chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received fom a physician concerning a 28-year-old pregnant female who on 28MAR97 was vaccinated with one dose of VARIVAX SC. The patient learned that she was pregnant that same day (LMP 28FEB97). The estimated date of delivery is 05DEC97. Follow-up was received froma a physician. Medications during the patient's pregnancy included a prenatal vitamin. Following exposure to a child with chickenpox in a school setting, the patient broke out with chickenpox on 08JUL97 (GW 19). The case was described as mild to moderate. In the physician's opinion, the chickenpox was due to exposure to wild-type virus ans not to VARIVAX vaccine.
SWELLING BELOW INJECTION SITE. WENT TO THE ER AND GOT A STEROID SHOT AND TOOK BENADRYL. PATIENT WAS FINE.
CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever.  On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. This report was non-serious.
developed COVID-19 infection, two days after vaccination; This is a spontaneous report from a Pfizer-sponsored program received from a contactable pharmacist. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID-19 infection two days after vaccination in Aug2021. The pharmacist reported that the patient received the first dose of the vaccine then afterwards, in the earlier part of August, he developed COVID-19 infection. The pharmacist wanted to know if the patient should proceed with the second dose, and what was the waiting period in between both doses. Outcome of the event was unknown.    The lot number for BNT162B2 was not provided and will be requested during follow-up.
On 08/13 2021 after my 2nd dose. My mouth was dripping out of no where in the morning when I woke up. It affected  my right side. I couldn't move at all. I went to my doctor on 08/13/2022. I was diagnosed with Bell's Palsy. After a week later they did an MRI it was non-stroke. My doctor prescribed me prednisone. He also referred me to a Neurologist. I got therapy for 2 times a week for 9 weeks. On June I went to ER because I was having issue with blood. I also had a mini stroke. I was also diagnosed with ITP 03/09/2022.
This spontaneous report was received from a pharmacist, and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with a dose of improperly stored ZOSTAVAX, for prophylaxis. No adverse effects reported.
Mom reported that Pt. woke up with itchy elbows, rash on face, arms, chest torso, chills, tired. Her arm was also sore. She only had a slight local reaction at vaccine site due to the bandaide. Mom describes the rash as similar to prickly heat. Temperature was not taken. Mom applied Cortisone Cream listed previously twice and the itching improved. Rash resolved over one week ago --a few days after the vaccine was given. Pt. has had GI upset and diarrhea x 6 on 10/13/23. She also complains of nausea and has not been back to school yet.
Swelling Lymph node on left arm pit; This is a spontaneous report from a contactable Healthcare Professional reporting for himself. A 34-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL3247, in Hospital, via intramuscular route in left arm on 25Jan2021 at 11:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EL0142, via intramuscular route in left arm on 05Jan2021 at 11:00. The patient was not tested for COVID-19 after the vaccination. There were no concomitant medications. On 27Jan2021 at 02:00 AM the patient experienced swelling lymph node on left arm pit. No treatment was received for the event. The reported event had not resolved yet at the time of the report.
mom called & said pt's rt foot is swollen & legs are purplish to diaper area; also arms are kind of purplish; advised to take pt to MD/clinic; no breathing problems & fine otherwise;
patient who does not meet criteria to receive GARDASIL 9 because "patient is in her 50s", but is planning to receive GARDASIL 9; There was no report of GARDASIL 9 being administered at time of the call; No additional AE reported.; This spontaneous report was received from a medical assistant and refers to a female patient who is in her 50s. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The reporter stated that on an unknown date, the patient was planning to receive a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), despite the fact she did not meet criteria to be vaccinated due to her age (product administered to patient of inappropriate age, circumstance or information capable of leading to medication error). No additional adverse event reported.
First night couldn?t breathe. Very tight chest. Extreme leg pain. Shivering. Couldn?t get warm. Fast heart beat.
CHEST PAIN; MUSCLE CRAMPS; MUSCLE WEAKNESS; LEG PAIN; SHARP PAINS IN HEAD/HEADACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and smoker, and other pre-existing medical conditions included the patient was healthy. The patient had no known allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced muscle cramps. On APR-2021, the subject experienced muscle weakness. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced sharp pains in head/headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pains in head/headaches, muscle weakness, muscle cramps, chest pain, and leg pain. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Nausea and vomiting, approx 45 min post injection, vital signs stable,  Rt deltoid slightly red and injection site has small knot, lightheaded.
vaccine at 0730, at 0740 vomited in Bathroom 0750 - nausea continues 0800 - mild nausea, improving, pt went home
She received her injection in her left arm. She stated that about a week after she received her shot she got a cold that kept on lingering, she had a body ache, was tired and lethargic. The first week her left arm was sore and she had a red area the size of a tangerine, it was hot to the touch. During the week it moved down her arm. It was all gone by 11/4/2009. She did not have any numbness or tingling. She does swell up with bug bites. Has received seasonal influenza vaccine 3 times previously.
L arm moderate erythema, moderate swelling all localized-Motrin 500mg 3 x daily, elevation.
Fever, aching body, tiredness.. arm where shot was given was swollen and tender and had  fever in it... took ibuprofen and Benadryl
Macular rash developed all over body 3 hrs after HPV vaccine. Pt has itchiness but no dyspnea or vomiting.
pt recvd flu vax & devel local redness & soreness in the arm of inject;
DIZZY; COULD NOT EAT FOOD; NOT FEELING GOOD; NAUSEA; BAD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNWON) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported an has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced dizzy, could not eat food, not feeling good, nausea, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling good, and the outcome of bad headache, dizzy, nausea and could not eat food was not reported. This report was non-serious.
I went to pharmacy to complete my Pfizer vaccination series. After my vaccination was complete, the vaccinator removed the needle and noticed I was bleeding considerably. She asked if I was on blood thinners and I told her I was not on any medication. The bleeding stopped and I went to sit in the waiting area. A few minutes later she came and told me that the syringe was empty and I would need a second shot. She did not explain how she knew it was empty. She administered the second shot, I waited the required amount of time, and then I left. I am reporting the error related to the presumably empty syringe.
Patient has had no reported side effects.; Nurse reported that a dose of PROQUAD was administered to an 18 year old male on Tuesday, 7/28/2022 instead of the individual MMR-II and VARIVAX.; Nurse reported that a dose of PROQUAD was administered to an 18 year old male on Tuesday, 7/28/2022 instead of the individual MMR-II and VARIVAX.; This spontaneous report was received from a certified medical assistant other health referring to an 18-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 26-JUL-2022 (also reported as on Tuesday), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milliliter, subcutaneously, lot number W006583 and expiration date of 23-AUG-2023 for prophylaxis. (anatomical location was not reported), instead of the individual Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient had no reported side effects (wrong product administered and product administered to patient of inappropriate age).
rash on arms and legs, small boils on skin, some medium size rings of boils, red areas highly irritating , persisting many weeks
high fever to 104 R x 3 days, jerking motions, lethargy & dec feeding, vomiting; pos CSF for WBC's neg gram stain; neg cx;
Moderate Facial swelling, Full body hives and itchy skin starting 10 days after injection.   Treated with benadryl, pepcid, steroids with little relief.  Symptoms still ongoing 2.5 weeks later slightly milder than when initially observed with ongoing medication.
Patient looked unsteady standing up immediately following vaccination. Patient was given support and sat in a chair. Patient reported dizziness and tiredness. Nurse and pharmacy student observed patient for half hour. Patient began to report memory loss and chills. Patient was closing her eyes and seemed to be falling asleep in the chair. Patient denied eating anything all day and acknowledged she very anxious and nervous. Patient reported missing her clonazepam dose at noon and reported that she feels very anxious often. 911 was called in order to obtain vitals on the patient. Vitals were stable and patient refused transport to hospital. Patient was wheeled out of facility in a wheelchair and was driven home by her fiancé approximately 35 minutes following vaccination.
DOES NOT SLEEP MUCH ONLY 4-6 HOURS INSTEAD OF 9 HOURS SLEEP AS USED TO; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included lyme disease, and concurrent conditions included headache.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for headache. On 23-JUN-2021, the subject experienced unexpected therapeutic benefit. On an unspecified date, the subject experienced does not sleep much only 4-6 hours instead of 9 hours sleep as used to. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unexpected therapeutic benefit and does not sleep much only 4-6 hours instead of 9 hours sleep as used to was not reported. This report was non-serious.
Patient received MENACTRA in (L) deltoid. Was fine, walked out of exam room. Fainting in waiting room. BP was down 70/40.
got terribly sick; was feeling horrible; because of her compromised immune system she may have had a delayed reaction; Diarrhea; Loss of appetite; Headache; Nausea; Fatigue; Body aches; 103 fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS ("has a bunch of autoimmune disease since before the vaccination").   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills). On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown and ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible), HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that the patient's doctor advised her to get tested in case she picked up Covid or the flu. She was subsequently tested and both were negative.  The patient reported that her reactions ("terribly sick", 103 fever, chills, body aches, "feeling horrible" and "may have had a delayed reaction") lasted for 4-5 days and then stopped and she no longer has symptoms.   This case was linked to MOD-2021-035549, MOD-2021-035549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received: Additional events were added ("got terribly sick", "feeling horrible" and "may have had a delayed reaction"); outcome for fever, chills and body aches updated; reporter details updated; narrative updated.
pt recv 1st dose of varivax 2/97 & 4/98 pt devel a ``mild case'' of varicella
Initial report received from a pharmacist on 08 Mar 2010: It was reported that, expired dose of Influenza virus vaccine (unknown batch no.) on an unknown date. It was also reported that the vaccine expired in Feb and was administered six days after the expiration date. The outcome of the event was reported as unknown.
ELEVATED HEARTBEAT; LIGHT-HEADEDNESS; SHORTNESS OF BREATH DURING THE NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 13:00 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient experienced shortness of breath during the night. On 25-MAR-2021, the patient experienced elevated heartbeat. On 25-MAR-2021, the patient experienced light-headedness. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Average of 120. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated heartbeat, and light-headedness, and the outcome of shortness of breath during the night was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Patient admitted for chest pain, occurred 2 days PTA as well as SOB. Tested positive for Covid-19. Patient was treated with antibiotics. Patient had a mild AKI that resolved by discharge. Patient has remained on room air. Patient discharged home.
(L) arm very sore, could not lift, caused a lump. Dizziness, weak, headache, fever, chills, very tired.
Sinus infection; COVID; Arthritis pain; 1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), COVID-19 (COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021) and ARTHRALGIA (Arthritis pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021). In July 2021, the patient experienced ARTHRALGIA (Arthritis pain). In February 2022, the patient experienced COVID-19 (COVID). On 15-Mar-2022, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021) outcome was unknown, COVID-19 (COVID) was resolving and ARTHRALGIA (Arthritis pain) had not resolved.            No concomitant medication was reported. In July 2021, the patient experienced ARTHRITIS PAIN. In February 2022, the patient experienced COVID. On 15 Mar 2022, the patient experienced SINUS INFECTION. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  On Feb 2022, patient had COVID and she still had the cough. On 15 Mar 2022, she was home sick with what she thought was a sinus infection. She also had a low grade fever. She thought that the two COVID vaccines triggered her RA and started to feel the arthritis pain about four months later after the vaccines.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I waited the 21 days plus 2 weeks to get the second dose. Immediately after receiving the second dose I had a headache. About a couple of hours later I started having palpitations. I used to have them once or twice a week and now I am having them every other day. I went to the doctor last week and she did an EKG, which came back with irregular heartbeat, delayed. She said everything else was fine. She prescribed me some high blood pressure medication because she said every time I come in my blood pressure is high but when I leave my blood pressure is normal. I did not take it because when I am not there I am not nervous and I do not need it. I am not taking the third shot because I am too scared and nervous. My doctor also told me not to take it until I  take care of my heart.
01/18/22 presents to EC ED for "SOB". PMHx of "recent MI and CABG"
This spontaneous report as received from a other health professional refers to two patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX lot # M005973 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005305.
Neck started to itch, breathing became difficult.  Took Alavert brand allergy medicine and used Xopenex inhaler several times over the next 12 hours.   Slept for 36 hours afterwards.