chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Route, anatomical location were not provided, lot # S038700 expiration date 01-DEC-2021) for prophylaxis.        The vaccine had temperature excursion of -6.6 °C during 1 hour 45 min. There were not previous excursions. Digital data logger was involved.
Arm started hurting and I could not raise it. It kept hurting for days. My arm has continued to hurt and I have trouble raising it.
No adverse reaction, patient was given HAVRIX 1440 and should have been given HAVRIX 720 due to age.
ringing in the ear; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who experienced ringing in the ear (tinnitus), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past 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 suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced ringing in the ear (tinnitus).  (Other relevant tests included no lab data.)  Final diagnosis was ringing in ears.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.
Rash 1 day after lasting 2 weeks.  Fever started 2 days after up to 101 lasting 4 weeks.  Currently still on going.  Tylenol no help. Advil no help
TOOK THREE UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-427) on 14-Feb-2019. The report describes an adult female consumer who "took three unrefrigerated dose". The consumer was receiving oral Vivotif capsule (one dose every other day; lot number: 3003240) for typhoid prophylaxis.   It was reported that the consumer took the three unrefrigerated doses of Vivotif. The doses were taken on 09-Feb-2019, 11-Feb-2019, and 13-Feb-2019 respectively.  The action taken with Vivotif with respect to the event "took three unrefrigerated dose" was not applicable.  The clinical outcome of the event "took three unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.
Left arm muscle and shoulder severe pain which started 3 days after injection (1/20/15) has continued.
I started to get ulcers in my mouth and sores on my body.  They come and go and I get a bloody metal taste at time in my mouth.  I went to the  doctors at first and seen the  NP (January 2022)  and  She  stated it was Canker sores.  They would not  go away .  I went  to my Dentist  and My dentist states it is Lichen Planus.  MY Dentist sent me to a Oral surgeon which I have an appt to see  (5/27/22)I  went back to my Doctor  for my routine check in April and showed hrer the sores in my mouth and she stated it is Lichen Planus , she agreed with  my dentist.  I never had anything like this until the 3rd Covid vaccine (booster)
Initial report received from a reporter on 15 November 2013. A 59-year-old female patient, whose medical history included NS and whose age and concomitant mediations were not reported, had received a dose of influenza USP trival a-b subvirion vaccine (flu vaccine) on 30  September 2013. On 08 October 2013, after receiving vaccine the patient feeling sick to her stomach and she has stomach issues. The patient has trouble walking. The patient also did not feel well. Corrective treatment ws not reported. At the time of this report the outcome of adverse event ws not resolved. Documents held by send: none.
Information has been received from a consumer concerning his daughter who in approximately 1998 was vaccinated with a dose of varicella virus vaccine live. Subsequently in approximately July 2000, the patient developed a slight case of chickenpox and developed shingles 3 weeks after having had the chicken pox. It was reported that the patient's sister had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.            No concomitant and treatment medications were reported. The patient had diarrhea.
Received Pfizer vaccines on 4/21/21, 5/12/21; Tested positive for COVID by PCR on 11/2/21; Admitted to Hospital on 11/2/21 d/t small bowel obstruction (h/o Crohn's disease)
fever; chills; body aches; DIZZY / LIGHT HEADED; SHAKING; barely walk; stomach cramps; diarrhea; headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAR-2021 16:00 PM for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced barely walk. On 16-MAR-2021, the subject experienced stomach cramps. On 16-MAR-2021, the subject experienced diarrhea. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021 18:00 PM , the subject experienced dizzy / light headed. On 16-MAR-2021 18:00 PM, the subject experienced shaking. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy / light headed, shaking, barely walk, stomach cramps, diarrhea, fever, chills, body aches and headache was not reported. This report was non-serious.
Four days later was exhausted; napped all day.; Bruise at the sight for a few days; arm sore at injection site; Maternal exposure during pregnancy (6 months); This is a spontaneous report received from a contactable consumer (patient). A 30-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 04:15 PM (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient did not have any allergies to food products, medications and others. The patient last menstrual date reported as 13Sep2020 and delivery date was reported as 20Jun2021. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient experienced with bruise at the sight for a few days, arm sore at injection site for a day or two and four days later was exhausted and napped all day. On 24Mar2021, the patient received first dose of vaccine (Maternal exposure during second trimester-6 months). The patient did not visit physician office and other healthcare professional clinic. The patient received treatment for events was unknown. On an unspecified date in Mar2021, the clinical outcome of the event bruise at the sight, arm sore at injection site, exhausted and napped all day were recovered. The clinical outcome of the event maternal exposure during second trimester-6 months was unknown.   Follow-up attempts completed. No further information expected.
Very hard rash, 4 inches around, going up her neck; It was itchy; Arm hurt for 2 or 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It was itchy), PAIN IN EXTREMITY (Arm hurt for 2 or 3 days) and RASH (Very hard rash, 4 inches around, going up her neck) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.    Co-suspect product included non-company product allergy for an unknown indication.    Concurrent medical conditions included Cholesterol. Concomitant products included Unkown.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started allergy (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced PRURITUS (It was itchy) and PAIN IN EXTREMITY (Arm hurt for 2 or 3 days). On 11-Jan-2021, the patient experienced RASH (Very hard rash, 4 inches around, going up her neck). On 11-Jan-2021, PRURITUS (It was itchy) and PAIN IN EXTREMITY (Arm hurt for 2 or 3 days) outcome was unknown. At the time of the report, RASH (Very hard rash, 4 inches around, going up her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I started with a headache at 10pm the day of the vaccine. Throughout the evening I had arm pain, chills, sweats, insomnia, joint and muscle pain. All of those things have lasted through today 3/23 and have not improved at all. I feel like I was hit by a truck.
Patient began feeling dizzy and a burning sensation in his throat directly after vaccination.  Vital signs were stable.
Swelling on left leg approximately 1in above the knee. Red, swollen, warm to the touch. No fever.
DRY SKIN ON THE FACE, NECK, EAR, AND EYES; ITCHY SKIN ON THE FACE, NECK, EAR, AND EYES; FLAKY SKIN ON THE FACE, NECK, EARS, AND EYES; FEVER; ACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 10:30 for prophylactic vaccination. Non-company suspect drugs included: diphenhydramine hydrochloride (tablet, batch number: UNKNOWN, route of admin was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included ibuprofen.  On 10-APR-2021 21:00, the subject experienced ache. On 10-APR-2021 21:00, the subject experienced fever. On 11-APR-2021, the subject experienced dry skin on the face, neck, ear, and eyes. On 11-APR-2021, the subject experienced itchy skin on the face, neck, ear, and eyes. On 11-APR-2021, the subject experienced flaky skin on the face, neck, ears, and eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and fever on 11-APR-2021, and had not recovered from dry skin on the face, neck, ear, and eyes, itchy skin on the face, neck, ear, and eyes, and flaky skin on the face, neck, ears, and eyes. This report was non-serious.
Abnormal mensural bleeding since the vaccine. The first time the bleeding lasted 3 weeks stop then started back. I got a Depo shot which just slowed the bleeding down but did not stop it. Been bleeding for 3 months.
This spontaneous report was received from a nurse refers to a 12 year old female patient. The patient's medical history included exposed to pertussis on 02-JUN-2014, prescribed azithromycin for five days. There were not drug reaction or allergies. On 02-JUL-2014 the patient was vaccinated with GARDASIL injection, 0.5 ml, intramuscular in the left thigh, lot # J006850, expiration date 31-MAR-201. Concomitant therapies included diptheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, MENVEO and BOOSTRIX all of them administered on 02-JUL-2014 intramuscularly on the right thigh. The nurse informed that approximately in July 2014 (also reported as after receiving GARDASIL) the patient experienced numbness and tingling of hands, weakness of finger strength and bumps on the palms of her hands, the left hand being worse that the right hand, for approximately the past two weeks, after receiving GARDASL. The patient was seen in office by physician, and was referred to neurologist. The patient was followed up with the physician if symptoms worsen or there was not improvement. The nurse also mentioned that the patient's sister, who was three years of age, and red bumps on her hands, but was not seen in the office. As treatment the patient was referred to the neurologist. There were not laboratories diagnostics performed. Additional information has been requested
Pediarix dosage given 10/25/2005 expiration date 10/15/2005.  No reaction reported.
C/O Nausea and headache Pt. Seen by EMT and discharged home at 10:50 A.M.
Nausea, fatigue and chills 10 hours after vaccination. Next morning woke up with rash red, itchy, slightly swollen  left ankle.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2002, stop date: Jun2022. No Known allergies and no other medical history. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid Treatment start date: 01Jun2022. Treatment stop date: 06Jun2022 Lot number: GA8851 Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt complained of severe pain in right arm and she couldn't move the arm for than 1 inch w/out more pain.
I26.99 ACUTE PULMONARY EMBOLISM 11/14/2021 ACUTE PULMONARY EMBOLISM J96.00 ACUTE RESPIRATORY FAILURE 11/11/2021 ACUTE PULMONARY EMBOLISM R09.02 HYPOXIA 11/10/2021 ACUTE PULMONARY EMBOLISM
After 7/23/10 joints aches, knees, shoulder, elbows started aching at about 3 wks post vaccination. 2nd vaccine 10/1/10 immediate extreme joint pain, appetite chg., & now has warts.
Before any shots were given, the patient was asked if they experienced any reactions to any previous Covid and Flu vaccines. The patient answered that she felt fine after each of her previous shots, so the vaccines were administered. The Flu shot was given on the left ahoulder and then the Covid shot was given on the right shoulder. There was no reaction immediately after each shot was given, but after 1-2 minutes the patient began to lose consciousness. Patient's head began to fall back and she began to slide down the chair as she started to shake. After getting the pharmacist, the mother comforted the patient. The patient was now awake and given water along with a glucose tablet (per mother's request). Patient's mother was asked if this was an issue before with any other vaccines, but we were told that she has a history of fainting (this was not indicated in the VAR form though). Patient was then laid down on the chair with feet elevated and was given space. Patient and mother were checked on periodically and given a plastic bag (in case needed to throw up) and more water. After about 20 minutes, we were informed that the patient was now feeling better and was walked outside by her mother.
Resident given expired flu vaccine Influenza Vaccine Adjuvanted Fluad Quadrivalent 0.5ml GTIN (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 Lot (10): 312866
Blisters on left foot and on the bottom of calf; This spontaneous case was reported by an other caregiver and describes the occurrence of BLISTER (Blisters on left foot and on the bottom of calf) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced BLISTER (Blisters on left foot and on the bottom of calf). The patient was treated with CHLORINE DIOXIDE, MENTHA X PIPERITA OIL (OXYFRESH FRESH BREATH FRESH MINT MOUTHWASH) for Blister, at an unspecified dose and frequency. On 14-Jan-2021, BLISTER (Blisters on left foot and on the bottom of calf) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-364515 (Patient Link).
5 adults exp local rxn @ inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/inj;
Headache with sensitivity to sound and chills, Ibuprofen 400 mg q6 hours for 24 hours
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Onset was itching on left arm in proximity to shot. Then bumps, dizziness, weakness, fast heart rate. Please note this is the 1st flu shot ever received.
Pt to ED 3/16 c/o cough, chest pain, shortness of breath for the past week. COVID+ upon adm 3/16. Pt A&Ox4, speech is clear, respirations are regular and unlabored, skin is warm and dry. Pt reported chest heaviness, denied need for pain intervention. Pt on room air. 3/17 Pt continued complaint of chest pain that dissipates over time. 3/18 pt still on room air, expressed no further needs. Pt discharged to home 3/18.
Patient is reporting moderate pain in left arm where second Monderna vaccine was administered on  04-17-21.  Patient describes pain as constant throbbing pain (like she is being punched in the arm) and states that moving her arm in a horizontal motion is painful and lifting things is a struggle.  She said the pain began the day she was vaccinated and has not subsided since that date.
swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation.  Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself  on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
Vaccine administered on 4/5/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Pt recv vax on 3/16/98; on 3/19/98 pt exp local rxn of redness & erythema
severe headache, chills, sweats and fever over 100 for 10 hours, brief period of vomiting, headache and slight temperature continued for another 8 hours
Patient went to pharmacy counter to pay for prescription and then felt very lightheaded and dizzy, he felt like he was going to faint and was weak in the knees. Got him to bench where he boke out in a cold sweat and felt that he was going to vomit. Paramedics were called and assessed the patient and verified that patient would be fine. His wife was called to pick him up.
Fever and severe chills set in about 11 hours after injection, severe headache about 15 hours after injection. Swollen and painful armpit lymph node began morning of the 21st, with some pain and swelling at base of throat. Taken Tylenol and warm compress to little effect.
This spontaneous report as received from a physician refers to an 18 year old male patient. On 28-JUN-2013 the patient received the first dose of GARDASIL and received the second dose of GARDASIL 10 days early on 16-JUL-2013. No adverse effect reported. Additional information has been requested.