chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details; expired vaccine administered; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.   On 04-MAY-2022, the patient vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, and indication were not provided; lot #T013727, expiration date: 21-APR-2022) for prophylaxis (expired product administered).  It was reported that both vaccine and sterile diluent used to reconstitute vaccine had been stored according to prescribing information through date of administration. No additional adverse event was reported.
9/16 Local ecchymosis and mild swelling at injection site, tender at site and distal to site redness is from top of site to 1 cm below the site and redness extends 11 cm towards lateral posterior upper arm as well and no pruritic.
I was given the SHINGRIX 50mcg inj (IM) SNG DSE VL10PK and the PREVNAR 13 inj, 0.5ml in the muscle as directed both in the left arm. Approximately 3:30 pm in the afternoon on 05/01/2018. Was told may have redness and soreness. Didn't notice any of that until the next day 05/02/2018 approximately 4:00pm. The redness got worse and beings I had a appointment with my doctor on 05/04/2018 10:30 AM. She said to watch it and if it spreads any more to call the office on Monday 05/07/2018. I did and was told to come in. Was seen. Was given meds. Ranitidine 150mg and Cephalexin 500mg.
Red rash near the place of the shot was noticed at 4/1/2021, around one week after the first dose of Moderna COVID-19 Vaccine been admitted. The size of the rash was about 2 inches by 3 inches, with no feeling of itchy or pain.
This case was reported by a consumer and described the occurrence of burn in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burn. On an unknown date, the outcome of the burn was unknown.   It was unknown if the reporter considered the burn to be related to Shingles vaccine.   Additonal details were provided as follows: Age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received dose of Shingles vaccine and was getting rich burn since the shot. The patient was waiting for second dose.
This case was reported by a healthcare professional via Merck and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified ages and gender who were vaccinated with ENGERIX B, (GlaxoSmithKline).  The subjects medical history included hepatitis C.  On unspecified dates, the subjects received unspecified doses of ENGERIX B (unknown) and experienced not responding to therapy.  The reporter stated "one-third" of her hepatitis C subjects who had received ENGERIX B did not seroconvert.  No other information was provided.  At the time of reporting the outcome of the event was unspecified.
pt recvd vax & 1-2 hrs later devel hives on trunk then later extremities; also exp nausea; awoke during th noc (4-430AM) feeling lightheaded, & exp a near-syncopal episode upon rising; presented to ER w/ a blood presusre 76/62;
I have like a big swelling underneath my arms and it is on the same arm that I got the shot in; This is spontaneous report received from contactable consumer (Patient). An unspecified age and gender patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date in May2021 (on Friday) at 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In May2021, the patient had like a big swelling underneath arms and it was on the same arm that the patient got the shot in. Reporter seriousness for the patient had like a big swelling underneath arms and it was on the same arm that the patient got the shot in was unspecified. The outcome of the event was unknown.  Consumer was informed about Pfizer Medical Information department and provided with the number Limited information was available over the call as consumer hung up abruptly.  Information on the Lot/Batch number has been requested.
Left deltoid IM injection was attempted, but suspect it was actually a SQ injection. Injection placed two to three cm below left acromion process.  Met firm resistance with needle (1.5" 23 gauge needle) at a depth of approximately 1/2" and suspected that the tip of the needle was deep enough within muscle.  Injected 0.5ml of Moderna COVID 19 vaccine and noted skin blanching after injection.  Patient otherwise tolerated procedure well and there were no other complications.
This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year 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 information was reported as follows: The age at vaccination was not reported. This case was previously reported to the physician. The batch number for SHINGRIX was not reported. The case was reported by the patient's husband, who stated that his wife was vaccinated with the 2nd dose of SHINGRIX and experienced fever. Further details were not obtained regarding this from the reporter. This case was linked with case US2018173510 (husband case), reported by the same reporter.
Bump; Redness; Pretty warm; Itchy; A spontaneous report  was received from a consumer concerning a 36-year-old, female patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program who had red bump and a pretty good sized ark, and it's pretty warm , itching.  The patient's medical history, is not provided by the reporter.   Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 15/Jan/2021. On prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Experienced had red bump and a pretty good sized ark, and it's pretty warm , itching.   No lab data is reported bye the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, had red bump and a pretty good sized ark, and it's pretty warm , itching were unknown.   The reporter did not provide an assessment for the events, had red bump and a pretty good sized ark, and it's pretty warm , itching.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Received shot on 1/30/07. Did not show signs until Wed/Thursday 1/31/07. By Saturday 2/3/07 had to go to ER due to facial paralysis. Restart series due to negative HbSAb titer.
Seizure due to intracerebral Hemorrhage (IPH). Treated with medications without surgery. Four days ICU inpatient care with follow-up medication. Evaluation is ongoing.
Information was received from a licensed practical nurse referring to a 4 year old female patient. The patient's concomitant medication, historical and concurrent conditions were not reported. On 06-AUG-2018, the patient was vaccinated at a private doctor's office/hospital with an improperly stored dose of (rHA) PROQUAD (lot # R002935) subcutaneously in the left arm with public funds for prophylaxis. The patient was also administered KINRIX concomitantly on the same day. It was reported that the patient was previously administered a dose of PROQUAD and a dose of KINRIX on unknown dates. No prescription drug treatment for the experience was required. Details of the temperature excursions were not reported. Data logger was involved. This is one of several reports received from the same reporter.
20 MINS INTO COOL FLUSH FEELING ALL OVER , HEART RACING , WENT HOME AND HAD REALLY BAD  HEART PALPUTATIONS , CALLED THE NURSE . EKG WAS NORMAL .. Blood pressure was 130/99 which is higher than normal ..Provided IV FLUIDS . HEADACHES, NASUEA ,CHILLS.
heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EL1284), via an unspecified route of administration in the left arm on 30Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included pulmonary embolism (PE's x 2) and left nephrectomy for kidney cancer (CA). Concomitant medications included apixaban (ELIQUIS), losartan and hctz. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 18:00, the patient experienced heart rate in the 120's which lasted 15 minutes while at rest and left arm deep aching for 2 days. Outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sick all day; Hurts on every bone.; Fever of 101 Deg F; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick all day), BONE PAIN (Hurts on every bone.) and PYREXIA (Fever of 101 Deg F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COPD. Concomitant products included MORPHINE, TRAMADOL and GABAPENTIN for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (Sick all day), BONE PAIN (Hurts on every bone.) and PYREXIA (Fever of 101 Deg F). At the time of the report, ILLNESS (Sick all day), BONE PAIN (Hurts on every bone.) and PYREXIA (Fever of 101 Deg F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 (High) 101 Deg F.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
5 pinpoint (approx. 2mm) areas of discoloration (red) and swelling (L) wrist area. 8 similar areas near (L) axilla - one of which is scabbed over. (L) knee with one approx. 3mm papule. Rashes noticed by sibling 7/9/13. (L) flank area itchy. No treatment.
All signs of heart problems.  ER tests came out as heathy heart but the DR guessed it is nerve damage due to the vaccine.  Chest tightness, chest pain, light headedness, numb tingling in right arm and fingers.
No side effects reported; HCP calling to report AE for expired dose of MMRII that was administered to a patient on 23OCT2023.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, lot #U033041, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The vaccine did not have any previous temperature excursions. No side effects reported.
Within 10 minutes of vaccination, patient felt heart palpitations, dizzyness, chest tightness, tingling in lips and dry mouth.  Pt felt hot and was clammy to the touch.  Symptoms resolved slightly in 20 minutes, but pt still unable to walk unassisted so she was taken to the ER for further evaluation.
Redness, swelling and pain around injection site.  Grew to a 3" diameter of redness.  Slightest touch to the area caused extreme pain.
This prospective pregnancy case was reported by a consumer and described the occurrence of muscle pain in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. Previous pregnancies included one preterm with fetal demise greater than 19 weeks and one at 40 weeks with normal birth. On 12 September 2012 the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, unknown). Her last menstrual period was 07 April 2012 and estimated delivery date was 14 January 2013. The subject was exposed to FLUARIX during the 2nd trimester at 24 weeks gestation. This pregnancy was by normal conception with no contraception. The subject had an ultrasound on 13 August 2012, results not provided. On 12 September 2012, at the time of vaccination with FLUARIX, the subject experienced vaccine exposure during pregnancy. On 13 September 2012, 1 day after vaccination with FLUARIX, the subject experienced muscle pain, sore throat, headache, feels awful, suspected transmission of an infectious agent via a medicinal product. The subject took TYLENOL and felt it was annoying to have the symptoms that she experienced after receiving the flu shot. This case was assessed as medically serious by GSK. The outcome of the pregnancy was ongoing. At the time of reporting the outcome of the muscle pain, sore throat, headache, feels awful, suspected transmission of an infectious agent via a medicinal product were unspecified.
Heart rate went up; A spontaneous report was received from a consumer concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine and experienced a heart rate increase.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not provided.  On 06 Jan 2021 at 14:00, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021 at 14:10, approximately 10 minutes after she received the mRNA-1273 vaccination, while she was waiting in her vehicle, patient experienced an increase in her heart rate to 164 for less than a minute, which then trended down to 120. On her drive home, it increased again to 152. She drove directly to her doctor's office who then told her she had the option of going to the emergency room since they did not know how to treat reactions to the vaccine. She waited in the waiting room until her heart rate went down to 109, at which point she went home. At approximately 16:00 she reports that her heart rate was 95.   Patient reports that her normal heart rate is 66-68. Consent has been given to contact.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a lawyer concerning a 48-year-old female patient. Her medical history included chickenpox. She was a smoker in the past. Her concomitant medications included influenza vaccine (FLU). The concurrent conditions were not reported. In November 1995, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, expiration date and route of administration were not reported) (inappropriate age at vaccine administration). No adverse reactions were reported. On 29-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) and experienced shingles (captured in MARRS 2109USA005241).; Sender's Comments:US-009507513-2109USA005241.
noc of vax temp to 103;day p/diffuse very erythematous maculopapular rash, fussy;
Bell's Palsy.  Developed right-side facial paralysis 4/30/21 12:00PM involving forehead, eye and mouth.  Evaluated in ED 4/30/21 6:00PM.  Diagnosed with Bell's palsy based on physical examination and imaging.  Discharged to home 4/30/21 9:00PM.  Prescribed 60mg prednisone q.d. x 5 days; 1g valcyclovir t.i.d.  x 7 days.  Follow-up with primary care.
ON 07/19/23 @ 1050AM RASH STARTED TO SPREAD AROUND CLIENT'S TORSO AND DOWN ARMS. MOM ADMINISTERED BENADRYL AT 1110. CLIENT IS EATING, DRINKING AND PLAYING AS NORMAL. MOM GIVIEN EDUCATION ON WHAT REACTIONS TO LOOK FOR IF IMPROVEMENT DOES NOT OCCUR WITH THE BENADRYL.
My adverse event started on the same day. I had a rash across my chest along with  pain on my left arm. I have history of cancer such Breast Cancer on 2011 and Thyroid Cancer on 2004. After few months of my third dose I've noticed there was a nodule on my right part of the neck. Since I get evaluations every year for cancer they said I had a lymph node but it turned out to be a cancerous nodule. Every vaccine I  got rashes afterwards my doctor said it was related to the vaccine. I had a CT scan on 04/13/2021 which showed the nodule. As of today I am waiting to get another surgery done. The rash I had on my chest it spread all over my body. Now it's on my hands, neck, head, back, and arms. I took prednisone skin ointment, and ALLEGRA, the rash flared up after the 2nd booster shot more. I even changed detergents but no one is sure where the rash is from known cause.
Grandmother reported a red rash on child's back, stomach and face. No fever. Not fussy. Slight chest congestion. Good appetite. Grandmother phoned 12/16/04 at 2:20pm.
blister in her mouth; lesions into to her throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A female patient received PF-06928316 (ABRYSVO), as dose number unknown, single  (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "blister in her mouth"; THROAT LESION (non-serious), outcome "unknown", described as "lesions into to her throat". Additional information: The caller was a pharmacist asking if the mouth blisters was part of the effects of Abrysvo. The caller stated a patient has reported blister in her mouth and lesions into to her throat.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Cardiac Arrest  (38 days after second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac Arrest  (38 days after second vaccine)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC ARREST (Cardiac Arrest  (38 days after second vaccine)) (seriousness criteria death, medically significant and life threatening). The patient died on 08-May-2021. The reported cause of death was cardiac arrest  (38 days after second vaccine). It is unknown if an autopsy was performed.            It was reported  that Lot number 023M20A was the only lot on the vaccination card. Caller was not sure if this lot is from first or second vaccine."  Treatment information was not reported but it was reported "Paramedics were there at home and they could not resuscitate him."  Concomitant medication was not reported.  Company Comment: 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.; Sender'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.; Reported Cause(s) of Death: Cardiac Arrest  (38 days after second vaccine)
Headache, Myalgia, headache, fatigue, arm soreness Narrative:
fatigue; chills; achy; This is a spontaneous report from a contactable consumer. A 48-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution of injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 28Feb2021 12:15 (at the age of 48-year-old) as Dose Number Unknown, Single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient received other medications within 2 weeks of vaccination, but list is unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient is not having any Allergies to medications, food, or other products. On 28Feb2021, the patient experienced fatigue, chills, achy. The patient did not receive any treatment for the adverse event. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Client states she had approximately a 4 inch red band that wrapped around her left upper arm from the injection site.  Area on Left upper arm 10/12/15 now approximately 2 inches in diameter, red, warm to touch and slightly itches.  Client states she has put cold compresses to area on Left upper arm where injection was given and that has improved the redness and swelling.
From 2/12 had nausea, fatigue, disoriented, spinning in waves one or two times a day until 2/21.  On 2/21 had extreme vertigo, diarrhea, vomiting, couldn't sit up or walk.  Called 911 at 10:45 am, hospitalized for 4 days.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). On an unknown date, the patient received KINRIX .5 ml. On 14th May 2015, an unknown time after receiving KINRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to KINRIX. Additional information received: There were also 2 other patients who experienced the same side effects.