chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles on 08/28/2021 after first dose; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (11 cases of shingles occurred before the vaccine in the past 8 years), shingles (occurred on 9th July 2021, refer case US2021190982) and breast cancer.   On 8th July 2021, the patient received the 1st dose of Shingrix. On 28th August 2021, 51 days after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient mentioned that she had 11 cases of shingles in past 8 years. Out of 11 cases, 4 cases of shingles occurred before Shingrix and that occurred during chemotherapy treatment due to breast cancer. The patient received Shingrix on the right deltoid (National drug code number 58160-0823-11) at the pharmacy. The patient again had a case of shingles last weekend from reporting date and again took a week regimen of acyclovir. The patient had been getting shingles on the same spot each time (upper left hip). The current state of shingles was that they were drying up and becoming smaller in size but were not completely resolved. The reporter gave a consent to follow-up with healthcare professional. However, she did not have a phone/fax number and an email address to healthcare professional. She did not have her personal email address. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021190982:Same reporter.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: DRY THROAT AND COUGHING-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild, Additional Details: PT SAID HER THROAT GOT VERY DRY, SHE KEPT COUGHING, AND SHE THOUGHT SHE WAS GOING TO PASS OUT. GAVE HER 50MG BENADRYL, 2 BOTTLES OF WATER, HAD HER LAY DOWN, COLD COMPRESS ON FOREHEAD AND FAN. OBSERVED FOR 30 MINUTES. CALLED HER 6 HOURS LATER AND SHE SAID SHE WAS OKAY AFTER HER NAP
Losing my breath; My fingers in my left arm (where I got my vaccine) started going numb; Prolonged panic attack; I was shaking profusely; Lost feeling in my fingers and legs; My heartbeat felt really irregular; My body went limp and I fell out of the bed; Unable to swallow; My eyes rolling in the back of my head; Unable to sit up; This is a spontaneous report from a contactable other HCP (patient). This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm at single dose for COVID-19 immunisation on 21Dec2020 at 12:30 (35-year-old at the time of vaccination). The Lot number reported as EH9899, EH1284, EW0153 (pending clarification). Relevant history was unknown. Relevant concomitant drug included fluoxetine hydrochloride (PROZAC). No other vaccine in four weeks. Known allergy was None. The patient was not pregnant. Within 30 minutes after receiving the vaccine on 21Dec2020 at 01:15 PM, her fingers in her left arm (where she got her vaccine) started going numb. Her heartbeat felt really irregular and she started losing her breath. Her husband immediately took her to the emergency department. She was shaking profusely, lost feeling in her fingers and legs, was unable to swallow, unable to sit up, and her eyes rolling in the back of her head. She felt as if she was having a prolonged panic attack but with no feeling in her body and that she could not breathe. She arrived at the hospital, they immediately put her in a bed, her body went limp and she fell out of the bed. They then took an EKG and saw her heart was beating irregular and that she needed medication to calm her heart down. Additional lab tests included Holters and MRI with unknown result. AES resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment therapy was received (not specified). Outcome of events was not resolved. No COVID prior vaccination. No COVID test post vaccination.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the events Dyspnoea, Hypoaesthesia, Panic attack, tremor, sensory loss, heart rate irregular, gait disturbance, dysphagia, eye movement disorder, sitting disability and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Flushing face and neck. "Feels like it was on fire. Is better now."
mom reports pt having h/a for 2 days p/vax;pt also had T102 for 1 days after;
Significant itchiness all over scalp, neck, in eyes/nostrils/ears + a scratchy throat and coughing from upper lung irritation. Dermatologist gave me an Epi-pen after which  dermatologist ruled out potential allergy saying it was more of a flare-up of my entire immune system. It lasted 4-5 months. Two courses of steroids reduced symptoms during treatment but all symptoms reappeared with same intensity 24hrs after end of treatment.
48 hours after DTaP and Hib child was seen with hives all over body. Treated with antihistamines.
weakness; chills; After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (weakness), CHILLS (chills) and THERAPEUTIC RESPONSE UNEXPECTED (After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Headache dull, Chest heaviness and Angina pectoris.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), CHILLS (chills) and THERAPEUTIC RESPONSE UNEXPECTED (After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.). At the time of the report, ASTHENIA (weakness) and CHILLS (chills) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Patient had chills and weakness with both doses of the vaccine. Before the shot, patient had already been dealing with a dull headache, heaviness in chest, some angina and some other things.  No treatment drug was reported.   Reporter did not allow further contact
fever; body aches; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced fever, body aches, nausea, fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red, hot, itches, upper arm is solid, painful to the touch, pain at shot location, muscle pain, feeling tired or weak, headache, fever, belly pain. Lasted all night but was gone in the morning except for the redness, hotness and solid feel to the upper arm, still sensitive to touch.
A non-serious spontaneous report of bilateral facial redness and bilateral facial swelling after FLUMIST has been received from a physician concerning a five-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 26-Oct-2011. On 26-Oct-2011, the patient experienced bilateral facial swelling (left side) along the jaw line; There were no redness and no tenderness on examination. On 27-Oct-2011, the patient experienced some redness in same area. The outcome of child experienced bilateral facial swelling after FLUMIST was resolved on 28-Oct-2011 and outcome of event bilateral facial redness was unknown.
VAERS report because patient hospitalized for COVID-19 after vaccination.  Patient had a COVID test pre-procedure - because the test was positive and the patient had an organ transplant, he was admitted to the hospital.
Information has been received from a certified medical assistant (C.M.A.) referring to a 13 weeks old male patient. Pertinent medical history and drug reactions/allergies were not reported. On 02-DEC-2015 the patient was vaccinated with his first dose of ROTATEQ (lot # K012432, expiration date 20-MAY-2016, dose was not reported) orally. Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date in October 2018 (reported as between 08-OCT-2018 and 15-OCT-2018), the patient received unspecified doses of GARDASIL 9 (lot # R003557 with expiration date 20-NOV-2020; strength, dose and route were not reported) for prophylaxis, which was improperly stored. Current temperature excursion was 7.7 Fahrenheit degrees for 1 hours and 6 minutes. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter (linked case # 1810USA007934; case # 1810USA008298). Sender's Comments: US-009507513-1810USA007934; US-009507513-1810USA008298.
L thigh: local golf ball sized swelling with redness than spread and became less swollen and less warm without antibiotics. Benadryl given.
Severe coccyx pain. Could not sit, and could barely walk. Having bowel movements also hurt for three days. I was given a medrol dose pack & received an x-ray which was negative. I am not sure if this was related to the
Information has been received from a physician referring to a 15 year old female patient. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patient was vaccinated with improperly stored (Temperature: 47 Fahrenheit to 77 Fahrenheit; Time frame: 40 minutes) doses of GARDASIL 9 (lot # M043731, expiration date: 22-JUN-2019; the dose and route were not reported) for prophylaxis on an unspecified after July 2017. No adverse effect reported. It was reported that there were no previous temperature excursions and there was a data logger involved. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006271:
Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications information was not reported. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: follow-up received on 21 may 2021.Additional info received such as event outcome.
Some severe pains in her stomach every so often but from there she had an abnormal menstrual cycle where she had bleed for 6 months straight and had to take birth control pills (which can cause cancer in her ovaries in her future) for two and a half years.
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).    Concomitant medications details were not reported by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment details were not reported by the reporter.  This case was considered for the 107 adult patient out of 190 reported who was received the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
patient starting shaking and fell down to the ground from chair.  No LOC or confusion.  Also felt light headed with VSS.  EMS called.  no known history of seizures.  Transported to the ED
CHILLS, INSOMNIA, FEVER, CHEST DISCOMFORT, COUGH
Patient reported swelling around collar bone (raised skin about 0.5 inch) with pain and coughing. Patient was instructed to take Benadryl and ibuprofen and to ice the affected areas. Patient was also told to call back if symptoms got worse.
This initial non-serious spontaneous case, was received on 20-Oct-2017, reported by other health professional and concerns a male patient of unspecified age. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: Jun-2018, dose, route of administration, anatomical location: not reported). On unspecified date after administration of vaccine, the patient experienced aches and pains all over his body, particularly in his legs. The pains were bad enough to cause him to miss his work after the day of vaccination. It was reported that, no known fever and no treatment was given other than self-administration. The outcome of the events was not reported. Non-significant follow-up received on 07-Nov-2017: It was reported that nothing had changed from the initial for the patient.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 15-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020) and a dose of VARIVAX lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
weakness; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Dec-2020, Fatigue on 19-Dec-2020 and Chills on 19-Dec-2020.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (weakness), CHILLS (chills) and FATIGUE (fatigue). On 18-Mar-2021, ASTHENIA (weakness), CHILLS (chills) and FATIGUE (fatigue) had resolved.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
BLOOD CLOTS IN LUNGS AND AROUND HEART; LARGE HEMOTHORAX ON BACK AND HIP; PASSED OUT; UNPROVOKED PULMONARY EMBOLISM; FELL; This spontaneous report received from a parent concerned a 41 year old female. 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) 1 total, administered on 06-APR-2021 for prophylactic vaccination (dose number in series is 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 22-SEP-2021, the patient was at work when she passed and fell and as a result of the fall she had a large hemothorax on her back and hip. Patient did not remember what she hit when she fell and the patient was admitted to the hospital for unprovoked pulmonary embolisms and blood clots in her lungs and around her heart. The patient remained in the ICU for three days then was transferred to the cardiac wing where she remained for two additional days. Reporter stated that the patient was not sick in fact, she had just a physical and everything was good. Patient was seen by a hematologist, had several computerised tomogram (CT) scans, a neurologist, her primary doctor had her on blood thinners and said she may be on them the rest of her life. Reporter stated that doctor knew exactly what to do and acted fast in administering the appropriate medicine to break up the clots to prevent her from serious illness or death according to the doctor. The reporter also reported that since her discharge from the hospital, she has had many follow-up appointments with her physicians but no one knows why this has happened to her because she received her vaccine shot in April and the clots, embolisms happened in September, every doctor says it could not have been a result from the vaccine because it has been too long from the shot to the illness. The physicians said that it would have happened within a shorter time frame maybe a few days to a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unprovoked pulmonary embolism, blood clots in lungs and around heart, passed out, large hemothorax on back and hip and fell was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211245486- COVID-19 VACCINE AD26.COV2.S- blood clots in lungs and around heart, large hemothorax on back and hip, passed out, unprovoked pulmonary embolism, fell. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The pentacel powder was mixed with a sterile diluent from the MMR vaccine and given to the patient, no AE; Initial information was received on 04-Jun-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves a patient of unknown demography who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] where the powder was mixed with a sterile diluent from the MMR vaccine (Product preparation error )  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.   It was a case of an actual medication error due to Wrong solution used in drug reconstitution. It was reported that the diluent was given and the powder was not mixed. The powder was mixed with a sterile diluent from the MMR vaccine and given to the patient.  At the time of report, no adverse event was reported.  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 Directive and Module VI of the 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.  There will be no information available on lot number
Pt. states that after she had a lot of pain in her (L) arm later that day. Then the swelling started along with redness.
Feb. 26 - dizzy spell & weakness in legs lasting less than 2 hours  Feb. 28 - hot red rash at site of injection, also swelling of upper arm