chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; HEART RACES; SHORTNESS OF BREATHE; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of vaccine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heart races. On 25-MAR-2021, the subject experienced shortness of breathe. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tired. On 25-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart races, shortness of breathe, tired, and headache, and the outcome of fever and chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Itchy face, head, back; no rash Administered 25mg diphenhydramine (po) Itching resided
swelling at injection site, hot to touch, itchy.  Advised cool compresses, Benadryl 25g 8 degrees
pt recv vax & devel inj site rxn characterized by pain & redness;both arms remained very red in large area for 5 days;pt recovered;
NOTE : The type of Influenza vaccine administered is unknown, but there was no option for that in item 17.  Received two vaccinations in left arm.  Significant pain at injection site during administration and almost immediately afterwards.  Seemed to be administered unusually high on the arm.  Have had significant pain in the upper arm and shoulder since.  It has impacted my ability to sleep, work, and just generally to live without pain.  Ibuprofen, recommended by Dr. at a physical on 09/29/2022 has not provided substantial relief.
This case was reported by a physician via call center representative and described the occurrence of white blood cell increased in a 76-year-old male patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included lymphocytic leukemia (chronic). On 26th April 2018, the patient received SHINGRIX. On 7th June 2018, 42 days after receiving SHINGRIX, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to SHINGRIX. Additional details were provided as follows: The reporter himself was the patient. The patient's white blood cell count (WBC) was normal before receiving the SHINGRIX. On 7th June 2018, the patient discovered that his white blood cell count (WBC) was doubled. No additional information was provided. This case was linked with case US2018GSK108192, reported by the same reporter.  Lab Comments: On an unknown date, before receiving the SHINGRIX, white blood cell (WBC) count was normal.
The patient felt like death. The patient literally felt like dying.; Anaphylactic shock; whole body was in the seizure; stomach felt like bonfire; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; legs hurt; angry; This is a spontaneous report from a non-contactable consumer (patient self).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) at the age of unknown as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date at the age of unknown as single dose for COVID-19 immunization.  The patient was angry in Aug2021 because the last night (24Aug2021) he/she was in an anaphylactic shock after taking second Pfizer jab. The stomach felt like bonfire on 24Aug2021.  The patient felt like death.  The patient literally felt like dying.  The patient called doctor.  And a bunch of other conditions. The vaccine destroyed the whole body. It was not the shock. It was lungs, back, shoulder blade, stomach and legs hurt on 24Aug2021.  The whole body was in the seizure on 24Aug2021.  Outcome of the events was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, body ache, fever, nausea, chills, sending shocking pains down arms
DEVELOPED STAPH INFECTION AROUND NOSE/ON FACE ON 5/10/22. RASH HAD NOT GONE AWAY BY 5/15/22 SO RX CREAM RX BY DOCTOR. ON 5/23/22. ON 5/29/22, DEVELOPED PAINFUL EYELID-SWELLING, PURPLE SKIN, PAINFUL TO OPEN EYE-DX WITH STYE AND SWOLLEN EYELID-RX KEFLEX PRESCRIBED-I HAVE NEVER HAD THIS ISSUE WITH MY EYE EVER IN MY LIFE
11/02/21 presents to EC ED  for "body aches, fatigue, fever (tmax 103F) and cough that started 4 days ago. Also SOB, worse with exertion". PMHx "diabetes, hypothyroidism, diverticulosis, anemia, fibromyalgia".
On 4th day, 103 hours, after first vaccine, I experienced the feeling of a racing heart for about 20-30 minutes. I have never before experienced my heart doing this, so I am not actually sure "racing" is the correctly identified reaction. It did not leave me breathless like a heart racing after exercise. I continued to go about my chores without feeling like a had to lie down, although the thought occurred to me that perhaps I might be able to calm my heart if I did lie down. The feeling did not escalate in severity and never caused pain. However, because I have never felt this particular reaction at any time for any reason, even with physical exertion, and because I had recently had the vaccine, I took particular note of the reaction.
leg pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain). At the time of the report, PAIN IN EXTREMITY (leg pain) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Reporter did not allow further contact
My tough went numb and swallow to where it was hard to talk for about 4 hours. The top of my tough still burns a week after.
lasting joint pain after the vaccinatiob; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (lasting joint pain after the vaccinatiob) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (lasting joint pain after the vaccinatiob). At the time of the report, ARTHRALGIA (lasting joint pain after the vaccinatiob) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not provided by the reporter.   Reporter did not allow further contact
Arm pain that radiated to elbow requiring treatment with Ibuprofen and moist heat frequently x 4 mo.- ongoing. Occurred with admin. of GARDASIL #1 (06/19/2008) and #2(10/27/2008). Onset immediately post injection both dates.
Moderna COVID-19 Vaccine EUA: Swelling/Closing of my throat, swelling of my left hand (the hand on the injection arm), body itching, chills, soreness at injection site
Fingers Cramp; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Fingers Cramp) and VACCINATION SITE PAIN (vaccination site pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol, Asthma, Depression, Allergy to animals (Cats), Allergy to plants (Trees), Grass allergy (Grasses), Allergy to chemicals (Sulfates), Allergy (Protronics) and Allergy (Seasick patch). Concomitant products included MONTELUKAST and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, ROSUVASTATIN for Cholesterol, ESCITALOPRAM for Depression, BISOPROLOL for Hypertension, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 31-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 29-Apr-2021, the patient experienced MUSCLE SPASMS (Fingers Cramp). At the time of the report, MUSCLE SPASMS (Fingers Cramp) had resolved and VACCINATION SITE PAIN (vaccination site pain) 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.   Treatment medications were not provided.   This case was linked to MOD-2021-106535 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up Information Received on 24-JUN-2021  contains No New Information On 29-Jun-2021: Follow up received on 29-JUN-2021. Updated patient demographic details[Race, Weight, height]. medical history, allergic information. Added new Event [ Finger Cramps].
Massive stroke; Still trying to get back his mobility; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criteria hospitalization, medically significant and life threatening) and MOBILITY DECREASED (Still trying to get back his mobility). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) and MOBILITY DECREASED (Still trying to get back his mobility) outcome was unknown.            Patient had a massive stroke a few weeks after receiving the second shot and was hospitalized. He was still trying to get back his mobility. Patient has had complications with any past surgery, commonly occurring as blood clots in his lungs.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding this event has been provided at this time. However subject's history of blood clots in his lungs can be a confounding factor. No further information is expected at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-142295 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. However subject's history of blood clots in his lungs can be a confounding factor. No further information is expected at this time. US-MODERNATX, INC.-MOD-2021-142295:crosslinked; niece
received third dose of shingrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number TM449, expiry date 2nd June 2023) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On 25th April 2022, the patient received the 3rd dose of Shingrix. On 25th April 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's Comments: The reporter stated that the patient received her third dose of shingrix on the day of reporting. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Alternate email address included mlakra@myfchc.org.  No relevant concomitant medications were reported.  No treatment information was provided.  Patient  received the dose from  the  vials that were first punctured on the 30th Nov 2021 and put on the refrigerator since then.
Developed fever up to 104  and  redness, pain and swelling in right arm  3 days after receiving vaccine.  Admitted to Hospital on 8/15/20 for fever and Cellulitis. Improved with IV antibiotics. Patient also developed rash from arm to back which resolved with antihistamines. Cellulitis was on right arm near injection site. Rash also developed during hospitalization. Discharged from hospital on 8/18/20.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008050:
Pain in left arm where vaccine was administered 10/28/2015, pain, chills, fatigue, after approximately 4 to 5 hours after injection.  The pain became extreme and worsened during the night, I was unable to have use of my left arm, unable to roll over in bed,difficulty getting out of bed, shower, clothe myself, cook food, carry groceries into my house, drive my vehicle, lacked the ability to live alone. PCP 11/10/2015, Tramadol 50mg 11/17/2015, Rheumatologist 11/21/2015, PCP 12/08/2015, Rheumatologist 12/12/2015.
patient requested a Hepatitis B vaccine but was given Hepatitis A. Pt informed of mistake and will come back in for correct vaccine
SM's reaction (SOB and pruritus) began approximately 15-20 minutes after receipt of vaccine.  Patient received 50mg PO Benadryl and had improvement and eventual cessation of sx over his 60 min obs on site.  Vitals remained stable (HR 60-72, SPO2 98-100).  Patient was written for epi-pen and was retrieved from the site by his spouse.  Instructions provided to both in regards to f/u and reasons to report to ED or call EMS.
Received first vaccines 2/13/15, no apparent problems that afternoon or evening, found dead in crib following AM - cold, likely died hours before. Complex PMH following anoxic/ischemic brain injury at birth. Hx seizures, weaned off anticonvulsants - 2m ago after EEG normal.
Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 06Jan2021 14:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme Headache, chills, sore throat, water eyes, runny nose, tiredness entire body aches on 07Jan2021. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19, the patient underwent lab tests and procedures which included Covid-19 test/Nasal Swab: negative on 05Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
Large local reaction measuring 20 cm in length, arm circumferance 34.5; other arm circumference 29.5. arm warm, tender to touch and painful at rest.
flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had flu (influenza), after patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Additionally, it was reported that, patient had a mask still got the flu and sick for 2 weeks and patient reported that flu was rough.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Patient reported event not totally gone till the time of reporting hence outcome of event was considered as not resolved.   There will be no information available on the batch number for this case.
This spontaneous report was received from a physician via company representatives and from a support services director, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. There were no concomitant medications provided. On 11-MAR-2015, the patient was vaccinated with an improperly stored and expired dose of RECOMBIVAX HB "PFS 6x1 10mg/1ml w/o SftySyr" (dose, dose number, route and anatomical location were not reported) lot # J010164 and expiration date 05-FEB-2015. On an unspecified date, the RECOMBIVAX HB had 2 temperature excursions of 1692 and 6660 hours. The lowest recorded temperature was 20 degrees Fahrenheit (-6.666666667 degrees Celsius). No adverse effects reported. No product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "Refrigerator (R)". This is one of several reports received from the same reporter. Addition information has been requested.
Patient vaccinated 1/3/2021.  On 1/11/2021 developed headache, chills, cough, aches, nausea, loss of taste/smell, and rhinorrhea.  Tested positive for COVID.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's past medical history included: Covid-19 in Mar-2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206H21A, expiry: not reported) dose was not reported, 1 total, administered on 22-MAY-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-AUG-2021, the patient had bloodwork or antibody test. Patient IgG was 0.36. Patient reported that, antibodies were not present (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210838354-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
allergy symptoms; runny nose; itchy eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE), for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy symptoms"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; EYE PRURITUS (non-serious), outcome "unknown", described as "itchy eyes". The events "allergy symptoms", "runny nose" and "itchy eyes" were evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a 76-year-old female patient. The patient had no known pertinent medical history and drug reaction or allergies. On 27-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R012976, expiration date 25-JAN-2020, in the left arm, one injection to avoid pneumococcal disease. On 27-NOV-2018 (reported as "a few hours later"), the patient developed a bump at the injection site, which spread towards the elbow and became red and swollen. The patient applied warm compresses and VICKS VAPORUB (reported as VICKS), which provided mild relief. The patient visited the medical office on 30-NOV-2018 and the swelling and redness had gone down a little. The patient returned to the medical office on 07-DEC-2018 and was fully recovered. There was no lab diagnostics and studies performed. The causality assessment between the events and the suspected therapy was not provided.
Severe BBPV Vertigo Migraine Vesibular Migraine Hearing loss in both ears