chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Obese; High blood pressure; Middle of January and second end of January; This is a spontaneous report from a contactable consumer reporting for himself. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on Jan2021 (end of January) (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Jan2021 (middle of January) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced high blood pressure and was obese on unknown date in Jan2021. The patient stated that he got the vaccination, Pfizer, in middle of January and second end of January, was obese and high blood pressure, otherwise not in terrible shape. If it was recommended to get the booster what vaccine should he get. Caller started that, "he lived in a home of the idiots who do not want to get the shot and our numbers show it even though the governor blocked the daily reporting, such a wonderful man, hope karma rains down on him sometime. Anyhow sorry for the rant, just very upset". The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Didn't describe exactly the adverse event but did say that he was ill for approximately 3 months. This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Didn't describe exactly the adverse event but did say that he was ill for approximately 3 months.". It was unknown if therapeutic measures were taken as a result of illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/30/20: increased tears and mucus in right eye, woke up next day with inability to control saliva. 1/4/21: valacyclovir 1 gm x's 21 given- feels like some symptoms listed are r/t this rather than Covid vaccine
Pt was seen at clinic for exam on 2/7/08.  MOCH stated infant developed 103 degree fever & uncontrollable crying after about 2 hrs from receiving DTaP/HepB/IPV #2, HIB #2, PCV #2, RTV #2 (no reaction to 1st series of shots).  Was taken to ER around 9:00 pm -> Dx with pneumonia & OM and prescribed ABX.  Informed of possible adverse reaction today by MOCH.  Referral made to PCP for evaluation for administration of 3rd series of immunizations.
Initial misuse report received from a healthcare professional on 23 April 2014. YF-VAX was administered which was reconstituted with sterile water instead of supplied diluent. It was a wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: None.
THE VACCINATION STATE REGISTRY WAS ON A GLITCH WHEN I SPOKE WITH THE PATIENT ABOUT THIS SHOT - SHE SAID SHE RECEIVED A SHINGLES SHOT 7 YEARS AGO, SO WE WENT AHEAD AND DID THE SHINGRIX TODAY BECAUSE SHINGRIX CAME OUT ABOUT 4 YEARS AGO. AFTER I WAS ABLE TO GET BACK INTO THE REGISTRY I DISCOVERED THE PATIENT ALREADY COMPLETED THE SHINGRIX SERIES PREVIOUSLY.
"received vaccination at 0900 with immediate site tenderness and progressive soreness with significant pain during overhead activities and daily activities that continued through the morning of 12/30 (still with slight pain, redness, and swelling, but able to engage in daily activities without limitations). The following day, developed significant fatigue, headache, and some generalized weakness. Had to leave work early in order to rest. "
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 12-SEP-2014, the patient was vaccinated with a dose of ROTATEQ (route of administration not reported, defaulted to oral; dose, indication, lot# and expiry date unspecified) and a dose of PEDVAXHIB injection (dose, route of administration, indication, lot# and expiry date unspecified) that were exposed to temperatures outside of the proper storage range. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
11/11/99, 6:00 am, felt "icky", arm swollen & red, nauseated, ? fever, chest congested. Has needed inhaler & nebulizer more often the last few days. States "feels worse today".
PAIN IN ARM NECK UNDER ARM CHEST, BREATHING, COUGH, LIGHT HEADED, DIZZY, NAUSEA, STABBING PAIN IN CHEST AS I COUGH, TIRED VERY TIRED, ARM GOING NUMB, PAIN IN ALL JONITS, MUSCLE SPASM IN ARMS AND LEGS, SHORT OF BREATH, HEAD ACHES.
Pt administered 0.25 ml booster dose in error for her first dose. Per CDC interim clinical guidance Appendix A, immediately administered additional 0.25 ml dose to equal one single full 0.5 ml dose.
Ringing in her ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 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: TINNITUS (non-serious), outcome "not recovered", described as "Ringing in her ear". The event "ringing in her ear" was evaluated at the physician office visit.  Additional information: Patient has been to 8 doctors and has not been able to receive relief from this side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recvd flu vax & arm felt itchy & hot to the touch, & inject site became red & swollen; pt states did not feel well for about a wk;
PATIENT CAME TO PHARMACY ON 10/16/16 AT 11:15 AM STATED SWOLLEN LEFT CORNER OF LIP AND NUMBNESS STARTED TO OCCUR AT 10:30 AM THE SAME MORNING.  HAS SOME REDNESS AND SORENESS AT INJECTION SITE.  ADVISED PATIENT TO TAKE BENADRYL FOR ALLERGIC REACTION AND SEEK MEDICAL TREATMENT.
Pt given immunizations on 4/18/06. Returned to primary care provider with red, raised lump approx 5cm, warm to touch, pt with c/o pain only when touched. Wound was on pt left thigh at site of Pediarix injection.
pt recvd vax & 2-3 minutes later felt faint, passed out, jerky movements of legs; unresponsive approx 2 mins; hit self on the rt side of the head; numbness;
Seen in ER upon initial presentation, exam noted right sided facial droop with high weakness and minor asymmetry of the forehead, with equal hearing bilaterally intact light touch intact. EOMS with no ptosis and equal stregth bilateral upper lower extremitamics. Labs unremarkable
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA001661:
only received the adjuvant /AS01B adjuvant /(without the lyophilized antigen component).; only received the adjuvant /AS01B adjuvant /(without the lyophilized antigen component).; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient had administered only AS01B adjuvant of Shingrix (without the lyophilized antigen component) in the left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Erythema multiforme recurring for 6 weeks. 2 er visits and 4 pediatrician visits. 2 visits to dermatologist. child was treated with repeated doses of prednisolone 3 times. I have asked pediatricians office twicw to report and document this and have gotten no response from them. the dermatologist has noted in his report that there is correlation between the Em dx and the vaccinations.
Information has been received from a health care professional concerning a 49 year old male patient who on 11/15/2002 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent.  His first dose was reported as being given on 10/02/2001.  On 11/20/2002 the patient complained of a red, swollen, hot and painful area at the injection site.  Unspecified medical attention was sought.  Additional information has been requested.
Received Hep A P.M. on 7/16/07; several hours later broke out in hives via phone call to on-call doctor
Superficial vein thrombosis; weight gain; Runny nose; legs were shaking; Flushing; face, ears and chest began to become red; Pain on her arm/pain was in the same area she gets her IV infusion; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOPHLEBITIS SUPERFICIAL (Superficial vein thrombosis), INFUSION SITE PAIN (Pain on her arm/pain was in the same area she gets her IV infusion), RHINORRHEA (Runny nose), TREMOR (legs were shaking) and FLUSHING (Flushing) in a 51-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.    Co-suspect product included non-company product AGALSIDASE BETA for Fabry's disease.    No Medical History information was reported.   On 04-Jan-2021, the patient started AGALSIDASE BETA (Intravenous) 70 milligram every two weeks. On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RHINORRHEA (Runny nose), TREMOR (legs were shaking), FLUSHING (Flushing) and ERYTHEMA (face, ears and chest began to become red). On 15-Feb-2021, the patient experienced WEIGHT INCREASED (weight gain). In 2021, the patient experienced INFUSION SITE PAIN (Pain on her arm/pain was in the same area she gets her IV infusion). On an unknown date, the patient experienced THROMBOPHLEBITIS SUPERFICIAL (Superficial vein thrombosis). At the time of the report, THROMBOPHLEBITIS SUPERFICIAL (Superficial vein thrombosis) and INFUSION SITE PAIN (Pain on her arm/pain was in the same area she gets her IV infusion) was resolving, RHINORRHEA (Runny nose), TREMOR (legs were shaking), FLUSHING (Flushing) and ERYTHEMA (face, ears and chest began to become red) had resolved and WEIGHT INCREASED (weight gain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment Medication was not provided.
Raised red rash on trunk and neck. No itching. Started 1.5 days after first dose, resolved 4 days after dose administration.
ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced asymptomatic covid-19. The action taken with covid-19 vaccine was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Patient with right arm pain without swelling, redness, tenderness. Pain started day vaccine was given.
Patient reports itchy, rash, swelling, joint pain, tired symptoms. She went to provider and was diagnosed with cellulites from vaccine.  The patient was prescribed clindamycin 300mg 1 tablet every 6 hours for 7 days.
Patient presented to the ED on 5/13/2021 with perforation of sigmoid colon due to diverticulitis and was subsequently hospitalized. Patient received second vaccination dose on 5/21/2021, and on the same day patient  presented to the ED on 5/21/2021 with pedal edema. These visits are within 6 weeks of receiving COVID vaccination.
This spontaneous report as received from a Medical Assistant refers to an unspecified patient of unknown gender and age. On 14-JUL-2014, the patient was vaccinated with an expired dose of M-M-R II lot # H012569, exp date reported as 29-JUN-2014 (dose number, route and indication not reported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
4/27/08 woke up wasn't breathing- Blue called 911- Sheriff and paramedics.  6/20/08 Autopsy states COD as undetermined.  Report states no injuries or disease; all tests neg; history of co-sleeping w/adult.  Found supine & unresponsive in bed w/parent w/numerous pillows arranged to keep patient from rolling.  CPR initiated.
AS PT WAS RECEIVING BEXSERO (2ND VACCINE GIVEN), PT JERKED AND EXHIBITED SEIZURE LIKE ACTIVITY TWICE. PT BECAME UNRESPONSIVE AND HIS HEART RATE AND PULSE DROPPED SIGNIFICANTLY. TIME FRAME OF EVENT LASTED >20 MINUTES, SEIZURE ACTIVITY LASTED AROUND 1 MINUTE EACH EPISODE. EMS WAS CALLED AND PATIENT'S PARENT TRANSPORTED HIM TO ER.
Patient began to feel trinity to lower lip. Similar reaction to when she eats grapes which she is allergic too
Headache, nausea, left side weakness, pain, seizures on 11/5, 11/6, 11/7, 11/11, 11/16. Hospitalized 11/7- 11/9.
I got the vaccination on 3/31/2021 at about 9 AM. At about 7 PM that evening, my ears got plugged and I had ringing in them. I had fever, extreme chills, and extreme tiredness. I still have a constant, very loud ringing in my ears. The ringing has gotten louder over time.
Patient stated that she had a seizure the day after getting her 2nd dose, patient stated that her eyes were swollen shut, and she also stated that she had vertigo. Patient stated that she started throwing up, and wasn't able to eat. Also stated that she was shaky and couldn't walk, and couldn't form a thought in her head. Patient is still having AEs.
Later that evening I begin getting dizzy, light headed and had difficulty breathing which lasted a little over an hour.  I took benedryl to help with the symptoms.
SOB, Elevated vitals. Evaluated by EMS-Transported to emergency room/department or urgent care.
Pt states her arm was swollen, pink, sore and hard. Says these symptoms are dissipating as the days progress. Pt was given diphenhydramine and asked to put cold compress on the area. Patient came to pharmacy two days after receiving her PPSV23 and High-dose FLUZONE in one arm. Certain spots on the arm were red and swollen. Pt. was instructed by the pharmacy to put cold compress on the arm and given diphenhydramine.
I woke up feeling nauseous, dizziness and challenging to walk and a lot of coughing. I went to the dr and he gave me prednisone.
very fatigued today; mild headache that progressed to a migraine; mild headache that progressed to a migraine; fatigue, muscle aches, and vomiting.; fatigue, muscle aches, and vomiting.; fatigue, muscle aches, and vomiting.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache that progressed to a migraine), FATIGUE (fatigue, muscle aches, and vomiting.), MYALGIA (fatigue, muscle aches, and vomiting.), VOMITING (fatigue, muscle aches, and vomiting.) and FATIGUE (very fatigued today) in a 67-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.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (mild headache that progressed to a migraine), FATIGUE (fatigue, muscle aches, and vomiting.), MYALGIA (fatigue, muscle aches, and vomiting.), VOMITING (fatigue, muscle aches, and vomiting.) and MIGRAINE (mild headache that progressed to a migraine). On 02-Mar-2021, the patient experienced FATIGUE (very fatigued today). At the time of the report, HEADACHE (mild headache that progressed to a migraine), FATIGUE (fatigue, muscle aches, and vomiting.), MYALGIA (fatigue, muscle aches, and vomiting.) and VOMITING (fatigue, muscle aches, and vomiting.) was resolving, FATIGUE (very fatigued today) outcome was unknown and MIGRAINE (mild headache that progressed to a migraine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
felt a little sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (old shingles shot years ago).   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR118369   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had the old shingles shot years ago back in March and felt a little sick the next day. The follow-up could not be possible as no contact details were available. For tolerance to the 2nd dose refer case US2022AMR118369.; Sender's Comments:  US-GSK-US2022AMR118369:Second dose case/Same reporter
COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction NOS (teeth pulled and dental work). Concurrent medical conditions included Infection, Autoimmune hepatitis and Cirrhosis liver. Concomitant products included LEVOFLOXACIN (LEVAQUIN) for Infection.    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 SWOLLEN TONGUE (COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth) and PYREXIA (Low grade fever). At the time of the report, SWOLLEN TONGUE (COVID tongue\tip of tongue swollen in a "V" shape\ her tongue was swollen to the point it felt as though she had a big hunk of meat in her mouth) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included immunosuppressants, chronic oral steroids. The patient reported her physician at the clinic suggested she should receive Johnson and Johnson instead of Moderna for her second COVID-19 Vaccine dose. No information regarding corrective treatment was reported by the patient.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments     Reporter did not allow further contact
Fever 101.1 - 103.7 - Started 8 hours after vaccine lasted 48 hours - relieved with TYLENOL elevated had fever after 4 mos vaccine - went to ER
Information has been received from a physician concerning a 6 year old female who on 21 dec 2000 was vaccinated with Varivax. Subsequently the patient experienced breakthrough as she developed 30 lesions on her legs and arms. The outcome was not reported. Additional information has been requested.
Severe muscle pain, severe weakness, slight shortness of breath.  Was unable to sleep because of severe muscle pain.  I passed out when I went to the bathroom at  3:53 am from the pain  I came to on the  floor at approximately 3:57 and had hit my head just below my eyebrow on the sink counter.  I was bleeding from a wound and sustained a black eye.
Right ear became plugged 1 hour after shot. Then severe cold symptoms the next day. Lost voice on day 3. Took 2 weeks to get over most of it. Sever stomach upset day 2.
See attached clinical summary. Reports being in good health with no prior adverse reactions to any previous immunization until November 2, 2002. She received 3 immunizations and a PPD (Hepatitis A #2, Influenza and Td) the morning of November 2nd, without apparent incident. States that approximately 30 minutes later recalls, a tingling feeling, a slight itchy in the throat and feeling tired, so went to lie down. Later that afternoon, @2:30PM noted itchiness on arms and neck followed by a generalized rash with hives and welts on the neck arms, chest and back. Also had swelling of the face and hands. Denies wheezing, fever, nausea or vomiting, but says tongue felt swollen and throat felt tight and felt woozy. Was seen in the clinic and immediately sent to the ER. Once there was given Benadryl 50mg IM, received IV fluids, O2, and observed until the symptoms began to subside. Was released on oral prednisone and given a referral to be evaluated by an Allergist. Subsequently under went skin testing that demonstrated positive reactions to trees, grass and weeds, but did not address vaccine allergies and or desensitization.