chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of stevens johnson syndrome in a 80-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Humira. In October 2018, the patient received the 1st dose of SHINGRIX .5 ml. In October 2018, less than a day after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria hospitalization and GSK medically significant), shortness of breath (serious criteria hospitalization), generalized erythema and rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the stevens johnson syndrome, shortness of breath, generalized erythema and rash were unknown.  The reporter considered the stevens johnson syndrome, shortness of breath, generalized erythema and rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had no immunodeficiency that would have caused these extreme reaction. The initial reporter saw the patient in the morning and referred her to the pharmacy for SHINGRIX. The patient went to the pharmacy and got the first dose of SHINGRIX that day mid October2018 and came back to the HCP office, on the same day, after getting the vaccine, which was when she saw the follow-up reporter. The patient experienced breakout of rash before returning home from pharmacy and also experienced shortness of breath and was admitted to hospital and was diagnosed with mild Stevens-Johnson syndrome. The follow-up reporter stated that the patient was lobster red from head to toe and went downhill from there. The patient required steroids which resulted in hospitalization for 8 days total to help reverse the effects. The reaction was believed to absolutely be direct result of SHINGRIX vaccine.
Primary CNS Lymphoma, diagnosis after a high-risk brain biopsy; Was in a coma-like state; Neurological symptoms; This case was reported by a consumer via sales rep and described the occurrence of central nervous system lymphoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced central nervous system lymphoma (serious criteria hospitalization and GSK medically significant), coma (serious criteria hospitalization and GSK medically significant) and neurological symptom. The patient was treated with rituximab and methotrexate. On an unknown date, the outcome of the central nervous system lymphoma, coma and neurological symptom were unknown.   It was unknown if the reporter considered the central nervous system lymphoma, coma and neurological symptom to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's son. The age at vaccination was not reported. The patient experienced neurological symptoms after 1st dose of shingrix. The patient was currently at the hospital and had been diagnosed with a rare case of Primary CNS Lymphoma. She was in a coma-like state two weeks ago but now after a Rituximab and methotrexate cocktail she was awake and eating/breathing on her own. The diagnosis was made after a high-risk brain biopsy deep near the brain stem. The reporter agree to follow up.
Muscle soreness; 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 MYALGIA (Muscle soreness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle soreness). At the time of the report, MYALGIA (Muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Reporter did not allow further contact
weak; unable to stand upright; dizzy; sweaty from the process of vomiting; nauseous; vomited; low-grade fever; headache; chills; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (tiredness), CHILLS (chills) and PYREXIA (fever). On 27-Mar-2021, the patient experienced ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting), NAUSEA (nauseous), VOMITING (vomited), PYREXIA (low-grade fever) and HEADACHE (headache). On 27-Mar-2021, ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting), FATIGUE (tiredness), NAUSEA (nauseous), VOMITING (vomited), CHILLS (chills), PYREXIA (fever), PYREXIA (low-grade fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was taken. no treatment medication was taken.   This case was linked to US-MODERNATX, INC.-MOD-2021-132333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132333:Dose 1
Patient received vaccine in left deltoid on 9/4/18. Vaccine was administered by pharmacy. On 9/6/18, the patient called the pharmacy and reported that her arm was swollen and inflamed. I, pharmacy manager advised patient to come in to see her administration site. The patient did come into the pharmacy. I did notice her arm was swollen and red from her elbow to her shoulder. I advised her to ice down the affected area and take TYLENOL as well as BENADRYL. I also advised her to go to the ER or doctors office if swelling didnt improve. I also contacted her primary doctor and let them know the situation. The pharmacy will continue calling the patient to see if there is any improvement
coroneal ulcer in the left eye; cranial nerve VI palsy; Double vision in the right eye; This is a spontaneous report from a Pfizer-sponsored program, Pfizer . A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date in Feb2021 (Batch/Lot number was not reported) for COVID-19 immunisation. On an unspecified date in 2021, the patient developed cranial nerve VI palsy and double vision in the right eye. The patient also developed a coroneal ulcer (corneal ulcer) in the left eye on an unspecified date in Sep2021. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Error: unauthorized age group (11-year-old, Pfizer EUA approved only for children 16 years and older. Parent signed consent form with incorrect DOB indicating age greater than 16 years). Event discovered and forwarded for reporting. Signs and symptoms: None known. Diagnosis and treatment: None known. Outcome: No adverse reaction reported.
Headache, NauseaVomiting, left eye swelling, injection site pain Narrative: 51-year-old female w h/o DM and migraines, who has been feeling unwell with nausea and headache since Janssen COVID-19 vaccination March 31, 2021. Missed work 1 hour 03/31/2021 after her vaccination and the following 2 days. Dull headache, onset 03/31/2021 during 30 minute observation. Later that day left eye swelling. Was released early from work. On drive home severe nausea which caused her to pull over to a grocery store parking lot. That evening vomited. Continued to have dull headache with nausea resulting and unable to work April 1 and 2. April 3 awoke with severe pain left arm injection site, interfered with her ADLs, and caused her to spend most of the day in bed, "like I had been hit with a baseball bat". Severe arm pain resolved April 4. Complains of persistent dull headache and intermittent nausea. Reports quality of headache is different from that of her typical migraine. Last nauseated April 15, 2021. Nausea provoked by sitting upright for long period and is her most bothersome symptom.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree (also reported as Celsius degree). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree (also reported as Celsius degree). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received first dose of Pfizer in 1/10/21 and for some reason received her second dose by Moderna on 2/10/21. She has been having chills, body aches, fever.  Resolved with over the counter tylenol.
07/15/2014 to first aid temp 100.00. Right deltoid a little swollen, says temp. went as high as 102 degrees F. 07/16/2014 to walk in clinic with IZ diagnosis and restrictions on use of right arm. Follow up 07/18/2014.
Angina Narrative:  Unclear if this is related however employee states 4 days after receipt of #2 dose of Moderna COVID vaccination, he sustained an MI and was hospitalized.
first dose just a sore arm with swelling in the hand and arm; first dose just a sore arm with swelling in the hand and arm; first dose just a sore arm with swelling in the hand and arm; This is a spontaneous report from a contactable consumer (patient).   A 52-years-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm right on 22Mar2021 at 10:30 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. Patient's medical history was reported as none. Patient had no known allergies. The patient was not pregnant at time of vaccination. Concomitant medication included escitalopram, cetirizine hydrochloride (ZYTREC) (in two weeks). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 12Apr2021 at 18.00, the Patient experienced after first dose just a sore arm with swelling in the hand and arm. It was unknown that the patient received the treatment for adverse event. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
developed a red and itchy rash in left arm at injection site that moved down arm; developed a red and itchy rash in left arm at injection site that moved down arm; developed a red and itchy rash in left arm at injection site that moved down arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (developed a red and itchy rash in left arm at injection site that moved down arm), VACCINATION SITE ERYTHEMA (developed a red and itchy rash in left arm at injection site that moved down arm) and VACCINATION SITE PRURITUS (developed a red and itchy rash in left arm at injection site that moved down arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced VACCINATION SITE RASH (developed a red and itchy rash in left arm at injection site that moved down arm), VACCINATION SITE ERYTHEMA (developed a red and itchy rash in left arm at injection site that moved down arm) and VACCINATION SITE PRURITUS (developed a red and itchy rash in left arm at injection site that moved down arm). At the time of the report, VACCINATION SITE RASH (developed a red and itchy rash in left arm at injection site that moved down arm), VACCINATION SITE ERYTHEMA (developed a red and itchy rash in left arm at injection site that moved down arm) and VACCINATION SITE PRURITUS (developed a red and itchy rash in left arm at injection site that moved down arm) outcome was unknown.            No concomitant medication were provided.   Steroid cream was used twice daily for rash.   This case was linked to MOD-2021-350950 (Patient Link).
Right thigh red and swollen with softball size knot. Hot and tender to touch. Child limping. TX: Amoxicillin, Prednisolone
Patient received vaccine on 10/8, on 10/13 patient experienced severe chest pain and was hospitalized in the ICU, then was diagnosed with the shingles.
Received her HRIG and Rabavert in the same arm; Case reference number US-BN-2021-002081 is a spontaneous case report initially received on 08-Jul-2021 from pharmacist via Agency (reference number: USBAV21-0343) and concerns a female patient of unknown age.  The patient's medical history was not provided.   Concomitant medication included HRIG.  On 06-Jul-2021, the patient was vaccinated with the first dose of RabAvert (Rabies Virus Inactivated, batch number: not provided) intramuscularly at dose reported as standard dose, for post exposure bat bite. It was reported that the patient Received her HRIG and Rabavert in the same arm (explicitly coded to product administration error).  At the time of this report it was unknown if the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: Product administration error is listed for RabAvert by convention. Reportedly, the patient received on the same day and in the same arm first dose of RabAvert vaccine and HRIG vaccine, which is considered as product administration error. No information regarding medical history was provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Product administration error is listed for RabAvert by convention. Reportedly, the patient received on the same day and in the same arm first dose of RabAvert vaccine and HRIG vaccine, which is considered as product administration error. No information regarding medical history was provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.
Extensive arm swelling/tightness/redness/heat to right upper arm from shoulder to elbow and extending to underside of arm. Skin tight to the point of splitting in a couple of linear lacerations. Notified her doctor accompanied by a picture and told to give her Benadryl. Was away from home that evening without her medication with me. Applied cool compress to area. Gave her Benadryl the following evening on 8/2/19 and again in the morning of 8/3/19. Swelling began to resolve.
1 week after 1st vaccine series (DPT, IPV, HIB/HEP-B and Prevnar) the pt had about 150, 2-3 second episodes, of grimacing, tonic positioning, tongue-thrusting and crying. The pt was hospitalized. Pt had repeat vaccinations at the age of 4 months with identical symptoms that evening. Discharge diagnosis for the 3/02 admission was gastresophageal reflux.
Super itchy and inflamed groin, buttcrack and armpits Thursday 5 hours after the vaccine,  also a vaccine welt at the site on injection.  Saturday afternoon noticed hives on palms of hands spreading up the arms.
Pain beginning date of injection 4/22/08.  Redness & warmth began 4/24/08 at 1600.  Nausea began approximately 1900 on 4/22/08.  Abdominal pain & diarrhea began 4/24/08. Using warm packs & ibuprofen prn with relief.
Patient was very anxious and breathing heavy. About 5 minutes after the vaccination they started to hyperventilate and ended up throwing up. After letting them sit and relax for 5 minutes, the patient then had to throw up again and told their mother they felt like they were going to faint. Mother and myself stood by, while patient did end up fainting. We slowly lowered them to the ground, and on the way down their body got stiff and patient had uncontrollable movements and was hardly responsive. Mother and myself finally got her safely to the floor as they came to and was responding to verbal ques and stimulation from mother. Mother went to get water and i stayed with the patient to ensure no other things happen. Patient ended up doing alright after relaxing for a few and then i walked them and mother to their car and ensured they were feeling good enough to go home. I then advised the mother to seek medical attention.
Approximately 2 hours after my injection I had severe nausea. I also began feeling feverish though I did not have a documented fever when taken with an oral thermometer. That night my sleep was interrupted by restlessness, chills, upper GI burning. The following morning I woke up feeling extremely fatigued, and was still having problems with thermoregulation. I was hot and cold at the same time, though still not recording a fever with an oral thermometer. I had decreased appetite, fatigue, difficulty concentrating. These symptoms lasted through the following 2 days.
This spontaneous report was received from a registered nurse refers to 6 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) that were improperly stored outside the proper storage range. No adverse effects reported. Additional information is not expected.
I am a very active 78 yr old women. Ever since I had the vaccine, my joints and muscles in legs and arms are extremely painful especially when I first wake up. This pain has limited my active life almost completely. Without Alieve or Tylenol, I would not have been able to function without pain.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Additional Details: patinet received the first dose of moderna. shortly after administration of the vaccine he fainted. woke up was dizzy and sweating. called 911 and int he meantime asked him to postion himself on his back and feet elevated and gave him water! 911 arrived and took hid blood pressure and sugar and heart rate. he mentioned he is feeling much better and does not need additional medical service. He stated this has happened once more at the dentist's office. He left and said he was feeling ok.
Fever, Angioedema, lymphadenopathy Narrative: approx 4 hours after vaccination began with angeoedema of tongue fever and lymphdenopathy
patient experienced feet/toes feel soar; Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient experienced feet/toes feel soar) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021). On 15-Nov-2021, the patient experienced PAIN IN EXTREMITY (patient experienced feet/toes feel soar). At the time of the report, PAIN IN EXTREMITY (patient experienced feet/toes feel soar) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622298 (Patient Link).
My left arm became really sore I could barely move it, halfway through the day on the 18th I started feeling really tired and kind of woozy. On the morning of the 19th I woke up with extreme body aches and I wasn't able to sleep that night, I am dealing with fatigue and I'm now feeling sore everywhere. Soreness started out in neck and shoulder and is now all over body.
I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurting and swollen and I was violently shaking.  Hypothermia.  Couldn't get warm.  It's like my body forgot  how to regulate temperature. I've only ever experienced similar coming out of anesthesia after surgery.  Took wearing multiple layers of clothes AND multiple blankets just to stabilize my body temp.  It lasted for around 2-3 hours.  This wasn't normal "chills".  This was whole-body shaking hypothermia.  Entire body sore afterwards from the involuntary shaking.  Unfortunately, I didn't get an actual reading as anything to measure body temp was downstairs and I didn't want to risk falling.
pt recvd 1 dose of Engerix-B & on 17JUN92 devel sore throat, fever & swollen glands; had mono test which was pos; sx persist; seen by MD;
I have got a bad rash all over my body, it started slowly just on my right arm and shoulder but then spread to the left shoulder/ arm and has been slowly spreading over my neck, forearms, torso, legs, and today it has spread on my face. It hasn?t been that bad but it itches from time to time, it seems to get worse whenever I shower, and now that it spread to my face I look all messed up. I have used an anti itch cream and some aloe to try and alleviate symptoms but they haven?t stopped the rash from spreading.
pain & swelling @ inj site 9MAY97;cont to hurt & swell;given APAP by mom;Sunday noc, pt cried w/pain & arm was more swollen & red;seen by PMD 12MAY97;rx Augmentin & APAP;
Severe headache, starting in the day of injection and continuing each day after injection; fever and vomiting on day 5 after injection; an episode of shortness of breath on Day 5.
Symptoms:  Chills and headache.  Measured temp 98.0, Ox% 97.  Treatment:  2 x 500mg Tylenol, water, rest.  Symptoms subsided overnight.