chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of movement disorder in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced movement disorder. On an unknown date, the outcome of the movement disorder was unknown. It was unknown if the reporter considered the movement disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had trouble lifting their arm after receiving SHINGRIX. No additional details was provided. This case has been linked to the case US2019GSK040430, reported by same reporter.
Information has been received from a public health nurse who found out from a physician who in turn heard from an OBGYN concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL. On an unspecified date, the patient experienced seizure and paralysis. Follow up information has been received from the physician concerning a female who on unspecified date, was vaccinated with a dose of GARDASIL at her OBGYN physician's office. On an unspecified date, the patient experienced seizure and syncope (not paralysis as previously reported) after receiving the GARDASIL vaccination. At the time of the report, the outcome was unknown. Additional and conflicting follow-up information was received from a licensed practical nurse. According to the licensed practical nurse, the physician did not have a patient that had a seizure and syncope after vaccination with GARDASIL. Upon internal review, seizure was considered to be an other important medical event. Additional information is not expected.
1st day of symptoms.  Hands started itching.  Felt like I had placed my hands in scalding hot water.  Slightly red blotchy look to palms of hands.  2nd day I have additional Symptoms, I woke up with strange feeling in my mouth.  Feels like i drank scolding hot drink.  Mouth is also Tingly feeling,   I am definitely having some kind of allergic reaction i-week after the Covid vaccination.
HAVE NOT BEEN ABLE TO CONTACT THE PATIENT TODAY. LEFT A MESSAGE TO CALL US AS SOON AS SHE CAN. PFIZER VIAL WAS RECONSTITUTED WITH 0.18 ML OF NACL INSTEAD OF 1.8 ML.
Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 18-Nov-2021.  No treatment medications were reported.
RAISED, RED, PRURITIC RASH AT THE INJECTION SITE THAT DID NOT APPEAR UNTIL DAY 11 FOLLOWING VACCINE ADMINISTRATION
Severe right arm pain; severe headache; Shortness of breath/Unable to take a deep breath; chest tightness; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: WE0187) via an unspecified route of administration in the arm right on 24Aug2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The medical history included chronic sinusitis, seasonal allergies, mild asthma only when sick and kidney cyst bilateral. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included vitamin d nos (VITAMIN D) and ascorbic acid (VITAMIN C), all for unknown indications from unknown dates and unknown if ongoing. On 24Aug2021 at 11:30, the patient experienced severe right arm pain, severe headache, shortness of breath and chest tightness and was unable to take a deep breath. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe right arm pain, severe headache, shortness of breath, chest tightness and unable to take a deep breath were not resolved at the time of this report.
Chills; fever; headache; muscle aches; pains; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9262), via an unspecified route of administration, administered in left arm on 11Feb2021 at 09:30 (at the age of 73 years old) as a single dose for COVID-19 immunisation. Medical history included lung cancer, allergic to NSAIDS. No concomitant medications were reported. Other medication in two weeks includes included one a day vitamin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: Not reported) in left arm on 22Jan2021 at 10:00 for COVID-19 immunisation. On 12Feb2021 at 12:30 the patient experienced, chills, fever, headache, muscle aches and pains. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.
Raised, red, painful, warm to touch area (8 cm X 8 cm) on evening after doses given. Area was below the injection sites and ran down to elbow. Patient went to urgent care and was given prednisone and cephalexin. Pharmacist reporting did not see patients reaction.
LEG PAIN; TIREDNESS; SORE MUSCLES; SHAKINESS; SORE SHOULDER; This spontaneous report received from a consumer concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatic in leg, sulfa allergy, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no other health conditions or current medication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced shakiness. On 12-MAY-2021, the subject experienced sore shoulder. On 12-MAY-2021, the subject experienced tiredness. On 12-MAY-2021, the subject experienced sore muscles. On 13-MAY-2021, the subject experienced leg pain. Laboratory data included: Screening test (NR: not provided) Unknown. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal (Platelet count was normal). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shakiness, tiredness, sore shoulder, and sore muscles, and the outcome of leg pain was not reported. This report was non-serious.
Back, chest and legs are extremely itchy, "possibly like a rash"; Itchy at the injection site; Really red at the injection site; Swollen at the injection site; Warm to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch at the injection site), PRURITUS (Back, chest and legs are extremely itchy, "possibly like a rash"), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Really red at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Really red at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site). On 22-Feb-2021, the patient experienced PRURITUS (Back, chest and legs are extremely itchy, "possibly like a rash"). At the time of the report, INJECTION SITE WARMTH (Warm to the touch at the injection site), PRURITUS (Back, chest and legs are extremely itchy, "possibly like a rash"), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Really red at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl
Diarrhea, cold sweats, achy, arm pain, nausea and exhaustion.
sudden hearing loss; This case was reported by a consumer via call center representative and described the occurrence of sudden hearing loss in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sudden hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the sudden hearing loss was unknown.   It was unknown if the reporter considered the sudden hearing loss to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced sudden hearing loss after getting a dose of Shingrix. No further details were available. This case had been linked with US2020033014, reported by same reporter
Patient developed a raised red itchy rash in the a.m. of 2-9-16 from the shoulder to the elbow of the (R) arm. Parent also reported the upper arm was reddened et tender. The child was taken to their HCP and the practitioner dx an allergic reaction et prescribed BENADRYL. The rash was resolved on 2-12-16 with no further f/u required.
Had a debilitating headache for a few days after, and an infection at site of shot. My left arm still hurts constantly.
for several hours my balance was much worse. By morning  i was okay.  Also, the next morning my right for arm was swollen and my skin  had a reddish  color.  This has continued as of this moment
At the time we brought her to the doctors office on 10/17/2022 due to mucous and a runny nose we had treated her with ZYRTEC and BENADRYL to relieve congestion. I had sent a message to her doctor regarding her bad cough and taking the OTC medications the doctor advised if no active infections proceed with vaccine. Since 10/13/2022 she had seen the doctor multiple times; 10/17/2022, 11/11/2022, 11/28/2022, 12/08/2022, 12/29/2022, 01/12/2022, and 01/16/2022.
Within minutes of injection developed sore arm. Next day I had an extreme headache, dizziness, lethargy.  About four or five days later I developed a pain in my left armpit and wasn?t sure if it was my lymph nodes or a scapular muscle. I woke up a weeke later with a large swollen rash at the injection site, about 2? in diameter.
DIZINESS, HX ASTHMA, LAST MEAL 7AM, NO SOB, NO RASH, NO HX ALLERGY OR SYNCOPE. SYMPTOMS RESOLVED.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On unknown dates, unspecified number of patients were inadvertently vaccinated with improperly stored doses (also reported as 10 doses in total of all administered vaccines) of PROQUAD (dose and route of administration were not reported; lot #L019997 with expiration date on 02-DEC-2016 and lot #L005293 with expiration date on 17-AUG-2016). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
weakness in her hands; inability to control her hands or carry anything/shakiness; This case was reported by a consumer via call center representative and described the occurrence of hands weakness of in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th September 2020, 2 hrs after receiving Shingrix, the patient experienced hands weakness of and tremor. On an unknown date, the outcome of the hands weakness of and tremor were not recovered/not resolved.   The reporter considered the hands weakness of and tremor to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm. Two hours after receiving vaccine, she began to experience multiple symptoms including inability to control her hands or carry anything, shakiness and weakness in her hands.  The patient provided with medical disclaimer and advised her to follow up with her healthcare professional.  The reporter consented to follow up.
Fever (102.9F) plus migraine as of 0130 following morning. Both fever and migraine continued throughout the day despite regular doses of acetaminophen. Body aches began around 1430. All symptoms subsided around 2130 and were nonexistent the next day.
This spontaneous report received from a nurse referred to a currently 7 month old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JAN-2017, the patient received a dose of M-M-R II (lot: L043702, expiry date: 03-NOV-2017) for an unspecified indication. The nurse reported that the patient was seen back in the office on 15-FEB-2017 because "he had developed a fever and rash for 1 week and had moderate petechia on both (facial) cheeks, arms and legs. The nurse stated a complete blood count test was performed (on 15-FEB-2017) which showed borderline normal. The nurse stated the patient was seen back in the office on 20-MAR-2017 for follow up and had another blood test performed which showed normal. The nurse stated "no rash was noted" on 20-MAR-2017. When asked the current status, the nurse stated that he was doing well. No treatment was given to the patient. Outcome of rash was recovered and other events were resolving. Causality assessment was not reported.  This is one of the two reports received associated with the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005492:
developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine; developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine; developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number zm749, expiry date 30-AUG-2025) for prophylaxis.   On 06-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 06-NOV-2023, less than a day after receiving Shingrix, the patient experienced injection site warmth (Verbatim: developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine), injection site erythema (Verbatim: developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine) and injection site pain (Verbatim: developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine). The outcome of the injection site warmth, injection site erythema and injection site pain were not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date - 09-NOV-2023 The patient is the reporter reported that he got first shingrix vaccine. The reported that at day one developed soreness, tenderness, warm to touch and redness at the injection site.  These have not resolved.  The reporter asked what he could for help.
Patient experienced vasovagal response 1 minute after vaccine administration. Put client in Trendelenburg position and repeated vital signs until BP reached 105/73. Gave client apple juice and fruit snacks when client reported feeling better.
got COVID; got COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP, patient's father). The reporter is the parent. Other Case identifier: 2023NVX-US-000001269 (Novavax).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". Clinical course: a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 Vaccine (dose/frequency not reported). It was reported the patient had "some trouble" (refused to elaborate) after getting the vaccine, and she got COVID. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
(1) Diarrhea x 3 days started 4/12/12 - > 4/15/12. (2) Vomiting 4/13/12 x 2. (3) Irritability 4/12 - 4/13/12 2 days. (4) Swelling & erythema 4/12/12 -> 3:00 pm left thigh.
Information has been received from a nurse practitioner concerning a 16 year old female with vaginal papilloma who in approximately November 2006, was vaccainted with HPV vaccine. Concomitant therapy included trichloroacetic acid. The nurse practitioner reported that the patient was treated wit trichloroacetic acid (strength unspecified) for existing vaginal warts one week after vaccination with HPV vaccine (the warts were existing prior to the vaccination with HPV Vaccine). Three weeks after the trichloroacetic acid treatment, on 28 Nov 2006, the warts appeared raised and very red, which was much different than normal treatment with trichloroacetic acid. Unspecified medical attention was sought. At the time of this report, the patient had not yet recovered. Additional information has been requested.
01/30/2022 pt diagnosed positive for COVID as outpatient; 2/8/22 pt brought to ED via EMS with worsening dyspnea; fever and increasing cough; intubated and on mechanical ventilation in ED for worsening dyspnea; positive COVID test; in A Fib; given ABX, dexamethasone; OG tube in place; coded in ED where pt passed away
Information has been received from a physician concerning a 15 month old patient who on an unknown date on the same day, was vaccinated with MMR II and VARIVAX (Lot numbers not reported). The physician reported that the patient started to experience 6 seizures over the course of 24 hours after vaccination. The patient was hospitalized for an unspecified period of time, and during the hospitalization the patient was treated with an unspecified "anti-seizure" medication. Subsequently, the patient was discharged from the hospital on an unspecified date and had not experienced any further seizures. At the time of the report, the patient had recovered from the experience. Follow up information has been received from the physician concerning the 15 month old female patient with no pertinent medical history, no drug reactions or allergies and no birth defects and fever, no adverse events following prior vaccination and fever at the time of vaccination, who on 01-MAR-2011 was vaccinated subcutaneously with first dose of VARIVAX (Lot number 667240/0675Z) and first dose of MMR II (lot number 667246/09072) at 8:48 A.M. The physician reported that on 06-MAR-2011 and 07-MAR-2011 the patient had fever and on 07-MAR-2011 at 00:30 the patient experienced six tonic-clonic seizures, all less than 5 minutes over 48 hours. The patient was hospitalized for 3 days. On an unspecified date, complete blood cell count (CBC), comprehensive metabolic panel (CMP), blood culture and electroencephalography (EEG) were performed and all of them showed normal results. At the time of the report, the patient's outcome for fever was unknown. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A 83-year-old female patient received PREVNAR 13, intramuscular on 18Oct2018 at 0.5 ml, single dose in the right arm for immunization/ pneumonia prevention, at a pharmacy/drug store. The patient's medical history and concomitant medications were reported as none. The patient experienced redness, swelling, and itching at injection site on 18Oct2018, a couple hours after receiving the injection. It was also reported that the patient's right arm was still a little sore on an unspecified date. The patient recovered with sequelae from the events, redness, swelling, and itching at injection site on an unknown date and outcome of the event, right arm was still a little sore was unknown.
Patient received her vaccination at approximately 13:35. Approximately 5 minutes later, in the observation area, patient began having a seizure and fell out of her chair. Several on site paramedics tended to the patient and emergency services was called. Patient declined transport and advised that husband would take her to car via private vehicle.
2019 Coronavirus SARS-CoV-2 Rapid~2019 Coronavirus SARS-CoV-2 Rapid performed on 7/26/21 at 19:30. Came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
MENVEO given on 9/30/14 to left upper deltoid. Mom called on 10/3/14 c/o sited red, swollen and tender mom states this happen with 1st MCV dose.
08/29/2022 presented to ED for abnormal lab values and fatigue. PMHx of breast cancer and multiple myeloma.
Pt. reported area turned bright red w/in a few hrs of administration - like a "sunburn" - took a few doses BENADRYL and was resolved by Sunday the 17th.
PATIENT REPORTED DIFFICULTY BREATHING UPON EXERTION AND CHEST PAIN STARTING AROUND 05/08/2021. PATIENT WENT TO MD ON 05/12/2021 WHERE MD FOUND EKG ABNORMAL. PATIENT PASSED AWAY THAT EVENING
patient presented with red rash on her arm.  she went to urgent care and was diagnosed with cellulitis post vaccination.