chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT DROVE SELF TO ER ON 01/04/2021 DUE TO SHORTNESS OF BREATH. WAS SEEN BY HOSPITAL AND SENT HOME STATING TO WAIT RESULTS OF COVID TEST.  SYMPTOMS DID NOT IMPROVE IN NEXT 2 DAYS & COVID TEST WAS NEGATIVE. SHE WOKE UP 1/6/2021 & HAD LOST FEELING IN LEFT LEG.  CALLED 911. THEY TRANSPORTED HER BACK TO medical facility AGAIN. AFTER HOURS OF TESTING AND EXPLAINING SHE COULDN'T FEEL LEFT LEG, FINALLY HAD VASCULAR SURGEON COME IN AND REALIZED IT WAS (3" BLOOD CLOT) IN GROIN ALONG WITH BILATERAL SUBMASSIVE PULMONARY EMBOLI WITH EVIDENCE OF ACUTE PULMONARY HYPERTENSION & AN ACUTELY ISCHEMIC/THREATHENED LOWER LEFT EXTREMITY FROM PARDOXIC EMBOLI TO HER LEFT POPLITEAL ARTERY AND LEFT EXTERNAL ILIAC ARTERY.  SHE WAS ON ACTICOAGUALTED ON ADMISSION AND TAKEN TO THE OR URGENTLY FOR 1: LEFT FEMORAL ARTERY EXPOSURE WITH ILIOFEMORAL BALLOON THROMBECTOMY, 2: LEFT BELOW-KNEE POPLITEAL EXPOSURE WITH LIMITED ENDARTERECTOMY, POPLITEAL AND TIBIAL BALLOON THROMBECTOMY AND PATCH ANGIOPLASTY OF THE POPLITEAL ARTERY AND 3: COMPARTMENT FASCTIOTOMY OF THE LEFT LOWER LEG.
No additional AEs were reported.; Nurse reported that a patient received PROQUAD via intramuscular route instead of subcutaneous route on 9/8/2022.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and previous drug reactions or allergies were not reported. The patient's concomitant medications included sterile diluent.  On 08-SEP-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection (lot number U031562 was verified to be a valid number, expiration date reported and established as 06-APR-2023), administered via intramuscular instead of subcutaneous for prophylaxis (exact dose, strength, anatomical injection site, and vaccination scheme were not provided) (incorrect route of product administration). No additional adverse events were reported.
Rash, SOB, Arthralgias/myalgia, fatigue, localized reaction, fever, clinical rubella.
202.2 fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced 102.2 fever with chills normal the day after the second shingles shot. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
pt recvd vax & 6wks following vax titers was neg;No further details were provided;
sore arm,hurt, and was sore for quite a while; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm,hurt, and was sore for quite a while) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high and High cholesterol.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm,hurt, and was sore for quite a while). At the time of the report, VACCINATION SITE PAIN (sore arm,hurt, and was sore for quite a while) outcome was unknown.            06-MAY-2022, the patient received Moderna booster dose. Reporter did not remember taking anything but if she took Tylenol. Reporter took high blood pressure medication, high cholesterol medication and did not remember what else. No treatment medications were reported.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of an unspecified age and sex. Initial information was processed along with additional information on 28-DEC-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Not specific, not significantly), and other pre-existing medical conditions included: The patient had no major medical history and concurrent conditions. The patient previously received covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin and route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, administered at left arm on 11-MAR-2021 for covid-19 prophylaxis.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in 2022, the patient had covid-19 and patient was tested positive for which patient received non company suspect paxlovid (form of admin and route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 07-DEC-2022 to 12-DEC-2022 for covid-19. On 18-DEC-2022 after six days of finishing paxlovid, the patient had mild symptoms. On 21-DEC-2022 nine days after paxlovid patient tested positive again for covid-19 virus (confirmed covid-19 infection) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with paxlovid was drug withdrawn.  The patient had not recovered from confirmed covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000264856.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
fever, headache, chills, muscle pains, stomach ache, unusual tiredness, general feeling of illness, slept so much
Myalgia, nausea, vomiting, chills, weakness/fatigue, dizziness and difficulty ambulating secondary to fatigue  Tylenol for myalgia with no significant improvement and hydration  Patient had a telehealth visit 4/23/21 and was advised to go to the ED for further assessment for possible dehydration
This spontaneous report as received from a pharmacist refers to a 72 years old female patient with hypercholesterolemia and no known drug allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot# reported as h018088, expiration date 04-JUN-2014) on 21-DEC-2012. No other co-suspects were reported. Concomitant medications included: CRESTOR. On 23-DEC-2012 the  patient developed redness, swelling and itching in the arm surrounding the injection site, 2 days after the injection. No treatment information was reported. No lab diagnostics studies performed. The patient did not seek medical attention. The outcome of redness, swelling and itching in the arm surrounding the injection site is unknown. Additional information has been requested.
Pt devel a herpes rash following the vax w/Hep B recomb;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Jan2023) Negative; (26Jan2023) Negative; (27Jan2023) Positive, notes: after symptoms returned, tested again and tested positive; (29Jan2023) Positive, notes: tested again today (29Jan2023) and it was again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Febrile seizure x 2 approx. 9 hrs after immunization given. The medical records state fever and congestion.
Information has been received from a physician concerning a 5 yr old female who on 05Sep01 was vaccinated with a dose of varicella virus vaccine live (lot638729/0238L). On 21Sep05, the pt developed mild break through  chickenpox characterized by approx 10 lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Fever; Muscle pain; Sore arm; Exhaustion; This is a spontaneous report from a non-contactable reporter (consumer or non-HCP). The reporter is the patient.   A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 18Dec2021 at 18:00 (Lot number: unknown) at the age of 52 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALLEGRA and ESTROGEN.  The following information was reported: PYREXIA (non-serious) with onset 19Dec2021 at 08:00, outcome "recovering", described as "Fever"; MYALGIA (non-serious) with onset 19Dec2021 at 08:00, outcome "recovering", described as "Muscle pain"; PAIN IN EXTREMITY (non-serious) with onset 19Dec2021 at 08:00, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 19Dec2021 at 08:00, outcome "recovering", described as "Exhaustion". Therapeutic measures were not taken as a result of pyrexia, myalgia, pain in extremity and fatigue.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's caregiver brought patient into the pharmacy on Wednesday 11/9/2022 to get a flu shot administered. A dose of Fluzone HD (Lot UJ918AE, IM Left Deltoid) was administered to patient per the caregiver's request in the pharmacy. Staff member who administered the shot in the pharmacy was not informed by patient's caregiver that patient already received a dose of Afluria (Lot P100473764, IM Left Deltoid) when our mobile team visited the carehome on 10/26/2022. The caregiver apparently the COVID booster was administered to patient on 10/26/2022 and not the flu shot.  We followed up with caregiver and caregiver reported patient experienced no adverse reaction after receiving the second flu shot.   We encouraged caregiver to inform patient's primary care physician of the incident.
he was diagnosed with Flu strain A; Influenza A virus infection; developed a fever of 103; chills; cough; Initial information received on 13-Jan-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's mother).  This case involves a 16 year old male patient who was diagnosed with flu strain A (influenza), with fever of 103 (pyrexia) chills (chills) and cough (cough) while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  In November 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site.  On 11-JAN-2020, the patient developed a serious fever (pyrexia), chills (chills), cough (cough) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were assessed as medically significant (as these were considered symptoms of Influenza).  On 12-JAN-2020, the patient was diagnosed with serious flu strain a (influenza) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  It was a case of vaccination failure and considered medically significant.  Relevant laboratory test results included: Body temperature - On 11-Jan-2020:  [103] then on an unknown date after therapy it was [101]  Final diagnosis was Influenza and vaccination failure.  The patient was treated with OSELTAMIVIR (OSELTAMIVIR) 75mg twice a day for 5 days and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (NYQUIL COLD & FLU).  The patient had not recovered from all the events at the time of report.  Information on the batch number is requested.; Sender's Comments: This case concerns a 16 year old male patient who presented with influenza A after and despite the administration of vaccine FLUZONE QUADRIVALENT. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Fever, chills, full body aches, fatigue, slight lightheadedness, muscle spasms mainly in legs and hips. Treated with ibuprofen and Tylenol alternating every 2 hours along with rest and fluids. Was back to normal within 24 hours with only slight pain at the injection site.
She exhibited no symptoms immediately after the shot and began driving home at approximately 6:30 pm. As she was driving home, she gradually developed perioral numbness with the sensation of a "gummy" throat and bilateral eye "warmth and numbness",
I first got sick like I had the flu. I had body aches and headaches and started to transition to chest pain for me. So I went to the emergency room and they did an x-ray and EKG and everything was fine. I went to the emergency room a total of 3 times. That went on for about a week and then I started to feel better but then a about a week later I started to have chest pain and body aches again and that lasted about another week. Overall it all lasted about a month. I also had a dry cough for the first 2-3 weeks.
skin hurt to the touch; soreness in the left arm; a low-grade fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had visited emergency room for observation and was given IV fluids.) in December 2020. Previously administered products included for Product used for unknown indication: J and J COVID-19 vaccine (J and J COVID-19 vaccine, 1st Dose and Left Deltoid) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J COVID-19 vaccine. Concurrent medical conditions included Immune system disorder NOS (Patient reported that her immune system was not that best.), Allergy to antibiotic (Amoxicillin), Penicillin allergy, Allergy to antibiotic (Erythromycin), Drug allergy (Codeine), Drug allergy (Darvocet), Allergy to antibiotic (Doxycycline), Latex allergy and Exercise induced asthma (It started in her late 20's. No change in the condition was reported. Patient stated that the condition was doing pretty good.).    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Dec-2021, the patient experienced PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive. On 15-Dec-2021, Body temperature: low grade fever Low grade fever.         Concomitant medication included Pro-Air Inhaler as needed for exercised induced asthma.  It was reported that the adverse events lasted for a day and a half and then resolved.   This case was linked to MOD-2022-552553 (Patient Link).
A week after receiving the second vaccine I started losing my balance. It felt as if I was falling back and I had to hold onto something solid so that I would not fall. As this past year has passed it has progressed to me having constant headaches that last for up to three weeks. I am constantly dizzy as if I have vertigo but without the nausea. I have been given medication for migraines which I have never had in my life and that is not offering me any relief. I am finding that I am sleeping up to seven hours a day because the pain wakes me up throughout the night and I am unable to sleep.
Had the shot, then got shingles/Suspected vaccination failure; then got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles so bad. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
I have armpit pain in the arm where I received the shot. It feels like the lymph noids in my armpit are completely swollen.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-APR-2015, the patient was inoculated with ZOSTAVAX at a healthcare facility/clinic, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-JUN-2016, the patient was treated by an advanced practice registered nurse (APRN) at a healthcare facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of VARIVAX (Merck) Lot # K011801, expiry date 21-AUG-2016; Lot # reported as L026413, expiry date 15-JUL-2017; Lot # L001330, expiry date 13-JAN-2017 and Lot # reported as L029471, expiry date 06-AUG-2017 (dose and route were not reported), were given to unspecified patients on unspecified dates. It was reported that the nurse did not know which of the above lots were actually administered. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
pneumonia; bronchitis; other zoster related injuries; shingles; chickenpox; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 70 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about an unknown date in September 2015, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a physician and a healthcare provider at an emergency room (ER), and at a healthcare facility, by other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles, chickenpox, pneumonia, bronchitis and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of pneumonia was determined to be medically significant.
Case previously recorded as MA2009-5223. Initial case report received from a physician via MedCom, on 19 OCT 2009. A 7 month-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 OCT 2009. No adverse events were reported. MedCom reference no: NA09-008308.
COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, FUZZY HEAD, DIZZY, LACK OF APPETITE, FATIGUED (SLEPT ALL DAY STARTING AT 3 PM DAY OF VACCINE TO ALL WAY NEXT DAY AND NIGHT), VERY ACHEY, COULD NOT LIFT MY RIGHT ARM, BRUISE WHERE INJECTION WAS GIVEN ALONG WITH A KNOT. TODAY IS 2.2.21 AND STILL FEEL FUZZY HEAD AND ACHEY.
Headache, Myalgia, Arthralgia, Fatigue, Chills, Pain and redness at injection site  Narrative: