chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ankylosing spondylitis flare up; Did injection and used inner part of thigh and angle of needle caused spillage of medication at injection site; Returned ankylosing spondylitis symptoms before the Humira injection was due with Humira (Adalimumab); This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4378911-00 (Company).  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "recovered", described as "Ankylosing spondylitis flare up"; INJECTION SITE EXTRAVASATION  (non-serious), outcome "not recovered", described as "Did injection and used inner part of thigh and angle of needle caused spillage of medication at injection site"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "unknown", described as "Returned ankylosing spondylitis symptoms before the Humira injection was due with Humira (Adalimumab)". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ankylosing spondylitis flare up", "did injection and used inner part of thigh and angle of needle caused spillage of medication at injection site" and "returned ankylosing spondylitis symptoms before the humira injection was due with humira (adalimumab)" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of DID INJECTION AND USED INNER PART OF THIGH AND ANGLE OF NEEDLE CAUSED SPILLAGE OF MEDICATION AT INJECTION SITE with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of ANKYLOSING SPONDYLITIS FLARE UP and RETURNED ANKYLOSING SPONDYLITIS SYMPTOMS BEFORE THE HUMIRA INJECTION WAS DUE was not provided.  Clinical information: PFIZER BIONTECH COVID-19 VACCINE (TOZPINAMERAN) was also considered suspect. It was unknown if patient has enrolled in a COVID-19 Vaccine Trail. Primary reporter does not had the lot number information, because the packaging was discarded. Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN: Daily Dose: (1 in 1 Once). Did event abate after stopping drug: NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and close temporal association , the event of  ankylosing spondylitis flare up, injection site extravasation , therapeutic response shortened is assessed as related to suspected vaccine
About 3/26 a rash started from my wrist going up to my shoulder and pretty much covers and it's still inflamed, it started going across my stomach and on both breast and now on right thigh. I was placed me on Zyrtec and Benadryl  cream for itching, this week she added Pepcid and she put me on Hydroxyzine for the itch.
BODY ACHES; LIGHT HEADEDNESS; DIARRHEA; FULL BLOWN FLU; CHILLS; HEADACHE; NAUSEA; FATIGUE; APPETITE LOST; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and other pre-existing medical conditions included the patient has no known allergies. The patient was previously treated with escitalopram, atorvastatin calcium, and vitamins nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry:UNKNOWN) dose was not reported, administered on 11-MAR-2021 16:30 for prophylactic vaccination. Concomitant medications included alprazolam, and nicotine. On 11-MAR-2021, the subject experienced appetite lost. On 11-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 02:30, the subject experienced body aches. On 12-MAR-2021 02:30, the subject experienced light headedness. On 12-MAR-2021 02:30, the subject experienced diarrhea. On 12-MAR-2021 02:30, the subject experienced full blown flu. On 12-MAR-2021 02:30, the subject experienced chills. On 12-MAR-2021 02:30, the subject experienced headache. On 12-MAR-2021 02:30, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, light headedness, diarrhea, full blown flu, appetite lost, chills, headache, and nausea on 18-MAR-2021, and had not recovered from fatigue. This report was non-serious.
tested positive for COVID; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID.         Patient believed that on the 16th or 17th of November of 2021, the patient tested positive for COVID disease. No concomitant medications were given. No treatment information was provided.  Company Comment: This case concerns a 59 year-old male patient with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19, reported as a positive COVID-19 test, and the unexpected non-serious event of drug ineffective which occurred on unknown dates in November 2021 after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 59 year-old male patient with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19, reported as a positive COVID-19 test, and the unexpected non-serious event of drug ineffective which occurred on unknown dates in November 2021 after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then noticed I had chills. Probably after 8AM I took my temp and I had a fever (102F) for about 10 hours. Started aching all over, joint and muscle aches, I also had headache (took Motrin and headache went away),  no pain at the injection site. Almost like I had flu symptoms. I felt miserable all day but next day when I woke up I was fine. Went to work as normal the next day. I forgot to state I had COVID in March 2020 and the symptoms I had felt very much like it.
Day 1: headache, lower back and leg pain, nerve pain all down left arm all the way to spine, slight tingling in fingers, sharp nerve pains throughout trunk of body.  Day 2: woke up with tingling in face and in lower legs below the knee. Left side of body drooped for about a week. Face tingling would come and go for about 4 weeks.  2-3 weeks out: tight squeezing pressure in head and fatigue that lasted about 2 1/2 weeks. Started having sporadic bouts of vertigo, and sharp sporadic nerve pains in legs and arms. Occasionally I would have sharp chest pains, but they were short lived.  5-6 weeks: had several days of intense tingling in arms and legs. Starting having random full body spasms, or jolts, that sometimes happen in clusters. I still get them several times a month. Did not have any of these issues before vaccine, other than vertigo which I hadn?t had in years.
pt recvd vax; PC to MD per mom reporting a varicella lesion;pt condition was determined to be hand, foot & mouth disease, not chicken pox like rash;
Patient with PMH of poorly controlled siezures and no regular health care who reported symptoms of feeling warm and lightheaded after recieving her vaccine. Pt had a generalized siezure with postictal symtpoms, AOx2. She was then observed and evaluated by medical staff and EMS, during which time she had a second witnessed generalized seizure. Pt was sent by EMS to a local hospital.
Information has been received from a physician concerning a 65 year old male who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# not reported), 0.5 ml, subcutaneously. Subsequently the patient experienced an infection developed at the injection site and was hospitalized. Lab diagnostics performed included: blood work. At the time of reporting, the patient was recovering. Additional information has been requested.
The pain prevent you from sitting. You can lie down but with very limited movement; Excruciating lower back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 17:00 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot/Batch number: EL9203 n 9263, Time of vaccination: 19:00, Anatomical location: Right arm, Dose no: 1), administration date: 31Jan2021, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 23Feb2021 06:00, outcome "recovered" (20Mar2021), described as "Excruciating lower back pain"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "The pain prevent you from sitting. You can lie down but with very limited movement". Therapeutic measures were not taken as a result of back pain.  Additional Information: Pfizer/BioNTech COVID-19 Vaccine Details: Dose no: 3, Lot/Batch number: FF2590, start date: 14Oct2021, Time of vaccination (24 hrs): 11:00, Arm left, patient age was 73.  Case narrative: Excruciating lower back pain after the 2nd shot and after the booster shot. Took about 5 weeks to recover from 2nd shot. Took 3 weeks to recover from booster shot. The pain prevents you from sitting you lie down but with very limited movement. After the booster shot, patient felt dizzy for a few hours.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On 31-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 1, lot#:0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
approx 3mos p/vax pt exp erythematous, pustules and papules. No vesicular lesion;no clinical sx of varicella zoster infect;
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
08/29/22 presents to ED for "breakthrough seizures". PMHx of "seizures disorder, morbid obesity" "nonverbal at baseline, wheelchair-bound, and HTN."
Malaise & lymph node swelling 2-3 days after MMR & Zoster vaccinations. Fever, morbilliform rash, pharyngeal lesions 21 days after vaccination.
Sore arm at injection site, tinnitus 2 days after injection in right ear only.
no additional adverse events; VAQTA was administered to 1 patient/ temperature excusrion/ excurions occured on 3/24/2021; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender.     In the morning on 25-MAR-2021, the patient was vaccinated with an improperly stored one dose of hepatitis a vaccine, inactivated (VAQTA) lot # T020442 has been verified to be a valid lot number, expiration date reported as 26-JAN-2022 for prophylaxis (exact dose, strength, route of administration and anatomical location were not reported). The temperature excursion was 34.65 degrees Fahrenheit (F) for 30 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020442; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 27-JAN-2018, the patient was inadvertently vaccinated with expired dose of VARIVAX, via subcutaneous route for prophylaxis (lot # M003439, expiration date 19-JAN-2018). The vaccine was reconstituted with sterile diluent (lot # N023308, expiration date 04-FEB-2020). No adverse effects were reported.
One year subsequent to receiving vax the pts had no antibody levels . the pts sought unspecified medical attention.  Additional information is requested.
Patient was sitting up, received first vaccine, DTap, in right arm. Immediately following, she received 2nd vaccine, Menactra, in the left arm. Immediately following 2nd injection, her eyes rolled back in her head. Nurse used mechanical exam table to lay her back, and father helped to lay supine as mechanical bed was moving down. It was noted that as dad pushed her toward the exam table, her arms jerked 3 times. No leg jerks. She became responsive after being layed down, was drowsy, oriented x3, bp 100/60. Neurologically intact. She was given orange juice and monitored for 1.5 hours in the office. Upon leaving, patient was alert, oriented, talking, laughing, and smiling. She was able to walk, was neurologically intact.
heavy arm sensation then tunnel vision, then pt passed. MONITORED FOR 30 MINUTES NO TREATMENT.
Pt experienced fever, body aches, extreme fatigue, headaches.   Missed 1 day off of work and caused to him to go home early on 2nd day.  Had sx's for 3 days.
pt recv vax APR96 & 2wk later pt devel a rash over the entire body;no further details were provided;
My left arm got red, hot, and swollen on Sunday morning after receiving the booster shot, my left eye lid on the corner also got red and swollen. Plus my lips got beat red.
Bell's palsy; Pain; Pyrexia; (Reference number: 1402825) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-May-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 10-Jun-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), PAIN (Pain) and PYREXIA (Pyrexia). At the time of the report, BELL'S PALSY (Bell's palsy), PAIN (Pain) and PYREXIA (Pyrexia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   steroid, anti viral, and antibiotic were prescribed by doctor.  The patient's past medical history included Lyme disease. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was unknown.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB, that was stored improperly (dosage, lot# and route of administration not provided). No adverse event effects reported. Additional information is not expected, as the reporter did not wish to be contacted. Additional information is not expected, as the reporter did not wish to be contacted.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hormone replacement therapy" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Patient has no Known allergies. Anti viral details: Product: COVID 19 treatment  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 available information, there is reasonable possibility of causal association between the events vaccination failure and COVID 19 and suspect vaccine BNT162B2.
This patient received a bivalent moderna vaccine when they should have completed their primary series first.  We realized that they should finish their primary series and they are coming back to the pharmacy to finish the series.
approx 3wk p/vax nose bleeding, bruising to the touch, red dots (petechia);went to pediatrician, upon exam dx ITP sent to hosp;bone marrow test taken negative;hosp 3 days given gamma immune globulin & pred;
Chills, fever, nausea, diarrhea, dizziness, near fainting, sore muscles all over, sore skin all over, paleness, drainage and coughing, thirst, weakness, inability to sleep, bad dreams during periodic few minutes of sleep. Symptoms persisting after 20 hours are tiredness and weakness.
Patient complained of headache, ringing in ears, + occasion blurred vision. Given a Medrol Dose pack.
numbness on my head/numbness in head/now the numbness has moved to the back of her head; feel dizzy; left arm pain; itching on forehead; left breast pain,; memory issue; scalp  is  making  noises,; body aches; headache; chest pain on the left side; back pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead) and CHEST PAIN (chest pain on the left side) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM and PERPHENAZINE for Paranoia, CHLORPHENAMINE MALEATE (CHLORAMINE S) and DIPYRIDAMOLE (PERSANTINE) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced CHEST PAIN (chest pain on the left side), BACK PAIN (back pain) and HEADACHE (headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches). On 06-Aug-2021, CHEST PAIN (chest pain on the left side) had resolved. At the time of the report, HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches) outcome was unknown and BACK PAIN (back pain) and HEADACHE (headache) had not resolved.        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.   No Treatment was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up recieved ,events were updated, On 09-Aug-2021: Significant follow up- Events updated On 11-Aug-2021: significant follow up appended
Soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s):  A 56-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; treprostinil sodium (TREPROSTINIL SODIUM), since 20Nov2020 (ongoing) (Lot number: 939656, Expiration Date: 31Jan2023) at 0.07 ug/kg (0.070 ug/kg), iv drip for pulmonary arterial hypertension. The patient's relevant medical history included: "pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: OPSUMIT. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Soreness". The action taken for treprostinil sodium was unknown.  Addition information: This is a 56 years old, 112 lb female patient began therapy with Remodulin (treprostinil sodium, concentration 2.5 mg/ml), on 20Nov2020 for primary pulmonary arterial hypertension. The current dose was reported as 0.070 µg/kg, continuous via intravenous (IV) route. On an unreported date in 2022, the patient experienced the event of soreness (pain). It was reported that patient had soreness after getting COVID booster shot. The reporter did not provide causality for the event of pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
acute hives secondary to unknown cause. Generalized allergic reaction with skin rash. Prednisone 20 mg: every day for 4 days. 20mg Pepcid daily.