chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA; WAS DEHYDRATED; URINARY TRACT INFECTION; CHILLS; VOMITING; HEADACHE; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS) and VOMITING (VOMITING) in a 60-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 TOFACITINIB CITRATE (XELJANZ XR) for Psoriasis.    No Medical History information was reported.   In October 2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS), VOMITING (VOMITING) and HEADACHE (HEADACHE). At the time of the report, DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS), VOMITING (VOMITING) and HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided
Patient reports waking up in middle of night from pain from her shoulder to her elbow.  No redness or swelling in arm.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000862: US-009507513-1906USA011674:
Information has been received from Merck Pregnancy Registry for the Gardasil vaccine from a health professional concerning a 17 year old female patient who on 31-MAY-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and antimicrobial (unspecified). The reporter reported that patient miscarried on 18-AUG-2007 after receiving the dose of Gardasil. The estimated date of conception was about 06-JUN-2007. On an unspecified day laboratory test serum beta-human chorionic gonadotropin test was done. Unspecified medical attention was sought. The outcome was unknown. Upon internal review, miscarried was considered an other important medical event. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to 3 patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 30-AUG-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # reported as M108637, expiration date 11-OCT-2017, subcutaneously, site and doses were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information is not expected due to lack of the reporter's contact details.
Narrative:  Per interim care note 12/31: "rash on bilateral cheeks of past week and then noted large erythematous area on right flank last night with burning and itching; impression: hives, seborrhea;" Treated with loratadine 10mg qdaily x 30d, prednisone 10mg qdaily x 5d, selsun blue shampoo to face and scalp, aquaphor
Continue to have pain and numbness to left arm.; Continue to have pain and numbness to left arm.; Chest pain on left side; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 01Sep2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Aug2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 01Sep2021 at 15:00, the patient continued to had pain and numbness to left arm. The patient also had chest pain on left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events continue to have pain and numbness to left arm and chest pain on left side was not recovered at the time of this report.
Patient has been fine all evening, then parents observed him to be unresponsive, drooling and grunting; face flushed, rash appearing; duration of approximate three minutes at time of call. Advised to go to ER. Temp 101
Fever. Swollen under arm near arm pit. Pains in heart. Headache. Chills.
8/12/02 Approximately 14:30 received in left arm IPV #4 and DTaP #5. He had MMR #2 and Hepatitis A #1 in his right arm. He awoke at 01:00 crying of pain in his left arm and a fever. His arm became very red, edematous and hot to touch and he saw doctor on 8/14/02 at 11:30 and diagnosed with vaccine reaction local vs. cellulitis. He was started on Keflex 250mg for 7 days.
Red swollen eyes.; Red swollen eyes.; Puffie face; This is a spontaneous report from a contactable consumer (patient) reporter for herself. A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FE3592), via an unspecified route of administration in left arm on 08Sep2021 at 18:30 (at the age of 51 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had known allergies to prednisone. There were no concomitant medications. The patient did not receive any other medications the patient received within 2 weeks of vaccination. 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 hasn't been tested for COVID-19. On 08Sep2021 at 18:30 patient experienced red swollen eyes, puffie face. Therapeutic measures were taken as a result of red swollen eyes, puffie face with eye drops. No hospitalization required. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up (14Sep2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094, expiry date: 31-AUG-2018, and M-M-R II lot # M045401, expiry date: 14-NOV-2018; dosing details were not reported, both for prophylaxis. The lot# of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Information has been received from a health professional concerning a 12 year old female who on 12-MAR-2008 was IM vaccinated with her first dose of Gardasil (lot number unspecified) in her deltoid of an unknown arm.  Report states a 175 pound female client was vaccinated and felt weak post vaccination.  Nurse observed client acted nervous during vaccination.  When client arrived at her home, she fainted, broke out into hives and fainted again.  When client fainted the second time she fell and hit her jaw.  Client went to the Emergency room for unspecified medical attention.  Additional information has been requested. Follow up information received from the physician indicated the patient also had shortness of breath. The emergency room ruled out reaction to the shot. Patient has history of hives when she gets excited. Additional information has been requested.
The pharmacist administered an 0.2 mL of undiluted Pfizer Bivalent Booster for 5-11 years old to the patient at 1 PM on 11/2/22. The pharmacist called the parent the same day at 3:30pm and told her about the incident. She was gracious and understanding of the situation. No adverse effects had been seen in the patient at the time of this call.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe
Significant increase in menstrual bleeding in first period post vaccine. Period occurred within 3 week waiting period for 2nd dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 intramuscular, administered in Arm Right on 12Apr2021 12:45 as DOSE 1, SINGLE for covid-19 immunisation administered at Pharmacy or Drug Store. Medical history included goitre. No known allergies. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was Thyroid medication (unspecified). The patient experienced significant increase in menstrual bleeding in first period post vaccine. period occurred within 3 week waiting period for 2nd dose on an unspecified date in Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The patient did not receive any treatment for the event. Covid was not tested prior vaccination or post vaccination. Outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US150960 (RA).  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown"; COVID-19 (medically significant), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a representative from a distributor ("healthcare worker") concerning a 62 year old male who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 654977/0888F).  Subsequently, on an unspecified date, the patient developed a severe reaction involving redness, swelling, tenderness, chills and fever.  It was unknown if the patient recovered.  At the time of the report, it was noted that the patient's symptoms lasted for three days.  The patient sought unspecified medical attention.  Additional information has been requested.
that the second dose appointment was cancelled, she thought they did not have enough of the vaccine; that the second dose appointment was cancelled, she thought they did not have enough of the vaccine; eye pain and turned out to be viral infection, clarified that herpes in her eye; pain in arm; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1282), via an unspecified route of administration in the left arm on 15Jan2021 (afternoon) as 1st dose, single dose for COVID-19 immunisation in hospital. Medical history included diabetes mellitus from an unknown date in 1985, blood cholesterol increased (diagnosed in the past, unknown exactly when), hypertension from an unknown date in 2001 (about 10 years ago), coronary arterial stent insertion from an unknown date in 2015, Glaucoma (twice she has had surgery for glaucoma once in 2019 and in 02Dec2020), hysterectomy (uterus removed) from an unknown date in 2000 (uterus removed in 2000 and then got a tumor) and oophorectomy (ovaries removed) from an unknown date in 2001 and cataract. The patient has no family medical history relevant to adverse events. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports, she was supposed to get second one on 19Feb2021, states she got the first on 15Jan2021, clarifies it was the Pfizer Covid vaccine, states the second dose appointment was cancelled, she thinks they did not have enough of the vaccine. States she was supposed to go on Monday, 1Mar2021 to get the second dose, appointment had been rescheduled but she had to go to the emergency room for eye pain and turned out to be viral infection, clarifies herpes in her eye and the ER doctor recommended her not to get the second dose of the vaccine. Asks if it is safe to have the vaccine because she is taking the medication for the eye infection, taking acyclovir 400mg 1 tablet 5 times daily for 10 days. States she also tried to reach out to her primary care, and they are going to send a message to him to see what he had to say about getting the second dose. Clarifies she had a stabbing pain in her eye, above eyebrow, and on side of eye, it stung and was itching and watering a lot for 2 weeks prior to going to the ER on 28Feb2021. Thinks maybe it started around the 12 or 13 of Feb2021. States her doctor said his second gave him body aches. States she had surgery in Dec2020 for glaucoma and for cataracts was wondering it if was her pressures going up or what is going on to make sure she was not going to confuse it with actual side effects of injection. States she also was a little painful in her arm for a day or so on 15Jan2021. Patient reported that she was not hospitalized but waited in emergency room from 12:00 (12 noon) until 23:00 (11:00 PM). No relevant tests were provided. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 12 month old male who on 22-JAN-2010 was vaccinated subcutaneously with a 0.5 mL first dose of VARIVAX (Merck) (lot # 665009/1042Y). Secondary suspect vaccination given on unspecified dates included doses of VAQTA (MSD), RECOMBIVAX HB (MSD) and MMR II (MSD). On 06-FEB-2010 the patient experienced diarrhea, swollen glands in the groin area and developed a nodule at the injection site. No laboratories studies performed. The patient sought medical attention through an office call. The patient recovered on an unspecified date. Additional information is not expected.
About 10-15 minutes after shot,  I developed a large red splotchy rash on my chest and it started spreading up my neck and face. I also felt dizzy, a little numbness and tingling and very cold/ shaky. I was given a total of 50 mg of Benadryl PO. 25 mg immediately and then an additional 25 mg about 30 minutes later. About 15 minutes after my second dose of Benadryl my rash started to subside and I began feeling better. ADTER about an hour I felt back to my baseline.
Pain began immediately after injection and worsened over time. I thought the pain from the shot was normal and that the progressing symptoms were due to a rotator cuff tear caused by a cartwheel a couple of weeks after the injection. When I went to the doctor on June 17th (I waited for the school year to end, thinking a rotator cuff injury wasn't an immediate fix anyway), the doctor that was filling in for my regular doctor's paternity leave confirmed that it was my rotator cuff and referred me for an MRI. My insurance wouldn't cover it until I had an xray, so I did that.  All this took over a month from the time I first sought help. I've still not had an MRI. When my regular doctor came back, I saw him on July 26, 2021 and he said that it isn't my rotator cuff, but rather bursitis caused by the vaccination. I was given a cortisone shot in my shoulder, and have seen a little relief from the pain, but not totally. I have been referred for physical therapy, and Dr. says my insurance won't cover an MRI until I have completed physical therapy. I haven't begun p.t. yet. I can't lift my left arm and have pain radiating into my neck, arm, wrist, and hand.
When the vaccinator was administering the vaccine, some of the vaccine leaked out on to patient's arm.  Patient describes feeling liquid on her arm.
Patient felt faint and had to be put on floor. Her bp was 158/116 and hr was100 she did not go to er was picked up by family member and felt fine the next day.
Child developed cellulitis of (L) thigh around injection site (KINRIX) (baseball size) and smaller area on (R) side (Hib given).
Rash with itching at wrists and upper chest - administered 50 mg Benadryl PO with rash fading/itching resolved within 30 minutes after Benadryl.
Patient was given vaccine that had expired (12/14/2021) the day prior to injection on 12/15/21
Patient said about 3 hours after taking the vaccine, he felt energized like he had taken multiple B12 shots. He has a sour stomach when he tries eating food. He was awake for 36 hours after the vaccine without any medication or caffeine. Patient stated the inflammation in his body from the gout, arthritis and lime disease is now gone. Patient hopes the reaction continues and hopes this will help his autism.
Pt developed abdominal cramping and trouble breathing with pain in side. Treated with Advil. Seen by physician the next day who diagnosed pleurisy, allergic reaction to immunizations. Given prescription for pain medicine. Pt has improved.
Vaccines given 7-3-07, patient seen in ED 7-4-07 for swelling and redness. Rocephin injection and Amoxicillin given. (See Attached). Diagnosis in ER-allergic reaction (? vaccine) and cellulitis.
10:50 AM Brought to nurse by teacher after seeing rash-large rash arms and back, upper chest c/o itchy. Face pale, no resp. distress, given Benadryl. Mother arrival at 11:10 am. Nurse concerned because lower BP and beginning to look swollen although no wheezing not rash was fading slightly on face but looking worse on back. Mom plans to take to ER.
Pt Tested positive for COVID-19 after vaccination with Janssen Vaccine and is symptomatic for COVID-19.
I am the epidemiologist reporting on behalf of patient.  Patient received two doses of Pfizer on 01/09/21 and 02/02/21. Case was admitted to hospital on 6/26 due to slurred speech, low heartrate, and low oxygen (75%) and tested positive for COVID-19 via a PCR test. The patient passed away on 07/01/21. Cause of death is listed as sepsis. Death cert # 20210042573.
Patient fainted momentarily and fell to the floor from seat. Patient was breathing and groaning before being flipped face-up. Patient was sat upright on the floor and was alert and awake within one minute. Mild impact to right forehead on fall with slight bruising. Suspected vasovagal syncope. ED called, but patient declined ambulance transport to hospital for further help/examination/treatment.  Patient stayed at pharmacy for extended amount of time for observation and in order to calm nerves. Patient called friend/family for transport from pharmacy.
caller (son) stayed w/ the pt for about an hour after he received the vax and the pt stated the only symptoms at that time  was some achiness on the arm around the injection site.  Son went home after that.  He tried to contact him on 3/1/2021 but wasn't able to reach him.  On 3/2/21 the brother tried to contact him and wasn't able to reach him.  They contacted the police dept on 3/2/2021 around 8:00 AM to do a well check.  Pt was found on the couch like he had fallen asleep but was deceased.  They suspect he probably expired on 3/1/2021.  No autopsy will be conducted per the son.
pt recv vax & devel 101t & inj site rxn of redness,swelling, warmth & pain. Arm felt weak. MD rx w/antibiotic. 08/06/96 pt to MD; small nodule at inj site & arm pain. 02/17/97 again to MD; arm pain & weakness, mild atrophy of biceps.
This spontaneous report was received from a registered nurse and refers to a multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, since January 2017, the patients were vaccinated with PROQUAD (route of administrations, lot numbers and expiry dates were not reported). No adverse effect was reported. Data logger was involved. At the time of the report, temperature excursion and time frame of temperature excursion were not known. There was no previous temperature excursion. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013078.