chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 70 male with no reported allergies, who on 20-JUN-2008 was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (route not provided) (lot number 659408/0300X). Concomitant therapy included SINGULAIR, simvastatin (unknown manufacturer), FEOSOL, aspirin, NEXIUM, verapamil, potassium (unspecified) and UROXATRAL. On 14-MAR-2009 the patient developed shingles. No lab tests were performed. Follow up information was received from an other health professional concerning the 70 year old male with quinine allergy who on 20-JUN-2008 (also report 12-JUN-2008) was vaccinated in the left deltoid with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number 659408/0300X). On 16-MAR-2009 (also reported as 14-AR-2009) the patient developed Herpes zoster. The vesicles were located on the left low back. The patient's pain rated as 4 out of 10. The patient did not exposure to chickenpox or shingles recently and he had a history of chickenpox when he was 10 years old. There was no rash at the site of injection or elsewhere within 42 days of the vaccination. It was also reported that the patient was afebrile. At the time of reporting the outcome was unknown. The sample of the lesion was collected on an unspecified date. The sample was taken from vesicles on the left low back. A direct fluorescent antibody was not done. There was no specimen collected for PCR. No photo was taken. Follow up information was received from an other health professional concerning the 70 year old male with IVP dye and quinine allergy as well as a history of thrombocytopenia induced by quinine in September 2006 who on 20-JUN-2008 was vaccinated in the left deltoid with a dose of ZOSTAVAX (Merck) (lot# 659408/0300X). There was no illness at the time of vaccination. The patient recovered in March 2009. The patient sought unspecified medical attention. Additional information has been requested.
Burning; Hard to breathe; Red splotches on the arms and torso; Terrible rash on the face/Terrible rash on neck; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Hypertension. Concomitant products included PRAVASTATIN for High cholesterol, AMLODIPINE, LABETALOL, POTASSIUM and FUROSEMIDE for Hypertension.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck). At the time of the report, BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Antihistamine and Aloe.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   This case was linked to MOD-2021-216334 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received on 02-JUL-2021 contained significant information.Outcome of event updated to Recovered
I started with a sore throat and then my ear was hurting with chills and a high fever and a cough. And only the coughing is still here, my throat and ear are still bothering me but it feels like I just have a cold.
This spontaneous report as received from a consumer refers to her 12 month old daughter. On 04-NOV-2013, the patient was administered ZOSTAVAX instead of VARIVAX and ZOSTAVAX was given in thigh. No medical attention was sought. No adverse effect reported. Additional information has been requested.
Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes; She lost her eyelashes a little bit too; says this is really bad & she doesn't want to be seen or go anywhere; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes), MADAROSIS (She lost her eyelashes a little bit too) and FEELING ABNORMAL (says this is really bad & she doesn't want to be seen or go anywhere) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included Alopecia (It had been in remission, and it had only happened a few times.).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes), MADAROSIS (She lost her eyelashes a little bit too) and FEELING ABNORMAL (says this is really bad & she doesn't want to be seen or go anywhere). At the time of the report, ALOPECIA (Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes), MADAROSIS (She lost her eyelashes a little bit too) and FEELING ABNORMAL (says this is really bad & she doesn't want to be seen or go anywhere) outcome was unknown.            No concomitant products were reported.  The patient had a history of alopecia, it had been in remission and had only happened a few times, that was the worst. Her hair started falling out about 6 weeks after getting the doses, before the vaccine it was just the hair on her head. She stated that was really bad and doesn't want to be seen or go anywhere. She was looks like a cancer patient.  No treatment information was reported.
Within a few hours my chest started hurting with spasms and I got a headache, shortness of breath, had a low grade fever for a few days, night sweats and fatigue.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was placed in refrigerator : 04-NOV-2021  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter
I never tested positive for COVID-19, but my doctor was certain that I had it in December 2022.  I had overwhelming fatigue, headache, sore throat, cough, and brain fog.  It felt like nothing I?ve had in my life before.  Even now when I get tired my cough and sore throat come back.  I have had a headache for seven months.  My eyes feel swollen, and I cannot see as well.  The brain fog is still here.  I cannot have a massage because it is too painful for my body afterwards.  My blood pressure is whacky as well.  At different periods of the day, it is way high or way low.  It has been as high as 155 and as low as 94 in the space of an hour.  I came to the conclusion that I was having long COVID-19 symptoms based on symptoms.
Diffuse truncal macular rash. No SOB. Fever of 101F.
Medical Assistant administered a Hep B vaccine without an order; informed pcp as soon as she became aware. Provider repots no harm having extra hep b vaccine; provider called and informed parent.
Pregnant of 24 weeks (second trimester); This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant of 24 weeks (second trimester)) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Patient had allergy towards shell fish). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ENOXAPARIN SODIUM (LOVENOX HP) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-May-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant of 24 weeks (second trimester)). On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant of 24 weeks (second trimester)) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received as no new information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 24-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
2/1/2022 unable to sleep. 2/2/2022 was fatigued and started fever, chills, shaking, skin was painful, joint pain, bladder irritation.  2/3/2022 Symptoms improved. Nausea, joint pain.
A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a 37-month-old patient. Neither relevant medical history nor concomitant medications have been reported for these patients. The product expired on 11-Dec-2011. The patient received the expired FLUMIST on 28-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. There was no late occurring adverse event reported.
Patient called 6 days following vaccination for a tip to Brazil. He reports facial swelling with sx. Starting on Sunday 2/22/09 a 1300, which was 5 days following vaccination. Advised to go to the local ER - He refused, but he is going to a local urgent care. 2/24/09 Call to client - taking ZYRTEC and BENADRYL - Swelling is decreasing.
10x14 cm redness, mild, swelling 72 degree after shot (MMR), right thigh. Drugs Benadryl.
Itching, redness and hard bump about 2 inches in diameter at the injection site.  Started 8 days after vaccination. Advil, Cortizone cream applied.
appendicitis; This is a spontaneous report from a contactable consumer (the patient). An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 18Jul2021 14:00 at age of 18-year-old at single dose for COVID-19 immunisation, it also reported the patient received other vaccine at first dose on 18Jul2021 in right arm. Medical history was none. No known allergies, no other medical history. There were no concomitant medications (no other vaccine in four weeks, no other medications in two weeks). No prior COVID vaccination. No COVID tested post vaccination. The patient experienced appendicitis on 18Aug2021 18:00. The event resulted in hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for the event for 2 days. Treatment for the event included surgery. The outcome of the event was recovered with sequelae (Recovered with lasting effects) in Aug2021.  The lot number for BNT162B was not provided and will be requested during follow up.
did not receive a second dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive a second dose) in a 70-year-old male patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive a second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment Medications were reported.
Pt recv vax on 10/1/97; on 10/2/97 pt exp fever (102F), chills, diaphoresis, headache, muscle aches
received second dose 8 weeks after the first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose). On 13-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose) had resolved.            This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
Patient received an undiluted Pfizer COVID19 vaccine (pediatric orange cap) volume of 0.2mL
A non-serious spontaneous report of received expired FLUMIST was received from a nurse concerning a female pediatric patient. No medical history was provided. The product expired on 15-Dec-2010. On 21-Dec-2010, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-APR-2010, the patient was inoculated with ZOSTAVAX at a clinic, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 27-SEP-2013, the patient was treated by the same clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and prednisone for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Exhaustion, nausea, threw up around 3 am till 4 am, experienced chills and cold sweat after throwing up but felt hot at the same time even though temperature was normal, sore throat, sore muscles,, temperature has been normal and the highest was only 99.7
After vaccination shots MMR/Varivax, pt experienced fever and developed rash which has appeared on face initially, then spread downward the neck/body/upper thigh in 12 hours.
3 days after receiving her 2nd dose of Shingrix, the patient broke out with spots all over her face, on her lip, and on her buttocks. She states that the spots burn. No spots located on her scalp. The area on her lip looks like a dry cracked cold sore without swelling. She did not think this was a big deal and just wanted to mention it to us. She has been trying to keep the spots covered with make-up. No treatment sought. She states that the spots are improving but are still uncomfortable.
74-year-old male with a past medical history significant for prostate cancer, AFib on Eliquis, hypertension, hyperlipidemia who presents emergency room for evaluation of multiple abdominal symptoms. The patient reports that he has been having intermittent episodes of abdominal pain which she describes as more intermittent in generalized. He reports that he has also been having increased loose stools which she reports at times can have at least 10 per day.
Where does one start.  My symptoms started around October of 2021.  I had my first vaccine March 19, 2021 and my 2nd one April 9, 2021.  My symptoms consist of  loud noise in my head; what I call body hugs almost like I am being hugged from the inside out from head to toe.  Vertigo/dizziness, loss of balance. eye issues. I saw my primary at the local healthcare facility, she wanted to make sure that we have all our i's dotted and our t's crossed.  She had me see a neurologist, an audiologist ( who wanted me to be referred to an ENT), a nerve specialist, my eye doctor.  Forgive me if I forget things as I also have memory and cognitive issues since this has all started.  Neurologist and the ENT specialist both sug
joint ache all over, headache and the following morning I woke conjested and coughing
Hives, rash, headaches, body pain, chills, red spots in all the body, swollen lips, itchy in all body.
Patient's arm was warm to the touch and swollen; pain from shoulder to forearm with chills the night after injection. Patient sought medical advice and was told that he likely had a reaction to the pneumonia shot and that the inflammation/pain should go away after a few days. Patient reports that the arm in which he received his injection is getting progressively better.
Expired Boostrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5e43j, expiry date 30th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 2nd September 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-SEP-2022  Reporter's Comment: The reporter was medical assistant. The reporter reported that, a patient received a expired dose of Boostrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that, a patient received a expired dose of Boostrix, which led to expired vaccine used.
GFR score dropped from 58 to 48 on a scale of >60; BNT162b2 and senior flu shot administered on the same day; BNT162b2 and senior flu shot administered on the same day; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FF8839) at the age of 74 years as dose 3 (booster), single for COVID-19 immunisation and also received influenza vaccine (FLU SHOTS), administration date 04Oct2021, for immunization. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing) and "Overweight" (unspecified if ongoing). Concomitant medications included: GABAPENTIN and PANTOPRAZOLE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0150; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 03Apr2021, when the patient was 74 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6202; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 13Mar2021, when the patient was 74 years old, for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious) and PRODUCT USE ISSUE (non-serious), both with onset 04Oct2021, outcome "unknown", and described as "BNT162b2 and senior flu shot administered on the same day"; IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "Dose number: 3"; GLOMERULAR FILTRATION RATE DECREASED (non-serious) with onset 24Nov2021, outcome "unknown", described as "GFR score dropped from 58 to 48 on a scale of >60". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of glomerular filtration rate decreased.  Additional information: The patient had no known allergies. The patient was not diabetic and had no high blood pressure. The patient received other vaccines within four weeks prior to the COVID vaccine which included influenza vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient queried if decrease in GFR was a known possible side effect of the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
After I gave her Tdap vaccine at 1235, and as I was conversing with her, she became limp, rolled her eyes back, her arms contracted and moved rhythmically, she became unconscious for less than 2 minutes, then she woke up, skin pale, became alert and oriented x3, she was clammy and complaining of hands tingling. We had call 911 and ambulance took her to emergency dept for evaluation. Denies history of seizures.