chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a male patient who was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast). Seven to toen days post vaccination with the first dose, the patient developed swelling of the left eye brow and upper lip. He went to his primary doctor and was treated with oral Benadryl and prednisone. The physician thought that this may be an allergy to orange juice or orange Koolaid. Seven to ten days post vaccination with the second dose the patient developed hives all over her back. He was again treated with Benadryl and prednisone. It was reported that the event improved on therapy and the patient has recovered. No product quality complaint was involved. Additional information has been requested.
PAIN IN THE CALVES OF HER LEGS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAY-2021, the subject experienced pain in the calves of her legs. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in the calves of her legs. This report was non-serious.
Breakthrough case/covid test result = Positive; Breakthrough case/covid test result = Positive; This is a spontaneous report from a contactable consumer (Patient). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: En6206 and Expiry date was not reported), via unspecified route of administration on 15Mar2021 (at the age of 37-years-old) in Arm Left as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8730 and Expiry date was not reported), via unspecified route of administration on 05Apr2021 (at the age of 37-years-old) in Arm Left as dose 2, single for COVID-19 immunization. The Patient Medical history included none from an unknown date and unknown if ongoing other medical history: None. The patient concomitant medications was not reported. The Patient had no known allergies. The patient had received other vaccine in 4 weeks. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had tested for COVID-19 post vaccination. On 09Jul2021 08:00, the patient experienced breakthrough case/COVID-19 test result positive. The Patient did not received treatment. Patient visited emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jul2021 Nasal Swab. The outcome for the events was recovered in 2021.   Follow-up attempts are completed. No further information is expected.
memory issues; focus; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus). At the time of the report, AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter. Follow thru and losing 30-60 mins of time were reported as adverse events.
Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (002191).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: The caller mentioned that the Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.
Many side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Many side effects) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Many side effects). At the time of the report, VACCINATION COMPLICATION (Many side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
first covid vaccine on April 19 is it too late to get 2nd one today; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first covid vaccine on April 19 is it too late to get 2nd one today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first covid vaccine on April 19 is it too late to get 2nd one today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first covid vaccine on April 19 is it too late to get 2nd one today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment information was reported.
I was having hip pain all down my back and it was a radiating pain. It increased as time went on. It got worse so after my second vaccine, it got worse. So, I went to the ER and was given pain medicine.
High fever (102.4) beginning around 2am on 2/4/2021 ending around 2pm on 2/4/2021 Vomiting numerous times from 2pm-4pm on 2/4 Chills starting at 9pm 2/3/2021 still continued  Headache starting at 9pm on 2/3/2021
Onset redness, swelling to left lateral thigh 3mm on 7/18/2002. Positive pruritis and systemic reaction. 7x9 cm area of erythema.
Swollen lymph node under ear on the left side; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Mar2021 at 15:15 (Lot Number: EL3248) (at the age of 30-year-old) as single dose for COVID-19 immunisation.  The patient was not pregnant. The patient medical history was not reported. No known allergies.  The patient did not have COVID-19 before vaccination and not tested positive to COVID-19 since vaccination. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Feb2021 (Lot Number: EL3247) (at the age of 30-year-old) as single dose for COVID-19 immunisation.  The patient experienced swollen lymph node under ear on the left side on 13Mar2021 at 15:30. No therapeutic measures were taken as a result of the event. The patient outcome of the event was outcome of recovering.   No follow-up attempts are possible. No further information is expected.
miscarried; Maternal Drug Exposure; This is a spontaneous report from a non-contactable consumer. A female patient (reporter's friend's daughter-in-law) of unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose, and via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarried on an unspecified date. Patient got pregnant, received the Pfizer vaccine, miscarried; got pregnant again, got the Pfizer vaccine and miscarried again. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First day after second shot  I woke with a heavy metallic aftertaste.  This is day 5 and the metallic taste is still strong and unrelenting.
Pt reported pain/limited range of motion in left arm after vaccine administration lasting for 3 months.
The patient is a 29 year old male. He received his 9th ANTHRAX vaccine on 24 February 2010. He reported that a day after he received the injection he had moderate amounts of swelling around the injection site and it feeling warm. He denies any fevers, chills, night sweats, shortness of breath, tongue swelling and has no other systemic symptoms. He stated that he got the vaccine also in September 2008 and had a similar reaction that lasted for about a week and then resolved.
Erythema and swelling at injection site approximately 1 week post vaccination  No treatment needed as of yet
Swelling, warmth, redness, itchiness, fever x 1 day.
After the shot my arm itched, swelled and was sore, by about 10:00 PM I had swelling to lip/mouth area and arm was very painful,  when I awoke my lip was swollen inside out with fever blister and I had flu systems painful joints and stayed in bed, The fever blister went away in about 4 to 5 days and returned in about 2 weeks, It took about 3 weeks for my body to settle down and arm not be sore.  My husband and I decided to get the COVID Antibody test around May, the antibody test was done by blood withdrawal, The test come back that we did not have any antibodies in our body. We had the COVID19 test Dec 15th, 2020. The test come back that we did not have COVID19.  Should I get the COVID19 vaccine?
BURNING SENSATION IN LEFT LEG; ITCHING IN LEFT LEG; BRUISING IN LEFT LEG; TENDER TO THE TOUCH IN LEFT LEG; KNOT IN LEFT LEG; SELF DIAGNOSED BLOOD CLOT IN HER LEFT LEG BEHIND THE KNEE; SUSPECTED COVID-19 INFECTION; SWELLING IN BOTH LEGS; MUSCLE TWITCHES; CHILLS; TINY LITTLE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included: blood clots prior to getting the vaccine, and concurrent conditions included: marijuana smoker, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no medical history and none medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-AUG-2021 at 16:00 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced chills, tiny little fever, muscle twitches for two days and then patient was fine. On 03-SEP-2021, the patient experienced shortness of breathe, coughing, sore throat, extremely tired as symptoms of COVID-19 (suspected COVID-19 infection) and swelling in both legs. The patient has not had a COVID-19 test performed to clinically confirm the diagnosis.  On 06-SEP-2021, the patient noticed self diagnosed blood clot in her left leg behind the knee. The patient described it as burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg, and knot in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitches, chills, and tiny little fever on 15-AUG-2021, and had not recovered from suspected COVID-19 infection, swelling in both legs, self diagnosed blood clot in her left leg behind the knee, burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg and knot in left leg. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210830488.; Sender's Comments: V0:20210913595- covid-19 vaccine ad26.cov2.s-self diagnosed blood clot in her left leg behind the knee.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient reports she is much more tired than usual, and has "trouble catching breath" 24 hour after Tdap. Encouraged MD eval. This report was by phone. Seen on 8/9/12 to read TST. Patient states she was seen for her symptoms. States WBC's were up a little, but nothing else found. Feels fully recovered on 8/9/12. I have not been able to get a release to obtain MD eval results.
No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent two previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Lump developed on forearm opposite side of injection site with intermittent sharp pain beginning  1/4/21 at approximately 10pm lasting 2 seconds like a sting.
According to spouse, the pt had difficulty breathing 4 hours later after the shot. He was taken to ER and kept overnight for observation. He was given Prednisone while in hospital. Infoirmationreceived from medical records states increased coughing. msv
This is a spontaneous report from a contactable other-HCP via Pfizer sales representative. A 76-year-old female patient received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose in the arm for immunisation. The same day the patient received a shot of Flu vaccine (brand non described) on a different arm. Relevant medical history and concomitant medications were not reported. The patient experienced fatigue, dizziness and fever up to 2 days after received both vaccines. The patient used acetaminophen for manage the fever symptom and rest was recommended. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
Softball sized enlarged right lymph node under right arm, right breast double in size, right eye swollen shut, no feeling in right fingers, right side swollen gland in throat.
Information has been received from a registered nurse concerning a 7 year old healthy male child who on 08/25/1995 was vaccinated with varicella virus vaccine live. On 01/06/2002 the child presented to his physician with a mild varicella rash. No treatment was ordered, and the child received comfort measure only. At the time of this report, the outcome of the event was unknown. No further info is expected. The nurse also reported that a 6 year old female and a 5 year old male developed varicella following vaccination with varicella virus vaccine live (WAES0201USA01185 and 0201USA02589).
by evening felt flu like, hot, chills, 100.5 temp, nauseous, very bad headache throwing covers on and off all night restless cud not sleep, got up husband saw me unsure if passed out of what, when tired to stand up fell forward head first into floor and landed on cheek about 3:30 am, he got me back into bed laid there fittfully until early am to get up and call the Dr.  Dr took till 4:30 pm to return my calls
ER three times, was given was given steroids' and benadrly IV. resolved and then restarted, revisited the ER again Sunday morning and then Sunday night and was medicated with the same and given prescriptions for prednisone, hydroxyzine. states she is itching all over
Immediate change to my menstrual cycle, which came several days earlier than expected after being steady and regular for years. This has been happening since June with unpredictability for my cycle start. Also combined with severe increase to menstrual pain and heavier loss of blood after vaccination. These changes to my body have not improved since vaccination.  I reported my concerns to my doctor, at which point she told me that is unlikely due to the Pfizer Covid-19 vaccine and suggested I do blood work to check on possible fibroids in my ovaries causing these symptoms. I did not do this testing because I know for a fact these changes are directly related to the Pfizer Covid-19 vaccine.
Temp increased 103 degrees Tues around 5 pm, vomited 1 time Wed 5 AM, left arm swelling began approx 4 pm Wed. Alterated Tylenol & Motrin (swelling extended down to elbow along with redness).
Side effects lasted 36 hours. Side effects started 5 hours after vaccine. Headache Severe joint pain Severe muscle pain Fever Chills Nausea/ threw up
No additional adverse symptoms reported; improperly stored PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from an office manager, concerning a patient of unknown age and gender. Information on concomitant medications, pertinent medical history and drug reactions/allergies was not reported.   On 23-JAN-2020, the patient was vaccinated with an improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAS23) one 0.5 mL injection, (dose number, route of administration and location of administration were not reported) (lot # S005856, expiration date: 03-DEC-2020), administered for prophylaxis.   The vaccine was exposed to a temperature of 47.8 degrees Fahrenheit for a time frame of 48 hours. There were no previous temperature excursions. A data logger was not involved. No additional adverse symptoms were reported.
gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Patient was sitting on the chair in front of the pharmacy and he passed out and fell out of the chair and hit his head. He said he felt dizzy. He passed out again but did not fall. The store called 911 and the paramedics came and took him away. I asked for a report but did not come back
I felt exhausted, nausea. dizzy, & headaches. On 1/8/2021 I had sever stomach pain as the days past by it got worse it was a sharp pain. I also felt throat pain I felt like my throat was closing. All this symptoms lasted about 6 days. I had a appointment on 1/11/2021.
After second dose, I have had more severe and longer lasting colds than at any time in my life. They are interfering with my ability to work.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of Zostavax. Subsequently he experienced injection site rash which was characterized by the physician as "not zoster like rash". Medical attention was sought. Subsequently, he received from injection site rash. The product quality complaint was not involved. Additional information has been requested.
Minor swelling/welt around injection site for a couple days now. Tender to the touch and itchy at times. It also feels slightly warmer than the rest of the surrounding skin.
Moderna COVID?19 Vaccine EUA  Extreme fatigue,  visual hallucinations, anorexia. Symptoms worse at ~12 hours, significantly improved by 72  hours but not resolved.
Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-366918, MOD-2021-366925 (Patient Link).
(R) upper arm, lateral subcutaneous injection site. 2 inch x 1 1/2 inch dark red, warm to touch, 2 smaller areas within the site appear raised, possibly pre-blister. The entire area measurement is 4 1/2 inch x 2 inch. Painful to touch.
4 day febrile illness. Tmax 103.8. Behavior during course of fever included high pitch unusual cry for 25 min at a time, apparent HA with slapping of head, unsteadiness of gait, and verbal language - after fever blanching macular eruption of rash cleared 48 hours.
Patient became fussy about 5 min after receiving immunizations.   Developed a couple of small raised areas above eyebrows and back of left forearm.  Epinephrine 0.1mg SQ was administered prior to EMT arrival.  She was subsequently transported to Emergency Department by EMS.