chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 63 year old female consumer refers to herself (demographics not provided). On 20-NOV-2014 the patient was vaccinated with ZOSTAVAX (dose, lot# and expiration date were not reported). On 20-NOV-2014 the patient "experienced soreness in her arm at the injection site, after receiving ZOSTAVAX". There was no treatment given for the event. The patient did not seek any medical attention. At the time of the report, the outcome of the event was not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because there was no patient's or physician's contact information.
This spontaneous report as received from a health professional refers to a 15 month old patient. On 25-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had spoken with the physician and she was told by the physican that the 2nd dose was worse than the 1st dose. The reporter stated that, the physician did not react at all after the 2nd dose. This case has been linked to the US2018GSK107501 reported by the same reporter.
pt recv vax & approx 2 days post vax pt devel chest pain, felt clammy & was sweaty;felt like was having heart attack & was adm to hosp from 5/23/99 to 5/25/99;tx & relevant lab data & results not specified;
STARTED WITH CHILLS AND FEVER@8PM,WENT TO BED, AT 10PM STARTED WITH LIQUID DIAHERRA ABOUT 20 TIMES,WENT TO BED,@4 AM VIOLENTLY VOIMITING ABOUT 8 TIMES,HORRIBLE HEADACHE,FEVER CHILLS,COULD BARELY STAND, WENT TO BED  ABOUT 6 AM,ARM WAS VERY SORE COULDNT MOVE ARM,WHEN WOKE UP FELT LIKE I HAD BEEN RAN OVER COULDNT BAERELY WALK DIZZY AND VERY WEAK,HEADACHE SO BAD COULD HARDLEY HOLD HEAD UP,VERY DEHYTERED STARTED DRINKING GATORADE AND SPRITE AND WATER SLEPT MOST OF THE DAY.HAD FEVER MOST OF DAY 100.5 TOOK IBROBHEN, THE MORNING OF THE 25TH  FEVER BROKE DURING THE NIGHT,ARM WAS STILL SORE AND THOART WAS SORE,STARTED EATING BLAN DIET,MORNING ON THE 26 ARM IS BETTER AND EATING NORMAL FEELING BETTER
passed out, vomiting, diarrhea, high blood sugars, generalized weakness, rash at injection site, head ache....did not seek treatment.   vomiting, diarrhea, fatigue continued for 2-3 days days.
Swollen, hot, raised bump at the injection site.  At 48 hours after injection, swollen, pink area is about 2 inches in diameter.
15 minutes after the shot i started seeing flashes of lightning type things in my right eye it kept it up for about a hour,, now i have blurring in that eye in the lower portion of it like there my glasses are dirty and eye seem to water more than normal..
This spontaneous report as received from a other health professional refers to a 23 year old male patient. Patient received both M-M-R vaccinations (M-M-R II) (injection, strength, lot#, dose/frequency, route and duration were unspecified) as a child. Nurse called regarding equivocal titers for Rubella drawn on an unspecified date in the patient. The outcome was unknown. Additional information has been requested.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "recovered" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient did not have covid prior to vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT WAS SICK, HAD MODERATE FLU LIKE SYMPTOMPS. SPENT THE WEEKEND IN BED.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date see case US2019015732). On 27th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with Steroid (Not Specified). On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient demographic details were updated. No error made in prescribing, dispensing or prescription. The doctor of medicine could not make a connection between the SHINGRIX shot and the patient's arm pain. The patient was still having pain 8 months later but found out other factors were involved, his doctor of medicine told him he had broken both collarbones at one timing his life has both a torn bicep and triceps. The doctor of medicine said these factors contribute to his arm pain. The arm pain was from elbow to shoulder. The doctor of medicine had given patient 2 steroid shots which has helped him a lot. They were contemplating surgery.
Patient reported dizziness and "adrenaline-like feeling" during administration of covid vaccine.
Swelling of armpit which is painful.  Other symptoms were listed as possible side effects (chills, fatigue, pain in place of vax,strong headache)
Administration error, patient receives boosters dose one month before corresponding date. Patient was administered her second dose on 06/26/2021 which indicates she would get the booster on 12/26/2021 and was administered on 11/23/2021. Patient had no adverse effects.
Local reaction with swelling and redness at site of injection. On 5/8/00, no redness or swelling.
This spontaneous report was received from a registered nurse and refers to a 60 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 22-AUG-2016. On 30-SEP-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot # M020921 with expiration date of 18-JUL-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014052:
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 had five temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 168 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 264 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, and -0.55 Celsius Degrees (31 Fahrenheit) for 368 hours respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)".  No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Noticed bone pain, started in hands/arms. Then as days passed continued into lower body and legs feet. Most bones hurt with minimal activities! Ongoing issue.
Per dad - Patient woke up in the middle of the night and had a febrile seizure. Patient has had these before. Patient recovered easily and TYLENOL was administered. No other treatment was done.
Patient may have received a dose that was drawn up the day prior and never disposed of at the end of the day. Meaning the dose was likely drawn up more than 12 hours prior (approximately 28 hours). Moderna was contacted and has been escalated to Modernas safety and assessment teams for further direction. The patient was made aware immediately following contact with Moderna.
Within half hour, experienced sharp nerve pain and numbness on right side of face, opposite side of injection. Later that evening ~8pm experienced sharp nerve pain at right fingertips and groin, and nausea. Had soreness on left arm (injection site) and nausea that lasted for 3 days. 6 days later, had soreness under left armpit that lasted for 3 days. No noticeable swelling. Next day had severe migraine that caused blurred vision and nausea.  Migraines lasted for 3 days, took Ibuprofen (2 - 200mg tabs 2x daily).  Next day, had subconjunctival hemorrhages of right eye, 2x . Only other medication I take is birth control pill, Tri-Previfem. Pt is in good health. No history of high blood pressure, blood clots, diabetes, or other known health conditions Pt has routine annual health exams, in good health.
Information has been received from a physician concerning a 6 year old male who in June 1998 was vaccinated with a dose of varicella virus vaccine live. On 10/28/03 the patient developed a case of chicken pox (severity unknown). Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. The physician also indicated that 3 other children experienced chicken pox after being vaccinated with a dose of varicella virus vaccine live. Additional information has been requested.
Buring at injection site.  Significant pain at injection site / shoulder post injection.  Patient pain did lessen but did not resolve upon waiting over 1/2 hour.  Improvement did occur but not completely resolve.
This spontaneous report was received from a physician and refers to a 44 year old male patient. The patient had no pertinent medical history, no drug reactions or allergies and no concomitant medications. On an unknown date, the patient's child was vaccinated with VARIVAX (Merck) (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date in November 2015, about a month later, the patient sought medical attention and was seen in the emergency room (ER) at the hospital because he was not feeling well. The patient was diagnosed at that time with an unspecified rash on an unspecified area of the body and varicella hepatitis. The physician stated that the patient had unspecified skin biopsy, unspecified blood work, a computerized tomogram (CT) scan of the liver and an ultrasound of the liver while he was in the ER (no result was provided). The patient was admitted to the hospital for about a week and received treatment for the events (unspecified). The patient has been recovered from the events since an unknown date approximately in 2016, since about 3 months after being discharged from the hospital on an unknown date approximately in 2015. The relatedness between the events and VARIVAX (Merck) was not reported. The physician considered the event of varicella hepatitis as life threatening. Upon internal review the event of varicella hepatitis was considered to be medically significant. Additional information has been requested.
A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide; It itched like crazy; A spot of inflammation right at the spot where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide), VACCINATION SITE PRURITUS (It itched like crazy) and VACCINATION SITE SWELLING (A spot of inflammation right at the spot where I got the shot) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide), VACCINATION SITE PRURITUS (It itched like crazy) and VACCINATION SITE SWELLING (A spot of inflammation right at the spot where I got the shot). At the time of the report, VACCINATION SITE DISCOLOURATION (A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide), VACCINATION SITE PRURITUS (It itched like crazy) and VACCINATION SITE SWELLING (A spot of inflammation right at the spot where I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.
both of us have had sore arm after every mRNA shot; both of us have had headaches after every mRNA shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (both of us have had sore arm after every mRNA shot) and HEADACHE (both of us have had headaches after every mRNA shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (both of us have had sore arm after every mRNA shot) and HEADACHE (both of us have had headaches after every mRNA shot). At the time of the report, PAIN IN EXTREMITY (both of us have had sore arm after every mRNA shot) and HEADACHE (both of us have had headaches after every mRNA shot) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-665445 (Linked Report). This case was linked to MOD-2022-665518 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665445:Wife cases-  (MOD-2022-665445-1st dose and MOD-2022-665505-Bivalent dose)
This spontaneous report was received from a pharmacist refers to a 66 year old female patient. Medical history and current conditions were not reported. On an unspecified dates in 2009, the patient received full series (dose 1, 2 and 3) of RECOMBIVAX HB (unspecified lots and strength). Concomitant medications were not reported. On an unknown date after the series of RECOMBIVAX HB in 2009, the patient received a liver transplant and had also experienced recurring Clostridium difficile infections. On 23-MAR-2015, the patient who was not on hemodialysis, started the new series of vaccination and received dose 4 which was an overdose of RECOMBIVAX HB 40 microgram (mcg) (lot number lot K011961). Again on 29-APR-2015 the patient was vaccinated with dose 5 of RECOMBIVAX HB 10 mcg (lot # K022265). The outcome of the events were unknown. The reporter stated that the events are not related to her receiving RECOMBIVAX HB in 2009. Upon internal review, the event liver transplant was determined to be medically significant. Additional information has been requested.
Breakthrough case admission after 4 vaccines Pfizer 1/19/21 Lot# EL3249;  Pfizer 2/9/21 Lot# 9265;  Pfizer 9/8/21 Lot# 30138A;  Pfizer 5/20/22 Lot# Fm017
On the morning of 2/22/21 Patient was found by care staff to have signs of stroke as evidence by left sided facial drooping. EMS were called and he was taken to a local hospital where he was admitted. He then was discharge to a skilled nursing facility for rehabilitation. He is still there as of today, 3/11/2021.
Pre medicated with 1000mg tylenol and 50mg Benadryl 24 hours after shot: sore throat and cough 48 hours after shot: voice lost, nasal passages closed 72 hours after shot: nasal passages closed, throat began closing. Went to ER per recommendation from on call nurse. Given breathing treatment, IV steroid, IV 50mg Benadryl, blood work taken (normal), chest x-ray (normal), oxygen levels fine.....released with Oral steroid for 5 days
heart rate slows it is irregular/heart rate increased to over 100-110; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 06Apr2021 at 11:00 (at the age of 63-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included replaced mitral valve from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine and folic acid, all taken for an unspecified indication, start and stop date were not reported. Two weeks after the patient's first shot, on 20Apr2021 at 07:00, her heart rate increased to over 100-110. She has an artificial mitral valve - Bio bovine. Her heart rate slows - it is irregular. They are testing now. Event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment was received for the event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21.
Every time I got a flu shot, I was sick with flu symptoms by that evening; Every time I got a flu shot, I was sick with flu symptoms by that evening; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case is linked to case 2020SA297164 (original case).  This case involves patient (unknown gender and age) who experienced every time got a flu shot,  was sick (illness) with flu symptoms (influenza) by that evening while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of INFLUENZA VACCINE (batch and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will no information on the batch number for this case.
This spontaneous report as received from a pharmacist refers to a 80 year old patient. On 04-FEB-2013 the patient was vaccinated with live ZOSTAVAX (0.65 ml, one shot, subcutaneous, lot # was unknown). On 06-FEB-2013 the patient experienced pain in her lower left arm and left shoulder joint pain. The skin on her left wrist was sore to touch (like nerve ending type) and behind her left ear lobe she had an area of pain and swelling. No demographics were provided for the patient. The outcome of event was unknown. The patient was told to take some ibuprofen. The patient sought medical attention via seeing the pharmacist. Additional information has been requested.
Very bad diarrhea; Hurt alot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Very bad diarrhea) and PAIN (Hurt alot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DIARRHOEA (Very bad diarrhea) and PAIN (Hurt alot). At the time of the report, DIARRHOEA (Very bad diarrhea) and PAIN (Hurt alot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were also not reported.  Treatment for the events were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.
2 of 4 pts who recvd 3 doses of Engerix-B were non-rresponders as detected by f/u titers;
Chief Complaint   Alterd Mental status from home Covid + 3 days ago, today drastic change in mentation Possible sepsis.   History of Present Illness     Patient is a pleasantly demented 81-year-old white male comes ER with complaints of altered mental status.  Apparently had worsening of his mentation over the last 2 days.  He has been disoriented, confused, and had decreased responsiveness.  Unfortunately patient is unable to given HPI at this time.  14 point review of systems attempted, unobtainable due to decreased mental status. Objective  Vitals & Measurements (Last Charted)  T: 98.9 °F(Oral)  TMIN: 98.3 °F(Oral)  TMAX: 103.5 °F(Oral)  HR: 59  RR: 18  BP: 137/49  SpO2: 100%  WT: 94.0 kg  BMI: 32.53