chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate age at vaccine administration; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Positive COVID test on 5/24/21, after patient received both doses of Moderna vaccine (3/19/21, 4/21/21) AND after previously having had COVID infection. She is otherwise healthy, does not have any known comorbidities.
Information was received from published article. This literature marketed report refers to a 10 year old female patient. The patient denied any systemic symptoms and had no family history of skin disorders. The patient took no medicines, no known drug allergies and was up to date on all vaccines. On an unknown date the patient was vaccinated with first dose of GARDASIL. Concomitant medications were not reported. A few days after receiving her first dose, the patient developed pruritic eruption of the arms, legs, trunk and neck diagnosed as lichenoid drug eruption. The patient initially sought treatment in the emergency department, where she received hydroxyzine, diphenhydramine and triamcinolone cream, but none of these agents improved her symptoms after 1 month of treatment. Physical examination revealed violaceous planar papules and plaques on the chest, lumbar back, extensor and flexural extremities, dorsal hands, palms and soles. Mucous membranes and nails appeared normal. A punch biopsy of a representative plaque on the left hip was performed. Histopathology demonstrated compact hyperkeratosis with parakeratosis, a saw tooth rete ridge pattern with a lymphocytic infiltrate and rare eosinophils. These findings were consistent with a diagnosis of lichenoid drug eruption (LDE). A 4-week prednisone taper improved the eruption dramatically. The action taken with GARDASIL was withdrawn (reported as advised to refrain from receiving subsequent vaccines). The outcome of lichenoid drug eruption was reported as recovered (reported as at her 6-week follow-up visit, the patient had only significant postinflammatory hyperpigmentation). The reporter considered the event lichenoid drug eruption to be related to GARDASIL. The GARDASIL contains relatively inert additives. It contains aluminum, which has been associated with cutaneous reactions. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-AUG-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a healthcare facility as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 03-MAY-2016, the patient was treated by a physician/MD for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
My Daughter received the shot on Tuesday 20 Nov. By Thursday 22 Nov late morning, she was throwing-up. Her symptoms lasted for approximately 5 hours. On 23 Nov, 24 hours after the onset of symptoms in my almost 3 year old daughter, my 45 year old sister, whom lives in my house-hold as well, became violently ill with vomiting, diarrhea chills, etc. On 24 Nov, 20 hours later, I became ill with the same symptoms and 2 hours after me, my wife became ill. My mother came into town that Thursday, 20 Nov, but never became ill. My stepson returned from his fathers on the Sunday, 25 Nov, and did not contract the illness. My 1 year old son was in the same room at the doctor's office when my 3 year old daughter received the Flu Mist inhaler. He threw-up on Thursday and acted ill as well as ran a temperature the same time my daughter did. But, he did not become more seriously ill until the evening of the 24th-25 of Nov. He threw-up several times during the same period that my wife and I became ill. He did not get diarrhea though. I am in the service and in very good health. I receive the flu shot every year and had had one 3-4 weeks prior to these illnesses. My wife is in good health and has not had the flu shot this year.  Interrogative; my stepson later received the Flu-Mist on 29 Nov. On 2 Dec, He became ill with the identical symptoms that my 3 year old displayed. They both vomited several times over a period of 4-5 hours.
Pt got in car and started having severe back spasms. Returned into store and had to sit down. 911 called - spasms eventually went away.
In Apr the patient had COVID, so the patient tested positive; In Apr the patient had COVID, so the patient tested positive; This is a spontaneous report from the Pfizer-sponsored program from a contactable pharmacist. A female patient of an unspecified age received BNT162B2, dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The pharmacist reported that they have a patient who got the first dose of Pfizer COVID-19 vaccine last 26Mar2021, however in Apr2021 the patient had COVID, so the patient tested positive and the patient didn't get the second dose yet and they wanted to know when they should get the second dose? The pharmacist wanted to know when should be the second dose for the patient? Because the patient got COVID in Apr2021 and until now she didn't get the second dose. Because when she got COVID, she was in hospital for 2 weeks, so it was not a mild case of COVID that she had, The pharmacist would say it was probably a stronger case. The patient underwent lab tests and procedures which included Covid-19 test positive in Apr2021. The outcome of the events was unknown.    Information on Lot/ Batch number has been requested.; Sender's Comments: Based on narrative given in the case there is reasonable possibility of causal association between the event Drug ineffective, COVID-19 and the suspect product BNT162B2.
Lg. hematoma at injection site, itching swelling at inj site, vomiting, nausea, fever 103 degrees F.
PATIENT WAS GIVEN KINRIX LOT NO YZ97N ON 02/08/2022 IN ERROR, PATIENT SHOULD HAVE RECEIVED INFANRIX LOT NO 49TM3
was administered into the Deltoid Tuberosity area instead of the deltoid itself; patient was concerned about the vaccine having been given SubQ instead of IM; there was a little bit of bleeding; the patient noticed a little bit of bruising; and a little bit of swelling; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, Expiry Date: May2021), subcutaneously on 28Jan2021 14:45 at 0.3mL single dose into the left deltoid tuberosity for COVID-19 immunization. Vaccination Facility Type was at Health Clinic. The patient's medical history and concomitant medications were not reported. Caller was an LVN and she had a vaccination clinic and there was an incident where one of the COVID vaccines that was administered to a patient, was administered into the Deltoid Tuberosity area instead of the deltoid itself. Caller stated that the patient was concerned about the vaccine having been given SubQ instead of IM. Caller was calling to find out how effective it would be if it was given SubQ. Caller stated that the patient was married to a doctor, and was a Nurse Practitioner herself, so she did not need to seek treatment. Caller stated that the patient was able to assess it herself, the patient noticed a little bit of bruising, but she suspected there would be, because there was a little bit of bleeding, and a little bit of swelling on 28Jan2021. The outcome of the events were unknown.
facial paralysis, started one week after vaccine. treated with Medrol dose pack. symptoms slowly improving
IMMOBILE; This spontaneous report received from a consumer via a company representative 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced immobile. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from immobile. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious
Bell's Palsy treated with Prednisone 70mg daily for 5 days and tapered to 5 mg over 5 days; Acyclovir 4000mg daily for 5 days Physical Therapy, Accupuncture
On 1/9/11 at 12pm - Pt called to say she had a reaction to the BOOSTRIX vaccine. Symptoms included red, swollen, hot & raised at the site of injection (left upper arm). Pt also complained of headache. These sx start to occur on Friday night 1/7/11. Per pt her sx is worsening.
pt recvd vax & w/in 8 hrs post vax pt exp a rash which started on legs & spread over body;tx w/DPH;
Stared with headaches, body aches, general ill feeling like flu symtoms. Excessive tiredness and no energy. Cant remeber exactly but with in a few days I started Bleeding like having a Menstal Period with abdominal cramping. Iwasnt sure what to think. It went on for about 3 days and stopped with blood spotting for the next couple of days or maybe a week. I dont remeber as I really got scared and thought I was having major health issues and scared to talk to health professionals being scared of Negative feed back.
Felt quite sickly for 2-3 days Lingering nausea for at least 2 weeks
High fevers 102.5 and 101 Severe headaches Aches Pains RED face
This spontaneous report as received from a nurse refers to three unspecified patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with a first dose of GARDASIL 9 (dose, route of administration. lot # and expiration date were not reported). On an unknown date, more than 12 months after the first dose, the patients were vaccinated with a second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported), which was reported as being outside of the recommendations in the GARDASIL 9 prescribing information. NO adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
Patient denied problems with previous immunizations. She stated on the day of vaccination she felt fine. The next day she began to feel chills, had body aches and her arm began to swell. She had swelling from the top of her shoulder to her elbow. No problems moving her arm but reported discomfort where the swelling was.  She spent 2 days in bed. The fever, chills, arm redness and swelling persisted for 2 days before she started to feel better. Is concerned about the persistent redness, swelling and heat from around her vaccination site. No longer having fevers and stated there is itching at the vaccination site. She has been taking ibuprofen and using cool packs on her arm. Reports that the swelling/redness has decreased in size.
pt. recv'd 3rd dose hepatitis B vac & later exp. weakness,sore throat,swollen lymph glands,T102,& rash covering body.
Feels light headiness and weakness to legs. BP 100/76 P 84 R 28. Mother took student home to rest. 3:00pm tl 2 mother-pt. recovered.
On May 14, 1999 pt developed a rash with 3 lesions, two macules and one vesicle, on his lower left  leg. The pt was afebrile.
Patient seen 2/5/20 for localized pain at injection site in R arm that she received 1/14/20. Had first HPV9 in 2018 without adverse reaction. Exam unremarkable except for pain in area and some induration. Likely hematoma or injection site nodule
This spontaneous report as received from a medical assistant via a representative refers to her 12 year old son. Her son experienced this same "shingles-like rash" on his torso, no matter what type of vaccine he received; and it always occurred seven days after the vaccine had been administered. On an unknown date the patient was vaccinated with M-M-R II (lot#, strength, dosage, frequency and route unknown). Other suspect therapies included Td (manufacturer, lot#, strength, dosage, frequency, route and indication unknown). On an unknown date the patient experienced a "shingles-like rash" on his torso after receiving the M-M-R II and the Td. The patient had been referred to an allergist to find out if he was allergic to any component of the M-M-R II and the Td most recently administered. The outcome of the event was unknown. Additional information has been requested.
Severe body aches and malaise, depression, unable to get out of bed for 2 days. Treatment: bed rest, Tylenol, Motrin.
Tested positive for covid 5 days after receiving the gray cap booster.; Tested positive for covid 5 days after receiving the gray cap booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Aug2022 at 16:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 35 years, in left 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: "Multiple sclerosis" (unspecified if ongoing), notes: other medical history: Multiple sclerosis. Concomitant medication(s) included: VUMERITY; TROSPIUM; XYZAL; PROZAC. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Sep2022, outcome "not recovered", COVID-19 (medically significant) with onset 04Sep2022, outcome "not recovered" and all described as "Tested positive for covid 5 days after receiving the gray cap booster.". The event "tested positive for covid 5 days after receiving the gray cap booster." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2022) Positive, notes: for covid 5 days after receiving the  gray cap booster; (05Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that, the dose received was more than 3. Patient did not have other vaccine in four weeks. Other medications in two weeks were VUMERITY, trospium, xyzal, Prozac, multivitamin. Adverse event was tested positive for covid 5 days after receiving the gray cap booster. Adverse events start date was 04Sep2022. AE resulted in Emergency room/department or urgent care .The treatment ae was TESSALON. The patient did not have covid prior vaccination, was tested post vaccination with Nasal Swab on 05Sep2022. Covid test result was Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After waited after the 15 minutes after the administration of the vaccines. Patient was about to check out and stated to the caregiver in the checck out area that she did not feel well and felt dizziness.  Patient was advised to sit down and it was taken to the room in wheel chair to laid down to recovery from the dizziness also stated that she felt some nausea. Patient never lost conciousness and was awake and able to follow instructions. Vital signs were monitor and enter in her medical record. Provider was notified. The episode last for about 5-7 minutes. Patient decided to go home after the dizziness and nause were gone. Patient was able to walk in her won with stable gate, oriented x 4, no shortness of breath no pain vital signs stable .A follow up call was done at 2:33pm  to see how patient was doing.
In May patient noticed progressive painful lower extremity edema (left greater than right). On June 11, patient came to the hospital with sudden onset dyspnea, palpitations, lightheadedness and dizziness while refereeing a basketball game. Ultrasound of lower extremities found non-occlusive thrombus in the left common and profunda femoral veins/occlusive thrombus throughout the left femoral vein/popliteal vein, and tibioperoneal trunk. Patient started on heparin drip and admitted to stepdown unit for concern of submassive PE given elevated BNP, DVTs, and dyspnea, and confirmed via VQ scan. Patient was transitioned to oral anticoagulation (apixaban). Swelling of legs greatly improved, and dyspnea improved though cough persistent by the time of discharge. Of note, patient also has a history of elevated PSA (to 80s), but patient has not seen urology for follow-up for possible malignancy. Patient also found to have UTI (klebsiella) secondary to his chronic urinary retention.
Mild allergic reaction; Itching at injection site; Itching throughout the body; body aches; Chills; fatigue; Slight metallic taste; Numbing sensation on tongue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 02Apr2021 at 11:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), diabetes, non-alcoholic steatohepatitis (NASH), overweight and COVID-19. Concomitant medications included telmisartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN),  metformin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (CETRIZINE)  and folic acid (MANUFACTURER UNKNOWN) all for unspecified indication started from an unknown date. The patient previously took fenofibrate (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously took prednisone (MANUFACTURER UNKNOWN) and experienced strong reaction (unspecified) to methyl-prednisone. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, minutes after the vaccination, the patient experienced slight metallic taste and numbing sensation on tongue. On 03Apr2021, the patient experienced body aches, chills, fatigue. On 04Apr2021 at 16:00, the patient experienced mild allergic reaction and itching at injection and itching throughout the body. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event metallic taste and numbing sensation on tongue was recovered on 02Apr2021 ; while that of body aches, chills and fatigue was recovered on an unknown date in Apr2021. The clinical outcome of events itching at injection site, itching throughout the body was recovering; while that of  mild allergic reaction was not recovered.      No follow-up attempts are needed. No further information is expected.
Within two hours of the vaccine I was running over a 103 fever.  That was almost two weeks ago and I am still running a low fever.
Itchy, raised, red "rash" that started around vaccination area and spread to trunk. Resembles acne.
Dizziness; vomiting, unable to move; unable to move; This is a spontaneous report from a contactable consumer, the patient. . A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the right arm on 13Mar2021 at 18:15 (at the age of 60-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The Patient did not have any allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient experienced Dizziness, vomiting and unable to move on unknown date (reported date 12Mar2021 at 09:15). It was unknown if patient received treatment for the events. The clinical outcome of the Dizziness, vomiting and unable to walk was not recovered.   Information about lot number cannot be obtained. No further information expected
Big case of shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Big case of shingles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0255202A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis since 07-Nov-2014 and High cholesterol since 01-Feb-2014. Concomitant products included ATORVASTATIN from 18-Dec-2019 to an unknown date for Cholesterol, VITAMIN D [VITAMIN D NOS] from 20-Jun-2011 to an unknown date for Osteoporosis, ALENDRONATE SODIUM (ALENDRONATE) from 07-Nov-2014 to an unknown date, CALCIUM, MAGNESIUM, ZINC (CALCIUM + MAGNESIUM + ZINK) from 20-Jun-2011 to an unknown date and VITAMIN B COMPLEX from 20-Jun-2011 to an unknown date for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HERPES ZOSTER (Big case of shingles). At the time of the report, HERPES ZOSTER (Big case of shingles) 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.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-017057 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information received on 23 APR 2021 Contain : Additional information received included reporter details. On 27-Apr-2021: Follow-up information received on 27 APR 2021 contains No New Information. On 29-Jun-2021: Significant follow-up information received