chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient shortly after receiving his Varivax vaccine and PPD fainted. He was by mom before regional rolling of the eyeball and stiff. When I came in the room he was jerking has arms, pale and was breathing. He was non responsive for about 5 minutes and by the time ambulance came he was awake.
Nausea, Vomiting, Diarrhea, Number of episodes, Greater than 10 x, Decreased appetite, Weak, Dizzy, Belching x 3 days after receiving Tdap vaccine
Fever > 102 x 1 d (+) with seven (7) hrs of not being able to keep anything down, started the night after 6 mo old wcc with 12's; resolved spontaneously shortly after nl exam. Only tx: TYLENOL.
My daughter has developed pain that starts in her neck and goes to her right chest when she breathes deeply or swallows.  It has not improved after 4 days post vaccine.
4DEC91 6PM appearance of whelps trunk, face et extremities, phoned MD, told to observe for inc s/s of allergic rxn & appt 5DEC91; Atarax TID prescribed on 5DEC91; Infant cranky, attempting to scratch @ lesions;
Leg pain, deep in right leg initially from hip to knee. Pain has settled into more of a ?sensation? than pain. Tingly but not numb.
blood clots in his left legs and also some in his lungs.; blood clots in his left legs and also some in his lungs.; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that he had to go to the emergency room (ER) where they discovered blood clots in his left legs and also some in his lungs in Mar2021. The events were serious, the patient was hospitalized for 2 days.  Therapeutic measures were taken as a result of the events and the patient was placed on blood thinners. The patient outcome of the events was unknown.  Information on the lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LEVALBUTEROL [LEVOSALBUTAMOL]; MONTELUKAST; SIMVASTATIN; LOSARTAN; LEVOTHYROXINE; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: wtih continued positive testing. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug Ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Pt came in on 04/22/2019 with a bumpy rash on his left thigh and states he had this since Friday 04/19/2019 an hour after of vaccine. Informed pt we would get with provider and give her a call as soon as we are told what needs to get done.
heart beating fast; achy; chills; nauseous; blood pressure spiked; feel fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED, FEELING ABNORMAL, HEART RATE INCREASED, PAIN, and CHILLS in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED and FEELING ABNORMAL. On 10-Apr-2021, the patient experienced HEART RATE INCREASED, PAIN, CHILLS, and NAUSEA. The patient was treated with TYLENOL at an unspecified dose and frequency and BENADRYL at an unspecified dose and frequency. On 09-Apr-2021, BLOOD PRESSURE INCREASED had resolved. At the time of the report, FEELING ABNORMAL, HEART RATE INCREASED, PAIN, CHILLS, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Moderna use for COVID-19 under Emergency Use Authorization (EUA): Lot number 047B21A was administered after the expiration date of 10-09-21. There was some confusion pertaining to the expiry extension pending for this lot from county public health guidance call, no clarifying statement received at the time of this report. No adverse effects noted post administration.
I, too, had discomfort after the shot but I didn't think to tell anyone about it because I though I was the only one. My arm was quite sore and hot at the injection site and it hurt a lotto raise my arm. That lasted for about 4 or 5 days but I did not go to the Dr. about it cause I thought  it would go away by itself, which it did and now it is fine.
Information has been received from a pediatrician regarding a 20 month old female. On 4/20/01, at 9 months of age, she received an injection of Prevnar. On 4/5/02, she developed Pneumococcal meningitis associated with hypertonia/heperreflexia and was hospitalized. No further information was available at the date of this report. Follow-up information received on May 22, 2002 indicated that this was her third dose of prevnar. Concomittant vaccines included Haemophilus B conjugate, Hep B, and DTP. Patient's results for Streptococcus pneumoniae IgG antibodies were as following: serotype 3 was <0.5 ug/ml, serotype 9 was 1.1 ug/ml, serotype 14 was 2.9 ug/ml, and serotype 51 was <0.5 ug/ml. On April 10, 2002, she was discharged in stable condition. The reporter indicated that she is doing well and shows no neurologic sequelae. A 15-day follow up report received 6/19/2002 adds: Follow-up info received on 06/11/2002 from a pediatrician regarding lab details, revised seriousness criteria and event outcome. Info has been received from a pediatrician regarding a 20 month-old female. On 04/20/2001 at 19 months of age, she received her 3rd dose of Prevnar along with Haemophilus B conjugate (manufacturer unknown), Hepatitis B (manufacturer unknown) and DTP (manufacturer unknown). On 04/05/2002, she developed Pneumococcal meningitis associated with hypertonia/hyperreflexia and was hospitalized. Laboratory tests revealed that a blood culture was positive for serotype 18C. A CSF culture was positive for gram positive diplococci and white blood cell count of 12,000. A chest X-ray was negative. A urine culture was negative. She was treated with intravenous ceftriaxone and intravenous vancomycin. ELISA results for Streptococcus pneumoniae IgG antibodies were as follows: serotype 3 was <0,5 ug/ml, serotype 9 was 1.1 ug/ml, serotype 14 was 2.9 ug/ml, and serotype 51 was <0.5 ug/ml. On 04/10/2002, she was discharged in stable condition. The reporter indicated that she recovered but it is unknown whether she experienced permanent disability.
First two days after the vaccine was normal Fever like symptoms, has developed into fast beating, irregular, pounding heart beats with shortness of breath.
This case was reported by another manufacturer Merck and described the occurrence of abnormal blood glucose level in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis and treatment for Hepatitis C. Concurrent medical conditions included diabetes and hepatitis C. On unspecified dates the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after the vaccination with TWINRIX, the subject experienced abnormal blood glucose level. "While taking TWINRIX the [subject's] blood sugar level went to 240. He is a diabetic and had been receiving his injections one month apart at an unspecified dose". At the time of reporting the outcome of the abnormal blood glucose level was unspecified. No further information was provided.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-012697 (Linked Report).; Sender's Comments:  MOD-2021-012697:same reporter, different patient
Pt exp fever day p/vaxs, had cyanosis; brought into ER by parents, noted to have listlessness w/sz activity, diarrhea, lethargic, full resuscitation, unresponsive, dec hydration; dx change of consciousness, sz, viral meningoencephalitis;
Pt was to receive MENVEO (HPV) and gave ENERGIX (Hep B) busy day and looked at order wrong.
double-vaxxed and boosted; Took a COVID PCR test this afternoon and she came back POSITIVE./double-vaxxed and boosted/zero symptoms; Took a COVID PCR test this afternoon and she came back POSITIVE./double-vaxxed and boosted/zero symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "Took a COVID PCR test this afternoon and she came back POSITIVE./double-vaxxed and boosted/zero symptoms"; IMMUNISATION (medically significant), outcome "unknown", described as "double-vaxxed and boosted". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive; (Dec2021) negative. Clinical course: The patient had COVID PCR test this afternoon (13Dec2021) and she came back POSITIVE. She is double-vaxxed and boosted. And she has ZERO symptoms. She tested negative on all of last week's tests.  The lot number for bnt162b2 was not provided and will be requested during follow up.
left eye was irritated; left eye was sensitive to light; left eye was painful weeping and red.; left eye was red; left eye weepy; entire left side was sore, achy, including her jaw and stuff; entire left side was sore, achy, including her jaw and stuff; This is a spontaneous report from a contactable consumer. A female patient of unspecified age (reported as 59 with no unit) received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine), via an unspecified route of administration on right arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was painless on 16Dec2020. On 17Dec2020, her entire left side was sore, achy, including her jaw and stuff, 18Dec2020 evening, her left eye was irritated, sensitive to light, painful weeping and red (left eye was painful, red, and weepy). She called her doctor on 19Dec2020 and he gave her some eye drops. On 20Dec2020, the eye drops seemed to irritate her eye more. She woke up in the morning and it was seeming to get better as she had been taking Excedrin. She was supposed to wait 6 hours between drops, then her eye again was sensitive to light and painful, so she took another Excedrin, which helped again. She was trying to see an eye specialist the day after the time of the report. She had asked around at work and nobody else had any issues. She was wondering if this was vaccine related. She wanted to get tested for COVID, not that she thought she had it now, but might be she had it before she got the vaccine. She had not even talked to her workplace about this or anything. They asked everyone the first day after, if there were any issues and to report them to HR/Employee Health. She had not done so yet, so she wanted to do that first. Outcome of the events left eye was irritated, sensitive to light, painful weeping and red, and left eye weepy was resolving, and of other events was unknown.  Lot/batch number has been requested.
I contracted COVID-19 on 07/03/2022 with symptoms of cough, fever, congestion, body aches, slight decline in oxygen level, fatigue, and sore throat. I was prescribed Paxlovid on 07/05/2022. I am still experiencing symptoms  of sore throat and cough. I have a metallic taste in my mouth and diarrhea from the Paxlovid. I am not recovered yet.
Woke up the next morning with a migraine, had chills and sweats. Extremely tired, nausea, no appetite. It's now Friday still Extremely tired and no appetite. I try to eat then feel nauseous. Left arm is sore.
pt recv vax 5JAN96 & 11FEB98 pt presented to MD office w/less than 20 scattered varicella lesions on trunk & arms;no fever noted;
she had a period after having been in menopause for 1.5 years with heavy bleeding; her belly hurt; cold; felt crappy; swollen lymph nodes in her left arm (injection site arm); something swollen/swollen lymph nodes; chills; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (she had a period after having been in menopause for 1.5 years with heavy bleeding), ABDOMINAL PAIN (her belly hurt), FEELING COLD (cold), MALAISE (felt crappy) and VACCINATION SITE SWELLING (swollen lymph nodes in her left arm (injection site arm)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (she had a period after having been in menopause for 1.5 years with heavy bleeding), ABDOMINAL PAIN (her belly hurt), FEELING COLD (cold), MALAISE (felt crappy), VACCINATION SITE SWELLING (swollen lymph nodes in her left arm (injection site arm)), LYMPHADENOPATHY (something swollen/swollen lymph nodes) and CHILLS (chills). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (she had a period after having been in menopause for 1.5 years with heavy bleeding), ABDOMINAL PAIN (her belly hurt), FEELING COLD (cold), MALAISE (felt crappy), VACCINATION SITE SWELLING (swollen lymph nodes in her left arm (injection site arm)), LYMPHADENOPATHY (something swollen/swollen lymph nodes) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: normal (normal) She had benign. On an unknown date, Blood follicle stimulating hormone: high (High) She is in menopause. On an unknown date, Ultrasound scan: abnormal (abnormal) showed something swollen.         Treatment details not provided. concomitant drug details not provided.  Patient had a period after having been in menopause for 1.5 years she had heavy bleeding.She is to return to the doctor in 4-6 months for another ultrasound. Caller states this happened because of the vaccine. She consents for safety to contact via email   This case was linked to MOD-2022-469103.
1st dose of Moderna Covid-19 vaccine was received 09/14/2021.   Abnormal heart rhythm with palpitations began on 10/5/21. Symptoms returned intermittently for one week. Second dose of Moderna Covid-19 Vaccine was received on 10/12/2021. Abnormal heart rhythm, palpitations, chest pain and tightness returned on 10/13/21 and persisted daily for one week.   Pregnancy (5 weeks) was confirmed on 10/11/2021. Miscarriage of pregnancy occurred on 10/14/2021, 2 days after 2nd dose of Moderna Covid Vaccine.
Visible spasm of the deltoid muscle immediately upon injection. Paresthesia and hypoesthesia in injected arm developing within minutes . And axillary lymphadenopathy developing within 12 hours.
Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypocholesteremia since 27-Jul-2018.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days).    It was unknown whether patient was ever diagnosed with COVID-19. It was unknown whether the patient had acute illness at the time of vaccination and up to 1 month before.  No concomitant medication information was provided.  On 16-Jun-2021, moderna vial (lot 032B21A) were delivered at refrigerator temperature. The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021. Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 23-Aug-2021 to thaw for one hour to room temperature. Dose of 0.5 ml then given to patient on 23-Aug-2021. Per Moderna one re-freeze was ok but could not be given beyond 30 days. This dose was beyond that time.  Patient had no signs or symptoms of any adverse reactions to the injection given.  No treatment medication were provided. Patient did not seek medical care.
This spontaneous report as received from a physician refers to a 15 months old male patient who on 22-JUN-2012, was vaccinated with a dose of M-M-R II in the arm (dose, route and lot number not reported). No other co-suspects were reported. Concomitant therapy included penicillin. It was stated that on the same day, on 22-JUN-2012, the patient broke out with a rash and hives. No treatment was given for the experienced. On an unspecified date in 2012, the patient recovered. The patient sought unspecified medical attention. The relatedness for patient broke out with a rash and hives was unknown for M-M-R II. Additional information has been requested.
Less than 30 min after vaccine, she felt her throat closing up. Seen in Emergency Dept.
Patient reports red and tenderness at the injection site.   injection site feels hard to touch. Patient also reports headache  that consists of sharp pain coming from middle of her skull
exp abdo pain w/in 1 hrs p/ax & lasted throughout evening-onset of fever 12 hrs p/vax-t103-resulted in 10 sec dz; taken to ER;
Information has been received from a healthcare worker concerning a 20 year old female with no known drug reactions/allergies and no pertinent medical history, who on 24-MAR-2008 was vaccinated with the first dose of GARDASIL (Lot #658282/0929U), 0.5ml, intramuscularly, on 25-APR-2008 with the second dose of GARDASIL (Lot #658282/0929U), 0.5ml, intramuscularly and on 25-SEP-2008 with the third dose of GARDASIL (Lot #659184/0843X), 0.5ml, intramuscularly. Concomitant therapy included HAVRIX. The healthcare worker reported that the patient, who received her third dose of GARDASIL on 25-SEP-2008, is pregnant. The last menstrual period was on 20-AUG-2008 and the estimated date of confinement is 27-MAY-2009. The patient experienced abdominal pain and discomfort which led to the diagnosis of pregnancy. The patient sough unspecified medical attention. Follow up information was received from a health care professional concerning a 20 year old female patient with no previous pregnancies or full terms deliveries who on 24-MAR-2008, 25-APR-2008 and 25-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively. Concomitant therapy used during the pregnancy included HAVRIX given on 25-SEP-2008, BACTRIM DS TABLET given on 27-DEC-2008 for a urinary tract infection. It was reported that the patient presented with an urinary tract infection during pregnancy. It was reported that ultrasounds were performed on 07-OCT-2008, 08-NOV-2008 and on 19-NOV-2008 (at 6 weeks 0 days, 12 weeks 3 days and 22 weeks 3 days, respectively). On 22-DEC-2008 a laboratory diagnostic test was performed and it was negative for Down syndrome, open spina bifida and Trisomy 18. It was reported that there were a premature rupture of membranes, preterm labor and short cervix. It was reported that on 03-APR-2009, at 32 weeks and 1 day of gestation, the patient delivered two female twins (ID # 36825, weight 1.660 Kg, the head circumference was 32.5 cm, APGAR score were 8/10 at the first minute and 9/10 at the 5 minute) and (ID # 36826, weight 1.645 Kg, Length was 44.5 cm, the head circumference was 29.0 cm, APGAR score were 8/10 at the first minute and 9/10 at the 5 minute). It was reported that the babies were premature but the reporter was not really sure if the babies were normal or had congenital anomalies. Additional information is not expected.