chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular) .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The reporter reported that the vaccine was possibly reconstituted with sterile water instead of appropriate diluent. Error was discovered and reported when staff thought an empty box was in refrigerator. The date issue was identified was 8th June 2022 The patient could have received inappropriately reconstituted vaccine. Centers for disease control and prevention/GlaxoSmithKline advised to reimmunize the patient. It was a medication error without harm. The reporter consented to follow-up. Additional supportive information: The patient received the inappropriately reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This is 1 of 5 linked case, reported by same reporter, for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117819:Same reporter US-GSK-US2022AMR117816:Same reporter US-GSK-US2022AMR117801:Same reporter
She was diagnosed with CIDP after her second dose of the COVID-19 shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 , Manufacturer Unknown), for COVID-19 Immunisation. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "She was diagnosed with CIDP after her second dose of the COVID-19 shot". Clinical course: A woman came up to reporter at the (Name withheld) at the conference and reported she was diagnosed with CIDP after her second dose of the COVID-19 shot. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
light ringing in my left ear started within a week of this vaccine.   Went to my Dr. as well as Ear Dr. to test if my hearing was different but hearing is still fine in both ears.   No treatment seems to be available and I am open to trying whatever as it has been 24 hours a day 7 days a week for 21 months.
THE NEXT DAY OF VACCINATION. VERY SORE ARM AND WHAT THE PATIENT DESCRIBED AS FLUISH LIKE SYMPTOMS THAT KEPT HER IN BED FOR A WHOLE DAY.
Moderna Vaccine  Red bumpy itchy rash on upper thighs,  back, and stomach.
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M010486, expiration date 25-MAY-2017 and lot # L046893 expiration date 23-FEB-2017 (dose, route of administration and anatomical location were not provided). The vaccines were frozen and exposed to the following temperatures and time frames out of range: -3 Celsius degrees for 261 hours between 17-JUN-2016 and 24-JUN-2016, -6 Celsius degrees for 50 hours between 28-JUN-2016 and 30-JUN-2016, -1 Celsius degree for 191.5 hours between 30-JUN-2016 and 07-JUL-2016, -3 Celsius degrees for 336 hours between 08-JUL-2016 and 19-JUL-2016, -3 Celsius degrees for 166.5 hours between 19-JUL-2016 and 27-JUL-2016, 0 Celsius degrees for 84 hours between 29-JUL-2016 and 01-AUG-2016, -1 Celsius degree for 36 hours between 01-AUG-2016 and 03-AUG-2016, 1 Celsius degree for 193 hours between 03-AUG-2016 and 10-AUG-2016, -1 Celsius degree for 344.25 hours between 11-AUG-2016 and 25-AUG-2016, 0 Celsius degrees for 161.25 hours between 26-AUG-2016 and 31-AUG-2016, -3 Celsius degrees for 21 hours between 01-SEP-2016 and 02-SEP-2016, -2 Celsius degrees for 131 hours between 02-SEP-2016 and 07-SEP-2016, -2 Celsius degrees for 46.5 hours between 07-SEP-2016 and 09-SEP-2016, 0 Celsius degrees for 143.75 hours between 09-SEP-2016 and 15-SEP-2016, -1 Celsius degree for 110.25 hours between 15-SEP-2016 and 20-SEP-2016, -3 Celsius degrees for 57 hours between 20-SEP-2016 and 22-SEP-2016, 0 Celsius degrees for 136 hours between 22-SEP-2016 and 28-SEP-2016, 0 Celsius degrees for 71.5 hours between 27-SEP-2016 and 30-SEP-2016, and -2 Celsius degrees for 94 hours between 03-OCT-2016 and 05-OCT-2016 (summary time of excursions 2634.5 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 14MAY98 & 29MAY98 sl fever started breaking out w/chickenpox-by Sunday had 10-12 pox crusted over by 3JUN98;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2008, a healthcare provider at a department of health administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (reported as PEDVAX HIB) (lot #, expiry date, route, dose, strength and indication not reported). The reporter stated that the unspecified number of patients received PEDVAX HIB at intervals of 2, 4, 6 and 12 months. No adverse symptoms reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF 10MCG FORMULA
Hives developing in different areas; not all at the same time. It started with gluteal area, moved to elbows, arms and waist. It disappears and reappears in different areas. No redness or irritations around the injection sites. Allergic reaction.
cellulitis surrounding the injection side, shoulder and upper chest; cellulitis surrounding the injection side, shoulder and upper chest; rash-like syndrome; This spontaneous report was received from a physician assistant via company representative and refers to a 66-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029916 has been verified to be a valid lot number, expiration date 12-JUN-2021, for prophylaxis (exact dose, dose number, route and site of administration were not reported). On 06-FEB-2020, the patient sought medical attention and came to the office, as she experienced fever, rash-like syndrome and cellulitis surrounding the injection site, shoulder, and upper chest.  The patient was prescribed an unspecified steroids as a treatment for adverse events. The outcome of events was not provided. Causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, the event of cellulitis was considered to be medically significant.
Large knot, about the size of a golf ball. Painful, red, and warm to the touch. Redness has increased from 24 hours to 48 hours. Loss of smell temporarily on day of vaccine.  Headache and fatigue for 48 hours.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017) (dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccine experienced the temperature excursion of 0 degrees Celsius for 6 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Diagnosed with shingles; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself. A 75-year-male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration date: unknown), via an unspecified route of administration in left arm on 24-JAN-2021 at 12:55 at single dose for COVID-19 immunization. The patient medical history was not reported. Patient concomitant included of unspecified flu shot, no further details provided about this medication. On 11Feb2021 patient diagnosed with shingles and prescribed Valtrex 1000 mg for shingles. patient wants to know if there was a contraindication for taking valtrex and getting the vaccine as well as having shingles and getting the vaccine. The outcome of event was unknown.   Follow-up (11Feb2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient).  Follow-up (11Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 75-year-old consumer (patient) reported that:
Mild swelling, soreness at injection site.  Probably normal reaction.  No tx needed.
Day 1-2: sore arm Day 3: splotchy rash at injection site Day 7: rash larger than 2" across, hives, itchiness, hot to the touch, and tender lymph nodes under the arm at/near the injection site.
Face including left eye, nose and cheek and started to swell. She said her ear and neck hurt also.
Sleepy within 2 hours of injections. Slept longer than normal for nap. Flushed cheeks around 4 PM,  fever about same time. Inconsolable for bedtime. Didnt want to nurse. Injection site a little red. Fever stayed at least 100.1 on next day 02/21/19. She was whiny as of she didnt feel good. In injection site super red and big on left thigh. 02/22/19 no fever finally. She hardly nursed. By noon she would have nursed like 3-4 times and she had only nursed once. She was like that all day. Also whiny again, as if she didnt feel good. Injection site still red and big. 02/23/19 injection site not red but a lump under skin. 02/25/19 lump still under skin at injection site.
Ongoing pain at injection site left deltoid: flu shot received: soft tissue injury. 4 weeks since injection now warmth, erythema edema at site when reported on 10-21-13 currently receiving OT.
No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 2-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error). The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004896: US-009507513-2108USA004878:
I wake up the next morning with rash on my chest and stomach that lasted for 2 days. I was very tired and fatigue. I had chills and fever. These lasted for the day. The next day, I had high blood pressure. My heart was racing and I could not sleep. The next day, I went to my doctor. They hooked up to a 24-hour heart monitor. They had to put me on high blood pressure medicine. I had a virtual visit with the cardiologist. They order an EKG and Echocardiogram, normal result. My symptoms lasted for about 3 weeks.
Follow up labs, Employee Health, new hire screening. 4/12/18. Went to ER, 4/20/18. 4/23/18 complaint of rash, fever, diarrhea. Seen at Employee Health 4/23/18. Generalized rash, fever, diarrhea, headache. Appointment scheduled Infectious Disease 4/25/18.
Mom asking if nosebleeds are adverse reaction to H1N1 intranasal received. No profuse blood but some on tissue when nose blown.
Severe muscle aches, chills, fever, and abdominal pain x8 hours   Flare up of underlying IgA nephropathy with gross hematuria x5 days
The afternoon of the injection my arm became a little red and puffy and was very sore to touch. By evening it hurt to move my arm. The following day I woke with a headache and a little nausea...as the day went on, I had aches and pains and was very lethargic. I took Tylenol and a 3 hour nap but still wasn't much better. I had a little soup for dinner and another Tylenol before bed. I woke feeling better but the arm is still very sore to touch. I had the same symptoms after the first injection so I almost didn't get the 2nd one.
An insignificant amount of Stiffness / Soreness in neck about 3 to 4 vertebrae south of the base of the skull.   Slight to noticable light headed or slight dizziness regardless of physical position. Drinking plenty of water, adding in Gatorade for electrolytes. Was wondering if any OTC (advil,tylenol,etc) was recommended for the light head. If not I'll probably be fine in a day, just reporting in and hoping to speed this along. I'll probably just go to sleep for the day and if anything gets worse I'll submit another report. The time is 2:50 pm. Thanks for the hard work everybody. Have a nice day.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with drug reaction or allergy to codeine. The patient was vaccinated with a dose of PNEUMOVAX 23 on 05-SEP-2012 (lot number reported as 1947AA with expiration date 20-OCT-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included VYTORIN and BENADRYL. It was reported that on 05-SEP-2012, the patient developed a fever that persisted for 3 days, pain, swelling, inflammation that extended to the patient's shoulder, difficulty in moving her arm and rash around the injection site after receiving PNEUMOVAX 23. On an unknown date, ultrasound was performed to check for blood clots, results were negative. FLEXERIL, ADVIL and MEDROL dosepak were given as treatment for the adverse events. The outcome of inflammation that extended to the patient's shoulder, rash around the injection site, pain, swelling and difficulty in moving her arm was reported as not recovered/not resolved. The outcome of fever was reported as recovered/resolved (persisted for 3 days). The relatedness for inflammation that extended to the patient's shoulder, pain, swelling, rash around the injection site, difficulty in moving her arm and fever is unknown for PNEUMOVAX 23. Additional information has been requested.
3/1 tired and diarrhea 3/2 I was ok. 3/3 I had chills all day and  I was dizzy. I was also nauseous in the mornings. 3/4 I had no nausea and no diarrhea but I had no appetite and food made me gag. still had chills and extremely dizzy. felt the same until 3/7 the chills went away. 3/8 I was and am still dizzy and I had soft stools and no appetite.
pt recvd vax; w/in 15mn of vax; pt exp chills; fever; & felt sick; pt exp also weakness & aches all over;
swollen lymph node; This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient asked that can a swollen lymph node under arm be a side effect of Shingles vaccine. It was unknown if reporter consented to follow-up.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast and vulvar cancer" (unspecified if ongoing); "vulvar cancer" (unspecified if ongoing); "Interchange of vaccine products" (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 "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : The patient received Paxlovid as a covid treatment is on 26May2022 and stop date of drug is 30May2022. The patient received Letrazole is as Other medication on 01Feb2022. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Since vaccination patient is experiencing nausea and vomiting when eating anything. She cannot keep food down. Last night she experienced severe epigastric pain (points to xiphoid process and sternum). She has had a similar sensation twice before this month as well, before receiving the vaccine. At the time of vaccine administration her BP was in normal range 122/82, today it is much elevated 151/98. Additionally, her hot flashes were under control but had a bad flash last night, currently is sweaty and clammy.
Tested positive for COVID on 07/29/2021 has had moderate symptoms, headache, muscle aches, cough, change in taste and smell, fatigue.
Does something physically he has pain in his arm at night; Pain in his arm periodically; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in his arm periodically) and PAIN (Does something physically he has pain in his arm at night) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm periodically). On an unknown date, the patient experienced PAIN (Does something physically he has pain in his arm at night). At the time of the report, PAIN IN EXTREMITY (Pain in his arm periodically) and PAIN (Does something physically he has pain in his arm at night) outcome was unknown.            no treatment and concomitant medications were reported.
A report has been received from a Health Professional concerning a 7 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 24-Jan-2014. The patient was inadvertently administered expired FLUMIST on 24-Jan-2014 with expiry date: 20-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by reporting health professional.
The 2nd shot, 2 months after the first, had many more severe reactions. Accompanying the extremely severe nausea was shivering that went on for hours along with fever within 4 hours of the 2nd injection. I also experienced fainting about 15 hours later which caused falling twice.
Approx 26 hrs post injection, uncontrollable rigors. Left work early and off flowing day. Crawled in bed under covers. Later che led temp. Fever 103.2. Never in my life. Drank 6 cans gatorade to avoid dehydration. Next morning fever 102.4. Got up strength later to pack clothes and drive home. Back in bed. Reported to my PCP. Felt adverse reaction to vaccine and consulted doc. By third morning all symptoms has essentially dissipated.
Swelling and pain at the injection site over a day later, limited range of motion in the upper arm (can't raise it), chills, fatigue, headache, and sneezing
After flu shot, patient experienced severe pain and inflammation of bursa sac on arm where flu shot administered. Pt's physician said caused by inappropriate placement of flu shot injection. Inflammation shown on MRI. Pt has been in physical therapy since 10/21/15 immunization  and has seen some improvement, but not 100%.
Swollen feet and ankles progressively worsening. Saw my doctor about it. Multiple lab tests,imaging tests,referred to a cardiovascular doctor. The Diagnosis was Bilateral Deep vein thrombosis. Blood test revealed tha I had  a genetic mutation Factor V Leiden, Which is known to be associated with DVT. I am now on a blood thinner, Xarelto.