chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a elderly female patient who received SHINGRIX for prophylaxis. On 3rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell and viral infection. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the headache was recovered/resolved and the outcome of the viral infection was unknown. The reporter considered the feeling unwell and headache to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the viral infection to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received SHINGRIX vaccine on the left arm. The patient stated that she did not feel well and felt almost like she had a virus. The patient stated that the symptoms lasted a couple of days and then resolved. The patient had denied permission to contact their physician.
DULL STOMACH PAIN; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, and other pre-existing medical conditions included: Patient did not have any drug abuse or illicit drug usage. Patient weight was normal. The patient experienced allergic reaction to polyethylene glycol when treated with mrna 1273, and drug allergy when treated with lidocaine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-DEC-2021, the patient experienced dull stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull stomach pain. This report was non-serious.
Redness/swelling/rash injection site x 8 days; night sweats; low-grade fever (on Tylenol); headache; dizziness, fatigue; itching (entire body and injection).
Diagnosis with Subserosal Fibroids; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 at the age of 31 years old (Lot Number: EW0151) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization in the hospital. The patient was not pregnant at time of vaccination. The patient's medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and moxifloxacin hydrochloride (TOPOMOX); taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced diagnosis with subserosal fibroids on 21Jun2021 with outcome of not recovered. No treatment given for the event. The event was reported as non serious as it did not result in death, or not life-threatening. No hospitalization and birth defect reported. The event resulted in doctor or other healthcare professional office/clinic visit.  Follow-up attempts are completed. No further information is expected.
A consumer reported that her 85 year old mother received Flu Shield on 11/8/02. Concomitant medication included triamterene/hydrochlorothiazide (manuf unk), Inderal, calcium and vitamin E. Medical history includes rheumatoid arthritis, hypertension, "heart problems" and "broken hip" 4 years ago. On the evening of 11/9/02, her mother "did not sleep well, had dreams all night and didn't look right in her eyes." On 11/12/02 she seemed confused and has been confused since. On 11/22/02, a MRI "of the head" was performed with negative results. The pt was living independently prior to the immunization but is now in senior facility. This case was serious since the event of confusion was considered medically important in this case (OMIC).
Shortly following the Moderna I became tired, achey, nauseated, head ache, heart rate increase and for two days I remained in bed most of the day and night.  Since that time I have had less energy and the heart palpitations have increase and I have developed headaches and now tinnutis.  I was energetic and played tennis and golfed prior to the vaccine injection.  I have not felt healthy since getting the injections.  This was my second dose of the Moderna. My blood pressure has been dangerously high and I've tried different medications.  The Tinnitus has increased also.
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
This spontaneous report as received from a consumer refers to a his/her female child of unknown age. On 14-OCT-2013 the patient had the first shot of GARDASIL (dose, route, lot # and expiration date not reported). ON 31-JAN-2014 the patient was vaccinated with a second dose of GARDASIL (dose and route not reported, lot # J007354, expiration date 20-FEB-2014). The child had headaches for a month (date unspecified), and did not have a menstrual cycle for 50 days (date unspecified). The child passed out in the office a week and a half ago from the second vaccination (approximately in February 2014). The outcome of the events was not reported. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
I developed a skin rash that started on my left arm and covered most of my body. I went to the doctor did a biopsy and said that it was a drug interaction. Doctor gave a cream, but it did not work.
Developmental delays. Loss of acquired language. Sensory issues. Fevers. 10/13/2009 records from specialist for ov 2/13/2009. Patient with sx noted at 18 months: loss of vocabulary, lack of interest, decreased social skills, resistant to physical contact, unresponsive to name and poor eye contact. PE significant for low muscle tone and bilateral simian creases.  DX'd with Autism. Recommended TX: behavioral, occupational, speech therapy, full time autistic support classroom, dietary changes. Recommended lab studies to r/o a genetic or metabolic cause of autism: DNA/Gene studies, CBC, CMP, ferritin levels,  blood and urine tests for amino and organic acids. Referred to PCP for these tests.  10/23/09:  Primary care and Immunization records recieved for dates of service 1/9/07 to 9/24/07. Seen on 1/9/07 for vomiting and rash x 3 days, groin and butttocks with peeling rash;  dx:  gastroenteritis, monilia. 3/15/07 runny nose, congestion x 1 month; bilateral OM.  3/27/07 discharge and tugging at ears;  OM resolved.  8/6/07 Rash on face and legs x 2 days; Insect bites-fleas?   7/10/07 Well child check;  immunized with MMR, Varivax, Hep B, Prevnar.  9/13/07 Well child check;  DTaP, HIB and Hep A given.   9/24/07 PPD given.
symptoms of Covid; symptoms of Covid; excessive bleeding from nose; This is a spontaneous report from a non-contactable consumer (patient's sister) Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Calling for her sister who took the 1st dose of the Covid vaccine and was experiencing excessive bleeding from nose and symptoms of Covid. Wondering if this was side effect from the Covid vaccine. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen, painful lumps below right calf. Two weeks no improvement. Ultrasounds done and ruled out blood clots and varicose veins. Still working with my physician to determine the cause. They believe it to be a muscle injury, though I have had no accidents, do not work out or run and no bruising.
Patients left arm was swollen, red and painful. Patient was advised to seek medical attention by a doctor right away.
This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Slight eye lid swelling, both eyes), SWELLING FACE (Face swelling), PARAESTHESIA ORAL (Tingling sensation in nose and lips), PARAESTHESIA (Tingling sensation in nose and lips) and COUGH (Coughing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (aspirin), Sulfonamide allergy, Allergic to cats, Allergic to dogs, Drug allergy, Drug allergy and Drug allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced SWELLING OF EYELID (Slight eye lid swelling, both eyes), SWELLING FACE (Face swelling), PARAESTHESIA ORAL (Tingling sensation in nose and lips), PARAESTHESIA (Tingling sensation in nose and lips) and FATIGUE (Felt tired,tiredness). On 21-Jan-2021, the patient experienced COUGH (Coughing), PRODUCTIVE COUGH (Bringing up yellow "stuff" when coughing), NASOPHARYNGITIS (Blowing nose a little bit), PYREXIA (Fever 100.3), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at site of injection). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING OF EYELID (Slight eye lid swelling, both eyes), SWELLING FACE (Face swelling), PARAESTHESIA ORAL (Tingling sensation in nose and lips) and PARAESTHESIA (Tingling sensation in nose and lips) had resolved and COUGH (Coughing), PRODUCTIVE COUGH (Bringing up yellow "stuff" when coughing), NASOPHARYNGITIS (Blowing nose a little bit), PYREXIA (Fever 100.3), FATIGUE (Felt tired,tiredness), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pyrexia: 100.3 (High) 100.3.
Patient didn't present or report prior c19 vaccination history. Administered Moderna Primary series. Scheduled the second appointment. Upon presenting for that appointment it was determined she had receive the following  in this order of Moderna: Primary: 3/11/21, 4/1/21, 10/19/21 Booster 11/15/22 Primary 2/25/23
shortly after getting vaccine patient experienced tingling down arm which happened over multiple hours, suggested patient take nsaid and apply ice and to contact a dr if it gets worse or doesn't get better within a day, patient understands, will follow up with patient
A 13 month old B/M who stopped talking on 4/25/01, 2 days, post vax. On 4/19/01, had a fever.
Client had a vasovagal reaction  with seizure like activity 5 minutes after receiving 2nd round dose of HPV9.  Reaction lasted 1-2 minutes, client was supported by staff in chair, eyes rolled up, and she was shaking and unresponsive, pulse was regular, and client was breathing,  making 1-2 snoring noises.  Clammy, pale skin. Client became responsive, and was lowered down to mat on floor. Apple juice and graham crackers given. Client reported issues with low blood sugar, and not having breakfast prior, also was feeling anxious about shot.  Vitals WNL RR 18,  BP 103/83 , HR 62 at 9:36. Client slowly returned to sitting then standing position, and walked out of the clinic  20- 30 min after adverse event.
aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
This spontaneous report as received from a nurse refers to an 18 year old male patient with an allergy to azithromycin and cefixime. The patient's pertinent medical history and concomitant medication were reported as none. On unknown dates in the past, the patient was vaccinated with the complete set of three pediatric doses of RECOMBIVAX HB (lot numbers, expiration dates and routes of administration were not specified). Then, on 21-JUL-2015, a blood titer was negative for hepatitis B antibodies for the patient. On 16-OCT-2015, the patient received an adult dose of RECOMBIVAX HB (lot# L014419, expiration date 15-APR-2017). However, the patient was 18 years old at the time of receiving the adult dose of RECOMBIVAX HB. The patient's present status and the causality assessment between the adverse event and the therapy with RECOMBIVAX HB were not specified. Additional information has been requested.
PATIENT FAINTED WHEN STANDING UP OUT OF CHAIR AFTER VACCINATION  REGAINED CONSCIOUSNESS IN SECONDS AFTER SITTING DOWN
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-NOV-2017, the patient was vaccinated with an expired dose of ZOSTAVAX dose and route were not reported (lot # M035692; expiration date 11-NOV-2017) for prophylaxis. It was reported that ZOSTAVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # L014262, expiration date 17-FEB-2018) prior to administration. The primary reporter denied any adverse effects reported by patient. The outcome of expired product administered and no adverse event was unknown.
The day after I had received the vaccine, I experienced an intolerable taste and smell with certain foods/drinks/mint- flavored things (toothpaste/chewing gum); certain things had a chemical/gasoline-like taste and smell.  It seemed to get a little better after about a week, then returned to how it originally was, and has been ongoing since.
Vesicular Rash with Oozing and Crusting; Vesicular Rash with Oozing and Crusting; Fever; Myalgia; This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, myalgia, vesicular rash and discharge. On an unknown date, the outcome of the fever, myalgia, vesicular rash and discharge were recovered/resolved.   It was unknown if the reporter considered the fever, myalgia, vesicular rash and discharge to be related to Shingrix.  Additional details were provided as follows: The reporting patient was physician herself. The patient received Shingrix in the left arm. After vaccination with a dose of Shingrix, the patient had fever of 102 degree F that lasted for 2 days and myalgia that lasted for 4 days. The patient also experienced vesicular rash on nose and across the lower back that had serum like oozing and crusted over which healed within a week. The patient consented to follow up. No futher details were provided.
Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) on 24 November 2015. Manufacturing control number: 2015406182. This case involves a 73-year-old female patient who was vaccinated with a first dose of Season flu double dose (batch number, expiration date, dose, dose number, route and site of administration were not reported) in right arm and a dose of PREVENAR 13 (batch number, expiration date, dose, dose number and site of administration were not reported) in left arm on 10 November 2015 at 10:00 hours. The patient's medical history and concomitant medication were not reported. The patient taking flu shot every year. The patient had the regular pneumonia shot 5 or more years ago. On 11 November 2015, one day following the vaccination the patient experienced feverish, coughing, lightheaded, lousy, all joints hurt, really painful in the muscles, couldn't move arm, pain in arm and feeling sick. Laboratory investigation and corrective treatment were not reported. The patient was not recovered from events. List of documents held by sender: none.
This case was reported by a physician and described the occurrence of headache in an adult female subject of unspecified age who was vaccinated with BOOSTRIX. Concurrent medications included an unknown thyroid medication. On an unspecified date the subject received a dose of BOOSTRIX as part of a routine vaccination at the school where the subject works. A few days later (not sure how many), the subject experienced headache and fatigue. At the time of reporting the events were unresolved. It was reported that the symptoms have persisted for a few weeks.
On 8/24, afebrile, however: L upper arm:  erythema & swelling long axes - 9 cm x 7 cm R upper arm:  erythema & swelling long axes - 3 cm x 4 cm RX - OTC ibuprofen (mom has at home); may continue Claritin. 8/31 - PC to mother:  child completely recovered by 8/27; without redness, swelling or itching.
STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA,  FEVER, LEFT ARM AND AXILLARY PAIN ,
Rash under bilateral axila, and cellulitis under right axila. Parent took patient to ER to be evaluated.  Resolved cellulitis on antibiotic.
Suspected Vaccination failure; VAX FOR SHIUNGLES I GOT IT ANYWAY/Suspected vaccination failure; UNRELENTING PAIN / LIKE YOU ARE BEING BORED WOTH A RED HOT POKER; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated for shingles but the patient got it anyway. The patient also said thankfully it did not enter patient's eye. The patient stated it also was unrelenting pain and felt like you were bored worth a red hot poker. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-286793 (Patient Link).
Patient was seen in Urgent Care on 3/24/21 for left sided facial drooping, symptoms began on 03/14/21, patient was diagnosed with Bell's palsy and was prescribed valacyclovir 1000 mg. Patient seen on 3/30/21 with pcp to follow up from urgent care.  Provider added methylprednisone 4mg and ordered ct scan.
Information has been received from a consumer concerning a 15 month old female who was well at the time of vaccination, who on 02/26/2003 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). On 03/02/2003 at 2 AM the child developed a fever of 101 and then the fever went up to 101-102.3. On 03/03/2003 at 4 AM the child's temperature was 104.3 in one ear and 102.3 in the other ear. It is unknown if medical attention was sought. Follow up information from the health care professional reported that the pt developed otitis media which was diagnosed on 08Mar03 and was treated with amoxicillin and she developed a rash on 11Mar03 (was not seen in office). The health care professional reported on follow up information that the pt recovered. No further information is available.