chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Significant throat constriction and difficulty swallowing 10 hours after first dose.  This lasted for two days. Same symptoms occurred on day 4 and and day 11.  Doctor recommended taking Benadryl every 6 hours and this did help.
This case was reported by a pharmacist and described the occurrence of inability to breathe well in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B. At an unspecified time after vaccination with ENGERIX B, the subject experienced inability to breathe well and visited the emergency room. Product complaint was reported as particles were found to be floating around in the syringe. The pharmacist considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of inability to breathe well was unspecified. The pharmacist considered this event probably related to vaccination with ENGERIX B. The reported indicated that two subjects experienced an inability to breathe well following administration of ENGERIX B where particles were found to be floating in the syringes. The following was reported with regard to the ENGERIX B product received and stored at this facility: The average temperature of the refrigerator was 4 degrees Celsius, there were no temperature excursions, the temperature was monitored daily, the product was stored inside the refrigerator, the vaccine was placed in the refrigerator as soon as it arrived, the status of the temperature tag upon receipt was not known and the product was shaken well. The linked case number is A0952399A.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose, frequency, route and site of administration were not reported). Concomitant therapy was not reported. The patient reported that on an unknown date she developed an injection site rash that later spread to her legs and back. The patient's legs had these bumps and welts on them and all of her skin was so flaky and itchy and it flaked off. The patient used about 10 bottles of an unspecified lotion and it was not helping and she was so very itchy. The patient did not recover from adverse events. The relatedness between therapy with ZOSTAVAX was not reported. Additional information has been requested.
Fever 101.2° F-2 days, 99°-100.8° 2days Severe headache day one, moderate 3 days Body aches first day only  Red hot around vaccination site, very sore still Nausea since day 1, took Tylenol 1,000mg 3X daily for 3 days (no relief, no fever reduction)  I drank lots of water but couldn?t eat much, if at all because of nausea for 3 days Lost 3-4 lbs  Diahrrea all 4 days, drank electrolytes
Received flu, pneumococcal, zoster vaccines at 5 PM on 12/8/14. 12/9/14 - fever, chills, sweats, weakness, couldn't stand, walk, diarrhea. Presented to ER. Ataxia present WBC 27,000. Admitted to hospital. Also developed local rxn (L) upper arm. SIRS criteria met - cult (-). Improving and discharged from hosp. 12/11/14.
Patient received vaccine 4/2/2021.  Evening of 4/13/2021 went to ER with fever, rash, headache, and joint pain.
Patient received a dose on day 34 of refrigeration, 4 days over use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Additional information received included that the vials were stored in liquid state for 34 days from 3C to 5C and only exposed to 70F for 30 minutes during administration. Upon visual inspection, the vaccine looked normal.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received on 15-Jul-2021 and included reporter details, suspect vaccine details and updated to events.
Blood Clot in the Lower Left Lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy bilateral on 20-Jan-2021 and Radiation therapy. Concurrent medical conditions included Breast cancer and Lung cancer (Has not been operated on as of yet).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) outcome was unknown.            No concomitant medications reported.  The patient developed a blood clot in the lower left lung, and was hospitalized. The doctor told her that because of cancer, radiation and recent mastectomy surgery she was at risk of developing blood clots. Treatment medication included apixaban for six months. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Patient's underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Patient's underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.
Case previously recorded as MA2009-4408. Initial case report received from a consumer on 07 NOV 2009. A female patient was vaccinated with of S-OIV FLUVIRIN (batch no. unknown) on 12 OCT 2009. The patient experienced mild body aches and stiff neck for one day after vaccination and a local ache in injection site for one week after vaccination. The outcome of the events was reported as recovered.
pt recv vax; became feverish; circular rash on both side of face (cheeks); spread down arms to buttocks; spread down legs; tired, cranky; scarred;
pt recvd vax;Lt leg swelled from diaper area to knee w/ warmth & tenderness;pt screamed for about 12 hrs anytime leg touched;t 101 R; relieved by apap;devel blister like lesions on top of both thighs;to MD & dx as allergic rxn to alcohol;
Swelling at injection site; Mild pain at injection site; Was remarked lethargic; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 11Feb2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, arthritis, Automatic Implantable Cardioverter-Defibrillator (AICD) pacemaker, Chronic Obstructive Pulmonary Disease (COPD), heart disease, obesity, oxygen therapy and sleep apnea. The patient had allergies to penicillin, milk, wool and cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salbutamol sulfate (ALBUTEROL), atorvastatin (MANUFACTURER UNKNOWN), digoxin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and furosemide (FUROSEM); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Feb2021 at 10:00, the patient experienced flu like symptoms, she had no fever, no chills and stayed in bed; also experienced swelling and mild pain at injection site and her adult son remarked that she was lethargic. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, swelling and mild pain at injection site and lethargic was recovered on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00am
12NOV96 unable to stand or walk;low (125) sodium, hands tingling, no reflex in both knees, GBS;
Information has been received from a physician concerning an 18 week old male with no pertinent medical history or drug allergies who on 16-NOV-2007 and 21-JAN-2008 was vaccinated with his first and second doses of ROTATEQ (lot# not provided).  There was no concomitant medication.  On 24-JAN-2008 the patient experienced vomiting and diarrhea.  On approximately 25-JAN-2008 the patient also experienced mild dehydration and lost one pound.  The physician stated that the patient appeared to be becoming worse.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a physician concerning an 18 week old male with no pertinent medical history or drug allergies who on 16-NOV-2007 and 21-JAN-2008 was vaccinated with his first and second dose of ROTATEQ (lot not provided). There was no concomitant medication. On 24-JAN-2008 the patient experienced vomiting and diarrhea. On approximately 25-JAN-2008 the patient also experienced mild dehydration and lost one pound. The physician stated that the patient appeared to be becoming worse. There was no product quality complaint. Follow-up information from the reporting physician indicated that the 18 week old male has a typical acute viral gastroenteritis that started on 24-JAN-2008 with symptoms of vomiting, diarrhea, mild dehydration and loss of one pound. There was no illness at the time of vaccination. There was no testing for rotavirus done or any other laboratory or diagnostic studies. The patient recovered well after 2 weeks. It was also noted that the event "may have been coincidental by chance." Additional information has been requested.
Went to emergency room with fever and vomiting on Wednesday 8/9/06.  Treated with IV hydration in ER.  Child had diarrhea 3 times on THursday 8/10/06.
fussy X 24 hr cried but could be comforted alternated /w high pitched shrill cry of shorter duration, from 12th thru 15th. Arms & leg pale, but pt not limp & hands blue. T only 102 @ time
A non-serious spontaneous report of administration to a seven-month-old has been received from a physician concerning a seven-month-old male who received FLUMIST on 01-Dec-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. on 16-Dec-2008, 15 days after the patient received FLUMIST, the physician's nurse confirmed that there were no late-occurring adverse events reported.
Starting on Tuesday, 05/16/2000, pt became irritable and developed a low grade fever. This continued until Friday, 05/18/2000 when he became increasingly lethargic and eventually lost all sensation and motor abilities in his lower limbs. 05/20/2000 MRI revealed swelling of spinal cord CS-T1 and conus medularis. Diagnosed with transverse myelitis. The 60 day follow up received on 7/24/03 states, "pt has permanent disabilities from this event. He continues to have partial paralysis in all four limbs, bowel and bladder issues, kefosis of the spine, and struggles with spasticity." The medical record received on 1/6/04 confirms the diagnosis of transverse myelitis.
Miscarriage 3 months after first shot. Continue to have issues with my menstrual cycle which went away and then became worse after my third vaccine. Dull achy pain 24/7 in my lower abdominal, extremely painful menstrual cycles and fatigue. Extremely heavy cycles that are uncontrollable and constant abdominal pain.
Information has been received from a 21 year old female with no pertinent medical history and no history of drug reactions/allergies who on 09-FEB-2007 was vaccinated with first dose of Gardasil (yeast ) (lot # not reported) injection. Concomitant therapy included cefdinir (OMNICEF), cetirizine hydrochloride (ZYRTEC), dexamethasone/tobramycin (TOBRADEX), cough, cold, and flu therapies ("VIGRAMOX") and antihistamine (unspecified). On 09-MAR-2007, the patient was vaccinated with second dose of Gardasil (yeast) (lot # not reported) injection. No concomitant therapy at the time of receiving the second dose of the vaccine. On approximately 09-FEB-2007, following the first injection, the patient experienced slight redness and itching which were gone by the next day (approximately 10-FEB-2007). Medical attention was sought. Also she had a "hard bump" at the injection site which lasted for approximately two weeks (approximately 23-FEB-2007) before going away. The hard bump felt like a knot in her skin. On 09-MAR-2007, the patient received second injection of Gardasil vaccine only one month after the first dose. At the time of reporting, she has not had any adverse experience following the second injection of vaccine. Additional information has been requested.
12/07/21 presents to EC ED for "palpitations". PMHx of "atrial fibrillation and supraventricular tachycardia with episodes of tachycardia and palpitations"
About 1540 pm MA had just finished giving pt IZZ's, when pt's foster mother asked if it was normal for pt to be all red MA turned to see pt and he was blotchy red all over trunk, face, neck, pt. scratching neck, eyes puffy, lips sl puffiness. No resp. distress, BENADRYL 12.5 mg given to R thigh and SOLUMEDROL 10mg given to L thigh IM. At 1600 rash resolving, child resting.
Patient is 12 years old and the Adult dose Pfizer,  is not recommended  for his age. He did not have any adverse reactions to the immunization.
sore arm; weak; problem with his jaw/muscle related and unable to open his mouth all the way; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), ASTHENIA (weak) and TRISMUS (problem with his jaw/muscle related and unable to open his mouth all the way) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), ASTHENIA (weak) and TRISMUS (problem with his jaw/muscle related and unable to open his mouth all the way). At the time of the report, INJECTION SITE PAIN (sore arm), ASTHENIA (weak) and TRISMUS (problem with his jaw/muscle related and unable to open his mouth all the way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Severe headache, generalized body pain  started around 8 PM.  Night sweats first two nights.   I now experience daily chronic headaches and chronic pain since the vaccine.   No history of headaches or pain prior to vaccine. New diagnosis of chronic headaches and chronic pain due to Covid vaccine.
8MAY93 pt had fever was given APAP; 9MAy93 t104-105 w/sz to ER; dx throat infect-febrile seizure;
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 34-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 22-NOV-2016 to 22-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 22-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Eight hours after receiving MMR/Varicella/PREVNAR 13 vaccine patient went for a one hr sleep with crying/screaming and then a grandmal seizure- lasted 1-2 min. and went limp and apneic -called 911. Taken to ER and she was stable and Rx TYLENOL 101.8 degrees C.
My right arm had a hard knot, red, raised, burning and bruise at the injection site along with itching redness, discoloration, burning and pain. My whole right arm from the shoulder down to the fingers were twice as swollen as my left arm. I have trouble raising my arm  and immense pain. My whole right arm was red, itching, swollen, disolored, painful, with  raised veins showing path of injection from injection site traveling  around my arm zigzagging until it arrived around under my  right armpit. I had and still have enlarged hard swollen painful multiple lymph nodes even today that have not changed. They were not there before the injection.  I could not use my right arm and hand which I am right handed dominant.
Chills, headache, body ache, weakness, extreme fatigue. Lasted 5 days.
Injection site is red, itchy, and hot to touch; Injection site is red, itchy, and hot to touch; Injection site is red, itchy, and hot to touch; Rash near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is red, itchy, and hot to touch), VACCINATION SITE PRURITUS (Injection site is red, itchy, and hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red, itchy, and hot to touch) and VACCINATION SITE RASH (Rash near the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Consumer is allergic to penicillin products.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is red, itchy, and hot to touch), VACCINATION SITE PRURITUS (Injection site is red, itchy, and hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red, itchy, and hot to touch) and VACCINATION SITE RASH (Rash near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site is red, itchy, and hot to touch), VACCINATION SITE PRURITUS (Injection site is red, itchy, and hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red, itchy, and hot to touch) and VACCINATION SITE RASH (Rash near the injection site) 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.  Treatment medication included oral allergy medicine (unspecified).
GI symptoms started 2 days after second dose - nausea, diarrhea, abdominal pain and lasted 4-5 days. I have had 4-5 recurrent episodes since the vaccine, most recently today. I never had any GI issues before receiving the second dose of the vaccine.
Fever 102, myalgias, arthalgia, malaise, headach, chills, sweats  Lasted about 6 hours
This spontaneous report was received from a nurse practitioner refers to a currently 27 days old male patient. The patient's concurrent conditions and concomitant medications were not reported. On 09-DEC-2015, the patient's mother was vaccinated with VARIVAX lot # L015048 with expiry date of 29-APR-2017, and the patient had a transplacental exposure. Mother's lab data included: On 09-MAR-2016, ultrasound scan at 12 weeks of pregnancy was normal. On 19-APR-2016 (at 19 weeks of pregnancy), maternal serum alpha-fetoprotein screening (MSAFP) was negative. On 27-APR-2016, ultrasound scan at 19 weeks and on 03-JUN-2016, ultrasound scan at 24 weeks of pregnancy were normal. At 39 weeks gestation, the patient's mother had a Cesarean section (captured in 1602USA001176) and the patient was born with a weight of 4167.37 grams and a length of 21 inches. The patient was born with a congenital anomaly. The infant's APGAR scores were 8 at one minute and 9 at five minutes. The outcome of congenital anomaly was unknown. Causality was not provided by the reporter. Additional information has been requested.
Approximately 6 to 8 hrs. after the vaccine the following symptoms were apparent: tiredness, headache, arm pain at the injections site along with muscular pain, injection swelling and site redness, feeling unwell, diminished appetite, and heightened irritability...