chrisvoncsefalvay/vaers-outcomes huggingface dataset:
03/09/21(2:00PM):received dose 1 moderna vaccine - no ill effects; 04/07/21 (10:00AM): received dose 2 Moderna vaccine;  04/11/21 (11:00PM): experienced what seamed muscle cramp in left upper calf muscle; 04/19/21: cramp diminished, some swelling left upper calf, slight swelling left inner ankle; 04/22/21: swelling entire left ankle and top left foot; 04/22/21: visited primary care, diagnosed possible Baker's cyst or venous thrombosis - sent to hospital for ultrasound; 04/22/21: ultrasound revealed deep venous thrombosis, upper left calf vicinity (popliteal vein); 04/22/21: hospital performed blood tests, prescribed Xarelto 15mg (2 daily) for 21 days; 04/26/21: primary care follow up, prescribed Xarelto20mg (once daily) for 90 days. 05/22/21: slight swelling inner left ankle persists, slight fullness upper left calf persists, otherwise no other ill effects; 05/22/21: further blood tests pending (as per primary care physician): cbc with differential, pcrp, ante, esr, 83891, cmbp, tshr, ptp, leid, misc, acab, lupus; NOTE:  Moderna dose 1: lot # 048A21A, intramuscular, left arm
Engerix-B pediatric dose given to adult (56 yrs old); Engerix-B pediatric 10 mcg dose given to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 56-year-old female patient who received HBV (Engerix B) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included engerix b (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Reported stated that Engerix-B pediatric 10 mcg dose given to patient which led to underdose and Adult use of a child product. Reporter consented to follow up.
Information has been received from a registered nurse concerning 5-year-old male with no reported medical history who, on 19-AUG-2002, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and a third dose of poliovirus vaccine inactivated (unspecified). On 10-MAY-2007 at 11:25 am, the patient developed break through chickenpox. It was unspecified if medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Swelling and numbness of the arm where I got the shot,  armpit pain, and mild fever
Information has been received from a physician concerning her 65 year old mother who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (no lot number was provided) about 6 months ago (approximately October 2008) and soon after broke out in what looked like a chicken pox rash all over her body. Last Thursday (16-APR-2009), she was complaining of her arm hurting really bad. She went to the emergency room and was diagnosed with Shingles. It was unknown if the patient was admitted into hospital. Lab diagnostics included biopsy. At the time of reporting (23-APR-2009) the patient was not recovered. Additional information has been requested.
ISSUES FROM A FEW DAYS AFTER SHOT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patients were in best health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced issues from a few days after shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues from a few days after shot was not reported. This report was non-serious.
vaccinator inadvertantly administered a Moderna spikevax into left and right arms.  Patient received 2 doses of covid vaccination patient was made aware of error.  was monitored for 15 minutes and was ok.  1 hr later patient called pharmacy of feeling a headache and woozie but no problems breathing or elevated heart rate or other symptoms.  Pharmacist recommended some tylenol..  Pharmacy called patient the next morning and patient was feeling much better
Constant migraine every day; This is a spontaneous report from a contactable other healthcare professional, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced constant migraine every day. The migraine resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of migraine and included treatment with steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant migraine every day was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
10/19/10 3:20pm inmate lying on back. Clutching chest. C/O chest pain, color gray, diaphoretic, shaking, dyspnic. Heart rate 170-180. O2 Sat. 87-90%. Sent to local Emergency dept. Dx of Reflux - returned to prison. On arrival to medical - temp 101.4 pulse 145, BP 124/80. O2 Sat. 94%. C/O chest pain. Labs drawn see below. Had shallow resp. chills and weakness. Sent to another hospital when labs returned. Hospitalized x approx 12 hours. Returned - no compl. vital signs stable.
received the second Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Jan-2021. Previously administered products included for an unreported indication: MMR in May 2020.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna dose). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         Reporter stated that he was prescribed an antibiotic.  Patient reported that he wears hearing aids  No concomitant medications were provided.   This case was linked to MOD-2021-029141 (Patient Link).
Pt. c/o tingling in Left arm and papitations. Blood pressure and Heart rate taken and ambulance called. Pt. left clinic at 11:20am.
Subsequent to receiving varicella virus vaccine live the pt experienced chickenpox with approximately 500 lesions.
A  non-patient, community member, received 1st COVID vaccine at dialysis clinic on 4/2/2021. A clinic teammate reached out to schedule the second dose and was informed, by the wife, that he suffered a stroke the day after the first vaccine and was currently hospitalized and stable.
Aches/  Arm pain; Little off; Chills; Fatigued; Injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/  Arm pain), VACCINATION COMPLICATION (Little off), CHILLS (Chills), FATIGUE (Fatigued) and INJECTION SITE PAIN (Injection site hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Aches/  Arm pain), VACCINATION COMPLICATION (Little off), CHILLS (Chills), FATIGUE (Fatigued) and INJECTION SITE PAIN (Injection site hurt). At the time of the report, PAIN (Aches/  Arm pain) had not resolved and VACCINATION COMPLICATION (Little off), CHILLS (Chills), FATIGUE (Fatigued) and INJECTION SITE PAIN (Injection site hurt) outcome was unknown.
1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heightens, slight chills, more fatigue 7pm ear itch both sides, all ear involved even lobe and red 9pm soreness, chills, arm pain  1/15 Friday 7:30am nausea, dizziness, sinus pressure, headache, arm pain 1pm extreme fatigue, sleep for afternoon, arm pain 4pm headache intensify, arm pain 6pm both ear swelling, warmth, extreme itch 9pm lingering headache, arm pain improves  1/16 Saturday 7am ear itch and rash spread to back of neck 12pm telehealth - recommended benadryl, Rx prednisone  Benadryl ineffective, rash remains  8pm- itch inside ears, red scaly ears, hot after washing, extremely scaly  1/17 Sunday 6 pills of methyl prednisone Hives moved to back of neck following the back of ear  1/18 Monday 6pills prednisone inside ear itch, ear lobes itch, skin very flaky  1/19 Tuesday Go to urgent care 6pills prednisone  1/21 Thursday Rash spreads to collarbone Go to TMC Dermatology  prednisone continued  1/24 Sunday  Stopped steroid under recommendation of MD Huge flare up around neck, chest, back and down to lower body Itch continues to night, lack of sleep  1/27 Wednesday  Placed back on steroid (16 day course) Rash remains, itch subsided Decision to not take second dose
Patient complained of feeling light headed and "weird".  Patient alert and oriented.  Denies n/v/d or itching.  BP 147/92, HR 97, SAO2 96%.  Patient reports similar feeling after annual influenza vaccine but did not require medical care.  Patient requests transport to ED for further evaluation.
Had 2nd shot of Pfizer vaccine. Within hours I passed out on the bathroom floor, uncontrollably shaking and profusely sweating soaking the rug and my clothing, severe abdominal cramping that is continuing even now and sudden and unexpected extreme vaginal bleeding that started with the stomach cramping and has continued to now as well.
Provider ordered Tdap vaccine for pt. Pulled vaccine for pt to be varified by co-staff, Dtap pulled by writer, verified by co-staff but not caught by either staff.   Gave Dtap as error to left deltoid.  Error discovered within minutes of pt leaving office when entering  vacc given into computer.  Talked with provider, called to inform pt. of lesser dose given.  Pt will be called back with correct timing  of dosing to  get as originally ordered.
No adverse event; administered a bivalent vaccine today 2/13/2023 that was drawn up friday; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday).    No concomitant medications were reported. It was reported that patient had primary vaccination series on 13-Apr-2021 and 11-May-2021. No treatment medications were reported.
slight fever overnight; lethargic for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever overnight) and LETHARGY (lethargic for 24 hours) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included IMIPRAMINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (slight fever overnight) and LETHARGY (lethargic for 24 hours). The patient was treated with PREDNISONE for Adverse event, at a dose of 2 days of 50 mg; PREDNISONE for Adverse event, at a dose of 2 days of 40mg; PREDNISONE for Adverse event, at a dose of 1 day of 30mg and HYDROXYZINE HCL for Adverse event, at a dose of 10mg at night. On 04-Mar-2021, LETHARGY (lethargic for 24 hours) had resolved. At the time of the report, PYREXIA (slight fever overnight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-404689, MOD-2021-404690 (Patient Link).
suspected vaccination failure; had shingle flare ups / got the vaccine/ had shingle flare ups since then; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient never had shingles but through the advice of the doctor because of the patients age got the vaccine and had shingle flare ups since then. The reporter stated that like any other vaccine it effected each person differently due to a lot of variables. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is one of the 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR184332:same reporter US-GLAXOSMITHKLINE-US2021AMR184305:Same reporter US-GLAXOSMITHKLINE-US2021AMR184304:Same reporter
EMPLOYEE REPORTS DAY AFER RECEIVING IMMUNIZATION THAT SHE WASN'T FEELING WELL, DEVELOPED DIARRHEA, GENERAL MALAISE, ARM SORE AT SIGHT, WITH REDNESS,TEMP WAS 101.0.
Second dose of COVID-19 vaccine (Pfizer) given 16 days after 1st dose, five days earlier than when the vaccine was due.
normal fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for COVID-19 immunization, reaction(s): "normal fatigue", "headache"; Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown), for COVID-19 immunization, reaction(s): "normal fatigue", "headache"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: unknown), for COVID-19 immunization, reaction(s): "normal fatigue", "headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "normal fatigue"; HEADACHE (non-serious), outcome "unknown".  Additional information: It was reported that, just normal fatigue, headache, sort of thing. Had that thing they were talking about with the period coming on sooner. Thought that was a normal event. Clarified that all occurred after Pfizer Covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
His arm blew up swollen and was red hot for a week. His body temperature rose and he could not use his arm well.
Initial report received from a nurse on 24 OCTOBER 2013. Four patients had received FLUZONE (lot # UH907AB and expiration date unknown) intramuscular (IM) on 22-OCT-2013. On 23-OCT-2013, the patients complained of red, swollen, hot injection sites with some hardness under the redness. On 24-OCT-2013, the whole deltoid on one female was red. At the time of this report, the outcome of the event was not recovered. No further relevant information reported.
This spontaneous report was received from a nurse practitioner via Pfizer and refers to a patient of unknown age and gender. On an unknown date, PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported) had an unspecified excursion in the refrigerator. It could not be probed if the vaccine was administered to any patient or not after the excursion. Additional information has been requested.
This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A 72-year-old male patient received PREVNAR 13 via an unspecified route of administration at single dose at upper left arm in the muscle on 04Feb2017 09:30 for immunization, received in the pharmacy. Medical history included hypertension diagnosed probably 10 years before and well maintained, PAA Diagnosed about 2 years before and well managed, mild chronic obstructive pulmonary disease (COPD), diagnosed about a year before, hasn't smoked in 50 years, arthritis. Patient took concomitant medications for arthritis but he did not feel like it is significant for this report. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 05Feb2017 the patient experienced hives, welts and itching. On 22Feb2017 he experienced minor rash. The outcome of all events was not recovered. Course of events: The patient first got welts and hives on the lower part of his legs the day after he received the PREVNAR 13. Went to the doctor 07Feb2017 and was placed on Prednisone and some other medication for anti-itching and it started helping. Prednisone was for 5 days and other medication was for 10 days. On 22Feb2017, he noticed some small welts/swelling like area. It was not as bad, under his right arm, near his armpit. On 24Feb2017 morning he went to a local provider and they basically said that everything was looking better and could be a second reoccurrence and put on hydrocortisone 1%. This was in a different part of the body though. Considered this like a mild rash. This time it was much, much smaller. Patient denied investigations. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017087330 Different patient, different drugs/events.
LocalizedL   arm soreness, progressed to fatigue and chills, 12/27 developed severe nausea, fever 12/27 night 100.9, slept for 18 hrs,, awoke this am with a pounding headache,w/mild dizziness, no SOB,has runny nose,post nasal drip and a dry cough, right sinus tenderness
Erythemic warm (R) upper arm. Benadryl, cool compresses. RTC if not improving.
04/09/03 - complained of rash on left wrist and 1 spot on right breast.  Complained of itching- this was gone by 04/11/03.  No fever-has headache. 04/12/03 - blotchy, red rash, "itchy on shoulders, back, stomach,legs, feet - reddened. No fever.  Consulted with Dr.  04/14/03 - patient in clinic-much improved-arm slightly reddened above vaccination site.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age who on unspecified date, was vaccinated with dose 1 GARDASIL (dose, lot # and route not provided). In 2011 (2 years ago) was vaccinated with dose 2 GARDASIL (dose, lot # and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated, the patient is late for the 3rd dose of GARDASIL. The patient was not experiencing any known symptoms. Additional information has been requested.
My left arm had a burning sensation about 2 minutes after receiving the covid 19 vaccine. Approximately 57 minutes after the vaccine was administered the left side of my face became numb and heavy. I am reporting this 5 hours after the Pfizer covid 19 vaccine was given to me and my symptoms have been consistent with a moderate increase in numbness in the left side of my face. My left arm is no longer burning as that actually subsided soon after it started. My concern is the numbness and heaviness in my face.
MD  made aware of pt with previous reaction here for 2nd pfizer. Per MD, ok to give and monitor for 30 minutes. 0856- Asked pt to take albuterol prior to vaccine administration.  0857- Pfizer 2nd dose administered.  0909- Pt complaining of mild tightness and itchiness to throat.  0916- 25 mg IM Benadryl given  0925- Wheezing noted when auscultating pt at this time.   MD made aware of pt with previous reaction here for 2nd pfizer. Per MD, ok to give and monitor for 30 minutes. 0856- Asked pt to take albuterol prior to vaccine administration.  0857- Pfizer 2nd dose administered.  0909- Pt complaining of mild tightness and itchiness to throat.  0916- 25 mg IM Benadryl given p of MD.  0925- Wheezing noted when auscultating pt at this time.    Spoke with allergist whom states MD to bedside and next rec would be epinephrine.  0948- MD at bedside.  0953- Epinephrine 0.3 mg IM given per standing order of vaccine reaction.  Spoke with allergist whom states MD to bedside and next rec would be epinephrine.  0948- MD at bedside.  0953- Epinephrine 0.3 mg IM given per standing order of vaccine reaction.