chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; Diarrhea; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DIARRHOEA (Diarrhea) and VOMITING (Throwing up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure fluctuation (high blood pressure). Concomitant products included LOSARTAN for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizzy), DIARRHOEA (Diarrhea) and VOMITING (Throwing up). At the time of the report, DIZZINESS (Dizzy), DIARRHOEA (Diarrhea) and VOMITING (Throwing up) outcome was unknown.            No treatment information was provided.
This spontaneous report as received from a physician, who read in an article that was published recently about a female patient of unknown age. The patient's concurrent conditions included an allergy to meat called "alpha-gal allergy" that was transmitted via tick bite. There was no information about the patient's medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) for prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2006, the patient died after resuscitation attempts in an unspecified emergency room, due to an anaphylactic reaction to the porcine gelatin content of ZOSTAVAX. The reporter considered the aphylactic reaction to be a life threatening event that required intervention to prevent serious criteria. It was unknown if an autopsy was performed. The reporter considered anaphylactic reaction to be related to ZOSTAVAX. Upon internal review, the event anaphylactic reaction was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA009391: Reported Cause(s) of Death: Anaphylactic reaction to the porcine gelatin content of ZOSTAVAX.
Suffered a transverse myelitis which resulted in temporary paralysis of legs and on-going loss of sensation of body from above the nipple-line to the bottom of feet.  8/14/09 Hospital records recieved DOS 11/30/2008 to 12/03/08. Assessment: Cervical transverse myelitis unclear etiology, Vitamin B12 deficiency, Possible subacute combined degeneration, Whole body numbness, lower extremity weakness and paresthesia, constipation, Insomnia.   Patient presents with left leg weakness and whole body numbness. Describes 'catch' between shoulder blades. Numbness in thighs that spread both caudally and cephalad. Weakness in both lower extremities. Difficulty standing. Slight edema abdomen. Decreased bilateral sensitivity to pinprick and touch sensation. Paresthesias, burning sensation.  ICD-9 Codes: 341.20 Acute (Transverse) Myelitis NOS, 281.1 Vitamin B12 Deficiency NEC, 336.2 Subacute Comb Spinal Cord Degen/Other Disease, 564.00 Uspecified Constipation, 780.52 Insomia Unspecified. \ksk
Based on the information provided on the consent form, the patient was provided the Moderna COVID-19 vaccine as a second dose since he was not allowed to return to the location that he received the first dose.  On the consent form it was noted the a previous Moderna dose was received but upon processing the vaccination, it was discovered that the Pfizer vaccine was given as his first dose.  The patient had a 15 minute observation period and left the pharmacy with his sister.
Tinglingly and numbness in fingers of left arm; Tinglingly and numbness in fingers of left arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) in the left arm on 04Apr2021 at 10:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (MINASTRIN 24 FE) for unknown indication from an unknown date and unknown if ongoing. On 22Mar2021, the patient underwent for COVID-19 virus test (nasal swab) and the result was negative. On 07Apr2021, the patient experienced tinglingly and numbness in fingers of left arm. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with ALIEVE. The clinical outcome of the events tinglingly and numbness in fingers of left arm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
morning of 5/8/23 our child appeared very ill. He was lethargic, limp, was unable to eat, vomited, and appeared almost lifeless. We went to the ER immediately (Approximately 7:15am). Later in the day, a jelly like blood was observed in his diaper. Hospital attempted two rounds of enemas to repair the intussusception which were unsuccessful. Early morning of 5/9/23 surgery was completed.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported that a child of unspecified age, gender and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient was up to date and still got invasive pneumococcal pneumonia and had emergency surgery. Head of infectious disease said that the bacteria had mutated and became antibiotic resistant because of the pneumococcal vaccine. No follow-up attempts possible. No further information expected.
pericarditis; initially presented to the ED with chest pain and then was ultimately referred to cardiology for further assessment. Received a course of colchicine, which was not well-tolerated by the patient due to diarrhea. This did not help to relieve symptoms, so she was started on a prednisone taper. This helped to relieve symptoms initially, but she continued to have recurrent chest pain once she was on a low dose of prednisone. Also tried the addition of high-dose aspirin, which helped temporarily but was stopped when inflammatory markers remained elevated.
22 patients vaccinated using old vial from 03/8/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/8/21) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-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 EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/8/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/8/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information provided.   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258660 (Patient Link).
Brown spotting evening of vaccine shot, continued next day with abdominal cramps, and 3rd day after initial vaccine seem to be starting period. I am two weeks from my normal birth control cycle week. Large amount of pain in shot arm for two days, extremely groggy the day after vaccine and less sleepy the following day. All day long dead ache the day after getting the vaccine shot and taking an excedrine did not help headache. Missed a couple days of work due to symptoms.
Tingling in ankles, lightheadedness, "heat" in the back of the throat. Pt was observed for an hour and felt better. Dr. stated she can leave, no additional care needed besides observation. BP 131/44, O2 98, Pulse 71. Pt reports similar reaction to 1st dose.
Rash, swelling and redness surrounding L arm injection site. Symptoms occurred 3 days after injection.
This case was reported by a consumer via call center representative and described the occurrence of Influenza in a adult female patient who received FLUARIX. Previously administered products included seasonal Influenza vaccine (the patient has received the Flu vaccine pretty much every year). Concurrent medical conditions included fibromyalgia. Concomitant products included simvastatin, BENADRYL, calcium, CENTRUM Silver and Vitamin D. In October 2013, the patient received Influenza vaccine unspecified. On an unknown date, 91 days after receiving Influenza vaccine, the patient experienced Influenza. On an unknown date, the outcome of the Influenza was recovered/resolved. The reporter considered the Influenza to be related to Influenza vaccine unspecified. Additional details provided were as follows: This case was previously reported to a doctor. This case was reported by the patient herself. The patient has received the Flu vaccine pretty much every year. Two years ago, in October 2013, the patient received a dose of trivalent Flu vaccine (unknown manufacturer). In January 2014, approximately 3 months later, the patient experienced the Flu. The patient stated, that she got the senior dose, one shot, but noted it was stronger than the quadrivalent vaccine. She also stated that, she was told the trivalent was stronger and better for seniors so that was what she was referring to when she noted senior dose. The patient stated that, she cannot recall that her physician was aware she got the Flu.
Patient had sever muscle spasms the approximately 15 hours after 2nd dose in left leg.  Pain persists in leg under stress.  PT describes it as an adhesion like pain.  Pain persists 6 mo after dose.  OTC magnesium supplements recommended, with no effect
HIP PAIN; TOES PAIN; 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: 042A21A,) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced hip pain. On 09-APR-2021, the subject experienced toes pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hip pain, and toes pain. This report was non-serious.
This individual called Pfizer earlier and reported never having an outbreak of her herpes since being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "This individual called Pfizer earlier and reported never having an outbreak of her herpes since being vaccinated".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684622 same reporter/drug/AE, different patient
Child was extremely irritable and crying uncontrollably for the whole day. We notice also that the child presented in pain with fever. One month after shots child was sick with upper respiratory infection and bronchitis. Child had blood in fecal matter multiple times and was rushed to emergency room  multiple times. Pediatrician did blood work and could not find reason for bloody stool but informed us it could possibly be from the Rota-virus Vaccine. Child has been struggling with chronic stomach ache and constant ear infections. We have been advised by our doctor to be cautious with the child receiving more vaccines.
Information has been received from a registered nurse concerning a 24 month old male who on 16-APR-2008 was vaccinated with a dose of VARIVAX (Merck) (Lot # 660409/1998U). On 31-AUG-2009, the patient developed a mild case of chickenpox with less than 50 lesions and no fever. The patient's outcome was not reported. The patient sought medical attention, was seen in the office. Follow up information has been received from a registered nurse concerning this patient. She stated that the patient also received a dose of MMR II (MSD) on 16-APR-2008. (Lot # not provided). Further follow up information has been received from a registered nurse concerning a patient with not known medical history who on 16-APR-2009 (previously reported as 16-APR-2008) received a dose of VARIVAX (Merck) (Lot # 660409/1998U) and also received on unspecified date (previously reported as 16-APR-2008) a dose of MMR II (MSD). The patient experienced a mild case of chicken pox. The patient was seen in emergency room (ER) on 02-SEP-2009 and released. No relevant diagnostic test was performed. At the time of this report, the patient recovered. Additional information has been requested.
Information has been received from a physician referring to a 14 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient inadvertently received a dose of PROQUAD injection (lot #, expiration date, dose and route were unknown) for prophylaxis, which was outside the recommendations per the prescribing information (drug administered to patient of inappropriate age). No adverse effects were reported. Follow up information has been received from the physician on 02-DEC-2016 referring to the 15 year old patient. On 26-AUG-2016 at 09:13, the patient received the first dose of PROQUAD (lot# M014302, subcutaneous in right arm) in private doctor's office/hospital with private funds. Additional information is not expected as all correspondence has been received. Reporter information, patient information, product, event and narrative had been updated. Sender's Comments: MERCK 1610USA002049:Mfr number.
Pt presented at community event requested 1st dose.   The county was offering 100$ gift cards for 1st doses.   The patient was vaccinated with J&J as requested.     Once Mass Event Registration form was entered into database, it was noted the patient had already received his 1st dose of MODERNA on January 6, 2021.
Ringing in ears started at 8am, as of 8:24 pm it's still going and not stopping.  Did get covid like symptoms after getting the shot, currently just congestion remaining.
Received full monovalent dose 0.50 ml instead of the bivalent booster dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-644888 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644888:Same reporter
Vaccine beyond use date 17APR2022; Past beyond use date Moderna Covid-19 vaccine given to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine beyond use date 17APR2022) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine beyond use date 17APR2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine beyond use date 17APR2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored in the refrigerator on 23-MAR-2022. Vial did not undergo any temperature excursion.  No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-546559, MOD-2022-546563, MOD-2022-546567, MOD-2022-546561 (Patient Link).
cardiac arrest; collapsed; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who had cardiac arrest and collapsed while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as Prophylactic vaccination.  On an unknown date the patient had cardiac arrest (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  On an unknown date the patient collapsed (fall) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (collapsed, cardiac arrest).  At time of reporting, the outcome was Unknown for all.; Sender's Comments: Company Comment dated 07-Feb-2022. This case involves a patient of unknown demographics who had cardiac arrest and collapsed while receiving vaccine Influenza Vaccine. Based upon the reported information, the role of a vaccine cannot be assessed Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
I felt a little woosy; This is a spontaneous report from a contactable other health care professional (patient).  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration, administered in Arm Right on 05Apr2021 13:00 as single dose for covid-19 immunisation. Medical history included Severe back problems. Patient had allergies to Chocolate. Concomitant medication was not reported. On 05Apr2021 01:15, patient felt a little woosy. She was not pregnant at the time of vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. She was not received treatment for the adverse event. Patient was not diagnosed with COVID-19 Prior to vaccination, since the vaccination, not been tested for COVID-19. The outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
9/29 6:00 shot left arm, 8:00 pm cough, 10:00 pm violent shaking, high fever, 2 blankets for chills, fever 101 degrees by 4:00a.m., 9/30 9:00am saw doctor, slept 2 1/2 days, ADVIL, 10/2 headache still a lot of fatigue, 10/3 ok again.
significant back pain; body aches; chills; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (significant back pain), MYALGIA (body aches), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (significant back pain), MYALGIA (body aches), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain). At the time of the report, BACK PAIN (significant back pain), MYALGIA (body aches), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9-Jul-2021 doesn't contain any new information.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Information has been received from a physician concerning a 25 year old female pt who is from another country and has no known allergies, who on 24OCT2003 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. The physician reported that on 18NOV2003 the patient had a chickenpox breakthrough. The physician reported the pt had developed itchy reddish papules and vesicles over her scalp (also
Low grade fever w/much arm discomfort, redness & swelling which persisted for 3 days; Seen by MD on 21MAR90 for recheck;