chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling sensation; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a elderly female patient who received Herpes zoster (Shingrix) (batch number 597C4) for prophylaxis.   The patient's past medical history included breast cancer (number of years ago) and lumpectomy (number of years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling sensation (Verbatim: tingling sensation). The outcome of the tingling sensation was resolved.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.   It was unknown if the company considered the tingling sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-AUG-2023 and 07-AUG-2023 The reporter clarified that the patient had a lumpectomy due to breast cancer a number of years ago.  After receiving Shingrix, the patient developed a tingling sensation where the lump was removed.  Not sure what side the lump was removed from and therefore not sure if Shingrix was administered on the same side or not.  Unsure if lymph nodes were removed.  The reporter stated that the patient mentioned this did not happen with other vaccines (COVID, flu, etc).  She received Shingrix two months ago and the tingling went on for several weeks following vaccination but then went away.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Filing for formality, Polio temperature excursion, no harm to patient, patient has been informed and will return for revaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Embolic stroke
Clinical narrative: ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Needle issue, Syringe issue
Clinical narrative: As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer -lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Needle issue, Off label use, Product use issue, Syringe issue
Clinical narrative: As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer -lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Filing for formality, Polio temperature excursion, no harm to patient, patient has been informed and will return for revaccination.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, Pyrexia
Clinical narrative: Per our records, patient was given an expired vaccination. This was several years ago. The only symptom mother of patient recalls following vaccination was a high fever. It is possible that the lot number that was entered was incorrect. Unfortunately our EMR does auto populate previously entered vaccines.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 1/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Neuropathy peripheral
Clinical narrative: NEUROPATHY HYPERSENSITIVITY REACTION, SUBSEQ
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Per review of her vaccine record, she received an expired vaccine. This was several years ago. No known adverse effects. It is possible the wrong lot number/expiration date were entered as our EMR does auto-populate previously used lot numbers/dates.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Per review of her vaccine record, she received an expired vaccine. This was several years ago. No known adverse effects. It is possible the wrong lot number/expiration date were entered as our EMR does auto-populate previously used lot numbers/dates.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Per review of her vaccine record, she received an expired vaccine. This was several years ago. No known adverse effects. It is possible the wrong lot number/expiration date were entered as our EMR does auto-populate previously used lot numbers/dates.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lacunar stroke, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Lethargy, Loss of personal independence in daily activities
Clinical narrative: following day (8/4/23) resident was lethargic, needed increase assistance with ADLs and eating. Lg loose stool. Low pulse throughout the day 49-52, diaphoresis noted.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and Pruritus to right arm
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This vaccine expired 8/4/2023, 5 days before it was administered. The patient has not experienced any adverse side effects.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, tiredness
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: My son received two MenB vaccines at the same rather than the one MenB and one MCV.  His arms were sore but no other symptoms noted.  He is also very stoic so symptoms may not be fully appreciated.  Concerned about unknown risk over time.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal swelling, Swelling face, Swelling of eyelid, Visual impairment
Clinical narrative: Patient received the 2nd shingrix vaccine and the following morning at 3 AM, patient states he woke up with swelling in face/eyes/throat. Couldn't not see very well and had family member take him to ER. He was given IV medications and was discharged with oral medications.  He states he did not have any reaction to the 1st shingrix ( which was administered in 4/2022).
Age: 37.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This is a vaccine administration error. The patient was given ProQuad (MMRV) rather than the intended MMR vaccine. This was given concurrently with other intended vaccinations today including Varicella vaccine (Varivax), Hepatitis B vaccine (Engerix B), and Tdap (Boostrix).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Lethargy, Pain, Pain in extremity
Clinical narrative: chills; feeling very lethargic; her arm is sore; Achy; lost of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On 03-AUG-2023, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: chills). In AUG-2023, the patient experienced lethargy (Verbatim: feeling very lethargic), pain in arm (Verbatim: her arm is sore), pain (Verbatim: Achy) and appetite lost (Verbatim: lost of appetite). The outcome of the chills, lethargy, pain in arm, pain and appetite lost were unknown.   It was unknown if the reporter considered the chills, lethargy, pain in arm, pain and appetite lost to be related to Shingrix.     It was unknown if the company considered the chills, lethargy, pain in arm, pain and appetite lost to be related to Shingrix.   Additional Information: GSK receipt date: 04-AUG-2023 The reporter was the patient who stated she received her second Shingrix dose one day before reporting and developed chills all night long and also feeling very lethargic, her arm was sore, achy and also had lost of appetite.  Education provided to caller on median duration of side effects.  The patient was referred to health care professional (HCP). The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Carpal tunnel decompression, Fatigue, Hypoaesthesia, Inflammation
Clinical narrative: Chronic inflammation wrists, shoulders, back, enlarge prostate, tingling and numbness in lower leg.    Carpal tunnel surgery both wrists, cortizone shot both shoulders, 8 week physical therapy on shoulders. 6 weeks therapy on back.  Meds for enlarged prostate, lost 20+ lbs, changed blood pressure meds, taking celecoxib for inflammation.  Fatigue easily. Loss of energy
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Prostatomegaly, Weight decreased
Clinical narrative: Chronic inflammation wrists, shoulders, back, enlarge prostate, tingling and numbness in lower leg.    Carpal tunnel surgery both wrists, cortizone shot both shoulders, 8 week physical therapy on shoulders. 6 weeks therapy on back.  Meds for enlarged prostate, lost 20+ lbs, changed blood pressure meds, taking celecoxib for inflammation.  Fatigue easily. Loss of energy
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms known
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Seizure occurred Sept. 21, 2021
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse reaction from patient. Medication dose was not reconstituted with diluent at time at administration. Diluent for Menveo was only administered, not reconstituted.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Chills, Computerised tomogram, Lymph node pain, Oropharyngeal pain
Clinical narrative: At the beginning, Had glands in neck hurt, fever,     Later have chills, no fever, glands hurt, body aches,    Now, have sore throat, no fever, glands hurt, sinus infections, Now have mucus in chest (yellow) coughing up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Productive cough, Pyrexia, Secretion discharge, Sinusitis
Clinical narrative: At the beginning, Had glands in neck hurt, fever,     Later have chills, no fever, glands hurt, body aches,    Now, have sore throat, no fever, glands hurt, sinus infections, Now have mucus in chest (yellow) coughing up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Sputum discoloured, X-ray
Clinical narrative: At the beginning, Had glands in neck hurt, fever,     Later have chills, no fever, glands hurt, body aches,    Now, have sore throat, no fever, glands hurt, sinus infections, Now have mucus in chest (yellow) coughing up.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site paraesthesia, Pain in extremity
Clinical narrative: Pt experienced tingling at the injection site. She described it as though she had laid in her arm too long and it fell asleep. She went home. I followed up with her an hour later and she said she still had tingling but it wasn't worse or better.  She called me back about 15 minutes later and said the tingling stopped shortly after I got off the phone with her and that she feels fine now (just the usual sore arm).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Varicella
Clinical narrative: having blisters and they were dark in the center; broke me up in pox after 7 to 10  days after vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blister (Verbatim: having blisters and they were dark in the center) and chickenpox (Verbatim: broke me up in pox after 7 to 10 days after vaccine). The outcome of the blister and chickenpox were resolved.   It was unknown if the reporter considered the blister and chickenpox to be related to Shingrix.  It was unknown if the company considered the blister and chickenpox to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR107200   Additional Information: GSK Receipt Date: 07-AUG-2023 The patient reported for both doses of Shingrix vaccine and received both doses at a local pharmacy The reporter reported that it broke him/her up in pox after 7 to 10 days after vaccine. The reporter reported that having blisters and they were dark in the center. The reporter had to disconnect from the call and not all information was collected.  Not all information was available.  The reporter did not provide injection site or lot numbers or expiration dates for neither one of the doses. The patient provided consent to follow up with healthcare professional. For tolerance of 2nd dose of Shingrix, refer case US2023AMR107200.; Sender's Comments:  US-GSK-US2023AMR107200:
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Mobility decreased, Pain in extremity
Clinical narrative: arm was killing him and he can hardly raise it; The patient also reported that his 2nd dose was 4 years after his first dose of Shingrix; arm was killing him; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Previously administered products included Shingrix (1st dose received 4 years ago).   On 06-AUG-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 06-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient also reported that his 2nd dose was 4 years after his first dose of Shingrix). In AUG-2023, the patient experienced pain in arm (Verbatim: arm was killing him). On an unknown date, the patient experienced mobility decreased (Verbatim: arm was killing him and he can hardly raise it). The outcome of the pain in arm and mobility decreased were resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date: 07-AUG-2023 The patient self-reported this case. The patient arm was killing him and he could hardly raise it. The patient said that his arm was feeling better now at 1:20 pm on the day of reporting. The patient was not sure of how to spell the physician name and did not had a phone number available. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case is linked with US2023106906, reported by same reporter.; Sender's Comments:  US-GSK-US2023106906:Same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: her arm was "killing her" and was still uncomfortable this morning; Arm  pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child) and shingles (had shingles about 4 years ago).   On 06-AUG-2023, the patient received the 1st dose of Shingrix (right arm). In AUG-2023, less than a day after receiving Shingrix, the patient experienced arm discomfort (Verbatim: her arm was "killing her" and was still uncomfortable this morning) and pain in arm (Verbatim: Arm  pain). The outcome of the arm discomfort and pain in arm were not resolved.   It was unknown if the reporter considered the arm discomfort and pain in arm to be related to Shingrix.     It was unknown if the company considered the arm discomfort and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 07-AUG-2023 The case was reported by patient's husband. The patient received her 1st dose of Shingrix in her one day before reporting and reported that her arm was killing her and was still uncomfortable this morning (on the morning of reporting). Consent to follow up with HCP was not asked as the patient was not on the phone. This case is linked with US2023106943, reported by same reporter.; Sender's Comments:  US-GSK-US2023106943:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: rash; fever; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced rash (Verbatim: rash) and fever (Verbatim: fever). The outcome of the rash and fever were unknown.   It was unknown if the reporter considered the rash and fever to be related to Shingrix.     It was unknown if the company considered the rash and fever to be related to Shingrix.   Additional Information: GSK receipt date: 7-Aug-2023 and 8-Aug-2023 The physician reported that last year she had a couple of patients that experienced rash and fever after their first dose of Shingrix. The reporter stated that they never came back for the second dose.  No further details were available at the time of reporting.  The representative will call back in if further information was obtained. The Vaccine Administration Facility was the same as Primary Reporter. The representative will call back with any further details and will ask health care professional about permission for follow-up.  If updates received, they will update the safety team via email. The reporter did not consent to follow-up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only liquid portion given; Menveo only liquid portion given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On 24-JUL-2023, the patient received Menveo. On 24-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid portion given) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 7-Aug-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient only received diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number X9KC7, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 07-AUG-2023, the patient received the 2nd dose of Shingrix. On 07-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Less than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: Receipt Date: 07-AUG-2023 They provided information about event, vaccine and patient. The vaccine administration facility was the same as primary reporter The pharmacist called to report that a patient received their second dose on 07 August 2023 after receiving the first in July 18th 2023, which led to shortening of vaccine schedule The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from literature: This report concerned multiple patients.  The patient's height, and weight were not reported. The patient's concurrent conditions included: non-hodgkin lymphoma, b-cell neoplasm, and chronic lymphocytic leukemia. The patients received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patients received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced suspected immunological vaccine failure (dose number in series 2). It was reported that 1 (3 percent) of patients were non-responders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. The authors concluded that, findings provide new insight into the nature of humoral and T-cell responses to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) vaccine booster and in vivo cellular dynamics in patients who have chronic B-cell neoplasms. The results support the usefulness of vaccination in patients with CLL (chronic lymphocytic leukemia) to boost anti-viral T cells, even in the absence of antibody responses, and shed new light on the determinants and variability of vaccine response. The differences in vaccine response between disease types warrant further investigation of the biology of adaptive responses in patients with distinct B-cell malignancies. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230808152-suspected immunological vaccine failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, SARS-CoV-2 antibody test
Clinical narrative: HORRIBLE COLD SORES ALL OVER BODY; This spontaneous report received from a health care professional concerned a 3 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced horrible cold sores all over body. Laboratory data (dates unspecified) included: SARS-CoV-2 IgG antibody test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible cold sores all over body was not reported. This report was non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Confusional state, Dyskinesia
Clinical narrative: Passed out; Felt weird, Felt run over by a truck; Was ice cold; Was bucking in bed; Did not know who I was nor what was going on; Shivering; Teeth chattering; Blood pressure dropped; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FEELING ABNORMAL (Felt weird, Felt run over by a truck), FEELING COLD (Was ice cold), JERKINESS (Was bucking in bed), CONFUSIONAL STATE (Did not know who I was nor what was going on), CHILLS (Shivering; Teeth chattering) and BLOOD PRESSURE DECREASED (Blood pressure dropped) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), FEELING ABNORMAL (Felt weird, Felt run over by a truck) (seriousness criterion medically significant), FEELING COLD (Was ice cold) (seriousness criterion medically significant), JERKINESS (Was bucking in bed) (seriousness criterion medically significant), CONFUSIONAL STATE (Did not know who I was nor what was going on) (seriousness criterion medically significant), CHILLS (Shivering; Teeth chattering) (seriousness criterion medically significant) and BLOOD PRESSURE DECREASED (Blood pressure dropped) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), FEELING ABNORMAL (Felt weird, Felt run over by a truck), FEELING COLD (Was ice cold), JERKINESS (Was bucking in bed), CONFUSIONAL STATE (Did not know who I was nor what was going on), CHILLS (Shivering; Teeth chattering) and BLOOD PRESSURE DECREASED (Blood pressure dropped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: Blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported. Company comment: This spontaneous case concerns an 80-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) events of LOSS OF CONSCIOUSNESS, BLOOD PRESSURE DECREASED, FEELING ABNORMAL, FEELING COLD, JERKINESS, CONFUSIONAL STATE AND CHILLS, on the same month of the first dose of mRNA-1273 vaccine. The vaccination date and the exact onset of the events were not reported; hence, latency to the dose of mRNA-1273 vaccine could not be properly assessed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Loss of consciousness
Clinical narrative: Passed out; Felt weird, Felt run over by a truck; Was ice cold; Was bucking in bed; Did not know who I was nor what was going on; Shivering; Teeth chattering; Blood pressure dropped; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FEELING ABNORMAL (Felt weird, Felt run over by a truck), FEELING COLD (Was ice cold), JERKINESS (Was bucking in bed), CONFUSIONAL STATE (Did not know who I was nor what was going on), CHILLS (Shivering; Teeth chattering) and BLOOD PRESSURE DECREASED (Blood pressure dropped) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), FEELING ABNORMAL (Felt weird, Felt run over by a truck) (seriousness criterion medically significant), FEELING COLD (Was ice cold) (seriousness criterion medically significant), JERKINESS (Was bucking in bed) (seriousness criterion medically significant), CONFUSIONAL STATE (Did not know who I was nor what was going on) (seriousness criterion medically significant), CHILLS (Shivering; Teeth chattering) (seriousness criterion medically significant) and BLOOD PRESSURE DECREASED (Blood pressure dropped) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), FEELING ABNORMAL (Felt weird, Felt run over by a truck), FEELING COLD (Was ice cold), JERKINESS (Was bucking in bed), CONFUSIONAL STATE (Did not know who I was nor what was going on), CHILLS (Shivering; Teeth chattering) and BLOOD PRESSURE DECREASED (Blood pressure dropped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: Blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported. Company comment: This spontaneous case concerns an 80-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) events of LOSS OF CONSCIOUSNESS, BLOOD PRESSURE DECREASED, FEELING ABNORMAL, FEELING COLD, JERKINESS, CONFUSIONAL STATE AND CHILLS, on the same month of the first dose of mRNA-1273 vaccine. The vaccination date and the exact onset of the events were not reported; hence, latency to the dose of mRNA-1273 vaccine could not be properly assessed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Mental impairment, Visual impairment
Clinical narrative: Major stroke within 24 hours; Left me mentally impaired; Took my eye site, my left side; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Major stroke within 24 hours) and MENTAL IMPAIRMENT (Left me mentally impaired) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 CEREBROVASCULAR ACCIDENT (Major stroke within 24 hours) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Left me mentally impaired) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Took my eye site, my left side). At the time of the report, CEREBROVASCULAR ACCIDENT (Major stroke within 24 hours), MENTAL IMPAIRMENT (Left me mentally impaired) and VISUAL IMPAIRMENT (Took my eye site, my left side) outcome was unknown.            Concomitant medication was not provided. Patient reported that there were young athletes those were suffering from non-specific heart failure. Treatment information was not reported.  Company comment: This is a spontaneous case concerning a patient of unknow age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of cerebrovascular accident (AESI) and mental impairment and the non-serious event of visual impairment. The events occurred after a dose of mRNA-1273.222 vaccine. It was reported that the event of cerebrovascular accident occurred within 24 hours after vaccination. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: The side effects of Moderna were short lived and minimal; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The side effects of Moderna were short lived and minimal) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient was taking blood pressure medication.  Concurrent medical conditions included Food allergy (Food allergies, all of which were avoid.). Concomitant products included DILTIAZEM, HCTZ, APIXABAN (ELIQUIS) and ATORVASTATIN for an unknown indication.   On 03-Mar-2022, the patient received fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (The side effects of Moderna were short lived and minimal). At the time of the report, IMMUNISATION REACTION (The side effects of Moderna were short lived and minimal) outcome was unknown. Not Provided          It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received other medications like Diltiazem, HCTZ, Eliquis, Atorvastatin within 2 weeks of vaccination. On 27-Jul-2023 at 2:30 PM the patient received Pfizer bivalent vaccine (Unknown batch/lot number) on left arm. On 29-Jul-2023 by 01:00 PM the patient had full of pressure in head, hearing was distorted, pressure in the ears. Patient was felt weak, general malaise and upper body aches and blood pressure was normal. Since the vaccination patient never been tested or diagnosed with Covid-19. No treatment medications were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, No adverse event, Therapeutic response unexpected
Clinical narrative: after taking the last dose of the COVID Vaccine, his blood pressure is no longer high, and he doesn't take medication for his blood pressure anymore; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (after taking the last dose of the COVID Vaccine, his blood pressure is no longer high, and he doesn't take medication for his blood pressure anymore) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Blood pressure high.    In May 2023, 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 THERAPEUTIC RESPONSE UNEXPECTED (after taking the last dose of the COVID Vaccine, his blood pressure is no longer high, and he doesn't take medication for his blood pressure anymore) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (after taking the last dose of the COVID Vaccine, his blood pressure is no longer high, and he doesn't take medication for his blood pressure anymore) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Blood pressure is no longer high.         Concomitant Medication use information was not provided by reporter.  It was reported that the unexpected beneficial effect of the last dose of Moderna COVID Vaccine he got last May of this year. The caller confirmed that it was a commercial product. The caller informed that after taking the last dose of the COVID Vaccine, his blood pressure was no longer high and he did not take medication for his blood pressure anymore.  Treatment Medication use information was not provided by reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 2 out of 25.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Mater case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.            It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that the those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine is poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the Kabal along with Moderna.  Treatment details was not reported by the reporter.  This case contains information about 5th patient out of 25 patients. Company comment- This is a fatal spontaneous case concerning a patient of unknown gender and age with no medical history reported who experienced the serious (death and medically significant) unexpected event of neoplasm malignant. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It is unknown if autopsy was performed. Reporter stated that vaccine caused cancer in 25 patients who are friends of her. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case is reported for patient 8 out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (death and medically significant) event of Neoplasm malignant. Latency is unknown but it was reported that the patient developed cancer, with fatal outcome after the administration of mRNA-1273.222 vaccine.  No further information was available in the report. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.     This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.   This case contains information for patient 9 out of 25.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case contains information about 10th patient out of 25 patients. Company comment- This is a fatal spontaneous case concerning a patient of unknown gender and age with no medical history reported who experienced the serious (death and medically significant) unexpected event of neoplasm malignant. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It is unknown if autopsy was performed. Reporter stated that vaccine caused cancer in 25 patients who are friends of her. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer