chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via patient support programs and described the occurrence of lethargy in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort. On an unknown date, the outcome of the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort were unknown. It was unknown if the reporter considered the lethargy, electric shock sensation, muscle cramp, headache and stomach discomfort to be related to SHINGRIX. Additional details were reported as follows: This case received from consumer via GlaxoSmithKline (GSK). The call center representative had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient stated that, she experienced a severe reaction to SHINGRIX vaccine. The patient experienced severe muscle cramping all over her body, felt electrical charge going up and down all over her spine. The patient had headache, she was sick to stomach and felt very lethargic. The reporter had agree to follow up via postal mail. This case did not include product complaint.
Pt recvd HIB/DTP/OPV 21MAY91; Pt seen in office on 3JUN91 for ear infect & was started on Amoxacillin; On 7JUN91 pt was hospitalized approx 5 days for HIB meningitis; Tx IV Rochphin & Mycostatin;  Pt given 1st HIB 18FEB91;
This spontaneous report as received from healthcare worker refers to a patient of unknown demographics. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with VARIVAX (merck) (1350 U) (0.5 ml, subcutaneously) that had been exposed to a temperature of -14.3 degree Celsius for 1 hour and 43 minutes. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (merck) was not reported. Product quality issues was not involved. Additional information has been requested.
Patient got vaccine on 3/16/22. She reported to me today 3/30/22 that she had redness, warmth, and swelling at injection site for 12 days after receiving vaccine. It has resolved at this point.
BODY ACHES; LIGHT HEADEDNESS; STOMACH ACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medication allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, light headedness, stomach ache, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, chills, body aches, light headedness and stomach ache was not reported. This report was non-serious.
NO ADVERSE EVENT. VACCINE GIVEN, NEXT DAY PREGNANCY TEST WAS GIVEN AND PATIENT WAS POSITIVE
Got anthrax on 12/10/99, left deltoid one week later site was itchy, swollen, red and warm to touch. Size today 12/20/99 11 x 8 cm. No rash, no systemic reaction . Rx clobetasol, tylenol, benadryl, naprosyn
Inflammation in the gum; joint pain that continues to move around the body; lymph node swollen under both arms; lymph node swollen in groin; Multisystem Inflammatory Syndrome; This spontaneous case was reported by a consumer and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (Multisystem Inflammatory Syndrome   ) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised (since age of 16 with "variable immune deficiency"). Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced NONINFECTIVE GINGIVITIS (Inflammation in the gum), ARTHRALGIA (joint pain that continues to move around the body), VACCINATION SITE LYMPHADENOPATHY (lymph node swollen under both arms), LYMPHADENOPATHY (lymph node swollen in groin) and MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (Multisystem Inflammatory Syndrome   ) (seriousness criterion medically significant). At the time of the report, NONINFECTIVE GINGIVITIS (Inflammation in the gum), ARTHRALGIA (joint pain that continues to move around the body), VACCINATION SITE LYMPHADENOPATHY (lymph node swollen under both arms), LYMPHADENOPATHY (lymph node swollen in groin) and MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (Multisystem Inflammatory Syndrome   ) outcome was unknown.            No treatment medication information provided.  Patient stated that 4-5 days after the 2nd dose lymph node were swollen under both arms and groin. Ten days following the second dose consumer started having joint pain that continued to move around the body and had been ongoing. She then saw her immunologist who recommended anti-body testing. She did not have the results of that. Also, the 2nd doctor recommended osteoporosis exam. She said she may have had covid prior to receiving the vaccine. Patient stated that she was having multisystem inflammatory syndrome after getting the vaccine. She might read something online, that covid causes MIS and she was linking it to the vaccine possibly. She had not been diagnosed with MIS by her HCP. She was self-diagnosing and thinking She had MIS.
Patient received IM injection of Fluvirin. She had a reaction within 5 minutes of hives. Given 25mg Benadryl PO with water.
vomiting, fainting, turning purple, unable to walk temporarily, drop in blood pressure, loosing body function, crying
Fever; Her arm is red, hard, itchy; Her arm is red, hard, itchy; Her arm is red, hard, itchy; Side effects in her left arm/Can't touch it/it's sore to the touch; Feels like a bad bee sting; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for herself. A female patient of age: 77 (unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient had been experiencing fever and side effects in her left arm which included that the arm was red, hard, itchy and she could not touch it/it was sore to touch. The patient also added that it felt like a bad bee sting. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
12/13/2022  I had a sore throat cough and a high temperature. After reaching out to my doctor the next day I tested positive for Covid-19. My doctor prescribed me Paxlovid. Symptoms lasted one week.
Myalgia, NauseaVomiting, chills Narrative:  Other Relevant History:
No additional AE/PQC.; inadvertently given PROQUAD and VARIVAX concomitantly; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 23-JUN-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, once, concomitantly, (strength, dose#, lot #, expiry date, route and anatomical site of vaccination for both vaccines were not provided) (accidental overdose). No additional adverse event (AE) was provided (no adverse event).
CLIENT RECEIVED EXPIRED VACCINE 2022JAN23. PHARMACY, MERCK, PCP, AND FAMILY NOTIFIED. 12:15PM NO ADVERSE EFFECTS REPORTED.
low grade fever, periorbital swelling, w/in 12 hrs following administartion; rash over chin;
Lymphedema near clavicle, fatigue Narrative:  1st dose: Lymphedema, fatigue, recovered
diagnosed with autoimmune hepatitis type 1; 10.87 igG index/ spike protein igg 10.87; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 16Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunisation at community hospital (to get protection from covid). Medical history included auto immune hepatitis type one, had fat in her liver, her liver was enlarged from an unknown date and unknown if ongoing. Concomitant medications included azathioprine taken for autoimmune hepatitis from 30Apr2021 to an unspecified stop date. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration on 19Feb2021 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation at community hospital and no reaction on previous exposure to vaccine. Investigation assessment was provided. It was reported that the patient's doctor called her on an unknown date in Jan2021 to get her liver levels test. The patient was diabetic and gets her liver levels tested four times a year. On an unknown date In Jan2021, her numbers were high, but not that high. She did not have any tumors or anything. She got an ultrasound done that showed she had fat in her liver, and her liver was enlarged. Last week, the patient went for an antibody test. Her test results said spike protein igg 10.87. She got a scan/fibroscan also, saw a hepatologist/ internist doctor at the hospital who ran some tests and did a liver biopsy. The pathologist told her that she had auto immune hepatitis type one. That was the bad news about the auto immune disease. But the good news was that there was an immune suppressor medication that was very successful, that she was taking. She was at stage one. The medication was supposed to make it better, or it may cure her completely. She must be on it for 2 or 3 years and will find out later. She read that the vaccine may not be effective to people with auto immune diseases. She called her immunologist, and he said she can get this test. She got a blood test last Friday, and her results came back on "Friday" evening. The patient would like to know what information Pfizer has on immunosuppressed patients who take the covid vaccine. She was asking what does the 10.7 mean. The reporter did not specify any seriousness for events. The patient underwent lab tests and procedures which included Antibody test, spike protein igg: 10.87 (unknown units), liver biopsy: auto immune hepatitis type one, blood test with unknown results on an unknown date. The patient received the treatment for all events. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
The vaccinee is not allergic to yeast. He had reactions to past IZ's. On 1/3/02, the vaccinee received his 1st dose of Engerix-B. He received 2 injections of the 10mcg pediatric dose (lot ENG5205A2) to provide the adult dose of 20mcg. Subsequently, on 1/3/02, he experienced nausea, vomiting, lethargy and diarrhea. In addition, he developed a cold on 1/5/02. The vaccinee did not receive medical attention for the events. As of 1/12/02, the events resolved.
STORAGE IN REFRIGERATOR (2C-8C) UP TP 30 DAYS. ( VACCINE USED AFTER 10/16/2021)
Patient reports after receiving her 1st Covid Vaccine to her Left Arm on 01/09/21 she experienced numbness/tingling to her left hand that improved. At time of booster visit on 10/01/21 endorses residual numbness since the initial injection on 01/09/21 only to her left pinky finger. Reports after 2nd Covid Vaccine on 01/30/21 to her right arm she experienced no numbness or tingling to her right arm.  After receiving her booster (3rd injection) to her right arm on 10/01/21 patient endorsed numbness to right hand pinky finger rated 9/10 and improved to 3/10 during observation period. Patient advised to report to ER for MD provider evaluation but declined. Encouraged to follow up with MD provider outpatient.  Patient reports history of cancer requiring chemotherapy infusion with infiltration during infusion due to loss of peripheral IV access with subsequent numbness/tingling to Left Arm.  Patient requested VAERS be completed.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored (Merck) VARIVAX (dose, route, lot # not reported) were administered to patients. No adverse effects were reported. This is one of several reports from the same source. Follow up information was received from the nurse on 26-SEP-2014. The excursion reported for (Merck) VARIVAX exposed to -12.1 centigrade for 21 hours (20 hours and 45 minutes). The nurse stated that she believed at least one or two individuals have received these various vaccines, but does not have specific data. She had not received any reports of adverse effects to patients post vaccination. Additional information has been requested.
symptoms: throat tightness treatment: diphenhydramine PO and Epipen IM transported by EMS to emergency department
Patient was given FLUZONE HD, about 3 hrs after she experienced palpitation and nausea and difficulty in breathing. Ambulance was called (911), she was taken to hospital. She was admitted with possibility of allergic reaction to the flu vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid 19 and drug ineffective.
Lips swollen, full feeling under tongue, eyes red et painful with greenish discharge. Some coughing et facial paresthesias. Symptoms started at 2:30 pm. Took Benadryl 50 at 4 pm and 7:15 pm. Went to hospital.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On unknown dates since 16-NOV-2015, unspecified number of patients have been vaccinated with VARIVAX (Merck) lot # K003410, expiry date: 06-MAR-2016) (dose, frequency and route were not reported). It was reported that the vaccines were exposed to the temperature between -15C and -10C for 126 hours and 50 minutes, and between -10C and -6.1C for 12 hours. There were no previous temperature excursions. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested. This is one of several reports received from the same reporter.
It's glomerulonephritis. Inflammation of the kidneys, such as proteinuria, hematuria, and bacteria. It started a few days after the booster shot. It is still under way. It has also become a lifelong condition to be treated. My daughter is only 13 years old. She needs to get vaccinated and take medicine for life.
Tested positive for Covid after receiving booster dose Vaccine; Tested positive for Covid after receiving booster dose Vaccine; booster dose; This is a spontaneous report from an agency from a contactable consumer (patient). This female of unspecified age received the first, the second and the third (booster) doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), all at single dose on an unspecified date for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient tested positive for Covid after receiving booster dose Pfizer Covid 19 Vaccine. Patient stated she was positive with Covid also and got Covid from her husband, which was why the patient was coughing every once in a while. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Pt was given smallpox imz for deployment on 9/12/05, approx 9 days later noticed bump distant from imz site that itched, thought it was a pimple, scratched it and later that day noticed other bumps.  Today has several pustules and erythematous papules that are suspicious for vaccinial lesions on trunk, back, buttocks.  Vaccine site is left arm and with scab.
This spontaneous report was received from a nurse practitioner and refers to a 16-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-JUN-2006, the patient was subcutaneously vaccinated with the first 0.5 ml dose of VARIVAX and on 08-AUG-2016, the patient was subcutaneously vaccinated with the second 0.5 ml dose of VARIVAX. On 15-AUG-2016, the patient developed an area on her body that was itchy, red, swollen and sore but there were no bumps. The affected area was on an unspecified part of the patient's body. The medical attention was sought, the patient's father called the reporter. The reporter had not seen the patient regarding her symptoms. The outcomes of the events were reported as recovering/resolving. The causality between the events and VARIVAX was not reported. Additional information has been requested.
Pfizer BioNTech EAU booster; Body aches; Headache; Nausea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer BioNTech EAU booster"; PAIN (non-serious), outcome "recovered", described as "Body aches"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; NAUSEA (non-serious), outcome "recovered", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased heart rate immediately to 164 then came down and has stayed around 90-100 Swelling at vaccine site and general joint pain Nausea Lethargy Severe pain entire left arm and shoulder
Pain in L shoulder started 2-3 hrs after flu vaccine.  Describes pain as pain with any abduction of her shoulder.  No redness or swelling.  Prevents her from doing her usual activities.  Instructed to use warm pack, ibuprofen and referred for physical therapy for range of motion.
Pt came to ED to be covid tested b/c her grandson recently tested positive.  C/O of some nasal congestion.
Two weeks after receiving vaccine I was diagnosed with COVID-19. Tested due to contact and had very mild symptoms.
Mother got first dose of vaccine and is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Mother got first dose of vaccine and is breastfeeding) in a  infant of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 030m20a) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): No medical history was reported.  Concurrent medical conditions included Breast feeding.    No Medical History information was reported.   On 18-Feb-2021 at 2:00 PM, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Feb-2021 at 2:00 PM, the infant was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING (Mother got first dose of vaccine and is breastfeeding). On 18-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Mother got first dose of vaccine and is breastfeeding) had resolved.            Concomitant medications were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Addt'l info uploaded.  Patient -parent tab: Added parent height, weight, race, ethnicity.  Product tab: Vaccination information was added for 2 doses of parent along with start date, batch number and anatomical location.   Updated event tab stop date and patient has been breast feeding for 8 months and outcome is updated as recovered or resolved.  Patient mentioned that she was breastfeeding at time of vaccination; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
23OCT92 pt was irritable; cried constantly for 4 hrs 24OCT92 for 5 1/2 hrs; 26OCT92 cried off & on all day; mom took pt to MD 28OCT92 & recommended half doses next time;
aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from contactable Other HCP. This Other HCP reported same events for 6 patients. This report is for 2nd of 6 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The other HCP was aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The event was reported as non-serious. The event outcome was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 same reporter, same drug, same event, different patients.
pt recv vax 19APR96 & pt devel a rash w/an unk number of vesicles;
severe itching, redness and swelling at injection site after ONE week treated with  Claritin Reditab and warm compresses. Improved