chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states aprox. 6hrs after injection had a neck ache, back ache, and a "migraine" headache. The neck/back ache went away the next day, but headache remained.
This case was reported by a physician via a sales representative and described the occurrence of hepatitis b antigen positive in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included chronic renal failure and dialysis. On an unspecified date the subject received 1st dose of ENGERIX B. Five days after vaccination with ENGERIX B, the subject turned out to be hepatitis b antigen positive. It was noted that the subject was hepatitis B surface antigen negative previously. Five days after receiving his first dose of ENGERIX B vaccine, a hepatitis serology was mistakenly drawn and the result was that the subject tested positive. The result persisted out to day 18. On day 20 and 21, the test results were negative. All of the other results in the hepatitis serology were negative. The subject was to have another test on day 30. At the time of reporting the outcome of the event was resolved.
PATIENT STATES FEELS LIGHTHEADED AND FLUSH AFTER INITAL 15 MINUTE WAIT TIME. PATIENT HAD NO INCREASE IN HEARTRATE. PATIENT STATES HAS NOT HAD ANYTHING TO EAT TODAY. PATIENT GIVEN WATER AND PEANUT BUTTER CRACKERS AND OBSERVED ADDITIONAL 15 MINS WITH NO OTHER COMPLAINTS AND FEELS BETTER.
patient woke at 11pm the day vaccine was given states he was cold + shaking, lasted a minute.
night sweats; Light headache; dizziness; loss of appetite; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite), FATIGUE (tiredness) and NIGHT SWEATS (night sweats) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (Light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness). On 15-Feb-2021, the patient experienced NIGHT SWEATS (night sweats). On 17-Feb-2021, NIGHT SWEATS (night sweats) had resolved. At the time of the report, HEADACHE (Light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment for the event included Tylenol.    This case was linked to US-MODERNATX, INC.-MOD-2021-016096 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016096:same reporter, different patient
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. (This VAERS writer assigned to form completion was not the administrator of this vaccine.)
At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours.  At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day.  I still get headaches in the front of my forehead since 2/5/21.
IBD; Fever of 100.1; Bad nausea; Chills; Dizziness; fell down from the dizziness, lost his footing; Dizziness; fell down from the dizziness, lost his footing/suffered from dizziness before, but that was maybe about a year ago; Dizziness; fell down from the dizziness, lost his footing; dehydrated; This is a spontaneous report from a contactable consumer. A 49-years-old male patient (husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK9231), via an unspecified route of administration on an unspecified date (49-years-old) at single dose (Left arm) for COVID-19 immunization. Medical history included dizziness. The patient's concomitant medications were not reported. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that the app is down, the safety app because they were trying it. Reporter was calling to report side effects.  Reporter and husband, for which they were calling about, they took the Pfizer COVID-19 Vaccine at 7:30 am on an unspecified date. When probed for side effects, reporter stated that the patient experienced Fever of 100.1, really bad nausea, and chills. He also experienced some dizziness, so much that he fell, he fell down from the dizziness, and he lost his footing. Reporter was informed about role of Pfizer Drug Safety. When asked about other medical conditions, reporter stated that he had dizziness, he had suffered from dizziness before, but that was maybe about a year ago, he suffered from occasional dizziness but he may have been dehydrated because he didn't have that much water today. On lab work, reporter stated that actually he did, it said something about the (statement incomplete), he did have blood work, but it said something about he has disposition, well, it's such a small sign of IBD (further details unknown). Reporter stated that they gave him two Tylenols 500 mg each as treatment. The outcome of the events was unknown.
Vomiting; Diarrhea; Shivers; Delusional thoughts; This is a spontaneous report from a contactable consumer. A 63-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 15:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient medical history included penicillin allergy. Concomitant medications were not received in two weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 20Mar2021 at 17:45, the patient experienced vomiting, diarrhoea, shivers, delusional thoughts. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vomiting, diarrhoea, shivers, delusional thoughts was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had around a 3-4 inch circle that was red, raised, warm, sore on my right arm after injection.  It went away after the first week and came back around the 10th day after vaccine more red, more raised, warmer, and sore.
Loss of consciousness and seizure at Dr. office.  Later that evening:  headache, neck pain, extreme muscle weakness, inability to walk, confusion.  She also missed the next two days of school.  Felt very sick.  I called the Dr's office thinking I would have to bring her to the emergency room.  The nurse called the Dr. saying she didn't know anything about the vaccine.  Dr. called her back to say keep an eye on her.
Patient had a low grade fever after the booster dose; Patient had slight fatigue after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had a low grade fever after the booster dose) and FATIGUE (Patient had slight fatigue after the booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced PYREXIA (Patient had a low grade fever after the booster dose) and FATIGUE (Patient had slight fatigue after the booster dose). At the time of the report, PYREXIA (Patient had a low grade fever after the booster dose) and FATIGUE (Patient had slight fatigue after the booster dose) outcome was unknown.            No concomitant medications were reported.  It was reported that, the patient had a low grade fever and felt like they had slight fatigue after booster dose.  No treatment information was reported.   This case was linked to MOD-2021-406507 (Patient Link).   Reporter did not allow further contact
Follow-up: spoke with Pt who states that some of the rash remains but has much improved, she applied some topical Benadryl over it, and has had no itching since.   the rash eventually spread from the arm to the shoulder and part of her collar bone, but has not progressed further.   *mild headache and aches she only experienced the day of  the shot and they only lasted a few hours.   Advised: to call us with any questions. If she experience return of symptoms or worsening f/u with physician
I began to feel dizzy or like I may faint 3 and a half hours after receiving the shot. Next day had serious fatigue and fever. Feeling much better now that the fever has broken
CHILLS; FEVER; 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, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered to the right arm, on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 16-MAR-2021. This report was non-serious.
passed out; sweating profusely; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history provided.  Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and HYPERHIDROSIS (sweating profusely). On 13-Apr-2021, LOSS OF CONSCIOUSNESS (passed out) and HYPERHIDROSIS (sweating profusely) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.; 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.
Shingles-pain started 12/13/18, rash 12/17/18.
Headache, Myalgia, Fever, Diarrhea, fatigue Narrative:
About 1 & 1/2 hours after patient received FLUVIRIN Injection he returned to pharmacy with symptoms of allergic reaction. Rash & itching on arms, chest & head. Dr. said for patient to take 1-2 BENADRYL 25mg every 4-6h & if not better to go to ER.
FLU LIKE SYMPTOMS; TASTE NOT AS USUAL; DECREASE IN SMELL; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of event reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1008609, and batch number: 1008609 expiry: 09-JUN-2021) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Vaccinated on Left arm. No concomitant medications were reported. On 28-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced decrease in smell. On an unspecified date, the subject experienced flu like symptoms, and taste not as usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 29-MAR-2021, and had not recovered from flu like symptoms, taste not as usual, and decrease in smell. This report was non-serious.
Initial unsolicited report received from a physician on 14-Feb-2018. This case is linked with: 2018SA057952, 2018SA058253. This case involves a 12 years old patient (gender not reported), who was vaccinated with FLUBLOK QIV (expiration date, lot number, route, dose, dose in series and site of administration not reported) on an unknown date. This was a case of actual medication error due to inappropriate age at vaccine administration. On an unknown date, the patient developed a non serious rash diagnosed as a reaction to latex a "few months ago" (rash) following the vaccination with  FLUBLOK QIV. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received from a physician on 17-Dec-2018. No new information was provided. Follow up information received on 31-Jan-2019 from other health care professional. Event added and corresponding changes was made in narrative and fields accordingly. Documents held by sender: none
Fever of 102; chills; muscle aches; headache; brief loss of taste; insomnia; tenderness at the site of injection; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 40 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 09Mar2021 07:15 (Batch/Lot Number: EL3248) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and oral birth control. The patient experienced fever of 102 causing pyrexia on 10Mar2021 03:00 with outcome of recovered, chills on 10Mar2021 03:00 with outcome of recovered, muscle aches causing myalgia on 10Mar2021 03:00 with outcome of recovered, headache on 10Mar2021 03:00 with outcome of recovered, brief loss of taste causing ageusia on 10Mar2021 03:00 with outcome of recovered, insomnia on 10Mar2021 03:00 with outcome of recovered and tenderness at the site of injection causing injection site pain on 10Mar2021 03:00 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature at 102.   No follow-up attempts are possible. No further information is expected.
Severe hives for a duration of 3 hours starting on stomach and spread throughout entire torso including back, arms, stomach, difficulty breathing.  Took antihistamine and symptoms subsided.
diagnosis of neuralgic amyotrophy  Arm pain and numbness within 48 hrs of first dose.  First dose received on March 22, 2021. Symptoms gone after two weeks.  Arm pain and numbness within 48 hrs of second dose. Second dose received on April 29, 2021. Symptoms more intense after second dose. Severe pain in upper shoulder and radiating down to fingers. Arm and hand weakness began within 1 week. Muscle atrophy of hand and back. Symptoms still continuing at date of report 7/24/2022.  Treatment by neurologic team consisting of pain management and physical therapy.
Received vaccine on 12/20/2001 at 4:30 PM. On 12/21/2001 arm swollen and painful. Developed urticaria which lasted about 10 days.
23JUN91 fever, not measured, joint pain & stiffness, "knot came upon rt wrist-dx ganglion; 28JUN91 still have knot on wrist & back hurting today;
presented with AMS, n/v, Upper GI bleed?;  Initial Covid test negative but + Influenza B;  + covid 9/21; tx with : 9/17 rocephin, 9/22 steroids, 9/23 actemra; Pt had GI bleed throughout visit; Initially no O2 needed; 9/23 resp decline and dx with covid PNA; began Covid tx; 9/24 intubated 0200.010201.010202.010203.010204.010205.010206.010207.010208.01Patient developed multiorgan failure, along with ARDS/DIC. Family decided withdrawal of care. And she is pronounced dead at 1803.
Menveo administered to patients greater than 55 years old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo administered to patients greater than 55 years old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The pharmacist reported that she saw Menveo administered to patients greater than 55 years old but not at this current facility. Pharmacist declined safety team follow-up as the administration of Menveo in patients over the age of 55 years did not occur at the current facility.  No patient involvement at current facility. The reporter did not consented to follow up. The 55 years old patients received Menveo, which led to inappropriate age at vaccine administration.
This spontaneous report was received from a 70-year-old female patient who refers to herself. The patient's medical history was not reported. The patient's concurrent conditions included high blood pressure, thyroid issues and allergy to codeine, morphine and TYLOX. The patient's concomitant therapies included unspecified high blood pressure and thyroid medications. On an unknown date in 2015 (reported as "about 2 years ago" and "on an unspecified date 2 years ago") at around 2-3 pm., the patient was vaccinated with 1 dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported), reconstituted with sterile diluent, for prevention of shingles. On an unknown date in 2015 (reported as "later that night"), the patient developed a burning sensation at the injection site with a little red round circle ("about the size of a half dollar") that was dark in the middle and then became lighter on the outside. The patient stated that she iced the area and went to sleep. The following morning, the circle developed into a 4 inch round circle and was still burning. The patient went to her pharmacist, who stated that she developed shingles. The pharmacist then talked with the patient's physician to ask the physician to prescribe an unspecified pain medication. The physician refused to prescribe any medication until he had seen the patient. When the patient went to her physician, the physician stated that it was not shingles, but an infection. The physician further stated that the ZOSTAVAX "was not mixed enough" and that the powder was "underneath her skin instead of having been mixed properly with the diluent". The patient was prescribed an unspecified antibiotic and had recovered about a "week, or week and half" after starting the antibiotic. Product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported.
Client stated she had not yet eaten today, given cookies while waiting for immunizations.  Client became light-headed within one minute after receiving immunization.  Assisted to supine position in chair (gravity chair).  Given juice to sip. 11:01 am  Pulse 60, skin slightly clammy, slightly pale.  Given juice to sip.    11:04 am BP 110/66 11:07 am  BP 112/64, pulse 60.  States feels better, skin no longer clammy, color improving, continues in reclining position.  11:10 am Pulse 64. Finished juice. Given a sucker.  Assisted to sitting position in gravity chair.  Tolerated well.  11:12 am  BP 110/56, pulse 72.  States feels good.  Color continues to improve, skin warm and dry.   11:14 am Ambulated to lobby with assistance, tolerated well, no c/o of light-headedness or other problem.  Mom instructed to wait in lobby for 10 minutes and okay to leave if patient was feeling well in 10 minutes. 5:37 pm P/C to client's residence, spoke with Mom: states patient did not have any more problems since she left the HD and she is feeling fine now.  Instructed to call PCP/HCHD prn.
pt felt faint, pale, clammy, and eyes rolled in back of head, major symptoms resolved in 10 minutes but continued to feel weak
got the flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and gender patient who got the flu after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient got the flu (influenza) (latency: unknown) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  The outcome was Unknown.