chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 24JUN96 & 27JUN96 pt exp malaise, fever, stiff neck, diff moving arms & muscle weakness;d/t medical history of meningitis & diff moving arm, pt to ER on 29JUN96;spinal tap was 99% neg for meningitis;not adm to hosp;
stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". A patient suffered stroke after booster. The reporting consumer did not know if it's related but she was more and more on the fact that it is related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200223241 same drug/reporter, different patient, similar event.
pt recvd vax & exp hives all over body,soft tissue swelling,pressure hives (blisters) on feet which are extremely painful;MD treating sx w/Pred & antihistamines w/limited effect
no adverse effects; patient received improperly stored dose of vaccine; This spontaneous report was received from a nurse and refers to a 11-year-old patient on unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 23-SEP-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637641, expiration date 16-FEB-2022 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the lowest temperature excursion below 36 degrees Fahrenheit (F) (29F) for 3 days. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion.
Patient experienced high fever over night after vaccine. Also felt extreme fatigue, aches, chills, and low grade fever 3 days later.
Sore arm day after immunization. 7 days post had enlarging rash (started small and slowly grew over all upper arm in ring like )
Ongoing hives spread out across the body, persisting for up to 2 hours.  Followed by persistent general itching.  Also mild swelling of hands and lips.
Tachycardia:   Palpitations started at 0900  Dr at bedside immediately.  Reports hx of SVT.  VS @ 0904 BP 142/85  HR 146-169 pulse ox on RA  PT husband called at 0908 came inside with wife at 09:11 with service dog.    Service dog presence made pt calm immediately  Palpiatations resolved at 0912 no complaints  VS @ 0913  130/85 HR 120 100@  Pt insisted she feels 100% better at 0930 on decided to leave facility with husband and service dog at this time
Approximately 2 minutes after receiving his 1st dose of pediatric Pfizer 0.2cc, patient began having fluttering-like motions to his extended arms.  He then became unresponsive while being eased to the floor from the chair.  Seizure-like arm motions and unresponsiveness persisted for about 5 seconds, after which he slowly opened his eyes and asked "What happened?"  Was fairly alert and oriented x 3.  Able to state and spell his name and state birthdate.  VS:  Respirations= 24-22  Pulse=64-72  BP=117/70  O2 sat= 98-99%. 911 called at 2:06.  Assessed first by fire fighters, then by paramedics.  Monitored by paramedics for about 15 minutes.  Was then tolerating sitting upright on floor , then chair.  No reoccurrence.  No other side effects noted.  Parents interviewed by both firemen and paramedics.  Parents decline transport to Emergency Dept. Patient eventually discharge from clinic to parents after another 30 minutes. Parent to observe patient at home, report incident to pediatrician, and discuss plans for future vaccine dose # 2 with pediatrician.
Breakthrough bleeding with menstrual cycle-currently on birth control continuous due to endometriosis and not suppose to have a period
She got her shots at 1:00 pm at Health Unit then went to taco Bell she didnt want to eat. We got home she took a 30-45 min. nap woke up layed there for 5 min. then went into a seizure. (the seizure happened on April 15th, 2011) She got her Hep. A shot at the Health Unit at 1:00 pm. After that we went to taco Bell she didn't eat. Then we went home and she took a 30-45 min. nap. She woke up from her nap and was fine for 5 min. She just layed there talking for 5 min. All of a sudden she got quiet. I (her mother) looked over at patient and she was in a seizure. I went to pick her up when her father ran to her and put her on her side he called 911. She had her eyes rolled back in her head and she was stiff and shaking and foaming from the mouth. That lasted for about 5-10 min by the time the ambulance got there she came out of seizure and was unresponsive. Took about 5 min to get her up. The ambulance took her. This all took place around 3:00 pm. The ER took blood and urine test and there was nothing wrong but a high fever of 103.9. The time of the shot (Hep A) she got at 1:00pm she did not have a fever. Only a runny nose. Health Unit did not take her temp. or any other vital signs before she got the shot. April 19th she had a Drs. apt. He sent us to get an EEG done of her. On April 21st, 2011, we are still waiting on the results of the test.
Temporary moderate pain and stiffness to joints. Began 4/4 to 4/6/04, no treatment.
This spontaneous report was received from a nurse concerning two unspecified patients of unknown age and gender. Information about medical history and concurrent conditions was not reported. On an unknown date the patients were vaccinated with a dose of PNEUMOVAX 23, lot # K019386, expiration date 09-JUN-2016, (dose, frequency and route were not provided). Concomitant medications were not reported. On an unknown date the patients experienced redness, infection and swelling at the injection site. The reporting nurse requested a time sensitive lot check. The outcome of the events was unknown. The causal relationship between PNEUMOVAX 23 and the events was not provided. Additional information has been requested.
Pain in shoulder, particularly upon raising arm above head, stretching arm behind back, and other shoulder rotations. This pain has persisted for 1 month.
My menstrual cramps were excruciating; severe allergies; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; restraining my ability to do my daily activities; This is a spontaneous report received from a contactable consumer (patient herself). A 19-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EW0171, Expiry date: Unknown) via an unspecified route of administration in the left arm on 10May2021 05:45 PM, (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number EW0161, Expiry date: Unknown), via an unspecified route of administration, in the left arm on 19Apr2021 05:30 PM, (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 14May2021, the patient experienced menstrual cramps excruciating, after the second dose she began having severe allergies, something she never had before. Intense burning of the eyes, nose, and throat and non-stop sneezing. These allergies are very severe, and it is restraining her ability to do daily activities. On 19May2021 the patient underwent lab tests and procedures which included Influenza and Covid-19 test results negative, Technique: Nasal Swab. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient did not receive any treatment for adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Starting the day after immunization, patient had significant redness and swelling of his left upper arm that spread towards his elbow, accompanied by fever. Patient presented to his doctor 2 days later, for which his doctor sent him to the hospital emergency room for fear of blood clot. In Emergency Room it was determined patient had Staph infection, he was given IV antibiotics in the hospital and discharged with PO antibiotics. Patient was fully recovered within 2 days after starting antibiotics.
Within 60 seconds of vaccines given, patient became lightheaded, headache, sweating, eyes rolled back, mild frothing at mouth, brief loss of consciousness, no tonic activity of extremities. Episode lasted approximately 2 minutes, then patient regained consciousness and oxygen applied. EMS called for transfer to ER.
Red rash at vaccination site developed approximately  10 days after injection.  Initially about 2 inches long but spreading.Not painful.
left arm numb, left hand numb, pain, aching, hand swelling. Injection site reddened, doctor notified.
Patient scheduled to receive their second dose of the COVID-19 vaccine. Patient scheduled to receive the pfizer vaccine. The medical assistant administered the pfizer vaccine but after confirming the patient's vaccination card she realized that his 1st dose was the Moderna COVID-19 vaccine. Patient was informed that he received the Moderna for his 1st dose and Pfizer for his second dose and waited in the office for his 15 minute observation period. Patient left with the fact sheet and was informed to contact the office if he had any questions. Patient experienced no symptoms.
Rash behind knee and down calf. Starting on elbows.  Very red and itchy. Headaches.
From telephone contact with reporting nurse it was stated that a 2 month old male patient received an IPOL, a Tripedia, a Prevnar and a Comvax vaccination on 5/23/01. Sometime after the vaccination the patient developed a fever of 105 degrees F. From additional correspondence received on 9/4/01 additional patient, vaccine and responsible physician information was provided. This case is closed.
had moderna shot; swelling of the extremities; shortness of breath,few days ago the shortness of breath symptom came back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (had moderna shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DYSPNOEA (shortness of breath,few days ago the shortness of breath symptom came back). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (had moderna shot) (seriousness criterion medically significant) and SWELLING (swelling of the extremities). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) ongoing since an unknown date for Congestive heart failure, at a dose of 40 mg twice a day. At the time of the report, CARDIAC FAILURE CONGESTIVE (had moderna shot) and SWELLING (swelling of the extremities) outcome was unknown and DYSPNOEA (shortness of breath,few days ago the shortness of breath symptom came back) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) showed CHF (Congestive Cardiac Failure ). On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient takes lot of medications and denied to provide the names of the regular medications.  Patient prescribed medication Lasix FUROSEMIDE 40 mg , to take twice a day in the beginning and later to once daily for the congestive heart failure.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  Very limited information regarding this events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-216178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Reporter's address, patient's demographics, Lab data, Vaccine information, events and treatment added.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Increased abdominal pain and bloody stools.  Now has a perforated bowel and is in need of surgical intervention
After 30 minutes, my skin became red and blotchy with a burning sensation and had increased heart rate which both lasted for about 20 minutes and the subsided. Then, around 11 pm and through the night I experienced severe joint and muscle pain, fever, severe headache and skin sensitivity. 24 hours later I am experiencing severe/painful skin sensitivity as well as sensitivity to light and sound, headache, fever, muscle and joint pain and nausea.
This 29 year old female was vaccinated with Vivotif (oral typhoid vaccine type Ty21a)(batch no: 3000231). She took the first capsule on 01/10/2004 and the last capsule on 01/18/2004. Four days after the intake of the last capsule, on 01/23/2004 she developed a rash and hives which required an emergency room visit. She was treated with diphenhydramine and prednisone. She left for Nicaragua on 01/26/2004 from where she forwarded by fax that the hives worsened again.
Advised she was given two doses in her vaccine yesterday.   (error occurred in multiple patients - reporting all patients here)  All received vaccine on the same day, at the same location, same manufacturer, same lot number.    Pfizer vaccine was drawn up incorrectly and given to six patients. Pfizer vaccine vial was mixed with another Pfizer vial, diluent was not used. Reached out to Pfizer manufacture and CDC. All patients called to follow up on them and advised what had happened and documented in their chart. Please see MRN's below. All patient's providers were notified.
Only the liquid portion was administered; Only the liquid portion was administered; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 Information: GSK Receipt date: 17-Jan-2023. Reporter's Comments: Only the liquid portion of Menveo from 2 vial presentation was administered to a patient. Reporter stated that she had a call from another HCP that only the liquid portion of Menveo was administered. The reporter did not consent to follow-up. Additional Supportive Information: Patient received only the liquid portion of Menveo from 2 vial presentation, which led to inappropriate preparation of medication and inappropriate dose of vaccine.
Pt states a rash on arms and joint pain in wrists and knee. Starting Friday evening, 7/24, got a rash (starting on face and chest), through Sunday, 7/26, spread over my body. Today, 8/3, the joint pain has spread to ankles and knees (moderate), toes (mild).
Immunizations administered to the patient at 9:30am. Patient then left the office. Grandmother states patient vomited when he got home (approx 30 min after injections). He then laid down and took a nap for several hours. When he awoke he had neck pain, rapid heart rate and a fever. Mother brought patient back to the doctor's office. Patient was transported from the doctor's office to the local emergency room via ambulance. Patient was discharged from the emergency room to home later that same afternoon.
FACIAL SWELLING OF CHEEKS, BENADRYL GIVEN BY PARENT.
Patient received both flu vaccine (2013/2014) and PNEUMOVAX in (L) arm at about 9am on 09/07/13 and by noon was sweaty, in pain, nauseous, vomiting and lethargic. Arm red and swollen. Patient coughed profusely and slept. Still feeling unwell at 72 hours. 9/11/13 pt feeling much better resumed to normal self.
INJECTION ARM NUMBNESS; SLIGHT WEAKNESS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had any reaction to injections before, patient got a flu shot every year was exposed to COVID-19 multiple times and never got COVID-19 and was in good health, not overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced injection arm numbness. On 05-AUG-2021, the patient experienced slight weakness. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection arm numbness and slight weakness was not reported. This report was non-serious.
pain in both arms-30mins; weak p/vax; fever in arm can hardly walk; nausea-top of legs have cramp
Arm soreness; Hives on her left arm and all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on her left arm and all over body) and MYALGIA (Arm soreness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (Hives on her left arm and all over body). On an unknown date, the patient experienced MYALGIA (Arm soreness). The patient was treated with CALAMINE for Pain in arm, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on her left arm and all over body) and MYALGIA (Arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, frequency, lot # and expiration date not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
got guillain barre syndrome from a flu shot; Initial information received on 30-Sep-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional. This case is linked to cases 2021SA330955(CLUSTER) and 2021SA330928(CLUSTER).  This case involves Adult male patient who had got guillain barre syndrome from a flu (guillain-barre syndrome) shot after receiving INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date the patient developed a serious got guillain barre syndrome from a flu shot (guillain-barre syndrome) (unknown latency) following the administration of vaccine. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  There will be no information on the batch number for this case.  It was not reported if the patient received a corrective treatment for the event (got guillain barre syndrome from a flu shot).  At time of reporting, the outcome was Unknown for the event got guillain barre syndrome from a flu shot.; Sender's Comments: This case concerns an Adult male patient who had guillain-barre syndrome after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Been having looser stools for 2 days. Vomiting for 3 days.
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA205710, 2018SA207505 and 2018SA207528. This case involves a 41 years old patient who experienced expired  TENIVACthat was administered, while he/she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-May-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5280AA, expiry date-16-Mar-2018 via intramuscular route in the right deltoid. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.