chrisvoncsefalvay/vaers-outcomes huggingface dataset:
irregular heart beat; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEART RATE IRREGULAR (irregular heart beat) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (irregular heart beat). At the time of the report, HEART RATE IRREGULAR (irregular heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: irregular.   No concomitant medication was reported.  No treatment medication was reported.  Company Comment:  This is a spontaneous case concerning a male of unknown age, patient with no reported medical history, who experienced the unexpected non-serious AESI of heart rate irregular. The event is reported in relationship with a dose of mRNA-1273.222 vaccine, however latency could not be assessed due to lack of information. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-681153, US-MODERNATX, INC.-MOD-2022-680935 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a male of unknown age, patient with no reported medical history, who experienced the unexpected non-serious AESI of heart rate irregular. The event is reported in relationship with a dose of mRNA-1273.222 vaccine, however latency could not be assessed due to lack of information. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-681153:Father-in-law US-MODERNATX, INC.-MOD-2022-680935:Stepdad
few seconds of apnea w/tremor & rigidity in otherwise fussy pt w/in few seconds of hypotonia p/event w/o sequelae occurred 10MAR96 p/tetraimmun & OPV vax on 8MAR96;
at 12:30am woke with headache and violent shaking chills at 2:15am woke with nausea and vomited, persistent headache at 3:30 am woke with headache and full body aches, took a tylenol at 4:45 am woke with fever, oral temp 100.4F, headache and body aches continue at 6 am woke with mild headache and full body aches which persisted throughout the day with fatigue, oral temp 98.6F all symptoms resolved the next day after a full night of sleep
t104.0 R APAP would not reduce x/sl; cried all noc;
Pt said she went home and started working in the yard. She said she collapsed, and could not move. She was sweating profusely and had severe abdominal pain, nausea and diarrhea.
Breakthrough case admission after 3 vaccines  Moderna 3/6/21 Lot# 029A21A;  Moderna 4/3/21 Lot# 040A21A;  Moderna 11/4/21 Lot# 012F21A;
Left thigh with 5X7 cm oval irregular salmon-colored area centered around shot site.  No warmth, no purulent drainage.  Shot site looks clean. Moves leg well without pain.  No fever, walking fine, no resp sx or other sx at all, only c/o itching.
The child received vax on 3/20/01. Developed a fever that night to 103. Was taken to ER and rests were done to rule out sepsis.
Loss of eye contact + awareness after shot on 2/14/07, Then even more, plus hyperactive after shot on 3/28/07 & stopped babbling.
Sick... body aches, fever, arm pain that has not gone away. I need to see a physician concerning the issue.
Very sore where injection was in the shoulder. Slightly warm. Swollen and slight fever of 99 degrees. Slight redness where swollen.
body aches, joint aches, skin sensitivity, sweating, malaise, possible fever but did not check temperature
the patient did not experience any adverse events; systemic 9-valent human papillomavirus vaccine for recalcitrant common cutaneous warts in preparation for renal transplant in 66-year-old woman; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 66-year-old female patient. Her concurrent conditions included chronic renal failure, type 2 diabetes, hypertension and thyroid cancer. The patient's historical conditions was not reported.   The patient presented with 10 recalcitrant cutaneous warts on both hands that had been present for 10 years (started in approximately 2008). On an unknown date, she was treated with liquid nitrogen (reported as countless treatments) but despite the treatment, the warts never improved.   In 2018, after informed consent, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose, intramuscularly (dose, anatomical location, lot# and expiration date were not provided) for recalcitrant cutaneous warts (off label use). The warts began to improve after the first dose of the vaccine. On an unspecified dates, she received second and third intramuscular vaccine injections with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, anatomical location, lot# and expiration date were not provided) at 2, and 6 months. The warts were completely resolved after the third dose.  The period of observation was from 2018-2021. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was well tolerated, the patient did not experience any adverse events (no adverse event), and she successfully underwent renal transplantation in 2019, in less than 3 months after the last injection. She did not experience post-transplant recurrence of the warts.    A copy of the published article is attached as further documentation of the patient's experience.
Low grade fever, chills, nausea, coughing, fatigue, full body soreness
This spontaneous report has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. From 18-SEP-2017 to 21-SEP-2017 the patients were vaccinated with improperly stored doses of ROTATEQ with lot number N005617 and expiration date on 03-OCT-2018 (dose and dose number were not provided), oral for prophylaxis.    It was reported that on an unspecified date, the vaccines were exposed to a temperature between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 2 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported.
Local reaction with bruising "green color" on arm.  On 10/17/2015, patient returns with resolved bruising but tenderness remains.
pain in side like with asthma attack, still fine, breathing, going to continue monitoring. chest pain began to resolve. followed up with patient at about 7:15, pt still symptomatic. asthma inhaler helped.
Patient experienced red itchy rash at injection site for ZOSTAVAX. The rash lasted approximately 2 weeks. Began to clear up around day 10.
There was more pain with injection of the vaccine than normal, as I receive flu vaccines annually. I also noted that the injection site was higher than it should be.  The pain in my shoulder/muscle has continued since the injection. I haven?t sought medical treatment yet, as I?m assuming this is tendinitis and I am waiting for it to resolve on its own (as I had happen about 8-10years ago as well).
It started itching midday at work and thought it was bug bite. Three days later, I went to the Urgent Care and was diagnosed with Shingles. It was on my back and came around to my left pectoral, and it was painful and itchy. I was treated with an antibiotic.
Extreme pain in upper arm, can not lift arm up at all; Extreme pain in upper arm, can not lift arm up at all; This is a spontaneous report from a contactable pharmacist, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 07May2021 at 19:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 08May2021, the patient experienced extreme pain in upper arm, could not lift arm up at all. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme pain in upper arm, can not lift arm up at all was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt recv vax on 9/18/98; on same day pt exp fever (105F), circumoral cyanosis & generalized tonic clonic seizure.  Pt seen at E.R.; tx=injection of Ceftriaxone.
Patient states her Lt. arm began hurting the day she received her flu shot. No redness, swelling or fever reported. Able to use her arm. Pain extends to middle of uppper arm and occasionally to base of neck. Still painful today which is 5 weeks later. Has not been seen by a MD but did call their office.
pt recvd vax 25JUN92  & 25JUN92 3PM high fever; 26JUN92 trembling & vomiting; mom gave pt bath & APAP lt arm swelled 2-3inch circle; pt couldn't move lt arm; no fever or problem w/arm p/27JUN92 noon;
She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot; she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY TRACT INFECTION (She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot) and VACCINATION SITE PAIN (she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot) and VACCINATION SITE PAIN (she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022). At the time of the report, RESPIRATORY TRACT INFECTION (She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot) had resolved and VACCINATION SITE PAIN (she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022) outcome was unknown.            No concomitant medication was reported.  Patient only had a sore arm with her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022. She mentioned that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot.   No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750042 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750042:Master case for dose 6 (Spikevax 2023-2024)
mom states while in car, noticed pt body shaking, eyes rolled back & drooling;no color change;10AM probable sz approx 7 hr later-no fever
Sharp pain on well on pounding to left side of head 2-3 times per week.
glaucoma; Inject site pain and minor redness; Inject site pain and minor redness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 14:00 as dose 1, single (Lot number: HF9275) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "acne" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Allergic to latex" (unspecified if ongoing); "Known allergies: environmental/seasonal" (unspecified if ongoing); "Known allergies: Rabbit meat, some plants" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Known allergies: Rabbit meat, some plants" (unspecified if ongoing). The patient did not receive other vaccines in four weeks. Concomitant medication(s) included: KARIVA; ATIVAN; CALCIUM.  The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 08Oct2023 at 23:00, outcome "recovering" and all described as "Inject site pain and minor redness"; FATIGUE (non-serious) with onset 08Oct2023 at 23:00, outcome "recovering"; GLAUCOMA (medically significant) with onset 09Oct2023, outcome "recovering". The event "glaucoma" required physician office visit.  Clinical course: Inject site pain & minor redness, fatigue, and on 08Oct2023 eye redness on both eyes. Sore on right eye socket. On 09Oct2023, the patient went to an eye doctor and was diagnosed with glaucoma. It was reported that a scheduled surgery is planned to treat the patient in response to the event.
warm, red, raised area by inj site Pt saw MD & given Benadryl cream.
Red spots on face on 1/12/07, more spots followed on neck, head, axilla. Spots are itchy.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a white, not Hispanic or Latino male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, 1 total administered on left arm on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, the patient started having chills and fever up to 102 F, also complained of sore throat, head congestion and upset stomach that appeared a day after. On 26-DEC-2021, the patient went to see his Health Care Professional (HCP) on 26-DEC-2021, where he was evaluated and Polymerase chain reaction (PCR) was performed, resulting positive (confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: Body temperature (NR: not provided) 102 F. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000208844.; Sender's Comments: V0 20211258412-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.
APROX. 10 MINUTES AFTER THE VACCINE WAS ADMINISTERED, THE PATIENT STARTED TO COMPLAIN OF LIGHT HEADEDNESS AND STOMACH CRAMPING. UPON INSPECTION OF THE PATIENT, I NOTICED THE PATIENT WAS SWEATING AND HAD A PALE COLOUR TO THE FACE, THEIR ARMS WERE IN A CRAMPED POSITION WITH WRISTS FLEXED INWARD. I ASKED THE PATIENT TO RELAX THEIR ARMS AND THEY SAID THAT THEY WERE. I CHECKED THE HEART RATE AND BLOOD PRESSURE, ASKED THE PATIENT TO SIT ON THE GROUND AGAINST A WALL, GAVE THEM WATER AND SNACKS TO HELP BRING BLOOD PRESSURE AND BLOOD GLUCOSE UP THEN CONTINUED TO MONITOR FOR 45 MIN WITH FREQUENT CHECKING OF BLOOD PRESSURE AND HEART RATE. THEIR BREATHING WAS NORMAL AND TALKING JUST FINE.
BODY ACHES; INSOMNIA; ENLARGED LYMPH NODE IN LEFT UNDERARM; TINGLING IN ARM; CHILLS; HEADACHE; FEVER; FATIGUE; MUSCLE SPASM; PAIN IN ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pre existing arthritis. The patient experienced drug allergy when treated with hydrochlorothiazide/methyldopa, cefalexin, and diazepam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced pain in arm. Laboratory data included: CAT scan (NR: not provided) Pre-existing arthritis, and X-ray (NR: not provided) Pre-existing arthritis. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced insomnia. On 01-APR-2021, the subject experienced enlarged lymph node in left underarm. On 01-APR-2021, the subject experienced tingling in arm. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced fatigue. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No problem in lymph node. Treatment medications (dates unspecified) included: paracetamol, and oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia on 13-APR-2021, chills, and headache, and fever on 06-APR-2021, was recovering from fatigue, had not recovered from body aches, and enlarged lymph node in left underarm, and the outcome of pain in arm, tingling in arm and muscle spasm was not reported. This report was non-serious.
Patient reported low HR 1/27/21 (one day after vaccine) and went to ER. Patient reports no interventions at hospital and he was not admitted. Patient slept for 5 days after vaccination. He experienced joint/muscle pain and occasional dizziness which has continued at 8 weeks post vaccination. Patient also reports neuropathy which started in half of foot and progressed to leg (below the knee). He uses acetaminophen and DMSO for pain.
light headedness, h/a, achey joints, stiff all over which lasted for 2 days;
10 after i got my vaccine , i got pneumonia had a temperature of 104 and had blood clots in both my arms and in my lungs. I went to the emergency room   i was kept there for a week. they tested me for covid, ct scan and pvc panal. I had an infection in my lungs.  took about a month to recover
Patient reports swelling in leg on the same side she received her IM injection (2nd booster). Swelling lasted for 5 days post-vaccination, then resolved.
sore arm; feeling internally cold; This is a spontaneous report from a contactable consumer. This 76- year-old male Consumer(patient) that:  A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 27Jan2021 as dose 2, single and also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 06Jan2021 as dose 1, single for COVID-19 immunization. Medical history included renal transplant from Nov2013 to an unknown date (anti-rejection drugs for kidney transplant), rheumatoid arthritis from an unknown date and unknown if ongoing (immunosuppressant drug for arthritis), blood pressure measurement from an unknown date and unknown if ongoing. Patient had,. Patient had living donor kidney transplant in NOV2013 (Donor: Son). Concomitant medications included tacrolimus (PROGRAF) taken 1mg twice daily /0.5mg daily for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken 5 mg daily for an unspecified indication, start and stop date were not reported; sulfamethoxazole, trimethoprim (BACTRIM) taken 400/89 daily for an unspecified indication, start and stop date were not reported; doxazosin (DOXAZOSIN) taken 2 mg twice daily for an unspecified indication, start and stop date were not reported; irbesartan (IRBESARTAN) taken 150mg daily for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken 199mg daily for an unspecified indication, start and stop date were not reported; leflunomide (LEFLUNOMIDE) taken 20mg daily for an unspecified indication, start and stop date were not reported; rituximab (RITUXAN) infusion taken 2 time every 6 months for an unspecified indication from 06Apr2021 to an unspecified stop date (first pair and recent : 06Apr2021 and 21Apr2021, 3 months after first Pfizer dose). On Jan2021 patient had very minor reactions to both shots- sore arm and feeling internally cold, although did not have a temperature after either. The patient underwent lab tests and procedures which included blood creatinine: between 0.8 and 0.95   on unspecified date, blood creatinine: 0.87 on 20Jul2021, blood pressure measurement: unknown on unspecified date, sars-cov-2 antibody test: negative. On 17Jun2021 Covid Antibody test showed no detectable SARS-CoV-2 IgG antibodies, sars-cov-2 antibody test: negative on 07Jul2021 This was confirmed with a second test. The clinical outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Initial report was received from a healthcare professional on 07 October 2013. An 86-year-old female patient had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 24 September 2013 and an unspecified amount of time following vaccination experienced decreased appetite, stomach and back pain, was dehydrated and had increased white blood cells. The patient passed away on 02 October 2013, 8 days post-vaccination. The patient had a history of a "bone marrow issue in that did not make enough red blood cells". No additional information was provided. Outcome was fatal. Documents held by sender: None.
31JAN99 pt exp rash in hip area, asthma, cough,wheezing & extreme irritability;2FEB99-3FEB99- pt had extreme audible wheezing/grunting, abd breathing, post nasal drip & OM; exp local rxn to MMR;dx bronchial asthma & egg allerg
I have had symptoms that mimic Breast Cancer  Nipple discarge Nipple redness Lymph Node Pain Swelling Discomfort