chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red mark at injection site; It is warm; Swollen and is getting larger; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number; Lot Number: EN6205) via an unspecified route of administration in the right arm on 02Mar2021 at 13:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0269) via an unspecified route of administration on 09Feb2021 at 13:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. On 07Mar2021 at 09:00, 5 days after injection, the patient woke up with large red mark at injection site. It was warm and swollen and was getting larger. At the time reporting, this was approximately 4 inches wide by 6 inches long. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events large red mark at injection site, warm and swollen and was getting larger was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Right thigh redness/slight swelling. Patient instructed to apply cool compress to (R) thigh, MOTRIN q 6hr-8hr.
Itchy rash that started on torso and spread to all of upper body. Treated with Diphenhydramine Hydrochloride 25mg at 8pm, which did not seem to provide relief.  Applied ice packs to worst areas to relieve itching. Itching and rash were still apparent at 10pm when patient fell asleep.  Itching and rash were gone the next morning. Patient ate eggs for dinner, which she has done many times in the past with no adverse effects.
size of dime area on rt thigh;rash in middle;another ring aorund it;no fever;no pain;no swelling rt thigh;2-3" above knee outer aspect;
Initial information was received from a healthcare professional on 06 September 2013 with additional information received on 09 September 2013. A 63-year-old female patient had received an injection of FLUZONE, lot number UH909AA, on 04 September 2013 (route and site not reported). Four to six hours later the patient experienced full body itching which progressed to her eyes the next day. The patient was seen at urgent care and by her own physician. Outcome was not recovered. Documents held by sender: None.
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 31-MAR-2015, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No treatment.  Constant chills began 12 hrs after receiving shot and continued for 18 hrs.  Other reactions included slight nausea and unsteadiness throughout the same time period.  This was followed by lack of energy for another 24 hours.  After that was over everything was fine!
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    The case reported for 173 of 190 Cases.   No concomitant medication was provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Itchiness; Rash on upper torso; Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), PRURITUS (Itchiness) and RASH (Rash on upper torso) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergies which causes itchiness.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 06-Feb-2021, the patient experienced PRURITUS (Itchiness) and RASH (Rash on upper torso). On 05-Feb-2021, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown. At the time of the report, PRURITUS (Itchiness) and RASH (Rash on upper torso) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and  treatment medications were provided.    This case was linked to MOD21-039854 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non Significant : email address provided; Sender's Comments:  MOD21-039854:
mother states child had rash on legs, abdomen, chest, and neck  that appeared 2 days ago, Tuesday 3/23/21. mother gave Benadryl on Wednesday night 3/24/21. Rash fade some with Benadryl.
I30.9 ACUTE PERICARDITIS, UNSPECIFIED 3/8/2023 SEVERE OBESITY, BMI 60-69.9, ADULT. J96.00 ACUTE RESPIRATORY FAILURE 3/23/2023 SEVERE OBESITY, BMI 60-69.9, ADULT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 SEVERE OBESITY, BMI 60-69.9, ADULT R09.02 HYPOXIA 3/23/2023 SEVERE OBESITY, BMI 60-69.9, ADULT.
there is leakage between the needle and syringe and probably half of the vaccine was leaked on the arm with no reported adverse event; Initial information received  on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 62 years old female patient for whom there was leakage between the needle and syringe and probably half of the vaccine was leaked on the arm with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received approximately 0.25 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7689NA and expiry date: 30-Jun-2023) (formulation and strength not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 03-Oct-2022, (latency: same day) there was leakage between the needle and syringe and probably half of the vaccine was leaked on the arm with no reported adverse event (incorrect dose administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "medical assistant reports that she tried to give FLUZONE QUADRIVALENT in prefilled syringe to a patient but there is leakage between the needle and syringe and probably half of the vaccine was leaked on the arm".   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Low-grade fever, shaking/tremors, muscle weakness that lasted over an hour until he fell asleep
BlurredVision, Dizziness, Headache, NauseaVomiting, New onset migraines Narrative: New onset of migraines following vaccine, continue daily at this time
Red rash at injection site approx 5 inches across, joint pain, fatigue, restless legs, arm pain in right arm
This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 59-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Flu vaccine with an associated reaction of pain (In 2012 or 2013 the patient received flu vaccine and was laying on the floor all day, no energy and motionless, refer case US2019GSK042498). On 4th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema and injection site swelling. On 5th March 2019, the patient experienced weakness and pain. In March 2019, the patient experienced shivering, coldness local, cold feet, pain in hip, bone pain and pain in extremity. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the shivering, coldness local, cold feet, pain in hip, weakness, bone pain and pain in extremity were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling, shivering, coldness local, cold feet, pain in hip, weakness, bone pain, pain in extremity and pain to be related to SHINGRIX. Additional details were reported as follows: On 4th March 2019 at 9:00 am, the patient received SHINGRIX on the left arm. On 5th March 2019 at 2:00 am, 17 hours after receiving SHINGRIX,the patient awoke with shivering, her nose was super cold, freezing feet, achiness in her hips, bones, thighs and calves. The patient put on extra layers of clothes and fell asleep and awoke today (5th March 2019) with achiness and she was still experiencing weakness. One day after vaccination, the patient experienced weakness, no energy and achiness. The patient had been laying on the couch today with no energy. The patient also experienced a reaction at the injection site and the injection site was tender, red, and swollen earlier but at the time of reporting, it had resolved. The reporter gave consent to follow up.
No adverse event. Flu vaccine labeled for adult use only administered in error to a 14 year old.
This spontaneous report was received from pharmacist refers to a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported. On 16-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (lot # S020254, has been verified to be a valid lot number, expiration date reported as 09-DEC-2021; strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The vaccine did not experience any temperature excursions. No additional adverse event was reported.
Patient had received second vaccine of Moderna on 4/8/21. Since getting the second vaccine, he had experienced fever and right arm pain. When he presented to Medical Center on 4/14/21, he was acutely confused and febrile (102.8 degrees Fahrenheit). He was empirically treated for meningitis with Vancomycin and Ceftriaxone. His CSF was unremarkable, so antibiotics were discontinued. Patient continued to be altered and required intubation. So far, our other workups have been negative and we are pending the NMDA antibodies. He was extubated 4/19/21 and mental status has returned back to normal and is afebrile.
Patient had a positive COVID-19 PCR test on 4/25/21. No symptoms, test was taken to facilitate transfer to a lower level of care. Given Moderna COVID vaccine 3/4/21 lot # 030A21A and Moderna COVID vaccine 4/1/21 lot # 025B21Ad
tripped on a mat & hit her shoulder on the corner of a wooden shelf; It might be a heart problem; having pain near my underarm; having pain underneath my shoulder; having pain left upper back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (having pain left upper back), LIMB INJURY (tripped on a mat & hit her shoulder on the corner of a wooden shelf), FEELING ABNORMAL (It might be a heart problem), VACCINATION SITE PAIN (having pain near my underarm) and ARTHRALGIA (having pain underneath my shoulder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-1961, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced BACK PAIN (having pain left upper back), VACCINATION SITE PAIN (having pain near my underarm) and ARTHRALGIA (having pain underneath my shoulder). On 06-May-2021, the patient experienced FEELING ABNORMAL (It might be a heart problem). On an unknown date, the patient experienced LIMB INJURY (tripped on a mat & hit her shoulder on the corner of a wooden shelf). At the time of the report, BACK PAIN (having pain left upper back), LIMB INJURY (tripped on a mat & hit her shoulder on the corner of a wooden shelf), FEELING ABNORMAL (It might be a heart problem), VACCINATION SITE PAIN (having pain near my underarm) and ARTHRALGIA (having pain underneath my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment provided was ice,Aspirin. concomitant drugs were not provided   This case was linked to MOD-2021-110381 (Patient Link).
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) 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 (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
3 injection sites red and swollen sore. 2-15-11 started went to ER-given VISTARIL po TID cool compresses.
Patient felt dizzy and tightness of chest after vaccination. He sweat a lot and claimed he want to lay down. gave him water and orange juice to drink. called the ambulance and they took him to hospital and found out he was dehydrated.
I experienced about 5-6 days later, numbness to both of my legs, from my calves all the way to my toes and also to my hands and face. I saw my PCP, she consulted with a neurologist and recommended that I get a MRI of the brain. MRI brain showed to be negative. At this time I only have numbness to my toes and face, slowly improving.
I was diagnosed with Shingles at my local MD. I first noticed the red area with flat bumps on April 15th while working out. As the days progressed, the area became more inflamed and now consists of red blisters. There is a burning sensation. It doesn't itch but there is discomfort. The left side of my torso is also irritated (itchy) but as of now, no visible bumps. The doctor prescribed me Valacyclovir 1gm tablets and instructed me to take 2 tablets per day for 7 days. It should be noted that there was no swab of the infected area. It was diagnosed based on looking at the infected area.
Severe nausea occurring when trying to eat. Zofran lessened symptoms but is not gone.
No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 11-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
30-45 minutes post injection experience severe dizziness and tingling of lips and mouth along with mild SOB.  This lasted about 20 minutes and slowly subsided.  That evening experienced moderately severe headache along with nausea, diarrhea, which lasted about 4 days.   Have felt lethargic since vaccine but as of 1-26-2021 this is improving.
A non-serious spontaneous report of "inadvertent administration of expired H1N1 LAIV" and "vaccine given to a patient" was received from a pharmacist concerning a 67-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 06-Feb-2010, but was then reassigned to 15-Jan-2010. On 26-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
FEBRUARY 15 - FEVER, CHILLS, BODY ACHES FEBRUARY 22 - WEEK LONG HEADACHE MAY 23 - SHOULDER PAIN FROM BLADE TO NECK DOWN TO ELBOW (RIGHT SIDE ONLY)
Red, warm, blotchy rash on right arm in general vicinity of the injection area. No treatment currently aside from applying Cortisone cream at home.
Pt has a history of bladder cancer, DVT/PE, COPD/emphysema, and is a direct admit from an outlying hospital. She reported that she had not been feeling well over the last 7 days with fatigue, muscle aches, cough and sputum production. She was found to be COVID positive.
I experienced a severe form of itchiness all over my body with no rash. I would get raises from the scratching. I'd take Zyrtec and it would last forty-eight hours and then I'd experience itchiness on the forty-nineth hour.
Arm started swelling and was very sore for 3 weeks before easing up .  Still swells up on and off . Muscle is still sore and tight . Looked like a bar code was on her arm .
Patient became pale and felt sick. Then fainted with eyes open. Came to after a few seconds. Blood pressure was very low. Had snack, laid down and began feeling better after about 15-20 minutes. Blood pressure was raised.