chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nsg reported that a pt rec'd his 5th injection of Acel-Imune, with MMR (manufacturer unknown) and IPV (manufacturer unknown) on 3/23/01. On an unspecified date, the child experienced pea-sized subcutaneous nodules at the site of the injection lasting for months. The nodules ere noticed on 5/21/01. the nsg reported the same event occurred in the child's twin brother. (HQ1771807JUN2001). No further info was available at the date of this report.
Developed a rash that started on my chest and forearms and is spreading throughout most of my body. It is slightly raised on my skin and minorly itchy in places, but not unbearable.
Information has been received from a health professional concerning a 4 month old male who on 5/24/02 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot 642221/0040M). On 5/24/02, the patient was concomitantly vaccinated with a dose of Streptococcus pneumoniae vaccine (PREVNAR) (lot 485997). The patient developed hoarseness 1 to 3 days post vaccination. Unspecified medical attention was sought. The hoarseness lasted for 3 to 4 days and the patient subsequently recovered. The patient's parents reported to the office that there seemed to be no residual effects. The parents also stated that the patient did not cry excessively after the injection. Additional information has been requested.
Shortly after injection the patient complained he felt dizzy and hot.  Per his mother "he always has this reaction with injections/immunization."  The patient was provided and ice pack to the back of the the neck and orange juice followed by 3 sets of vitals. 1.  1:10, temp 96, BP 102/72, 0xygen 99%, HR 66 2.  1:20, temp 95.3, BP 126/62, Oxygen 99%,  HR 77 3.   1:30, temp 96.9, BP, 120/58, Oxygen 98%, HR 67  patient commented he felt better and based on vitals, verbal communication, and visual ques ...he was cleared by the nurse.
Abnormal Menstruation.  After receiving the Covid vaccine, Menstruation came mid-cycle. Menstruation came one week after vaccination. Got my period early on day 18 of my cycle. I record and track my cycle regularly. I have a very regular 28 to 30 day cycle.  Having my period come 10 to 12 days early mid-cycle  was not normal. Menstruation has been heavier and has more clots than normal in subsequent period.
Slight nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Slight nose bleed) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     The patient's past medical history included Cautery to nose. Concurrent medical conditions included Hypertension.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced EPISTAXIS (Slight nose bleed). At the time of the report, EPISTAXIS (Slight nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product included as blood pressure medication. No Treatment Medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Reporter's address is updated.current condition hypertension was added.Concomitant products included as blood pressure medication.
ADMINISTRATION ERROR : Administered 3 days after expiration date. 09/05/2021
This case is a report from a spontaneous literature article referring to a 50 Year-old Female patient. This patient was referred for recurrent respiratory infections and poorly controlled asthma including multiple ICU admissions. She had a history of mild asthma and allergic rhinitis but her clinical symptoms worsened significantly in her 40's. Her total IgE was 4 25 mg/dL and specific IgEs were positive to multiple environmental allergens. Her FEV1 was 57% predicted. Omalizumab was started for her severe asthma with improvement in severity of exacerbations, however she continued to have respiratory infections and intermittent need for corticosteroids and antibiotics. Further workup revealed hypogammaglobulinemia (lgG 428 mg/dl). It was reported that the patient was diagnosed with Common variable immunedeficiency(CVID). On an unknown date the patient was vaccinated with PNEUMOVAX23 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis. No concomitant medications were reported. On an unknown date the patient experienced poor pneumococcal vaccine response. The action taken and outcome of the event were not reported. Additional information has been requested.
She did not know whether she was sick or was having a reaction. Her much younger daughter had a weekend of it.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She did not know whether she was sick or was having a reaction. Her much younger daughter had a weekend of it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
General fatigue after 12 hours Increased fatigue around 28 hours Nausea, cold sweats/feeling clammy, and fitful sleep after 37 hours
Information has been received from a female patient. In February 2008, she was vaccinated with the first dose of GARDASIL. On 29-SEP-2008, she was vaccinated with the second dose of GARDASIL. After getting the second dose of GARDASIL the patient experienced pain at the injection site. No additional information expected.
Felt weak right after injection, Then on the 3rd I called the Pharmacist could not see was unable to walk without dizzness, could no longer get to my car to drive. Very ill shaking hands. Trimers in all fingers. Legs and body so weak I couldn't stand without assistance. Headache an ringing in my ears. Its been 3 months and I still have difficulty walking and getting out of bed without help.I am awakened each morning with my right arm hurting at injection site.
RAPID ONSET FLUSHED FEELING, LIGHT HEADED, PAIN IN ARM, NUMB FEELING ARM.
Dizzy; Hives; Numbness in face and jaw; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), URTICARIA (Hives) and HYPOAESTHESIA (Numbness in face and jaw) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizzy), URTICARIA (Hives) and HYPOAESTHESIA (Numbness in face and jaw). At the time of the report, DIZZINESS (Dizzy), URTICARIA (Hives) and HYPOAESTHESIA (Numbness in face and jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.  She reported that HPC told to her she had a severe allergic reaction and should not get second dose. However, she was concerned that if she does not have proof of both doses, she will not be able to work or travel.  Treatment information not provided.
Blisters; Swollen gums; Dizziness; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). On 07-May-2021, BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.            No concomitant medication was reported  No treatment medication were provided.   This case was linked to MOD-2021-068600 (Patient Link).
LOW GRADE FEVER; FLUSHED; TIRED; This spontaneous report received from a consumer 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 in the left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 units unspecified. On 20-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced flushed. On 23-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, flushed, and low grade fever. This report was non-serious.
Day 2 - day 7 after injection, arm pain, shoulder and neck pain. Day 14 after injection underarm and left breast pain  Day 15 after injection underarm and left breast pain like I suffered when I had shingles in the same area, but without the rash. Intense pain alleviated only by moist heat, the same treatment I used when I had shingles.  FYI I also had a viral infection following the shingles outbreak.
3 persons felt dizziness after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (3 persons felt dizziness after vaccination) 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 DIZZINESS (3 persons felt dizziness after vaccination). At the time of the report, DIZZINESS (3 persons felt dizziness after vaccination) outcome was unknown. Not Provided    No concomitant and treatment details were provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089650, US-MODERNATX, INC.-MOD-2021-089271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089650:Wife case US-MODERNATX, INC.-MOD-2021-089271:Reporter case
This spontaneous report as received from a lawyer regarding a case in litigation concerning a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in April 2011 (reported as on or about 21-APR-2011), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in July 2015 (reported as on or about 14-JUL-2015), the patient was treated for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. On an unknown date in April 2015 (reported as on or about 10-AUG-2015), the patient sought subsequent treatment for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. On an unknown date in August 2015 (reported as on or about 19-AUG-2015), the patient sought additional treatment for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of 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 has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Really sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO151) via an unspecified route of administration in the right arm on 02Apr2021 at 12:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included mometasone furoate (ASMANEX) and montelukast (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. On 02Apr2021 at 13:30, the patient experienced really sore arm. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient received treatment for the reported event which included ibuprofen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event really sore arm was recovered on an unknown date in Apr2021.    No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown. Not Provided      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.   Concomitant medications were not reported.  HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response (QR) code scanned. On 12 OCT 2021, vial was initially stored in the refrigerator. No temperature excursions was noted and patient did not experience any adverse event.  Treatment medications were not reported.
PATIENT RECEIVED COVID PFIZER VACCINE DESIGNATED FOR PATIENTS AGED 5-11.
Headaches, body aches, fever, chills, vomiting, dehydration, redness at injection site
Pt had Td vax and abx due to chemical burn on foot. Presents 2 d later to ER with 103 fever, arm pain, injection site reaction. Given ibuprofen and return precautions. Stated in narrative as Td with no pertussis component (given at physician office), unknown details.
Feeling progressively ill and fatigued, progressively getting worse each month.  Daytime sleepiness, exhaustion.
Moderna inadvertently administrated by vaccine nurse.  NO ADVERSE REACTION, just reporting medication error.  Thanks.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 01-NOV-2013 the patient was vaccinated with an expired dose of M-M-R II HSA, lot # 1405AA, exp. date 06-SEP-2013, subcutaneously, dose, strength, indication and site of administration not reported). No know adverse effects. Additional information has been requested.
07/22/2010pts grandmother calls stating slight redness to site, 07/23/2010 grandmother brings child by clinic for eval of reaction, redness noted to right upper outer arm of child with some swelling and fever noted to area, 3x4inch oblong area noted of redness, pt has taken Benadryl and Tylenol, instructed to continue with the Benadryl and Tylenol and to do cool compresses to affected site
a patient was given the incorrect dose of IPOL,the patient was given 2cc instead of 0.5cc; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient of an unknown demographics who received vaccine IPV (VERO) [IPOL] and reported that a patient was given the incorrect dose of Ipol, the patient was given 2cc instead of 0.5cc.  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 2cc instead of 0.5cc suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was a case of overdose.  It was unknown if the patient had any adverse event.  List of documents held by sender: none.
A few days after IM injection, I had blisters on my left foot, focused on the toe area. These progressed into an excema reaction to follow. Never having been diagnosed with excema prior. This situation took weeks to reside. Followed by multiple more breakouts on my left foot and also urticaria reactions now all over my torso, abdomen, thighs, and neck at times. These giant hives will surface and last several hours, after residing they will then appear in another area the next day on my body.  Most softball size in nature.
Migraine headache - Left forehead; pounding pain lasting several hours. 400mg MOTRIN OTC - for pain; rest. Muscle ache - Legs bilaterally effected with cramps lasting 1-2 hours. Rest/400mg MOTRIN.
26y/o F presented to DET covid vaccine clinic for 1st dose Pfizer. While pt doing observation period, pt c/o of SOB. Pt noted to be hyperventilating and hands stiffened up. Pt reports sxs started w/ fatigue and dry throat, followed by sensation of choking.    Vitals at 3:15pm: BP 139/97 O2 Sat 100% O2 at RA HR 156 Oral temp 98.4F   Albuterol inhaler x2 puffs given at 3:18pm.    HR improved to 110.   Pt reports sx improvement, but notes whole body numbness.    Transported to ED via wheelchair for further eval. Advised she had to be cleared by provider for 2nd dose Pfizer.
Felt tired and short of breath about 2 weeks after last vaccination along with swollen ankles.  Had strong chest pain and lower jaw pain 3 weeks after vaccination. Saw a cardiologist and had stress test and heart catherization.  No significant problems found and have had with no symptoms ever since.
Seen in office 7/24 for possible site reaction. No fevers or difficulty walking or fussiness. Had 7x6 in area of redness around injection site noted PM 7/23. Vaccine given AM 7/22. No streaking or concerns for cellulitis, so treated as localized reaction with cool compresses, Benadryl prn, and hydrocortisone if itching. Area marked to monitor for possible spread and close return precautions given. No history of vaccine reactions in child or family members, and family members comfortable with plan.
Red circle on child's (L) thigh 1.25" x 1.50" tender to touch.
VERY DRY HANDS WITH OPEN AREAS; BODY RASH; ITCHING BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient experienced itching body. On 25-MAR-2021, the patient experienced body rash. On 01-SEP-2021, the patient experienced very dry hands with open areas. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching body, and body rash on 29-APR-2021, and had not recovered from very dry hands with open areas. This report was non-serious.
Patient reported having itchy eyes on 11/8/20 and took loratidine.  On 11/11/20 called the pharmacy complaining of fever. Took Tylenol. Complained about having arm aches , including the back.  The pharmacy followed up with her on 11/13/20.  She said her fever had resolved and was feeling better.
BLOOD SUGAR HASN'T GONE OVER  250; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin aspart for high blood sugar, insulin degludec for high blood sugar, liraglutide for high blood sugar, and metformin for high blood sugar. On an unspecified date, the subject experienced blood sugar hasn't gone over 250. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 250, 400. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar hasn't gone over 250 was not reported. This report was non-serious.
48hrs later joint pain, body aches, chills & fever, sore throat duration 72hrs;
Rash; This is a spontaneous report received from a contactable consumer (patient).  An 83-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 17Feb2021 at 00:00 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine.  Patient had no concomitant medications. The patient did not receive any vaccine within 4 weeks prior to vaccine or any medication within 2 weeks of vaccination.  Past vaccine history included pneumococcal vaccine and had the same reaction to it.  On 18Feb2021, the patient experienced rash. Patient did not receive any treatment for rash. The clinical outcome of rash was recovered on an unknown date in 2021.  No follow up attempts are needed. No further information is expected.
10 days post vax, t105 r, taken to ER dx tonsillitis, 2 tiny red bumps on stomach; Strep test negative, inc rash on stomach & back; tx ATB; Has tubes in ears;
sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.