chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH PAIN; DIARRHEA; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported, and dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-MAR-2021, the patient experienced off label use, and inappropriate schedule of vaccine administered. On 28-MAR-2021, the patient experienced stomach pain, and diarrhea. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, stomach pain, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Patient received Moderna vaccines on 3/1/2021 and 4/10/2021. He then tested positive for Covid infection on 7/26/2021 after having been fully vaccinated.
Bump / Red and raised; Bump / Red and raised; Pain at his thigh; exhausted; This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in last 5 years had shingles 20 times). Concomitant products included etanercept (Embrel).   On 30th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2020, 2 days after receiving Shingrix, the patient experienced exhaustion. On 5th October 2020, the patient experienced pain in thigh. On 7th October 2020, the patient experienced local swelling and redness of legs. On an unknown date, the outcome of the exhaustion, pain in thigh, local swelling and redness of legs were unknown.   It was unknown if the reporter considered the exhaustion, pain in thigh, local swelling and redness of legs to be related to Shingrix.  Additional details were provided as follows: The patient had a history of shingles in the last 5 years having had shingles 20 times but it was limited to the same spot on his thigh. The patient had not been taking his Embrel for 3 weeks once he started again in May, he experienced four breakouts of shingles on the back of his left thigh. The patient received the 1st dose of Shingrix in left arm and by 2nd October he was exhausted. On 4th October 2020, the patient took his Embrel medication. On 5th October 2020, 5 days after vaccination the patient had pain at his thigh. The pain he experienced was not a blistering breakout but on 7th October 2020, 7 days after vaccination he had a bump where he initially had the breakout and it was red and raised but could barely be seen on his left thigh. The back of left thigh is where he was experiencing the single bump at the time of reporting. The reporter consented to follow up.
L upper extremity swelling, pain, redness, and numbness extending from upper arm to below the elbow.
Patient tolerated Tdap well. After administering the MCV, patient was seated and leaned back into her mother and I observed her eyes rolling into the back of her head. Patient then stopped responding for less then 15 seconds. Then came to. Called for help, then laid patient down with feet elevated. Vitals were taken. Dr. examined patient, patient appeared to have vasovagal response to the injection. Observed patient for 30 minutes, gave orange juice and brownie. Patient after 30 minutes verbalized that she felt better and was able to leave ambulatory accompanied by mother.
Patient is a 44yo female patient with h/o HTN, asthma. Patient reports that she initially developed a rash over her abdomen 6 days after receiving the H1N1 live attenuated nasal flu vaccine on 11/14/09. The rash began as red to purple spots and patches over her abdomen that were itchy. She developed concomitant nausea, vomiting and headaches, unaccompanied by fever. The rash subsequently spread to involve her face, arms, legs, and most recently the buttocks area. Patient presented to hospital for evaluation on 11/21/09. There she was found to have an E Coli UTI and bacteremia -with 3 out of 4 blood cultures positive for coag negative staph-. Patient was placed on vanc, zosyn, and LEVAQUIN for treatment. A skin biopsy was performed from the left lower quadrant of the abdomen. The biopsy was taken on 11/24/09 and showed "Extensive acute vasculitis and focal thrombosis." Further workup included C3 and C4 levels -normal-, ANCA levels -+, 1:320 with speckled pattern echocardiogram -normal-, and abdominal ultrasound, which showed gallbladder sludge and splenomegaly. Of note patient was found to be Hep C antibody positive and HIV negative. Pt was also found to be slightly leukopenic with WBC of 5 and was given NEUPOGEN. Rash continued to spread and became tender to palpation. Patient denied taking any medications regularly or taking any meds prior to onset of rash. Denies known drug allergies. Denies fever, cough, chills, shortness of breath, pain or burning on urination, urgency, joint pains or current headaches. It is unknown whether pt's rash represented ANCA-associated vasculitis secondary to vaccine or cyrofibrinogenemia related to patient's previously undiagnosed hepatitis C on other vasculitis of unknown etiology. Pt responded well after treatment with high dose IV steroids and then transition to high dose PO steroids. Had to be readmitted to hospital after initial admission due to uncontrolled pain and for wound care. Eventually healed with significant scarring.
Neuropathy feet/hands/elbows, nerve pain everywhere, especially in neck. Symptoms still persist 6+ months out
Pt. presented on 01/08/11 (31 5/7 wks pregnant) to MD triage with fever 101.1, tachycardia (maternal and fetal); flu-like symptoms. Tx: Started treatment with TAMIFLU; monitor on L&D; provide supportive care. Vaccine failure.
It was red and swollen. The Dr. prescribed cefdinir capsule 300 mg.
Swelling & redness at site of injection and upper arm, diarrhea, nausea. 1/17/01 pt called in to update her record. October 2000 kidney infection URI November 2000 pneumonia December 2000 stomach ulcers and stomach virus. Diarrhea s/p any amount of food. Diarrhea persisting to present. Awaiting results of blood, urine and stool tests. Has infectious disease. Consult pending. Received a total of 3 ANTHRAX injections.
It started with an extremely sore throat and I thought it was the pollen or strep throat. From there, the next day it turned into a productive cough. I would get into coughing fits and would cough for 4 to 5 minutes at a time. It was very productive. I tested positive on 03/12/2023, then I tested again on Monday 03/13/2023. I called my doctor and was prescribed Paxlovid. I started getting better fairly quickly.  I didn't have any other symptoms that I know of. By Sunday of that week 03/19/2023, I took a test and it came back negative. After I was out and had 3 negative tests, I had a dry hacking cough that lasted up until a week ago, then it went away. I did recover, but I did have a lingering hacking cough that lasted for a few weeks after.
This case was reported by a consumer via interactive digital media and described the occurrence of bronchitis in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced bronchitis (serious criteria hospitalization), asthma (serious criteria hospitalization) and near death experience (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the bronchitis, asthma and near death experience were recovered/resolved. It was unknown if the reporter considered the bronchitis, asthma and near death experience to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient suffered very much with bronchitis and asthma after taking flu jabs and was admitted into hospital twice and felt nearly died. The patient stated that the Lord showed her it was the flu jabs and she stopped them 7 years ago. The patient had no bronchitis or asthma.
a sore upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore upper arm) 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 19-Apr-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 PAIN IN EXTREMITY (a sore upper arm). At the time of the report, PAIN IN EXTREMITY (a sore upper arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-083954 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083954:Reporter(Caller) case
2/20/21 - 1630 - 2 small, painful bumps appear on left cheekbone 2/20/21 - 0900 - Fatigue, pain at injection site, muscle aches, low grade temp begins, bumps on cheek become lesions which increase in size and pain; lesion develops under left lower lip. The symptoms increase over the next 24 hours - fever gets as high as 101 2/21/20 - Afebrile and major side effects significantly decrease.  Lesions on cheek and under lip increase, becoming bumpy and red with discharge noted.  Nerves under lip become affected.  Lesions appear as individual sites, increasing in size and infection, but never spreading to other sites on the face or body. 2/24/21 - Appointment with PA-C, Dermatology.  Unable to give definitive diagnosis, but suspects 2 different types of infections. Cultures taken. Started on oral and topical antibiotics and oral and topical antivirals. Requisition for bloodwork given. 2/298/21 - Lesions begin to dry up and scabs form.
About 5 minuest after vaccine given, pt went out to meet parent in waiting room. She did not sit again at this time, as parent got up to leave with her. As they were leaving, pt reported to mom that she felt lightheaded and her legs felt a little weak, they kept walking and got into an elevator where the patient passed out/fell to the floor. She came to in less than a minute and felt completely fine in less than 5 minutes. As she was still in the clinic, she was brought to a room via wheelchair where vitals were taken and were normal. Pt and parent walked out of clinic approx 10 minutes after the event, she reported feeling completely normal.
Large erythematous area 3.5 inches x 2.25" hot to touch, Pt states she has had fever, chills, headache, hard 2" x 2" lump. Painful to touch.
Patient is a 75-year-old gentleman with history of HFrEF, CAD status post CABG, diabetes, who presented to Hospital for nausea, vomiting, hyperglycemia, and fatigue.  He is found to be hypotensive upon arrival, requiring 3 L of cannula, and also tested positive for COVID-19.     Acute respiratory failure with hypoxia....resolved COVID-19 infection Presents with hypoxia, not on O2 at baseline.  Exact etiology possibly volume overload in the setting of holding home Lasix, however COVID is likely playing a role. Patient has no overt respiratory distress  Patient was given IV Lasix on arrival to the ED with drop in blood pressure, would avoid further diuresis for now Required 3 L upon arrival, now weaned to room air Started on daily steroids, on hold per pulmonary.  Remdesivir was discussed with patient and family at bedside.  After discussing risk/benefits with him at bedside, they preferred to hold off on initiating this therapy  Appreciate pulmonary input.  Aggressive pulmonary hygiene with incentive spirometry and early ambulation as tolerated Stable to Dc home Ambulating fine and saturating well on RA   Hypotension..... Resolved Volume status unclear on arrival.  Systolic dropping to the 70s here in the ED.  Patient did receive a dose of Lasix on arrival for perceived volume overload with hypoxia.  Given Vanco and Zosyn  in the ED, culture data so far unrevealing   Nausea and vomiting.... Resolved Hyperglycemia Fatigue Possibly a result of COVID-19 and other acute issues described above. Supportive care, treatment as described above   HFrEF Coronary disease status post CABG PAF History of VT Resume appropriate home medications.  No clear signs or symptoms to suggest ACS at this time. Continue to follow volume status and for any worsening symptoms Appreciate cardiology input, continue to hold Entresto and Toprol for now, resumed Toprol 03/27, BP stable and tolerating BB so far Continue current medications pe rcardiology   Type 2 diabetes, requiring long-term insulin use Patient confirms that he takes 35 units of basal insulin in the mornings, along with short acting throughout the day. Blood glucose remains elevated.  Was receiving 35 units of insulin Uptitrated insulin to 45 units and change insulin sliding scale to resistant 03/27 Monitor, blood glucose stable   CKD stage III Continue long-term monitoring in the outpatient setting.  Baseline around 1.6-2.0 Stable at baseline
c/o on awakening rash entire body;mom states they are pinpoint dots;denied fever;mom states is cranky
Child developed fever 07/13/07 night and started to have runny nose 7/15/07. Exam on 07/16/2007, child had nasal congestion and red and exudated tonsils, temp 101.7. Med. Motrin/Tylenol.
sore; Cannot sleep for a night; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (sore), INSOMNIA (Cannot sleep for a night), PYREXIA (fever) and HEADACHE (headache) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) .5 milliliter. On 27-Aug-2023, the patient experienced TENDERNESS (sore), INSOMNIA (Cannot sleep for a night), PYREXIA (fever) and HEADACHE (headache). At the time of the report, TENDERNESS (sore), INSOMNIA (Cannot sleep for a night), PYREXIA (fever) and HEADACHE (headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2023, Body temperature: up to 101F for one day.         No concomitant medications were reported. No treatment medications were provided. It was unknown if the patient experienced any additional symptoms/events.   Reporter did not allow further contact
On Monday, March 21, 2022, I got the Moderna booster at 2:00 PM.   Tinnitus started up again within an hour. *   I was very tired that evening but otherwise fine.  Tuesday night, March 22,  at 9:00 PM, when I went to wash my face, I noticed a bulging vein going down the middle of my forehead toward my nose, about 2+ inches long!   Prior, I have never seen even the slightest trace of a vein in that area.   By 10:30 PM, it was reduced by half in length.  There was no pain but the presence of it was worrisome.  Wednesday evening, March 22, it was 2+ inches long again and worrisome.  As of March 23, it had remained like that and I had a video appt. with my doctor's office at 4:30 PM.  The doctors were not worried about vein.  By Friday, March 25, it was completely gone, so no doubt a side effect of the booster.  In addition to this, I also had a recurrence of tinnitus about an hour after the booster.   * Tinnitus had developed three months after the second Pfizer vaccine that I had on 3/16/2021.  By January, 2022, it was tapering off, and by mid February, was intermittent and infrequent.  I no longer had it until getting the Moderna booster.
had vaccine and in the middle of second bout/suspected vaccination failure; in the middle of second bout; pain; red streak on cheek; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccine and in the middle of second bout/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: in the middle of second bout), pain (Verbatim: pain) and red rash (Verbatim: red streak on cheek). The outcome of the vaccination failure and pain were not reported and the outcome of the shingles was not recovered/not resolved and the outcome of the red rash was recovered/resolved.   It was not reported if the reporter considered the vaccination failure, shingles, pain and red rash to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure, shingles, pain and red rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The patient had shingles vaccine and he/she was in the middle of his/her second bout shingles patient never really had much pain.  The patient had the vaccine for more than 5 years ago and had a very small red streak on his/her cheek. .  The patient just happened to be in the clinic and asked to see his/her physician assistant.  She knew immediately what it was, called in a script to the medical and by the next morning it was gone.  The reporter stated that patient still finish the medication. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow up would not possible as no contact detail were available.
acute deep vein thrombosis (DVT) in the right upper extremity; This literature-non-study case was reported in a literature article and describes the occurrence of DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEEP VEIN THROMBOSIS (acute deep vein thrombosis (DVT) in the right upper extremity) to be possibly related.    Patient relevant thrombophilia workup was negative on initial presentation. She was treated with rivaroxaban for 3 months and her symptoms of right upper extremity swelling, and pain improved.  Company Comment: This case concerns a 27-year-old female patient with no relevant medical history, who experienced the unexpected serious event/AESI of Deep venous thrombosis in arm after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the second dose of mRNA- 1273 vaccine. Treatment with Rivaroxaban was given. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report; Sender's Comments: This case concerns a 27-year-old female patient with no relevant medical history, who experienced the unexpected serious event/AESI of Deep venous thrombosis in arm after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the second dose of mRNA- 1273 vaccine. Treatment with Rivaroxaban was given. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
On 6/15/15 2 inches redness, warmest & swelling at site of injection in the back pt the arm. On 6/16/15 pt. stated she has 3 spots on her arm. The next day, she noticed it became round. No itchiness & no other symptoms, spreading. Refer to the doctor but she refuse. She said it is not spreading. Asked patient to cover her rash as a precaution.
pt devel diffuse hives & diarrhea;pt devel 4x2cm hive @ inj site;
I had the J&J shot first in March and got the Moderna as a booster in October. Since the booster, I have gotten my period every 2 weeks. I had an early period after the J&J shot, but not the same as the period every 2 weeks.
Right arm, anterior inlet, shoulder and upper back with edema, tense, large area of erythema and warmth extending 17 cm down arm from shoulder and 14 cm of circumference of arm. Non tender, no drainage, but small blisters near elbow. Treated with prednisolone BID x 5 days and AUGMENTIN BID x 10 days for diagnosed cellulitis.
LEFT ARM NUMBNESS SENSATION; LEFT ARM TINGLING SENSATION; SEVERE PAIN AT NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On JUL-2021, the subject experienced left arm numbness sensation. On JUL-2021, the subject experienced left arm tingling sensation. On JUL-2021, the subject experienced severe pain at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm numbness sensation, severe pain at night and left arm tingling sensation was not reported. This report was non-serious.
Pt got her COVID booster at the pharmacy yesterday.  States she felt fine when she left, but by the time she got home she had a sensation of tightness in her chest and felt as if her heart was pounding (not racing, not skipping beats, felt as though it was beating very strongly) Felt as though her vertigo was acting up.  She checked her BP at this time- 156/94.  Took one of her HCTZ, CP resolved, recheck on BP 149/92.   CP resolved after first HCTZ, but pt states she still felt that her vertigo was acting up so she checked BP- 142/102 and took another HCTZ.  Recheck about a half an hour later wa 144/87.  All s/s now resolved, had pt check BP while on the phone- 162/99, but she states she did not take any of her medications yet today
Irritation of ulnar nerve leading to symptoms associated with tennis elbow.  (Pain between fingers and elbow, twitching of pinky finger).  Symptoms are receding slowly (four weeks in), still present