chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX. On 9th November 2018, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, his nurse had seen more side effects with 2nd dose of SHINGRIX compared to 1st dose of SHINGRIX. The patient did not consent to follow-up. For tolerance to 2nd dose of SHINGRIX refer case US2019009734.
Same day post vax, the pt developed vomiting. It was recommended for the pt to go to the ER for evaluation.
This case was reported by a physician via sales rep and described the occurrence of fever in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were provided as follows: The day before reporting (yesterday), the patient received SHINGRIX. After receiving SHINGRIX, the patient had a fever with body temperature of 100.3 degree F. On the day of reporting at morning, the patient called to the physician to report the fever.
Per EMS observation staff: "Patient experienced throat tightness, feeling funny, and had syncope after receiving the vaccine. Patient had a syncopal episode with convulsions for approximately 30 seconds. Patient was given 50mg of IM Benadryl at 11:18 and 911 was called. After administering IM Benadryl patient seemed to improve. Patient was transported by Fire Department at 11:26 and transported to Hospital." VS per obs staff: 11:18: BP 80/palp, HR 54, resp 24 labored, oxygen 94% on RA. 11:23: BP 80/40, HR 56, resp 20 semi labored, oxygen 92% on RA. Per roommate pt received dose of epi upon arrival in ED. Attempted to make FU phone call. No answer at this time. Will continue to call and verify patients condition.
Fever of 102.1, flu like symptoms, achiness, sensitivity to light, severe headache.
RASH ALL OVER MY CHEST SIDES DOCTOR PRESCRIBED ANTIFUNGAL CREAM HAS NOT WORKED
12 year old male had a vasovagal syncope from a pfizer covid 19 shot that lasted a few second. I laid him on the floor and elevated his leg. His skin became very pale but eventually return back to normal after 30 min of monitor. His blood pressure was low at first, but eventually return back to normal.
I noticed an aggressive change with my eyesight so I went to a GA eye DR. During the initial part of the visit it was determined that I was a good candidate for surgery. The DR said I had 4th nerve Palsy. My insurance company said I had to go somewhere else for surgery. The DR said there is a lot of things going on with my eye, depth perception issues, torsion issues, and possibly may need 2 surgeries or prism glasses. I had surgery on May 14th 2021. I'm sorry my father in law died during this time so it has been quite crazy. I had a tele visit with the DR again and I see her again in June. I will be retested again on this Friday 6/11/2021 for another eye test to see if I will need a second surgery. The other thing I forgot to mention, I also went to a chiropractor. I had severe neck pain and problems with my neck and shoulders. I even got a massage and haven't had one of those in years. The pain was incredible. I went to the chiropractor the second week of January and saw DR. This DR said there may be a correlation with the Covid vaccine.
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 09-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back is hurting), FEELING COLD (cold with chills) and CHILLS (chills this morning) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back is hurting), FEELING COLD (cold with chills) and CHILLS (chills this morning). At the time of the report, BACK PAIN (back is hurting), FEELING COLD (cold with chills) and CHILLS (chills this morning) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact.
Adult Hepatitis  B 10 mcg/5 ml  given in error. Should have been pediatric dose.  No adverse reaction noted. Parent notified 1 hour after event occurred.
Rash to left arm (injection site), then appeared on bilateral legs, face, bilateral flanks.  Mild itchiness to rash.
body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Additional information: The patient wanted to know if it's okay for her to take the second dose since she experienced body aches and fatigue after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DISTORTED TASTE OF FOODS FIVE; SENSITIVITY TO CHEMICAL ODORS; SENSITIVITY TO METALS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced distorted taste of foods five, sensitivity to chemical odors, and sensitivity to metals. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from distorted taste of foods five, sensitivity to chemical odors, and sensitivity to metals. This report was non-serious.
24 hrs p/vax sore shoulder; next morning lt foot draging, lt knee puffy & swollen, foot red & puffy on toe; rt leg became involved; extremities warm to touch; no fever was seen by MD treated w/DPH & Prelone syrup w/relief & dose APAP;
Chills, joint pain, muscle aches, fever of 100 degrees F, malaise and fatigue for 24+ hours post vaccination.
first dose of Shingrix on 1/4/2020 / not received a second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 4th January 2020, batch number-L9F99, expiration date-10th May 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details was reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient had only provided year of birth. The reporter did not consented to follow up. The case is linked with US2021117065, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117065:same reporter
Zostavax on 9/5/12. On 9/25/12 was prescribed and started taking Valtrex for a facial peel to be done 9/26/12. On 9/29/12, developed multiple clusters of fluid filled blisters that drain, scab over then she gets more of them. No pain, only itching at site.
Pain, warmth, itching from top of shoulder to elbow, tingling feeling radiating to hand, difficulty to move and/or raise arm due to pain.  At 24 hrs post vaccine pain mainly top of shoulder to elbow, difficult to raise arm.  No visible redness at injection site.
Pruritus on right side on back across to buttock extending almost to front on right side/itching on leg; Halfway up right leg, caller describes an area that feels hot; multiple sores that burn on his head; reports underneath skin it feels like sandpaper; difficulty sleeping at night; very small bumps underneath the skin; Skin reportedly can become red; scratch; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number not known, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose in left deltoid approximately 4-5 months ago, refer case US2019AMR224850).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus, feeling hot, skin ulcer, skin rough, difficulty sleeping, contusion, skin red and scratch. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus, feeling hot, skin ulcer, skin rough and difficulty sleeping were not recovered/not resolved and the outcome of the contusion, skin red and scratch were unknown.   It was unknown if the reporter considered the pruritus, feeling hot, skin ulcer, skin rough, difficulty sleeping, contusion, skin red and scratch to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left deltoid approximately 2 months after receiving the first dose. Following the second dose, caller reports the itching became severe. Severe itching following 2nd dose reported on right side on back across to buttock extending almost to front on right side. The consumer reported itching on left leg near ankle. Halfway up right leg, caller describes an area that feels hot and itchy.  The caller reported the left side on his head or his side did not itch. Severe itching on head caused consumer to scratch and as a result he developed multiple sores that burn on his head.  The caller reported a prescription from his dermatologist that he puts in his head after showering which helps subside itching for approximately 1 hour but then itching returns. Skin on right side of forehead reportedly has not broken out, but the caller reported underneath skin it feels like sandpaper or very small bumps underneath.  The Skin reportedly can become red but no large bumps have appeared. The caller reported seeing his family doctor and specialist several times and was prescribed undisclosed anti-itch medication although severe itching still occurs resulting in difficulty sleeping at night. The caller reported taking Benadryl with some relief but it did not completely resolve itching.  He stated that due to taking other unspecified medication he cannot take Benadryl. The caller would like an acknowledgement letter sent to his personal address as well as to the physicians.
Initial report received from a health care professional on 07 Jan 2010: The patient was received FLUVIRIN (batch no 10127606) on 07 Jan 2010. The patient had received the FLUVIRIN at the age of 2 years on 07 Jan 2010. The outcome of the event was not reported.
Pt received Moderna COVID19 vaccine at age 17 which is outside the EUA accepted use range.
The patient received an expired vaccine on 3/4/21, the vaccine expired at 1230pm, the patient received the dose at 128pm. The patient was contacted and revaccinated 3/5/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Within 1-1/2 hours of taking each dose, there was a very strong metallic taste in her mouth. It went away about 2 hours prior to 2nd dose each day but then returns with each dose. The patient had no known allergies and medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In the patient's words: "Wed night after I saw you I started getting the shivers and I was really really cold. The next day I couldn't sleep. My left side is better but my right side is sore. I feel awful. My right arm feels like it got punched and it's a little bit hard to move. I have a very minor coughing. I have body aches and I can't get comfortable." Rash was noted to have a temp of 103.6F in the office on July 20, 2018. He did not appear toxic. The right deltoid (where the vaccine was administered) was slightly red and warm. There were no other remarkable findings on exam. The above history was taken on 7/20/2018. His influenza nasopharyngeal swab was negative for A and B. His chest x-ray and urinalysis were unremarkable. I notified him of test results via secure messaging but he has not gotten back to me regarding how he is feeling since July 20. The vaccine was given because he smokes tobacco.
Vaccination site turned red & large. Patient experienced rash 2-3 days after but not itchy or blistery, no crusting. Still visible 8/2/11 but doesn't require treatment. Still has rash under skin.
PAIN ON INJECTION SITE. CHEST PAIN INITIALLY RIGHT SIDED BUT SPREAD TO LEFT SIDED CHEST PAIN RADIATING TOWARDS THE BACK. SHORTNESS OF BREATH.
chills when had the vaccination/chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills when had the vaccination/chills), PYREXIA (fever) and HEADACHE (headache) 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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 experienced CHILLS (chills when had the vaccination/chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (chills when had the vaccination/chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested for COVID twice during that period and was negative on the blood work..         No concomitant medication were  provided. No treatment medication were  provided.
One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in and eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported the event is considered resolved.
hives, tightness in throat-started 1 1/2 hour after injection-given Zyrtec 10 mg and Benadryl and Adsar
Sore arm; nausea; Fatigue; chills; Headache; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PAIN (injection site tender), FATIGUE (Fatigue) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PAIN (injection site tender). On 20-Mar-2021, the patient experienced NAUSEA (nausea), FATIGUE (Fatigue), CHILLS (chills) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 13-Mar-2021, VACCINATION SITE ERYTHEMA (injection site red) was resolving, VACCINATION SITE PAIN (injection site tender) had resolved. At the time of the report, NAUSEA (nausea), FATIGUE (Fatigue), CHILLS (chills) and HEADACHE (Headache) was resolving and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Aspirin. Concomitant medications included blood pressure medicine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
syncopal episode began 2pm 02/13/2021.  Began to get dizzy while standing so sat down in chair.  Felt voices becoming further away before eyesight turned black.  Patient fell out of chair but was caught by family member.  Patient immediately came back to consciousness.
Pt. called with complaint of feeling lightheaded, dizzy and nausea. Pt. called on call MD who instructed him to take BP, 111/72. 10/1/14 follow up call pt. still not 100% will see MD. Instructed pt. to call us if any symptoms worsen.
Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that the vaccine was stored in freezer, one of two vials were taken out and placed in fridge each day as needed.  No treatment given to the patient.
Patient received a dose of Moderna vaccine in error. We should not have administered as he is under the age of 18 and it is not approved for this age group. It was an error due to mom working here and dad coming in to get his first dose so son came and no one caught the fact that he wasn't proper age group.
Sore left arm, swollen & sensitive left axillary lymph nodes. Soreness, swelling, and pain persisted for up to 5 days after vaccination, getting slightly better on the 6th day, and then disappearing entirely over 7-8 days after vaccination.
NO ADVERSE EVENT, SWELLING WITH THIS SHOT, PATIENT WAS GIVEN A SHOT PREVIOUSLY BECAUSE HE HAS SEVERE PEANUT ALLERGIES AND WHEN HE WAS 2, HE WHEEZED. 1ST H1N1 SHOT HE HAD A REACTION.
Lightheadedness and 5/10 chest pain. History of HTN and sarcoidosis. Blood pressure was 168/86. HR 64 and 100% spo2 on RA. CP resolved within 5 min of initial vitals. Evaluated by ems and released home in stable condition. Patient advised to follow up with PCM as soon as possible.
Two days post vax, the patient developed a full body rash. The rash was bright pink with distinct lesions. The patient's mother reports the patient had a fever for 4 days.
Headache, Myalgia, Arthralgia, Fever & Tachycardia Narrative:  She reported having a temp of 104. She is RN house supervisor, she was able to reduce her temperature to 103.8 after tylenol. She as asked to call her PCP for recommendations. She was asked to go to E.D. She went to the E.D. on 1/7/21 had high fever of 104.3, dehydrated and tachycardic with pulse of 130. She was treated with I.V. tylenol, and given two liters of Fluids. She was sent home with normal pulse of 78, and temp down to 100.9. Today 1/8/21 she continues to run a fever, high of 101. She is to return to the E.D. if temp continues. She apparently had edema and rash on palms after first dose of COVID 19, so staff in COVID 19 vaccination clinic pre medicated her with benadryl 25mg. po.
11 days post vax, the pt had a severe HA with rash over trunk, on arms and legs.