chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Turned cherry red from mid torso up, including throat. Rapid heart rate, abnormal ekg Rash on buttocks and stomach IV Benadryl and IV steroids given in Er
did not received the second dose; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 14th August 2020, less than a year after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of the Shingrix vaccine about one year ago and did not receive the second dose, which led to incomplete course of vaccination. On 14th September 2020, the patient was diagnosed with shingles and was started on Valacyclovir.  The reporter did not consent to follow up.
Information has been received from a healthcare worker, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with no pertinent medical history and no drug reactions or allergies who on 07OCT-2009 was vaccinated IM with the 0.5 ml of the first dose of GARDASIL (lot#was not reported). On 20-MAY-2011, the patient was vaccinated IM with the 0.5 ml of the second dose of GARDASIL (lot # was not reported). On 25-MAY-2012 the patient was vaccinated IM with the 0.5 ml of the third dose of GARDASIL (lot number 0121AA is an invalid lot number for GARDASIL. There was no concomitant medication. The health care worker reported that the patient became pregnant after receiving GARDASIL. No treatment was given for the adverse event. Ultrasound test was performed (results not provided). It was reported that the patient saw a physician. This spontaneous prospective pregnancy report as received from a registered nurse via Pragnancy Questionnaire, refers to a 18 years old female patient with medical history of lactose intolerance, who on 07-OCT-2009 was vaccinated with the first dose of GARDASIL lot # (659184/0843X), on 20-MAY-2011 the patient received the second dose of GARDASIL (lot # 0298AA) and on 25-MAY-2012 the patient received the third dose of GARDASIL (lot number 0121AE - in verification process). On 12-JUN-2012 ultrasound test was performed to confirm uncertain dates. Results of the test revealed normal fetal anatomy and EDC would be on 09-AUG-2012. Additional information has been requested.
Within 2 hours of injection site became  swollen with heat present,  arm was swollen almost to elbow.  Then it improved, but 7-10 days later had "massive Hives" .  Went to allergist who prescribed steroid but when dosage was reduced hives retuned and dosage had to be increased again.
On December 25, 2022, I woke up with a sore throat and major congestion. The sore throat lasted for three days, but the congestion continued. I also had muffled hearing. I went to the doctor on January 3, 2023. The doctor said I had a sinus infection with swollen lymph nodes and liquid in my middle ears. I was prescribed Amoxicillin for 10 days. I am still taking it, but I haven't noticed much of an improvement yet.
second vaccination received outside of the recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination received outside of the recommended time frame) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination received outside of the recommended time frame). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination received outside of the recommended time frame) outcome was unknown.            No concomitant medications included.  Treatment medications were not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Severe migraine to the point of physical illness, vision impairment, vertigo.  Symptoms are so severe my lifestyle is impacted as I cannot drive and unable to preform job duties or continue previous life style.
Nausea, stabbing headache pains, skin ultra sensitive to touch, fatigue, sore arm (but no redness)
Case completed primary covid vaccine in March 2021, then was hospitalized for Covid in March 2022.  Briefly, this is a 82 y.o. female who presented with shortness of breath and GI complaints, found to have a positive Covid test as well as COVID-19 pneumonia on chest x-ray. Patient was admitted for supportive care and oxygen supplementation. She was started on dexamethasone 6 mg daily. Oxygen requirement remained stable at 3 L but never had acute respiratory failure because she was never in any respiratory distress. Patient will be discharged today given clinical stability and subjective improvement in her symptoms. Home oxygen is arranged and she will complete a 10-day course of dexamethasone upon discharge. Also sent her home with scheduled Combivent for 2 weeks and a rescue albuterol inhaler. Tessalon Perles and Robitussin also recommended. Patient will complete her isolation at home.
Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022; No Adverse Event; Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022).    No concomitant product use was reported. The number of doses/vials -around 50 doses from 5 vials. On 08-Jul-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 07-Aug-2022 until the 11-Aug-2022 Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
Pt called and stated that the shot may not have been administered incorrectly by pharmacy technician. She states that the shot may have been given outside the area of the deltoid. She stated she felt feverish and reported headaches.
Muscle spasms/twitching in left arm/shoulder area where shot was administered. They come and go, but have been a constant, daily nuisance since the day after my flu shot. Only happens in spot on arm where shot was given. Hasn't gotten any better. Haven't treated the symptoms with any medication yet.
2 weeks after second dose of vaccine, had itchy painful rashes on neck, lips darkened and painful, darkened skin around right eye, forearms, back, arthritic leg was inflamed. Have had permanent discoloration because of rashes. Went to urgent care, given Zyrtec for allergic reaction, 1 course of steroids. Zyrtec has helped noticeably with itching.  Went to herbalist (alternative medicine), determined connective tissue reaction and allergic reaction. Given herbal remedy, seems to have helped with connective tissue problem.  No longer itching.
Shortness of breath, fever, weakness, headache 24 hours after injection. Continued weakness and shortness of breath for 8 days after injection.  Injection site welt 4 inches in diameter and warm, itchy sore for 8 days and still going.
This spontaneous report was received from a nurse practitioner refers to a 63 year old male patient. On 29-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant therapies included LIPITOR, ZOLOFT, aspirin and oxycodone. On 03-FEB-2014, 6 days after onset of therapy, the patient experienced shingles. The patient sought medical attention and visited the office. No treatment was given for the event. The outcome of shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
This spontaneous report was received from an office manager concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, lot # M018436, expiration date 13-APR-2017, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was 10.6 F for 98 hours 51 minutes. No digital data logger was involved and no previous excursions were performed. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About an hour after the patient received the H1N1 vaccine, she called us concerned that her L hand (same as arm given shot) was tingling. Later (about 3 hr) we f/u and the sx was the same.
Extreme sore arm, body aches, chills, nausea,  loss of appetite, diarrhea, slight headache
Received ZOSTAVAX 9/26/12 developed zoster lesions L1 dermatome 10/2/12.
This child had pain in the left thigh and diffuse swelling from the groin to the knee.
Fever; muscle aches; joint pain; tiredness; headache; BNT162B2 first dose on 21Dec2020 and second dose on 09Jan2021, spaced less than 3 weeks; This is a spontaneous report from a contactable nurse (patient self). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 09Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD).  Patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot: EL0140) on 21Dec2020 12:00 pm left arm for COVID-19 immunisation. Patient experienced fever, muscle aches, joint pain, tiredness, headache on 10Jan2021 02:00 am with outcome recovering. No treatment was received for the events.
Sedation, Myalgia, Arthralgia, Chills, Redness/Swelling @ injection site Narrative:
Arm begun to get red "about the size of an orange"; Hard underneath; Warm; Middle has started to turn purple; Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm begun to get red "about the size of an orange"), VACCINATION SITE INDURATION (Hard underneath), VACCINATION SITE WARMTH (Warm), VACCINATION SITE DISCOLOURATION (Middle has started to turn purple) and EXTRA DOSE ADMINISTERED (Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 047621A, 022M20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Arthritis. Concomitant products included METHOTREXATE for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Arm begun to get red "about the size of an orange"), VACCINATION SITE INDURATION (Hard underneath), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE DISCOLOURATION (Middle has started to turn purple). At the time of the report, VACCINATION SITE ERYTHEMA (Arm begun to get red "about the size of an orange"), VACCINATION SITE INDURATION (Hard underneath), VACCINATION SITE WARMTH (Warm), VACCINATION SITE DISCOLOURATION (Middle has started to turn purple) and EXTRA DOSE ADMINISTERED (Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A) outcome was unknown.     No treatment medication was provided by the reporter.   This case was linked to MOD-2022-504008 (Patient Link).
Itching on arm 6 days after getting shot, that then Turned into itchy, red warm rash at injection site on arm on the 7th day. Almost completely gone on the 8th day.
"Covid arm" Moderate left arm swelling, itching, warmth, and numbness that appeared approximately 1 week after vaccination.  Symptoms resolved on its own over the course of 6 days after initial onset.
Too late to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Too late to get the second dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Too late to get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Too late to get the second dose) had resolved.            Patient has not experienced any symptoms after the first dose. Concomitant medications include medications for type-2 diabetes mellitus and high blood pressure. Treatment information was not provided.
On the third day I felt extreme fatigue Then on day 5 I started to have sharp pain in the armit lymph node area of the arm where I got the shot. Day 6 I woke up with my arm fully hot red and swollen on injection site.
11 days after vaccination, patient c/o shortness of breath at rest, confusion and cough
I had a runny nose, coughing, sore throat, headache, body aches very tires. I had been out of the country, so I used a home COVID-19 test that did come back positive. I called and had a telehealth visit with my doctor. I was prescribed the PAXLOVID on March 25, 2023, the headaches and body aches went away, the fatigue took another week. I have tested negative but I am still suffering from a cough and runny.
Severe body aches, fever, chills, weakness.  Could barely move - was quite painful,
10 pox on body 19FEB98 c/o itching- (outbreak in daycare);
panniculitis; erythematous rash on upper extremities/ rash migrated further distally on her forearms with a prominent new lesion on the left forearm with symptoms of tenderness and itching; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 03-DEC-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its untended purpose: the prevention of shingles (herpes zoster). Shortly after the vaccination, the pt suffered an erythematous rash on upper extremities with development of associated subcutaneously nodules on the posterior upper arms and posterior lower legs and diagnosed as panniculitis. In addition, the rash migrated further distally on her forearms with a prominent new lesion on the left forearm with symptoms of tenderness and itching. As a direct and proximate result of the vaccination, the pt had resulted in physical limitations not present prior to the vaccination. The pt also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the vaccination, the pt sustained severe and permanent personal injury. Further, as a tragic consequence of the vaccination, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical limitation and injury. As a direct and proximate result of vaccination, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  The events of panniculitis and erythematous rash on upper extremities/ rash migrated further distally on her forearms with a prominent new lesion on the left forearm with symptoms of tenderness and itching were considered to be disabling.  Upon internal review, the event of panniculitis was considered to be medically significant.
Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending from shoulder to hand  Within 48 hours following administration: - Progressive pain in left upper extremity - Greatly reduced range of motion in left upper extremity - Inability to bear any weight in left upper extremity - Large ecchymotic lesion at head of left humerus  After 48 hours to current presentation: - Pain in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Painful spasticity in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Pain-restricted impaired range of motion of the neck including flexion, extension, lateral rotation, medial rotation, and lateral bending - Pain restricted impaired range of motion of the left upper arm including flexion, extension, lateral rotation, medial rotation, and abduction - Painful left-sided dysphagia at the level of the cricoid cartilage - Use of left arm impaired versus baseline with no signs of improvement
Left deltoid- 6x8cm well demarcated area surrounding injection site of ecchymosis and erythema.  No induration, warmth.  Treatment: ice and triamcinolone cream 1%.
At approximately 8pm , I went to void and when cleaning found 6-7 small red blood stains.  I didn?t have any pain or cramps. The following morning I had a  large  mucus discharge after voiding. The days following up until around Jume 17tb  I continue to have spotting off and on almost daily.  Not red. Blood more like a dark old blood.
Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling continued until Thursday (4 days later). Feeling ?off? or unwell without any other symptoms -3 hours after injection and lasted until 5:00pm next day when symptoms increased. Starting 5:45pm  Lethargy, shaking all over, feeling of ?freezing ?, upset stomach, fever of 101- continued into the evening. Fever resolved with Advil and rest. Shaking and upset stomach stopped sometime overnight. Feeling very tired next day.
Per mother of patient: child was "pale and shaky," was taken to Emergency Department in the evening of the day the vaccine was administered; Child was observed at ER and then released. Per Mother, doing well the next day.
patient got nauseous after the shot. I have checked her vital. She was ok after 15 minutes and left the waiting area.
This initial spontaneous case was received from a lawyer regarding a case in litigation concerning a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX (onset date not further specified), the patient began experiencing issues with her vision. Over the next few months (date not further specified), these issues worsened, resulting in her suffering diminished peripheral vision in both eyes, damage to the optic nerve in her left eye, and severe damage to her right eye. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the Company's product. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered/not resolved. Causality assessment was related. Issues with her vision, diminished peripheral vision in both eyes, damage to the optic nerve in her left eye, and severe damage to her right eye were considered disabling. Upon internal review, damage to the optic nerve in her left eye was considered to be medically significant. Additional information has been requested.