chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have experienced intense shoulder pain in my shoulder joint. I don't have pain and never did at the injection site only in the joint. I am 35 weeks pregnant and have to sleep completely upright because the pain is so bad. It causes radiating pain down my entire arm and limits my mobility. I cannot even pull a quilt up with my left arm because the pain is excruciating. I am desperate for someone to tell me this will get better soon or something I can do to correct, because I have an infant coming in a few weeks. I have never had this happen with a vaccine in the past.
Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced vomiting within one to two days following administration of vaccine. The patient received a dose in 2010. The patients experienced vomiting within one to two days following administration of vaccine on unknown dates in 2010. The outcome is unknown. No additional information was available at the time of this report.
enlarged anterior axillary lymph node; My breast tumor grew to size of golf ball in six months; This is a spontaneous report from a contactable other health care professional. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0142), intramuscular, administered in Arm Right on 12Jan2021 08:00 AM and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3249) intramuscular, administered in Arm Right on 29Jan2021 08:00 AM as single dose for COVID-19 immunisation. Medical history included breast cancer, restless legs syndrome, insomnia, hypertension, PALB2, CKD, NF1, and few known allergies to codeine, Morphine and Mollusks from an unknown date and unknown if ongoing. The patient's concomitant medications included Lasix, Kdur, anastrozole, requip, Metoprolol, trazadone, nortriptyline, melatonin, MV, Vit C. On 23Jan2021 04:00, the patient experienced enlarged anterior axillary lymph node and reported my breast tumor grew to size of golf ball in six months on an unspecified date. approximately 7-10 days following first injection on 12Jan2021 noted an enlarged anterior axillary lymph node. I watched it for approximately one week. It was slightly larger but definitely not smaller Received 2nd covid vaccine on 29Jan2021. notified provider on 01Feb2021 ordered US done 09Feb2021. I have PALB2 mutation, breast cancer post chemo, a RUL and LLL lung nodules. I am being told it is from my first Covid vaccine and to recheck in two months. My breast tumor grew to size of golf ball in six months. I am unsure of exact date it became enlarged or what day i noticed it. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events Not recovered.
Information has been received from a woman in a medical office concerning a 4 year old white male pt with no allergies and no past medical history who on 18Oct01 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 13Oct2003, the pt developed varicella. On 16Oct2003, the pt presented to the medical office with 50 to 100 lesions that were noted by the medical doctor. Additional information has been requested.
PAIN; ALTERED MENTAL STATE; INTENSE INSOMNIA; ACUTE DIGESTIVE DISTRESS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from other company (Pfizer, Inc) concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: neurofibromatosis type 2, and iodine allergy (if injected intravenously). The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total, dose 1 administered in left arm on 01-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 47 years old. The batch number was not reported and has been requested.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient additionally received non-company suspect vaccine tozinameran (Pfizer BioNTech covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered to left arm on 01-NOV-2021 for covid-19 prophylaxis. Concomitant medications included brigatinib. On an unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series: 2). The patient received (5 days of treatment) non-company suspect drug Pfizer (drug unspecified) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) from 06-AUG-2022 (Day 1) to 10-AUG-2022 (Day 5) for treatment of covid-19. On 07-AUG-2022 (Day 2), the patient experienced intense insomnia, altered mental state and Diarrhea (Dose number in series: 2). On 10-AUG-2022 (Day 5) at 10:00, the patient had acute digestive distress, pain and vomiting (Dose number in series: 2). On the same day, the patient resulted in emergency room visit and received treatment of IV (intravenous) fluids (Unspecified). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Pfizer BioNTech covid-19 vaccine) was not applicable, and with Pfizer (drug unspecified) was not reported. The patient recovered from altered mental state, and intense insomnia on 10-AUG-2022, was recovering from acute digestive distress, and pain, and the outcome of suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220848341-covid-19 vaccine ad26.cov2.s-Acute digestive distress, Pain. 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). Therefore, this event(s) is considered unassessable.
Pt mom called 4:30pm, advisted 3-4 dots, red-like bug bites on L/arm at vax site. Told to use cold pack in 20 min increments. Denies swelling, fever or other signs of infection. Go to ER if worsens. Pt moved at vax/caused bubble on skin.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. Pt reports he is doing well. Denies all symptoms following vaccine and at this time.
Site never got swollen or red. Just very painful. Continues to throb, hurts to raise arm up above head after few seconds gets a shooting pain from the injection site to her finger tips.
Headache,Nausea,Extreme weakness,,Fatigue,,soreness at injection site
Per pt arm where Gardasil was administered felt painful then numb and then pt fainted for a few seconds.
This spontaneous report was received from a pharmacist referring to a 20-year-old female patient. The patient did not have pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date, the patient received de first and second dose of GARDASIL 9 for an unknown indication (dose, frequency, route of administration, lot number and expiration date were not reported). The patient did not present any side effects with those two doses. On 19-MAR-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # M007764 expiration date 20-JAN-2018) intramuscular as prophylaxis (dose was not reported). A day after receiving the vaccine (on 20-MAR-2017), the patient experienced a leg muscle pain (myalgia).  Due to the event, the patient was instructed to take ibuprofen and acetaminophen (TYLENOL) as treatment; however, it was not known by the reporter whether or not the leg muscle pain was relieved by the medication. There were no lab diagnostics studies performed. On approximately 27-MAR-2017, the patient recovered from the event. At the time of the report, no further information was available. The causal relationship between the event and therapy was not reported. Additional information has been requested.
Late on Feb 8th I started to get a tickle in my throat, the following day, by 8pm I had a 102 F. fever.  I took 2 at home tests and both were positive. I called my Transplant team and they scheduled Monoclonal Antibodies for the following day 2/10/22 at 2pm. My fever broke over night and all symptoms worked there way out by 2/14/22. I AM IMMUNOCOMPROMISED. I got my 4th vaccine right on the 4 month mark per Dr. guidelines. I am very certain that I caught this at the grocery store the morning of 2/7/22 when I accidentally ran into someone coughing severely in the parking lot.
Patient experienced syncope, momentary loss of consciousness, profuse sweating, and nausea minutes after vaccine administration.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022 at 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Feb-2022 at 10:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Allergies to medications, food, or other; Initial information was received on 26-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional   This case involves an adult female patient who experienced allergies to medications, food, or other, while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergies to medications, food, or other (hypersensitivity) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
right leg a little swollen and red, size of baseball. Warm. To appkly cool compresses and take Motrin PRN.
ERROR: UNUATHORIZED AGE GROUP (14 years old, Pfizer EUA approved only for persons 16 years and older at time of administration. Parent signed consent form with incorrect DOB indicating age greater than 16 yo).  Event discovered and forwarded for VAERS reporting. Signs and symptoms: None known Diagnosis and treatment: None known Outcome: No adverse reaction reported
Received shingles vaccine on 11/27/15.  Arm became swollen and red on 11/29/15- large egg shaped swollen area about 5 inches w/mottled skin. Experienced low grade fever, body aches and headache on 11/29 and 11/30/15.  By Tuesday, Dec 1 there was one large fluid filled blister surrounded by a red, sore, tender area of five inches. Redness, itchiness and mottled skin continued through Friday, Dec 4, 2015.
The second dose of the Gardasil series was given 3 weeks after the first dose.  Merck Co was contacted, due to early timing of the second dose, notified no harm would come to the patient.  Merck provided timing for additional dose to be 5 months from the initial dose to complete the series.  Pt notified and verbalized understanding.
Immediate pain in collar bone and hand. 2 minutes later feeling hot, dizzy and  nauseated and about to lose consciousness.  Went to medical within facility and was monitored for 30 min until getting better. In addition,  woke up with dizziness 48 hours later.
MAJOR STROKE; 4 BLOOD CLOTS IN BRAIN; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient also received second dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 2). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis which was off label dosing frequency (Dose number in series 3). The drug was associated with off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced major stroke which was ended up with 4 blood clots in brain (Dose number in series 3). It was reported as "I have taken 3 Covid shots and had a major stroke in November end up with 4. Blood Clots in my brain so did not take no more". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the major stroke, 4 blood clots in brain and off label dosing frequency was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221242030-major stroke, 4 blood clots in brain. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021: Contains Non-significant information
she has bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (she has bells palsy) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057, 066F21A, 036D21A and 038A21A) for COVID-19 vaccination.     Patient reported that she did not test or diagnosed for COVID.  Concurrent medical conditions included Food allergy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (she has bells palsy) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Bell's palsy, at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] for Bell's palsy, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (she has bells palsy) outcome was unknown.            Patient's height was reported as 5'2". Patient had been taking concomitant medications, but did not specified them.  Company comment: This spontaneous case concerns an 86-year-old female patient with no relevant medical history, who experienced the expected serious (medically significant) AESI Bell's palsy, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine.  Patient was treated with Prednisone and Valacyclovir. The outcome was reported as unknown. Details of concurrent conditions, clinical course, and investigation reports were not provided. Previously patient was received first three doses mRNA-1273 vaccine and no information present on any adverse event.  Elderly age of the patient could be a risk factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an 86-year-old female patient with no relevant medical history, who experienced the expected serious (medically significant) AESI Bell's palsy, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine.  Patient was treated with Prednisone and Valacyclovir. The outcome was reported as unknown. Details of concurrent conditions, clinical course, and investigation reports were not provided. Previously patient was received first three doses mRNA-1273 vaccine and no information present on any adverse event.  Elderly age of the patient could be a risk factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt had flu-like symptoms start about 5 hours after 2nd dose,  increased fatigue x 3 days, nausea. No fever or chills. Injection site pain.  Missed work x 2 days due to symptoms. No known prior covid infection.
shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2015 the patient was prescribed and/or administered by a healthcare provider with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as subsequent to the vaccination), the patient was treated by a physician for shingles, and other zoster-related conditions. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not provided. The reporter considered both events to be related to zoster vaccine live(ZOSTAVAX).
Shoulder pain since vaccination.  The intensity has improved but do not have full ROM and continue to have pain with certain movements.  Uncomfortable to sleep. Using Motrin, ice, and heat
Hair falling; Strong Headache; Fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling), HEADACHE (Strong Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371C20A) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included VITAMIN 15 and BIOTIN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ALOPECIA (Hair falling), HEADACHE (Strong Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ALOPECIA (Hair falling), HEADACHE (Strong Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
swollen lymph node under left armpit the day after receiving the 2nd Phizer shot.  It was a large size, about the size of a golf ball
Extreme chills, aches body and head, swollen lymph node in left arm.  Very sore left arm and difficulty lifting it.  Fatigue.  LARGE RED CIRCLE ON UPPER LEFT ARM NEXT TO INJECTION SITE.  The red spot is warm and tender and has persisted for 3 days.
No adverse event. But patient received Moderna 1st COVID Vaccine dose and unfortunately got Pfizer, as a second dose.