chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, improperly stored doses of GARDASIL lot # K010215 exp. 05-MAY-2017 (route of administration, dose were not reported) were administered to unspecified patients. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included heart attack (in 2006). Concurrent medical conditions included cardiac pacemaker insertion (in the left side of chest) and implantable defibrillator insertion (in the left side of chest). Concomitant products included ramipril, atorvastatin calcium (Atorvastatin), acetylsalicylic acid (Ecotrin), clopidogrel bisulphate (Plavix), carvedilol, spironolactone and alfuzosin. On 15th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 12 hrs after receiving SHINGRIX, the patient experienced shivering and muscle pain. On 16th February 2019, the patient experienced fever, tiredness and headache. The patient was treated with paracetamol (Tylenol). In February 2019, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the shivering, fever, tiredness and headache were recovered/resolved. It was unknown if the reporter considered the shivering, muscle pain, fever, tiredness and headache to be related to SHINGRIX. Additional details were received as follows: This case was reported by the patient's wife. At 1:00 pm, the patient received SHINGRIX in the left arm. On 16th February 2019, Saturday, at 1:00 am, the patient woke with shivering. It lasted a couple of hours and then it resolved. The shivering presented again for 3 to 4 hours later and lasted for 30 minutes. In the morning of Saturday, 16th February 2019, several hours after vaccination, the patient experienced muscle aches all over which lasted for 12 to 16 hours. One day after vaccination, the patient experienced headache and fever. On early Saturday evening, the patient experienced headache. It resolved but came back 5 to 6 hours later. The patient had slight fever of 100 degrees F and it was present most of the day on Saturday. The patient was very tired on Saturday afternoon and slept for a few hours. On Sunday, 17th February 2019, the patient was fine. The reporter did not consent to follow up.
No reaction whatsoever to first 2 shots.  Alopecia Areata Univesalis confirmed by biopsy began roughly 2.5 months to 3 months after 3 shot. High dose Flu vaccine given at the same time! No history or family history of autoimmune diseases. Progressed from single thin spot to almost complete scalp baldness and extensive eyebrow eyelash & body hair involvement within 2 months of onset
Since vaccine till currently reports shortness of breath, fatigue, pain in head, blood sugar illness, blood pressure issues, overall wellness decreased and reports had no prior illnesses before vaccine.
Stiff neck and headache; Stiff neck and headache; Migraine with vomitting for 10 hours; Migraine with vomitting for 10 hours/throwing up; Eye infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune thyroiditis" (ongoing), notes: Verbatim: Hashimoto's disease, diagnosed 5 years ago; "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia, diagnosed about 15 years ago; "Arthritis" (ongoing), notes: Verbatim: Arthritis, diagnosed about 15 years ago. The patient's concomitant medications were not reported.The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "unknown" and all described as "Stiff neck and headache"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Migraine with vomitting for 10 hours"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Migraine with vomitting for 10 hours/throwing up"; EYE INFECTION (non-serious) with onset 2021, outcome "unknown", described as "Eye infection". Therapeutic measures were taken as a result of eye infection.  Additional information: Reporter states her husband and she got headache and really stiff necks on Day 1, eventually it went away, states it was gone in the morning when they woke up on Day 2, states on day three she ended up throwing up and had a migraine for 10 hours. Caller states on day four husband was fine and she felt good just a headache. Caller states they were supposed to get their second shot on 01May2021, and she got an eye infection in her left eye the day before, gave her a z pack, so she had to wait to get over the infection and had to get second shot, they got the second dose on 12May2021.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, NauseaVomiting, chills Narrative:
Case number PHEH2012US008130, is an initial spontaneous report received from a nurse on 30 Mar 2012: This case refers to a unknown age and gender. The patient was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X10028), intramuscularly, without reconstituting with Men A component on an unspecified date. No adverse event was occurred during this administration error.
Became inconsolable and increasingly fussy as time went on.  Started to regress in speech.  Stopped trying to interact with people as often and didn?t want to make eye contact.
Large, swollen, red inflamed area surrounding injection site measuring about 6" x 8" in diameter.
This is a spontaneous report from contactable nurse. This is the second of 2 reports. This 45-years-old nurse (Patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 23Sep2021 (at the age of 45 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bystolic and experienced allergy, bnt162b2 (Pfizer Covid -19 Vaccine) at left arm as dose 1, single on 02Sep2021 (at the age of 45 years) for covid-19 immunisation and experienced fatigue for 3 weeks, mental fog for 3 days, feeling of someone ringing out her heart and lungs like a wet washcloth for 1 day, sore left arm. Facility where the most recent COVID-19 vaccine was administered was available. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021 (after dose 2), she had fatigue for 3 weeks, fever for 8 days, muscle pain for 8 days, joint pain for 8 days, hurt to touch her skin for 5 days, headache for 8 days, shortness of breath for 5 days, heart palpitations for 8 days, nausea for 8 days, period for 1 month, sore left arm. No hospitalization was prolonged. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The seriousness of events was non-serious. Treatment received was Advil and Tylenol. The outcome of events was recovered on unspecified dates in 2021.Device Date : 13Nov2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Administered at hospital after birth by nurse l. Was suppose to get hep b vaccine. He was taken to NICU for observation for 8 hours. No symptoms
Patient experience burning sensation in left upper arm with mild itching. Ice pack applied. Monitored vitals for 45 minutes. Patient released and instructed to follow up with doctor if worsening. And also follow up with doctor before 2nd injection
Two days after my second shot I had flu like symptoms but the symptom that bothered me the most was a swollen gland near my left clavicle. It was  very swollen and sore. As time went on the node continued to bother me and I couldn't wear a seat belt as it would rub on that area. It is now 7 weeks post vaccination and the node has decreased in size but has not gone away.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXIPRON taken for depression, start date: 01Jan2020, stop date: 16Aug2022; BUPROPION taken for depression, start date: 01Jan2020, stop date: 16Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Aug2022 to 08Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Early miscarriage occurred on Sunday, 2/7/2021. No previous  pregnancies
palpitation; extra beats; This case was reported by a consumer and described the occurrence of palpitation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced palpitation and heartbeats increased. On an unknown date, the outcome of the palpitation and heartbeats increased were unknown.   It was unknown if the reporter considered the palpitation and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient began to experiencing palpitations and was evaluated by her physician and cardiologist including a 72 hours holter monitor which showed episodes of extra beats. The reporter did not provide additional information other than that she did call the event in to the GSK Consumer line and also that her physician was provided forms to report the event if he so chose.
UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient concerned a male of unspecified age. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse events was not reported. This report was non-serious.
entire 1/2 upper lt arm, erythematous & sl warm, indurated, swollen;not tender; not ill;cheerful bright, significant local rxn to DTAP;better today 5SEP96 than yesterday;APAP, DPH given;
Painful injection site followed with achy arm, rash on trunk, legs and neck. Patient says he has never had a reaction to a flu shot.
itching where she got her vaccine/bad itchy rash; rash where she got the vaccine; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:00 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid, caffeine, ergotamine tartrate (SYDOLIL) taken for migraine, start and stop date were not reported. On 10Feb2021, the patient experienced headache. The next day she had to take Tylenol for her headache and by midday on 11Feb2021 the headache was gone. Tylenol: Lot Number: SFA011 and Expiry: Apr2022. On 18Feb2021, the patient experienced bad itchy rash. This morning she experienced some itching where she got her vaccine. Last week she got the vaccine on Wednesday. The only thing she had was a headache that night until the next day. It is really itching bad and there is a rash where she got the vaccine. She wants to see if it is still safe to get the second? Caller clarified that she would like information about her side effects and the second dose. The itch won't go away. It has gotten less red but it is more itchy. The rash and itchiness is on left arm where she got the vaccine. Therapeutic measures were taken as a result of headache. The outcome of the event headache was recovered on 11Feb2021, while not recovered for the event itching where she got her vaccine/bad itchy rash, recovering for the event rash where she got the vaccine.   No follow up attempts are possible. No further information is expected.
Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21.  She demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was initiated on 1/7/21.  Oxygen saturation was initiated on 1/12/21 at 4L per nasal cannula.  for shortness of breath.  On 1/22/21 at 0310 Patient was unresponsive and without vital signs.  Orders were for DNR and CPR was not initiated.
Evening  of day of vaccination, arm redness, swelling, warm, itchy  No treatment Lasted approximately 10 days
Information has been received form an advanced registered nurse practitioner concerning a teenage female who was vaccinated with GARDASIL vaccine. Subsequently the patient experienced fever. The fever lasted for 2 days. It was reported the patient sought unspecified medical attention. This was one of 3 reports from the same resource. Additional information has been requested.
This spontaneous Non-valid report was received from a Registered Nurse referring to unknown number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II lot # N023149 and expiration date on 24-AUG-2019 (strength, dose number, route and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The temperature was 47°F to 77 °F and the time frame was reported as 2 hours, no previous temperature excursions. The case involved data logger.
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9265, via an unspecified route of administration, in the right arm, on01Feb2021 11:30 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes, high cholesterol, high blood pressure and penicillin allergy. 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. The patient's concomitant medications were not reported. The patient experienced soreness at injection site on 01Feb2021 11:30. The outcome of event was recovered.   No follow-up attempts possible. No further information expected.
I ached all over my body as though I had the Flu. My Left arm turned purple where the shot was given. My breathing was fine, so I didn't seek a doctor. I was in pain for about four days. This was my second shot-the first one was given one yr. ago.
swelling lymph nodes for at least 6 months.  Started with right underarm, then to left.  Neck and throat have recently stated to hurt.  I go for an ultrasound (3rd time) in October.  Result show swelling several months after vaccine
Uncontrollable screaming mid afternoon on 11/4.  Seen at local ER, given TYLENOL suppository and examination.  No testing.  Discharged home and seemed fine.  Began uncontrollable screaming again approximately 1/2 hour after emergency room visit.  Taken to different hospital emergency room, then transferred to another hospital as rule out intussusception.  Admitted, stayed 2 days.  Kidney, Ureter, Bladder and Abdomen ultrasound negative.  No surgery.  11/27/06 Received records from PCP which included hospital diagnostic records & reveals patient admitted to hospital 11/5 with abdominal pain.  Abdominal xray could not r/o intussusception (IS).  US of abdomen/scrotum was found to be WNL & w/o evidence of IS but positive for small left hydrocele. PCP records indicate patient at birth had hypospadius, fractured left clavicle & elevated bilirubin (resolved).  Patient was irritable & fussy but developing well.  Dx w/GERD./ss  12/4/06 Received medical records from hospital which reveal patient admitted overnight, 11/5-11/6/06.  US was WNL & tol oral feedings.   Final Dx: Abdominal pain./ss
Sore arm day 2 and 3,  Day 2: headahce, mild fatigue day 3 also began with left sided axillary lymphadenopathy. Day 5: improved all of the above
Information has been received from a physician concerning a female patient in her early 20's who was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, the patient experienced a high amount of pain and swelling at the injection site.  Medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning a 24 year old female who on 29-AUG-2006 at 9:00 a.m. was vaccinated in the left arm with her first dose of GARDASIL, lot #653736/0589F. Concomitant therapy included AMBIEN, doxycycline, ALLEGRA-D, and unspecified oral contraceptive pills. Following the vaccination, on 29-AUG-2006 at 9:00 a.m. the patient experienced pain (burning) in her left arm plus swelling and tenderness x 3 days. Additional information is not expected.
Pt recvd 2nd dose of Hep B on 6NOV91; then exp burning @ inject site; pt recovered; no further details were provided;
Very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Very sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received shingles vaccine and experienced Sick. The physician stated that was normal and not as bad as the real virus and your description sounds a lot worse. Follow-up would not possible as no contact details were available.
On 10/31/2022 the patient was given Pfizer Monovalent instead of Bivalent
Patient hospitalized due to COVID-19 after testing positive on 5/21/2021. Patient is fully vaccinated.
Infant became listless, fussy, irritable and had smnolence, then restless sleep for 5 days following lst immunization.
Persistent headache/migraine; Persistent headache/migraine; chills; extreme fatigue; insomnia; This is a spontaneous report from a contactable Physician (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:00 (Lot Number: EL3248) at single dose for COVID-19 immunisation. The patient medical history was none, no known allergies. Patient didn't have COVID prior vaccination. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received the first dose of bnt162b2, lot number: EL1284, at 30 years old on 30Dec2020 11:00 AM in Left arm for COVID-19 immunization. The patient experienced persistent headache/migraine, chills, extreme fatigue, insomnia. Adverse events started from 20Jan2021, 04:00 PM. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab COVID Test: negative on 04Jan2021. The outcome of the events was recovering.
intractable vomiting; This is a spontaneous report from a contactable physician (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), intramuscular on 22Dec2020 at 13:00 at single dose in right deltoid for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced intractable vomiting on 22Dec2020. The reporter was a physician, she received the Covid-19 vaccine on 22Dec2020 at 1:00 pm. At night on 22Dec2020, she started experiencing intractable vomiting, it was less frequent at time reporting, happening every 2-3 hours. The outcome of the event was resolving.
head cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (head cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (head cold). At the time of the report, NASOPHARYNGITIS (head cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported
swelling in the groin area; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in the groin area) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling in the groin area). At the time of the report, SWELLING (swelling in the groin area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. The patient got his first shot after 72 hours experienced swelling in the groin area, and the patient  isstill experiencing this. No treatment information was provided.
Pt vaccinated with Influenza developed tender hot (fire) feeling in lt arm, redness in arm at site of injection. Abscess formed advised by MD to apply hot compresses & Bactorban ointment. Abscessed drained on own.