chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was likely in first days of pregnancy during receipt of the second dose of Pfizer vaccine on 22/apr/21. Pregnancy was not discovered until several weeks after vaccination. At the first ultrasound (scheduled for 9 weeks from proposed date of conception?02/jun/21 the fetus was reported as measuring small and after second ultrasound the following week it was determined that the pregnancy was not viable and miscarriage began on 18-Jun and completed on 25-Jun-2021.
Flulaval Quadrivalent NDC 19515-0808-41 I received the flu shot at my annual wellness visit on Friday 1/6/2023.  It was administered in my left shoulder. There was some swelling and tenderness that went away by the next morning.  On Sunday 1/8/2023, I noticed a large swelling of tissue over my left clavicle (filled up the space that is normally hollow).  It had some redness and sensitive to the touch if pressed.  I still have the swollen lymph node as I write this notification.  I do not have any other symptoms and feel fine.  No rash, fever, headache, etc.
- No Adverse effects w/ Shot #1 - 24 hrs after Shot #2 I experienced headache and rising fever that eventually spiked to 101.  At 2am, the fever finally broke and I was fine the next day. - CURRENT SYMPTOM began several weeks later, in late March, early April.  I have developed Tinnitus and have made appointment with an ENT specialist for help.  I have never had this condition before and frankly don't know if it is related to the vaccine or high fever I had from the vaccine.  It may be stress-related.  I pray it will resolve at some point.  Maddening does not begin to describe living w/ constant ringing in the ears.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000439: US-009507513-1707USA000440: US-009507513-1707USA000442: US-009507513-1707USA000443.
headache; shoulder aching; arm red and her back,; back hurting/aching; neck hurting/aching; underarm hurting; was sore; tired; noticed swelling on her right armpit, a lymph node or something; arm aching; burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting; right arm felt pretty numb; burning sensation went down her right arm later in the day; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching) and HYPOAESTHESIA (right arm felt pretty numb) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jun-2022, the patient experienced BURNING SENSATION (burning sensation went down her right arm later in the day), HYPOAESTHESIA (right arm felt pretty numb) and PAIN IN EXTREMITY (arm aching). 19-Jun-2022, the patient experienced VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting). On 20-Jun-2022, the patient experienced ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), AXILLARY PAIN (underarm hurting), MYALGIA (was sore), FATIGUE (tired) and VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something). On an unknown date, the patient experienced HEADACHE (headache) and ARTHRALGIA (shoulder aching). At the time of the report, BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), HYPOAESTHESIA (right arm felt pretty numb), AXILLARY PAIN (underarm hurting), PAIN IN EXTREMITY (arm aching), VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting), MYALGIA (was sore), FATIGUE (tired), VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something), HEADACHE (headache) and ARTHRALGIA (shoulder aching) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient was not taking any concomitant medications  No known allergy; always been sensitive. Every time she got a vaccine she would get a flu like feeling but will be good after 3 days; Sensitive after blood extractions she will get skin bruises that will disappear after 2 weeks.  No treatment medications were reported.
Extreme exhaustion: dozing off while driving to work. I left early and had to be picked up, because I was too tired to drive.  Pounding headache: my head feels like it?s in a rock tumbler. Body aches: my body feels like I got hit by a truck. Anything that touches me hurts, including clothes or blankets.  Fever: 101.3F Injection site pain: my arm feels like it?s severed. Treatment: I have been taking 800mg of Ibuprofen every few hours, but have not had any relief. I took Tylenol initially and also did not have any relief.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 3rd March 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-Mar-2023 Reporter comment: The nurse called to inform that earlier on the day of reporting, a patient had been administered a dose of Havrix that had expired on 16th February 2023.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
PATIENT GOT THE VACCINED AT 130PM COMPLAINED OF ITCHY THROAT, COUGH AND MILD THROAT TIGHTNESS AT 140PM DOCTOR EVALUATED THE PATIENT , NO RESPIRATORY DISTRESS, TALKING IN FULL SENTENCES.  BENADRYL 50MG IM ADMINISTERED AT 203PM.  MD EVALUATED THE PATIENT 5 MINUTES LATER AND PATIENT DENIED THROAT TIGHTNESS, ITCH OR COUGH.  VS STABLE AT 140PM   BP 110/65  HR  80  O2 96% VS AT 223PM 106/64  HR 74  O2  96% PATIENT WAS OBERSEVED FOR HALF HOUR AND SENT HOME WITH INSTRUCTIONS TO CALL 911 IF HE DEVELOPS ANY RESPIRATORY DIFFICULTY. PATIENT VERBALIZED UNDERSTANDING
sick for three days; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (Patient ) via the agency through social media.  This case involves a patient (age and gender unknown) who was sick for three days (illness), while the patient received Influenza vaccine.  The patient's medical history, past medical treatments, concomitant therapy, past vaccinations and family history were not provided.   On an unknown date in 2019 (reported as last year), the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date of 2019 (latency: unknown), after starting the suspect vaccine therapy, the patient was sick for three days (illness) and was not taking this year.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on lot number for this case.
Sever flare up of Lupus symptoms. Swelling of joints. Pain internal organ swelling. Symptoms sever for four weeks until infusion of drugs. Symptom relief within 2 hours of treatment.
Patient came to our public health clinic for dose number 2.  She reported that after receiving the first dose on 12/26/2020 at another site she experienced numbness in the left upper arm and right face (cheek) that began about 20-30 minutes after receiving the vaccine and lasted 10 minutes.  She has been well since.
he had bleeding in his eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (he had bleeding in his eye) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced EYE HAEMORRHAGE (he had bleeding in his eye) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (he had bleeding in his eye) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: 5.6 within the normal range.     mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was withdrawn on an unknown date.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatments were reported.  Patient went for eye doctor checkup on 19 OCT 2023. Doctor looked in her husband's eye and he had bleeding in his eye. This was not in his field of vision. This occurred after his 5th covid shot on 20 SEP 2023. The Optometrist thinks that the COVID-19 vaccine and this symptom might be related. He recommended that this individual not receive any additional covid-19 vaccines.  Company Comment This spontaneous case concerns a male patient of an unknown age with no medical history reported who experienced the unexpected seriousness criterion medically significant event of eye haemorrhage unknown days after a dose of mRNA-1273.815 vaccine. Approximately 1 month after vaccination the patient went to optometrist and he looked bleeding in his eye. At the time of the report, the event had not resolved. Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
8 yo female arrived to COVID vaccine clinic with her mother.  The mother filled out a consent form for her daughter to be vaccinated and was told by a National Guard member that her daughter could not be vaccinated.  Mother continued through process for her own vaccine and after receiving her COVID 19 vaccine, she presented her child's form to the National Guard member/vaccinator and had her child sit in the chair for vaccination.  The National Guard member/vaccinator did not verify the age of the child  and proceeded to vaccinate her.
Initial unsolicited report received from a non- healthcare professional on 6 October 2015. This case involves a 61-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Influenza) (batch number U53388A, route, dose and site of administration was not reported) 3 October 2015 at 10:00 AM. Patient medical history and concomitant medications were not reported. On 3 October 2015 at 5:00 PM, seven hours following the vaccination, the patient experienced chills, body aches and muscle tightness and same day at 11:00 PM, 13 hours following vaccination the patient experienced severe sweating, body aches, muscle tightness, arm tingling and stomach pain or soreness. On 3 October 2015, same day the patient also experienced rash at injection site. The patient required emergency room or doctor visit. Lab data included blood work, urinalysis, x-ray and CAT scan of abdomen. Corrective treatments were not reported. The patient was recovered from the events. List of documents held by sender: none. Follow-up information received from non-healthcare professional in the United States on 01 December 2015. No further information available.
Patient developed feeling of "burning in mid-chest" and palpitations 15 minutes after COVID vaccine administered. She also experienced intermittent tingling in hands and feet. Patient was evaluated by EMS in the vaccine clinic. The chest symptoms were episodic, occurring every 5 minutes and lasting 1-2 minutes with each episode. Intermittent dizziness also occurred during the chest-discomfort symptoms. Vital signs were stable and oxygen saturation was 100% on room air.  Patient denied SOB, stridor and no labored breathing. Patient was transported to the hospital emergency department for further evaluation/observation. After 2 hours of observation, patient's symptoms resolved spontaneously. She discharged from the emergency department to home with family.
Per niece a couple hours after getting the vaccine started to have issues with arm and his wife took him to the hospital to get checked out.  It was took late by the time getting to the hospital and patient passed away around 1 pm.   Per the coroner the preliminary cause of death is a blood clot.  This information was provided to the pharmacy by the patients niece around 3 pm.
Swelling and erythema of left arm. Two days, post vax, some decrease in symptoms on 3rd day. On exam (3rd day), splotching erythema mid 1/3 to 1/2 of arm and slight swelling at deltoid.
Suspected vaccination failure; Shingles in the same dermatome where the injection was given; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient was return within 3 months with a case of shingles in the same dermatome where the injection was given. At the time of reporting, the reporter did not have specific patient information. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with case US2019AMR208357, reported by the same reporter.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: About 5 minutes after vaccination he had possible seizure for ~10-20 seconds with loss of consciousness & arched back posture followed by leaning forward and coughing, bit his lip, was confused & unaware of what happened as he began to resond to questions. Had "waves" of lightheadedness, tingling fingers, distorted perception of contrast in pictures with a white background, warm & thirsty .
Dad reports fluid-filled blister at site of MMR injection. Some redness, no fever. Was seen by physician who prescribed acetaminophen and cold compresses.
Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.            Caller stated she took Aspirin earlier and was currently itching so wanted to know if she could take Benadryl.
CRAMP IN UNDERARM OF RIGHT ARM; BURNING IN UNDERARM OF RIGHT ARM; This spontaneous report received from a patient concerned a 19 year old of unspecified sex. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 22-APR-2021, the subject experienced cramp in underarm of right arm. On 22-APR-2021, the subject experienced burning in underarm of right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramp in underarm of right arm, and burning in underarm of right arm. This report was non-serious.
Large area of inflammation outside of vaccine injection site. High amount of swelling, warm to the touch.
Hardening under skin at the injection site; This spontaneous report was received from a pharmacist regarding a 13-year-old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 03-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2, via intramuscular (strength, dose) for prophylaxis. Lot number (R028380) is an invalid lot number for [hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On the same day patient received influenza virus vaccine (unspecified) (strength, dose, frequency, route, lot # and expiry date were not reported) in the same arm. It was reported that on 31-JAN-2020, patient called pharmacy to report hardening under skin at injection site (injection site induration), but patient has no pain, warmth, or swelling. On 31-JAN-2020, the patient experienced injection site induration. The outcome of injection site induration was unknown.
The morning after injection pt developed swelling at site that progressed for several days. The pain also continued to progress until severe. Pt seen in the office 7/3/07), evaluated and treated with analgesics.  xrays done at the visit were unremarkable.
Intense flu like symptoms and soreness at vaccination site. Fever, muscle aches, congestion, swollen lymph nodes.
He got fever a couple hours after the injections, had diarrhea, and spit up abnormally
Patient developed consistent Parotitis with Mumps, Received vaccine 2/19/04, developed Parotitis 3/8/04.
booster; fainted; crashed the vehicle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570; 159558).  A 25-year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunization in a pharmacy. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First Dose, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Second Dose, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown"; SYNCOPE (medically significant) with onset 14Dec2021, outcome "recovered" (Dec2021); ROAD TRAFFIC ACCIDENT (non-serious) with onset 14Dec2021, outcome "unknown". The events were described as follows. The patient received her Pfizer covid-19 vaccine booster on 14Dec2021 and got in her car and drove off and fainted while in the car and crashed the vehicle. After she got the booster, nobody informed her about staying around for the 15 minutes like they had had on the previous vaccinations, therefore she left. She was driving home and within 10 minutes of getting the vaccine, she fainted and crashed her vehicle. She didn't have any serious injuries but does have some car damages and things like that. She had no serious injuries. She has recovered completely from the fainting.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pfizer-BioNTech COVID-19 Vaccine EUA,  - headache - chills - fever - swollen lymph nodes (sore throat)
tested positive for Covid on 15Oct2022 and started Paxlovid treatment; tested positive for Covid on 15Oct2022 and started Paxlovid treatment; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Oct2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200), on 19Mar2021 as dose 2, single (Lot number: ER2613), on 13Oct2021 as dose 3 (booster), single (Lot number: 30155BA) and on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "tested positive for Covid on 15Oct2022 and started Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Phone answered by the reporter who confirmed he has had a total of 4 Pfizer Covid-19 vaccine doses. Reporter also confirmed he did not experience any adverse events with any of the 4 Pfizer Covid-19 vaccine doses. Reporter stated he tested positive for Covid on 15Oct2022 and started Paxlovid treatment on 16Oct2022 and completed Paxlovid treatment on 20Oct2022.
SWEATING; RASH ON NECK; SORE ARM; This spontaneous report received from a patient via a company representative concerned a 21 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sweating, rash on neck, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, rash on neck and sore arm was not reported. This report was non-serious.