID-19 and was quarantined, and would became more short of breath with exertion.  His shortness of breath worsened, and he called EMS and was admitted to a local HCF on 10/31/2021 with acute hypoxic respiratory failure.
patient received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30 day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30 day use by date). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30 day use by date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 07-May-2021.  Treatment information was not provided.   This case was linked to MOD-2021-365165 (Patient Link).
Patient left Pediatrics and was taken by mother to the flu station nurse in the lobby area for Influenza vaccine. There she suffered apparent first seizure episode with eye rolling, stiffening of arms and arching of back with extension of neck over a period of 10 minutes in the lobby at facility. There was brief loss of consciousness and enuresis noted. This all occurred 45 seconds to 1 minute after Influeniza vaccine was administered by nurse. There is no h/o allergies, adverse reaction to vaccines and/ or previous seizure as per mother. Patient regained consciousness but was disoriented and confused for approximately 15 minutes before being able to state her name and location. She was initially pale on re-exam but with full spontaneous respirations and regular heart rhythm with steady rate. Ambulance service was called for transport to ER.
BREATHING DIFFICULTIES; UNSPECIFIED SIDE EFFECTS; FEVER MORE THAN 103 FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and other pre-existing medical conditions included it is unknown the patient had drug abuse or illicit drug usage, consumption of alcohol and smoking.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced breathing difficulties, unspecified side effects, and fever more than 103 for 3 days. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) more than 103 (103+). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever more than 103 for 3 days, breathing difficulties and unspecified side effects was not reported. This report was non-serious.
Moderna's injections kicked my T1D butt; caused my blood sugars to be dangerously low early every morning for about two weeks; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Moderna's injections kicked my T1D butt) and BLOOD GLUCOSE DECREASED (caused my blood sugars to be dangerously low early every morning for about two weeks) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer booster (Pfizer booster and The patient had no noticeable effect on Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer booster.    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 IMMUNISATION REACTION (Moderna's injections kicked my T1D butt) and BLOOD GLUCOSE DECREASED (caused my blood sugars to be dangerously low early every morning for about two weeks). At the time of the report, IMMUNISATION REACTION (Moderna's injections kicked my T1D butt) and BLOOD GLUCOSE DECREASED (caused my blood sugars to be dangerously low early every morning for about two weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Dangerously low early every morning for about two weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant and treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Follow up received: No new information
Information has been received from a medical assistant, via a company representative, concerning an 11 or 12 year old female patient who in approximately late January or early February 2008, was vaccinated with the first dose of GARDASIL (lot # not reported).  She broke out in a cold sweat, was in a daze and had an elevated heart rate.  The patient stated that she had not eaten yet that day.  The outcome of the event was not specified.  This is one of several reports received from the same source.  Additional information is not expected.
BP:161/89 (11/22/2004 07:50)   T:95.7 F [35.4 C] (11/22/2004 07:50)   P:64 (11/22/2004 07:50)   R:20 (11/22/2004 07:50)  Pain: 3 (11/22/2004 07:50) HT:61 in [154.9 cm] (11/14/2003 08:58)    WT:226 lb [102.7 kg] (11/22/2004 07:50)  AGE:68  Allergies:PENICILLIN CLINICAL REMINDER ACTIVITY *Pneumovax: Patient educated about adverse reactions that may occur with pneumonia vaccine to include: Soreness around the vaccination site for up to 1-2 days, Fever, Malaise, Myalgia may occur 6-12 hours after vaccination and can persist for 1-2 days. Patient instructed to remain in waitng room for 20 minutes to be observed for any adverse reactions. Patient given handout on Pneumococcal Vaccine, Injection. Level of Understanding: Good Outpatient Pneumococcal vaccine ordered Patient received pneumo-vac at this encounter. Site: right deltoid Present Illness: This is a 68yo, FEMALE, came  To ER with: pain to the right arm from where she  had an injection of pneumococcal vaccine  earlier today there is a family hx of similar  problems developing in abscesses. In the er she  was treated with gatiflox 400 mg iv and she was  to be discharged. she felt weak and shaky and  she was admitted for observation. Allergies: PENICILLIN  TEMP:  95.7 F [35.4 C] (11/22/2004 07:50) BP:    134/83 (11/22/2004 08:05) RESP:  20 (11/22/2004 07:50) PULSE: 64 (11/22/2004 07:50) PAIN:  3 (11/22/2004 07:50)  Physical exam:General: ambulatory, awake,  alert, oriented x3, Lungs: clear,  Extremities: No edema.  Assessment:  cellulitis        Plan: admit 23 hour recheck cbc Patient's age:  68          Sex:  FEMALE Temp:    98 F [36.7 C] (11/23/2004 06:45) Pulse:   66 (11/23/2004 06:45) B.P.     140/67 (11/23/2004 06:45) Resp.    18 (11/23/2004 06:45) Pain: 0 (11/23/2004 06:45)                        HISTORY - PRESENT ILLNESS Chief Complaint: RIGHT ARM SWELLING History of Present Illness: SHE HAD A PNEUMOCOCCAL VACCINE INJECTION YESTERDAY AND SOON AFTERWARD DEVELOPED PAIN AND SWELLING TO THE RIGHT ARM. THIS KIND OF REACTION HAS OCCURRED BEFORE IN HER AS WELL AS HER SON WHO HAD TO HAVE DRAINS AFTER AN ABSCESS DEVELOPED. SHE WAS TREATED WITH 400 MG IV GATIFLOX IN THE ER AND ADMITTED FOR OBSERVATION AND FOR HOT PACKS TO THE RIGHT ARM. Review of Systems: Repiratory:  NO SHORTNESS OF BREATH, NO COUGH                        PHYSICAL EXAMINATION General Appearance:    Good Heart:  Normal to inspection, palpation, and auscultation.  Sinus rhythm, S1 and S2 normal, no murmurs, gallops, clicks or rubs.   Extremities: THERE IS SWELLING AND TENDERNESS TO THE RIGHT ARM AT THE POSTERIOR ASPECT THE ARE OF INDURATION WHICH IS VERY TENDER TO PALPATION IS 6 INCHES BY 3 INCHES Initial Impression: ACUTE CELLULITIS POST VACCINATION WITH PNEUMO 11/23/2004 ADDENDUM  SHE HAD FLU SHOT TO LEFT ARM AND PNEUMOVAX TO RIGHT ARM YESTERDAY MORNING. SHE HAD PNEUMOVAX 5 YRS AGO WITHOUT PROBLEMS HAD SOME CHILLS YESTERDAY
1 day p/vax pt became fussy & devel a raspy voice & barking cough;pt recovered p/1 day;
The evening after the vaccine,  Chills, muscle aches and "hung-over" feeling. Approximately 16 hours later, arm pain and swollen lymph nodes in injection arm.
This spontaneous report as received from physician assistant via company representative refers to a patient of unknown age and gender. Patients medical history was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose number, dose, frequency, route, lot # and expiry date unknown) injection was administered, patient developed shingles. Patient contacted physician assistant for medical attention and received acyclovir (manufacturer unknown) as treatment. On an unknown date, patient recovered from event. No product quality issue has been filed. Action taken with ZOSTAVAX was unknown. The outcome of shingles was reported as recovered/resolved. The reporter did not provide the causality of ZOSTAVAX to shingles. Additional information is not expected.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 65.02.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.Vial was moved to fridge on 09-Mar-2021 and moved to clinic on 20-Mar-2021. Vial was punctured right before administration. Vial best before use date was 08-Apr-2021. Vial was undergone temperature excursion at 09:00 AM and 10:00 AM with 34 and 37 degree Fahrenheit respectively. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
gout; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown".  Additional information: The patient having an adverse reaction to the past 2 Pfizer Covid-19 vaccinations and submitted my issues in the CDC VAERS reporting. Until after Apr2022 shot, gout attacks were at best mild and rare, maybe 1 attack in about a year. After Apr2022's shot, about 2mos/2wks. The patient had the worst attack lasted over 4wks in my foot/ankle. About 2.5 wks after Oct22 Pfizer shot, had a major attack in left hand/wrist. The patient felt like joints everywhere in body all the time now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
CHILD DATE OF BIRTH  WRITTEN WRONG ON CONSENT SIGNED BY PERSON IDENTIFYING AS MTOHER.  CHILD ONLY 11 YEARS OLD AND TOO YOUNG FOR VACCINE ON 8/12/2021.
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9.  Husband gave me Advil & Tylenol.  Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work.  I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired.  Took temperature after someone noticed I looked pale at work. My temp was 99.7.  At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6.  I will see if the adverse side affects go away after today.
Pt developed fever, chills, shakes, and swelling in left arm the next day.  Pt notified PCP and took ibuprofen. Symptoms are improving.
Some swelling 6/26/08. Increasing pain 06/27/08. ER visit 06/28/08, diagnosis cellulitis. Cephalexin 500 mg.q.6 hrs prescribed for 8 days. 7/12/08, no pain, no swelling, client reports minor bump, not palpable.
Fever, uncontrollable shaking, extreme lethargy, unbearable headache, all over body pain.  Symptoms lasted approximately 72 hours
Youth under 18 years of age.  Moderna only approved for 18+ years of age.
This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. On 07-APR-2015 the patients were vaccinated subcutaneously with PROQUAD (Merck) (dose, lot# and expiration date were not reported) which underwent a supported temperature excursion. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
left arm swelling started from 4/18, extended from upper arm to lower arm in the afternoon. went to Urgent care on 4/19 morning, the NP reviewed my blood report and referred me to do ultrasound and also ask me to go to ER if the swell extend. as the swell extend, i went to ER in the afternoon. blood test shows high D-dimer and then ultrasound finds blood clot in the vessel near left neck. diagonised to be Deep Vein Thrombosis. no family history of such problem. in the hospital, they gave me a shot of blood thinner and also prescript oral blood thinner to be take at home.
patient suffered a 2-minute long seizure. She has a history of known seizure disorder. Her last seizure was 3 months ago. She also suffers from severe anxiety. patient was alert and oriented times 3 and refused transport to a local hospital by EMS. She left.
Pt has erythematous, edematous, firm, hard nodule on L shoulder next to vaccine site.  Appears vaccine was administered too high on the arm.
Pt received an MMR vaccine at another clinic on 9/30/23. Received varicella on 10/9/23 at health department. Varicella given too close to MMR vaccine, making varicella dose invalid. Notified mother of child, let her know when to get additional varicella vaccine.
This case was reported by a other health professional via call center representative and described the occurrence of multiple sclerosis in a 45-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced multiple sclerosis (serious criteria GSK medically significant), shingles, off label use and inappropriate age at vaccine administration. On an unknown date, the outcome of the multiple sclerosis, shingles, off label use and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the multiple sclerosis and shingles to be related to SHINGRIX. Additional details were reported as follows: A 45-years-old patient might potentially receive a dose of SHINGRIX based on the recommendation from her physician which led to off label use. The patient had multiple sclerosis and experienced an episode of Shingles about six weeks ago from the time of report. No additional information was provided.