chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy) and erythema (red) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 309K209) for COVID-19 immunization. The patient's past medical history included no reported medical event. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Dec 31, 2020, patient experienced pruritus (itchy) and erythema (red). At the time of the report, pruritus (itchy) and erythema (red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medications reported. Treatment for the events included diphenhydramine hydrochloride cream. Most recent follow-up information incorporated above included: Mar 29, 2021: No new information. Reporter's comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swelling of the feet and lower legs; 4lbs water weight gain overnight; intermittent swelling; This is a spontaneous report from a non-contactable physician (patient) via sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling of the feet and lower legs, 4lbs water weight gain overnight, and intermittent swelling. Events were treated with aspirin. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that a 61 year old female patient received a Fluzone SV '2001-'2002 vaccination on 10/25/01. Reportedly, 10/26/01, the patient experienced hives on her chest, shoulders, back , waist and hip area. Patient was treated in ER (at an undisclosed hospital) and prescribed Medrol pack and Benadryl for itching. Patient has a history of pulmonary fibrosis.  Reportedly, the patient experienced flu last week (Feb 2000 exact date not specified) during that time, began breaking out in hives again and put on the Medrol pack again.  patient states sbe had received flu vaccinations before.
Generalized urticaria began 10 days after Moderna booster.  Also experienced swollen lip and eyelids. Still experiencing extremely itchy hives all over body. Not yet resolved. Treating with Zyrtec and a short course of prednisone
Breast tenderness, then 3 days later started period.  (I'm post menopausal)
patient received pneumovax in right arm on 9/262008. returns on 9/29/2008 with 6cmby 12cm erythematous patch on right arm that has continued to spread in size over lastthree days.  area is hot to touch and extremely tender to touch. no nodes are palpable in right axilla and there is no red streaking. Patient advised to go to urgent care for antibiotic therapy TONIGHT as her doctor's office is closed. suggensted that she may need IM injection of antibiotics to begin treatment  notes she had s similar reaction to a tetanus shot sometimein the past
Pt fainted approx 30 seconds after seasonal Flu shot with tonic-clonic movements; came to briefly then fainted again with tonic-clonic. Gradually gained consciousness, c/o leg tingling, H/A and nausea, lethargic but alert, ok after approx 60 min. Staff assisted her home - pt has 10 mo old baby - as still feeling weak. Took fluids well. States she has Hx of fainting with shots.
no adverse event; expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022) and NO ADVERSE EVENT (no adverse event) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022).    Patient age was reported as 65 Year 05 Month. It was reported that lot 070H21A, that has an expiration date of 7-Apr-2022. Patients received this Moderna vaccine between 8-Apr-2022 and 15-Dec-2022. No concomitant medication were reported. No treatment medication were reported.
Patient experienced swelling of the entire upper arm (shoulder to elbow) after receiving the ZOSTAVAX vaccine. She reported that the arm was swollen for approximately 1 week and then remained slightly less swollen for an additional 1 week. Patient did not require medical attention but did see her physician. After follow up after 2 and 1/2 weeks total all symptoms had resolved.
At 2:00am 12/19/20 I woke up to an episode of diarrhea and was left feeling nauseous. I woke up again at 4:30am with another episode of diarrhea and severe nausea which led me to throw up. I feel better after throwing up and proceeded to get rest before going to work at 6:00am. By 8:00am I had developed a severe headache, severe nausea, muscle fatigue and overall felt bad. When I got home I had become extremely nauseous and developed severe muscle fatigue and severe arthralgia and my headache had increased and became sweaty and dizzy. I slept from 9:00am to 2:00pm where the symptoms had gotten no better and the headache had gotten worse. I slept from 3:00pm to around 6:00pm with the same symptoms but managed to eat some soup and kept it down. I slept from 10pm to 12pm the next day 12/10/20. My fatigue and joint pain had somewhat dissipated but I was still experiencing severe nausea and a severe headache. By the end of 12/10/20 around 8pm my joint pain and muscle fatigue had gotten better but the nausea and headache were still there. 12/11/20 I was well enough to drive and receive a covid test. My nausea and headache did not go away until the end of day 12/11/20
No additional AE/PQC.; Caller reported AE for inadvertent administration of VAXELIS and ROTATEQ after TE`; This spontaneous report has been received from a consumer referring to a 1-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On unspecified date rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), experienced 2 temperature excursions, one at 65.2 F for 9 hours and 45 minutes and another one at 32.4 F for 42 hours and 45 minutes. On 01-MAY-2023, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number: W020326, expiration date: 17-OCT-2023) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (lot number: U7217AA, expiration date: 12-NOV-2024) via unspecified route for prophylaxis (strengths, exact doses and dose numbers, were not known) after the aforementioned temperature excursions (TE) (product storage error). No symptoms were reported. At the time, no additional adverse event (AE) or product quality complaint (PQC) was reported.
p/vax pt c/o nausea & vomited,about 1 min p/that pt appeared to have a sz lasting less than 30sec;arms & back were arched & eyes rolled back & pt fell to floor;adrenalin given immed SC BP 110/65,P104,R18;paramedics arrived @ 11:13 & to ER
Heart palpitations, and period was suddenly very heavy, and long, lasted over 1 month( 3 weeks of spotting )
Nausea; Shivers; Body ache; Booster; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the arm right on 05Oct2021 at 09:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN) taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration both as a single dose for COVID-19 immunisation. On 05Oct2021 at 18:00 the patient experienced nausea, shivers and body ache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events nausea, shivers and body ache were recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a consumer refers to a 4 day old premature baby girl. On 05-MAR-2014 the patient was vaccinated with an unspecified Hepatitis B vaccine (manufacturer unknown) (route, dose number, dosage and lot number unknown). After receiving the vaccine the newborn baby experienced two short episodes of sleep apnea where her lips turned blue, but the nurse brought her back around both times and the baby stayed in the hospital for a couple extra days before discharging. Medical attention was sought for the baby while in the hospital. The outcome of the events was reported as recovered. Additional information has been requested.
significant uticarial rash over entire body approximately 1 hr after 2nd dose.  Treated w/ benadryl and condition resolved.  No further doses will be given.  Will do titer check.
Arm pain at injection site .  Intensity differs. Radiates from injection site to elbow and to mid foram. The more I use my arm the worse pain gets. Cannot sleep on that side.
Between 10 and 15 days after vaccination,  I began to develop noticeable tinnitus.
This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. On an unknown dates, the patient was vaccinated with two doses of VARIVAX (merck) (lot numbers, doses and routes not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient was found to have negative antibody titers. The patient sought unspecified medical attention. No treatment was given. The outcome of negative antibody titers was unknown. The relatedness for negative antibody titers was unknown for VARIVAX (Merck). Additional information has been requested.
A few minutes after receiving a second vaccination of pfizer covid vaccine, the patient became pale, white and her eyes rolled back and she fainted. She was momentarily passed out (unconscious) for approximately one minute. She also urinated in the immunization booth. I attended to her care and I shook her arms and I called her name. The mom was there and she shook the patient(her daughter) which woke her up. I applied ice packs to the patient's forehead and arms and her sit in relaxed position. I had her remove her jacket as she was dizzy and sweating a lot. After 10 minutes of applying the ice packs her skin color came back and she was acting normal without anymore symptoms. I monitored the patient for 20 more minutes and the mom said she was fine and they left the pharmacy area.
Patient received Moderna COVID 19 vaccination, patient became anxious and began crying, stated " she became dizzy and lighted headed,  patient assessed no acute distress noted was stable at time of release
No fever, redness, slight swelling, RA, warm to touch, slightly firm advised to go to ER. Treatment per ER physician Claritin, Benadryl, Ibuprofen 200mg.
Information has been received from a licensed practical nurse concerning an approximately 12 month old male patient who was vaccinated with a dose of VARIVAX (Merck) (dose, route, and lot # not reported).  The patient was seen in the office on 09-SEP-2009 with what was diagnosed as a case of breakthrough after receiving a dose of VARIVAX (Merck).  At the time of the report, the patient had not recovered.  Additional information has been requested.
This spontaneous report was received from Pfizer, via medical record and was assigned manufacturer report number (2016474292) referring to a currently 85 year old female patient. The patient's concurrent condition and medical history were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dosage, route, frequency, indication and lot# were not provided). Concomitant therapies were not reported. On an unknown date, the patient experienced an unspecified allergy to PNEUMOVAX 23. The outcome of allergy to vaccine was unknown. It was considered allergy to vaccine to be related to PNEUMOVAX 23. This was originally reported by a physician. All available medical records will be provided upon request. This is one of two reports received from the same reporter. Additional information has been requested.
After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
11/12/2021 Dizzy with headache within minutes. Body ache and fatigue set in and was in bed for about 3 days. After some time and the other symptoms subsided the headache remained and it comes up about 1-2 times a week. Sought care from acupuncturist and later OMT where I received acupuncture treatment and had neck and shoulder adjustments. Had yearly check-up labs done. (Thyroid med increased, kidney function down, and Lipid was high). Received results from PCP over the phone. No discussion about headaches as of yet.
Normal tightness and mild soreness by next morning. Friday (9-7-12) showed signs and symptoms of nerve damage? pain worsened. Recovered using hot compresses and menthol ointment, mild flu symptoms.
Woke up with Uncontrollable shivering and shaking. The room felt like ice and and this lasted for approximately 5 minutes. Around 9:30AM I had a fever of 100.5 and took Tylenol. I was fatigued and had light chills on and off throughout the day as well as a low grade fever. The injection site was extremely sore beginning several hours after the vaccination, and areas on my back under my scapulas are also sore to the touch.
Just got mine this sm/ boy is my arm sore; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involved adult patient for whom just got mine this sm/ boy is my arm sore (Arthralgia) was reported, while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient just got mine this sm/ boy is my arm sore (Arthralgia) was reported, unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 06-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The registered nurse reported that on 27-AUG-2010 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, route and anatomical location unspecified). On 05-JUN-2012, the patient received the second dose of GARDASIL (lot #, expiration date, route and anatomical location unspecified) and on 24-APR-2013 the patient received the third dose of GARDASIL (lot #, expiration date, route and anatomical location unspecified). No adverse event reported. The patient's outcome was unknown. Additional information is not expected.
Pt recv vax on 8/31/98; on 9/1/98 pt exp swelling, itching, pain at vax site
Rash, hives, swelling face, mouth tongue, nose, ears, eyes.  Beet red face.  Blood pressure normally low 110/70 but went from 166/86  at 1333 HR 80 02 100%, then BP 163/88 at 1404 HR 74 02 100%, then at 1409 HR 68  BP 175/110 RR24  O2 100%   1405  - 911 called took benadryll at 1330 (25 mg) then again 1349 took 2nd dose of benadryll 25 mg liquid capsules.  PT has adverse reactions to epinephrine.    1412 tongue swelling.  by 330 pm patient went home prepared to go to ER if anything changed.  She walked around in cool air and had hives move around her body.    Not shot in upper right arm.  It was tasted during injection.  Then after the shot reactions kicked in at 20 minutes moving up the right side primarily same as shot side.   Arms, chest, and face flush off and on.  Swelling moved around.
Body ache; Has fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and PYREXIA (Has fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache) and PYREXIA (Has fever). At the time of the report, MYALGIA (Body ache) and PYREXIA (Has fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Severe heart pain occurred same day, about 3:45pm with patient expressing 10/10 pain level (I witness a pill given to patient and soon after the pain subsided They kept the patient in hospital to monitor 3 more days because of low grade fever. The patient was released on Jan 8, 2022 (he had diarrhea that day) and was readmitted on Jan 12, 2022 because developed shallow and rapid breathing. Tested +for Covid on the 12th. After readmission to hospital he lost his ability to speak clearly and swallow. He died Feb. 9, 2022. I believe he suffered a stroke after Jan 12th. Patient was active before getting the 3rd Covid vaccine. he then declined rapidly after receiving it.
Patient experienced 4x4 red area on arm that was painful the evening of her imz that last about 7 days, she also had the chills the night of the imz and last 1.5 days, she was able to go to work 2 days after and did not seek any medical care.
pain, tenderness, fatigue, headache, chills, nausea and fever.   No treatment.  Symptoms gone by the following day.  First shot experienced rash in left arm after 10 days.  This disappeared in about 6 days.  It did not itch and did not bother me.
A few hours after 2nd shot the left side of my face became numb and had a tingling sensation that lasted for 1-1/2 days. It slowly started to go away.
"Complete paralysis below neck" rapidly improved.  12/26/2007 MR received for DOS 9/30-10/10/2007 with D/C DX:  Conversion Disorder.  Anxiety Disorder.  Major Depression.  Mild Demyelinating Polyneuropathy.  Hx of Ovarian CA.  Celiac Artery Stenosis s/p angioplasty and stent.  Bradycardia. Pt presented to local hospital with sudden onset of severe upper and lower extremity weakness rapidly progressing to the point of paraplegia.  Transfered to higher level of care at this facility.  On PE loss of sensation from shoulders down.  Absent reflexes upper and lower except plantar flexor is neutral. Loss of strength in upper and lower extremities.  Multiple consultations.  Pt noted to be under multiple stresses with significant anxiety.  Similar episode 3 yrs ago. Bradycardia noted in ICU. Pt showed rapid improvement over 24 hr period however c/o significant numbness/paresthesias in lower extremities which continued.  Exam 10/8/07 shows continued hyporeflexia, no motor deficits.  Requiring use of walker for ambulation. D/Cd home after unable to get into rehab facility.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-AUG-2014 the patient was vaccinated with a ZOSTAVAX (dose: 0.65 ml, frequency: unknown, subcutaneously) which underwent a supported temperature excursion. No adverse experience was reported. No product quality complaint was involved. Additional information has been reported.