chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was 2nd dose/booster shot. Sore arm with mild or moderate pain , with redness and swelling where I  got the shot.  Also  have felt tired, had muscle pain, headache, shivering, fever, stomach pain, or nausea. These side effects have me from doing regular activities.  Left work early and slept for 20 hours.  Day 4 still have soreness and  most of the side effects, but able to work with discomfort . I experienced the same side erect with Dose  1 and. Contact the Dr  and they advised giving it a few days. Eventually subsided but was. More like 5-7 days
High fever, pain, redness, swollen on left arm from shoulder area to upper 3/4 of humerus area.
2 days after receiving DTaP and Hib, noted right thigh swelling (the "size of an orange"), redness, warmth. Seen in office next day. Symptoms better but still with induration around both immunization sites. Since otherwise asymptomatic observed. No treatment.
can't eat at all; can't keep any thing down, not even water; vomiting; a bruise on her arm; Arm Hurt; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a bruise on her arm), PAIN IN EXTREMITY (Arm Hurt), FEEDING DISORDER (can't eat at all), HYPOKINESIA (can't keep any thing down, not even water) and VOMITING (vomiting) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 04-Mar-2021, the patient experienced CONTUSION (a bruise on her arm) and PAIN IN EXTREMITY (Arm Hurt). On 08-Mar-2021, the patient experienced FEEDING DISORDER (can't eat at all), HYPOKINESIA (can't keep any thing down, not even water) and VOMITING (vomiting). At the time of the report, CONTUSION (a bruise on her arm), PAIN IN EXTREMITY (Arm Hurt), FEEDING DISORDER (can't eat at all), HYPOKINESIA (can't keep any thing down, not even water) and VOMITING (vomiting) had resolved.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03-MAY-2021, contains information such as events outcome has changed.
Temp of 103 the night of administration arm swelling with fluid filled sac hanging from arm.
Information has been received from a healthcare worker (certified medical assistant) concerning multiple patients. The healthcare worker reported that multiple unspecified patients were administered improperly stored ROTATEQ (lot # L033545, expiry date 30-MAY-2017, dose and frequency was not reported) on an unknown date. Data logger shown the vaccine was excursed in temperature of 0.3 C, duration of excursion was 2 hours. There was no previous temperature excursion. There was no adverse effect reported. Additional information has been requested.
the night of injection - nausea, vomitting, fatigue, migrane. sx lasted  about 2 days then tapered off. Exactly one week later- Swelling, itching on whole body, hot to the touch , burning at injection site.  muscle spasms only on R side ( R arm, R thigh) Locking of fingers on r hand mainly ring finger. Swelling  is gone , I still have itching an slight pain at injection site only now.  Muscle spasms are still constant on R arm and R thigh. Spasm are more frequent in the arm  down to the hand.
Left arm described as swollen and red at injection site. Pneumovax was administered the previous day. 06/16/02.
Fever (101.9F), chills, arthralgia, myalgia, headache
pt recv 2 doses of vax 20JUN97 & 8AUG97 & lab eval revealed a lack of seroconversion;
Subsequent to receiving vax, the pt developed swelling at the injection site. The pt reported that in 01/2001 a lump appeared at the injection site and was tender and sore. In 03/2001 a biopsy of the injection site tissue revealed fat necrosis with calcifications.
On Saturday April 10th I began to experience symptoms of dry eyes, eye twitching and watering and sensitivity to light.  It continued to progress, by monday the 12th it led to left side of my face in paralysis.  I've never experienced this before or had issues.
LIP HERPES, AND EYE LID HERPES, TX. VALACICLOVIR 4 MG X DAY, COLD PACK.  VIGINAL DYSPLASIA  SECONDARY TO HPV
The pharmacist contacted me about thirty minutes after the injection that they had accidentally injected my son with an undiluted vial of vaccine. She stated that the vial was an older vial that required dilution and they had confused it with a newer vial that didn?t require dilution. She could not tell me how much vaccine my son had actually received. She told me to watch him closely for the next few days and to give Tylenol or ibuprofen as needed for increased adverse reactions. No symptoms so far aside from increased fatigue, at 9:30 pm on the day the vaccine was given.
Tachycardia LYMPH NODES UNDER ARM PAINFUL & SWOLLEN, ARM SWELLING, PAIN AT INJECTION SITE Narrative:
expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 24-MAY-2023, the patient received the 1st dose of Kinrix. On 24-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix). 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: 25-May-2023 and 26-May-2023 The nurse explained that this would be patient's 4th dose of Polio and 5th dose of Dtap. The reporter consented to follow-up via email. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Initial report received from a healthcare professional on 11 Dec 2009: This patient received FLUVIRIN, 0.5 ml, intramuscularly on 11 Dec 2009. Immediately after vaccination, the patient's injection site began to bleed and had swelling and redness at the injection site. It was reported that bleeding was subsided but swelling and redness were still present. The outcome of the events was reported as ongoing.
With 10 minutes post vaccination full body hives . 40minutes later throat itching . + fatigue , headache , nausea .  Benadryl 50mg chewed , hydrocortisone cream applied , Zantac 50mg taken .   Will do Benadryl around the clock for 24hr?s . Epi not advised due to Hx of SVT and VTACH. Epi pen on hand if allergic reaction worsens .
After receiving the vaccine, I stated experiencing skipping heartbeats. That lead up to that morning my pulse elevating up to 180. I went to the emergency room, where they ran an EKG, magnesium test came back normal, calcium test came back normal; Thyroid test came back normal; Electrolytes were normal; Glucose came back slightly elevated; Creatinine came back normal; BUN came back normal; my ventricular rate when I showed up was 158 after medication it came down to 91; CBC labs came back normal. The symptoms have diminished greatly but I do take a Beta blocker to help with it and don't drink alcohol to help with the skipping of the heart beats. I have been experiencing a lot of GI gas and belching and then I have a skipped heartbeat.
08/27 9:30 pm noticing  right facial numbness & tingling. slept well. 8/28 7 am note the  right facial numbness & tingling feeling like entire right side of face, right side of tongue, right nostril had been numbed with novacaine like when getting a dental procedure. went to Urgency Room saw ED doctor to rule out stroke.  labs & CT within normal limits and labs electrolytes within normal limits. diagnosis right facial paresthesia.  Followed up with PCP in Sept. told by PCP to wait on COVID dose #2 until my symptoms resolved 100% for 4-6 weeks. followed up with dentist and Pain Center for ongoing care of TMD (temporal mandibular disease) no dental or TMD issues causing ongoing  right facial paresthesia. Plan is to follow up with PCP in mid Nov and possibly refer onto neurology.
Inflammation at injection site, Aching of musculature incld. deltoiod, shoulder and axilla.
Daily stomach discomfort; This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received BNT162B2, via an unspecified route of administration on 15Jul2021, (at the age of 17-years old), (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were reported as none. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced daily stomach discomfort on 16Jul2021. Since the vaccination, the patient had not been tested for COVID. No treatment was given for the event. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Rash began on back,  moved to neck and chest, arms, hands and  tops of legs.  My dr. advised to take Claritin.
Pt was age 17 at vaccination. Vaccine is not currently approved for use in persons under the age of 18.
Patient completed the screening tool and denied having received covid vaccine in the past. Patient was given one dose of Janssen vaccine 0.5mg IM in right deltoid. This medication administration error was noted the following day when the when staff went to enter the vaccine dose into the immunization data base it was determined that the patient had received two doses of Pfizer previously.  Both previous doses were given at clinic (8/18/21 and 9/8/2021).  The nurse upon realizing the error immediately made a follow-up phone call to the patient who initially denied knowledge of receiving prior vaccine. Then indicated that she had only received one dose "because I walked out before they gave it". Student indicates that she is feeling fine. That she has the typical side effects, "sore arm, tired and achy".  Instructed to call nurse if issues or concerns arise.
Chills; sweats; headache; myalgia; fatigue; This is a spontaneous report from a contactable other hcp reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at right arm on 11Jan2021 09:00 AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination, no COVID tested post vaccination. No other vaccine in four weeks. NO other medications in two weeks. Patient received first dose of BNT162B2 (lot number= EJ1685) at right arm on 20Dec2020 07:15 PM. On 11Jan2021 08:30 PM, the patient experienced Chills, sweats, headache, myalgia, fatigue. No treatment received. The event outcome was recovered.
Info has been received from a physician concerning a 2 year old male who "one year ago" in 2004 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination "most likely" included a dose of MMRII. Subsequently, the pt presented with mild leg pain and a limp. An x-ray was taken, results not reported. The pt returned 2 days later with what appeared to be poison ivy. He then returned 3 days later, after the original complaint. He "still" had a fever. A culture was taken which showed that the pt had the varicella zoster virus. It was reported that the pt had 3 lesions in a line and lesions down his calf to the side of his foot. The pt was not hospitalized. The pt was treated with acyclovir (unspecified). After taking one day of acyclovir (unspecified), the pt "appeared to be" uninfected and was not limping. Additional info has been requested.
PEDIATRIC DOSE (AGES 5-11)  WAS ADMINISTERED INSTEAD OF THE ADULT DOSE (AGES 12+).  NO ADVERSE EVENT REPORTED.
Prevnar was given in error.  Pt received Prevnar 13 originally 7/7/2020  Pt stated approximately two hours after vaccine administration, she had two episodes of vomiting, 1 episode of diarrhea, and severe muscle pain in bilateral extremities.
she fainted; hit her head; This is a spontaneous report from a contactable consumer (patient's mother) reported that a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171), via an unspecified route of administration, administered in arm left on 23Apr2021 (at the age of 16-years-old) as 1st dose, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she fainted and hit her head. Clinical course details was reported as the patient got her Pfizer COVID vaccine on Friday (23Apr2021), and she fainted on Saturday (24Apr2021), knocked her head on counter and was knocked out. The doctor was taking her to ER. The patient was not yet admitted to the hospital, since when the patient's mother called they were going there (hospital) now. The doctor had her blood drawn to find out what was going on. The patient underwent lab tests and procedures included weight: 58.97 (no unit), and height: 157 (no unit) both on an unspecified date. The patient was scheduled on 15May2021 for 2nd vaccine. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Patient reported she started feeling chilled at work at 6:00pm that evening. Did not sleep well due to the arm pain form the injection site. Achy, low grade fever.
INFLAMMATION ALL LEFT SIDE OF BODY,PAIN IN LEFT ARM,SPREAD TO SHOULDERS,NECK AND RIGHT ARM,TACHYCARDIA,THROAT TIGHTENING,DIZZINESS ON STANDING,HEADACHE,FEVER,NAUSEA,UNBEARABLE MUSCLE PAIN,WEAKNESS ALL OVER BODY STILL TODAY,PAIN BETWEEN AXILLA AND LEFT BREAST,DECREASED APPETITE,I GET TIRED QUICKLY,AND EVEN TODAY,,NAUSEA,DIZZINESS BODILY WEAKNESS,HEADACHE,AND I STILL HAVE INFLAMMATION....I THOUGHT I WOULD DIE!!!!,THE ADVERSE REACTION WAS EXTREMELY HORRIBLE
Hypersensitive skin on back and underside of arm. Clothes and goosebumps feel mildly painful. Persistent dull pain in arm, armpit, shoulder blade, and chest. Intense pain on left side of arm and left side of arm pit when touched. Intermittent stabbing pain in underside of arm and shoulder. Pain from armpit radiates down into chest. Pain from shoulder radiates across back and up the neck. Occasional burning sensation in shoulder blade and up neck.
7x5 mm raised, red pruritic reaction R arm warm, itching - not tender. Given Benadryl and observe.
pt recvd 1st dose of Hep B vax 30NOV90. On 01DEC90 pt devel lumps on posterior aspect of elbow & along medial aspect of arm w/ soreness.
Headaches, muscle aches, joint pain from 3/16/21 to present. Blood and residue in urine beginning 4/3/21 and continuing to present.
runny nose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose".  Additional information: Patient did not get her booster shot due to a runny nose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sweating, dizziness, increase in heart rate within 10 minutes of injection. Completely subsided within 30 minutes. Sore arm at injection site for the next 3 days.
Breakthrough covid19 / severe sore throat with swelling/ received prednisone to counter the inflammation and took Advil and Tylenol for persistent fever
2 days after vaccine went to the ED --SOB  85%o2 sat cough wheezy-- Blood sugar elevated  to 480-Tachacardia CHF EKG showed New onset A-fib withRVR troponin elevated to 0.75 the  to 2.9-- Airlifted to facility
choking a bit.; Right after the vaccination, I felt dizzy; my heart rate went up; is_pregnant-yes; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 36-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0172 Expiry date: UNKNOWN), via an unspecified route of administration at right arm on 26May2021 at 17:00 (pregnant at the time of vaccination and 36-years-old) as a dose 1, single for COVID-19 immunization. Last menstrual period date was 26Dec2020. Patient had no known allergies. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and she did not receive any other vaccines within 4 weeks and did not receive any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine administered was Hospital. On 26May2021 at 17:00 patient was exposed to vaccination during pregnancy. On 26May2021 at 17:00 after the vaccination patient experienced felt dizzy, heart rate went up and felt choking a bit. No treatment received for the events. The outcome of the events was recovered.
presenting with worsening shortness of breath and detected hypoxic and at home monitoring with confirmed COVID-19 5 days ago.  On arrival to the emergency department he is oxygenating at low 90's on room air, he dips to 87% with ambulation.  Placed 3 L via nasal cannula and he has oxygen 97% at rest.  If get tachypnea or increased work of breathing.  Abdomen is soft and nontender.  Afebrile, normotensive in overall well-appearing.  He x-ray a confirms COVID pneumonia,  No Lot # . Vaccine administered at Outside facility.
Received first Covid vaccine on 11/12/2021.  On 11/17/2021 he had to stay home from school sick with nausea, stomach pains, nausea, vomiting, and diarrhea.  The same thing happened again today, 12/9/2021 and his second dose was 12/3/2021.  I?ll report separately for the incident related to his second vaccine dose.
patient stated getting dizzy/faint while seated on exam table - change in color of face (pale), bradycardia, tachypnea, laid patient down on exam table, monitored vitals, deep breathing, inhaled ammonia salt stick, drank cool water, reassess after 5 mins patient stable, vitals stable,  allowed to rest additional 5 min on exam table with knees bent
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a four months old male patient who was vaccinated with PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 13-Mar-2019, the patient received only DTap-IPV portion of the suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ082AA, expiry date: 13-Oct-2020) via intramuscular route in the right thigh. It was an actual medication error due to inappropriate reconstitution technique. It was reported that DTap-IPV portion of the PENTACEL was given and not the ACT-HIB portion as they forgot to mix it together. It was unknown if the patient had any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
2 cm diameter erythematous patch of crusted vesicles at the tail of the right brow with neuralgia type pain occurring 4 days after Zostavax immunization in right arm.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  There had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Were filling out a temperature excursion assessment with the State at the time of report. No adverse reactions were reported by patient.  No treatment medication was provided.   This case was linked to MOD-2022-501575.
1 dose of V ARIV AX administered 10/08/2020 after the vaccine experienced a temp excursion; No additional AE details; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.   On 08-OCT-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T000344 and expiration date 05-JAN-2022, frequency and route were not reported) for prophylaxis. It was reported that the suspect vaccine was exposed to a temperature minus 13.5 degree Celsius for a time frame of 8 hours and 55 minutes, the temperature excursions were detected by a data logger. There was no previous temperature excursion. No additional adverse event (AE) information provided.
In mid April, I had a bad asthma event that didn't really respond to albuterol inhaler or anti-histamines.  I called my Dr after a week and was RX'd a different anti-histamine (Singulair) which did not help.  A week later they gave me an Advair inhaler.  A week later they gave me steroids which cleared everything up.