chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: RECEIVED ONE DOSE J & J VACCINE ON NOV 1, 2021 MATTER OF 3-4 HOURS AFTER VACCINE DEVELOPED GENERALIZED JOINT PAIN - SO SEVERE NOTHING RELIEVED IT - NO MED, NO POSITION ETC. - SLIGHT NAUSEA SUBSIDED QUICKLY, GENERALIZED WEAKNESS, LETHARGY, UNSTEAD GAIT, LOSS OF APPETITE, SIGNIFICANT WT LOSS THIS LED TO 3-4 FALLS DURING THIS PERIOD OF 3 - 3 1/2 MONTHS IN WHICH I FURTHER DEVELOPED (L) SIDED ABDOMINAL PAIN WHICH PERSISTED ANTACIDS ETC NO EFFECT - NO CHANGE WITH ANTIBODIES ETC. - THIS CONTINUED SEVERAL DAYS BEFORE SUBSIDING AS TIME WENT ON - BILATERAL LOWER EXTREMITY MUSCLE CRAMPS (EVEN IN ANKLES) DEVELOPED PHLEBITIS/CELLULITIS IN ONE LOWER EXTREMITY WITH BILATERAL ANKLE EDEMA RX FOR KEFLEX PRESCRIBED BY MY PRIMAR MD VIA VERBAL CONTACT - UNABLE TO GO TO OFFICE IN MY CONDITION - THIS RESOLVED AFTER TREATMENT - STILL HAD "VEIN SORENESS" BOTH LOWER EXTREM JOINT / MUSCULAR PAIN SUBSIDED AFTER SEVERAL DAYS WITH EXCEPTION OF SCIATI (L) AND CERVICAL PAIN IN ADDITION (L) EAR / JAW AREA DISCOMFOR LASTED SEVERAL DAYS  LATER IN THIS PERIOD DEVELOPED PELVIC PAIN - 72 YRS OLD SYMPTOMS REMINDED ME OF PRE-MENSTRUAL SYMPTOMS YEARS AGO HEADACHE, LOWER BACK PAIN SUBSIDED WITHIN A FEW DAYS HAD EPISODES OF AMNESIA (LOSS/MEMORY) COLOR VISION CHANGES - MULTIPLE DAYS OF NAPPING FREQUENTLY PLEASE NOTE NO FEVER, NO LOSS OF SMELL ETC. 11/29/21 TAKEN TO HOSPITAL - MD NEVER EXAMINED ME THIS WAS TOLD TO MEDICAL DIRECTOR OF ER - ORDERED BLOOD WORK ONLY NEVER EXPLAINED TO ME - AS A NURSE READ HOSPITAL PAPERS (DX AS ACUTE RENAL FAILURE, DEHYDRATION) ONLY TX GIVEN WAS 1 LITTER OF NORMAL SALINE AFTER HOURS OF WAITING FOR ATTENTION 21 DAYS AFTER VACCINE ADMINISTRATION ABLE TO SLEEP WITHOUT AWAKENING WITH EARLIER DESCRIBED JOINT/MUSCULAR PAIN 2 WKS AFTER VACCINE DEVELOPED SORENESS AT INJECTION SITE - NONE PREVIOUSLY SUBSIDED QUICKLY DEVELOPED BILATERAL HAND TREMORS NOT SURE OF DURATION OBTAINED MEDICAL RECORDS WHICH DIDN'T REVEAL TRUTH RE: MY LACK OF CARE RE: PHYSICAL EXA PLEASE NOTE SAME BLOOD TESTS WERE NORMAL (APROX) 1 MONTH PRIOR TO LABS DRAWN AT HOSPITAL HOSPITAL LABS INDICATED INCREASED LIVER ENZYMES LOW PLATELET COUNT, LOW PROTEIN, ELECTROLYTE IMBALANCE, LOW BLOOD COUNT (ANEMIA) INCREASED BUN / KIDNEY FUNCTION TESTS GROSSLY ABNORMAL FORGOT TO MENTION EPISODES OF COUGHING PERSIST PRODUCTIVE AND NON-PRODUCTIVE - NEEDED NEBULIZER TX INHALERS ETC. - COUGH LESSENED TIME BUT HAD FOR GOOD 3 MONTHS ALSO (L) THIGH PAIN NOTICED NO GROWTH OF HAIR SINCE ONSET OF THIS - VERIFIED BY BEAUTY INSTRURCTOR - NO GROWTH OF HAIR ON LOWER EXTREIMITES ALSO - SAID MY HAIR WASN'T AS FULL AS USUAL - THIS IS ONLY THING THAT HAS REMAINED 3 - 4 MONTHS AFTER INCIDENT ALL LABS BACK TO NORMAL PLEASE NOTE UNFORTUNATELY MD LISTED ON ER RECORD NEVER EXAMINED ME - JUST ORDERED LABS - TOO SICK TO VISIT MY PRIMARY PHYSICIAN SAW ME AFTER SYMPTOMS SUBSIDED
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dermatitis, Insomnia, Visual impairment
Clinical narrative: MIGRATORY JOINT PAIN decreased VISION INSOMNIA CHEST DERMATITIS #1 3-18-21 #2 4-8-21 #3 12-16-21 Booster #4 7-13-22 Booster
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood pressure abnormal, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 19Feb2021 as dose 2, single (Lot number: EM9809), in right arm and on 30Sep2021 at 12:00 as dose 3 (bosster), single (Lot number: FF2588) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Functional Neurological Disorder" (unspecified if ongoing); "Soy" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Low potassium" (unspecified if ongoing); "Autoimmune Thyroiditis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; BUSPIRONE, stop date: 01Jul2022; POTASSIUM; PROPANOL, stop date: 29Jun2022; GABAPENTIN; TRAZODONE; ATARAX ANTI ITCH LOTION; SIMVASTATIN, stop date: 01Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood potassium: Low, notes: Low potassium; Blood pressure abnormal: High, notes: high blood pressure; SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received other medication in 2 weeks. Anti-viral details were Paxlovid product-COVID 19 treatment received on 01Jul2022 and stop on 06Jul2022 for treatment of COVID-19. On 10Jul2022, the patient had an adverse event rebound of symptoms five days after completing the prescription, and the patient was not recovered. No treatment was received.  No follow-up attempts are required. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Blood test, Erythema, Hypersensitivity, Immunisation
Clinical narrative: Covid test positive post vaccination; Covid test positive post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2021 at 11:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2021 at 09:00 as dose 1, single (Lot number: 037B21A), in left leg and on 05May2021 at 09:00 as dose 2, single (Lot number: 037B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No known allergies. No other medical history. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" and all described as "Covid test positive post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Inflammation, Interchange of vaccine products, Pruritus, Rash
Clinical narrative: Covid test positive post vaccination; Covid test positive post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2021 at 11:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2021 at 09:00 as dose 1, single (Lot number: 037B21A), in left leg and on 05May2021 at 09:00 as dose 2, single (Lot number: 037B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No known allergies. No other medical history. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" and all described as "Covid test positive post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Rash pruritic, Skin irritation
Clinical narrative: Covid test positive post vaccination; Covid test positive post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2021 at 11:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2021 at 09:00 as dose 1, single (Lot number: 037B21A), in left leg and on 05May2021 at 09:00 as dose 2, single (Lot number: 037B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No known allergies. No other medical history. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" and all described as "Covid test positive post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Blood test, Hypersensitivity, Inflammation, Paraesthesia
Clinical narrative: Covid test positive post vaccination; Covid test positive post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2021 at 11:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2021 at 09:00 as dose 1, single (Lot number: 037B21A), in left leg and on 05May2021 at 09:00 as dose 2, single (Lot number: 037B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No known allergies. No other medical history. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" and all described as "Covid test positive post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Covid test positive post vaccination; Covid test positive post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2021 at 11:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2021 at 09:00 as dose 1, single (Lot number: 037B21A), in left leg and on 05May2021 at 09:00 as dose 2, single (Lot number: 037B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No known allergies. No other medical history. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" and all described as "Covid test positive post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test positive post vaccination; Covid test positive post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2021 at 11:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2021 at 09:00 as dose 1, single (Lot number: 037B21A), in left leg and on 05May2021 at 09:00 as dose 2, single (Lot number: 037B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No known allergies. No other medical history. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" and all described as "Covid test positive post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram, Renal disorder, Renal function test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3302) intramuscular, in left arm, on 04Mar2021 as dose 2, single (Lot number: EL3302) intramuscular, in left arm, on 22Sep2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular, in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years for covid-19 immunization. The patient's relevant medical history included: "1ST vaccine post lumpectomy" (not ongoing), notes: Illness/AE: 1st vaccine post lumpectomy. The patient's concomitant medications were not reported. Vaccination history included: Flu, administration date: Oct2021, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid 19". The patient underwent the following laboratory tests and procedures: Blood glucose: (24May2022) 100, notes: Glucose H-100; Blood test: (24May2022) Normal, notes: 24May2022-Bloods normal; Globulin: (24May2022) 4.2, notes: Globulin H 4.2; Iron binding capacity total: (24May2022) 226, notes:  panel Iron binding capacity L 226; Magnetic resonance imaging: (Jan2021) 100% positive, notes: Test: MRI with contrast. Comments: 100% positive. No kidney issues as of Jan2021 tests; (Jan2021) Confirm Breast lump, notes: Test: MRI with Contrast. Result: Confirm breast lump. Comments: Pre surgery; Metabolic function test: (unspecified date) Unknown results, notes: She took blood+ comprehensive metabolic panel; Positron emission tomogram: (Jan2021) All good investigation left lung, notes: Test: PET/CT. Result: All good investigation left lung. Comments: Pre surgery; Protein total: (24May2022) 8.3, notes: Protein total- H 8.3; Red blood cell sedimentation rate: (24May2022) 86, notes: SED rate H 86; SARS-CoV-2 test: (24Jan2021) Negative, notes: Result: Ng. Comments: Pre surgery 26Jan2021; (Apr2022) Positive, notes: I also had tested positive for Covid 19 with only symptom chest rash sometime in April; Transferrin saturation: (24May2022) 54, notes: Saturation H 54. Clinical course: Other vaccinations within four weeks prior to the first administration date of the suspect vaccine included Flu vaccine in Oct2021. No Concomitant drugs were administered more than two weeks before the event, and No drug was used to treat the event or taken after event onset. Since 24May2022 plus massage/by water melon/Root boosted. Patient's left back kidney from is almost 100% well. She also had tested positive for Covid 19 with only symptom chest rash sometime in April.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood test, COVID-19, Drug ineffective, Globulin
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3302) intramuscular, in left arm, on 04Mar2021 as dose 2, single (Lot number: EL3302) intramuscular, in left arm, on 22Sep2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular, in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years for covid-19 immunization. The patient's relevant medical history included: "1ST vaccine post lumpectomy" (not ongoing), notes: Illness/AE: 1st vaccine post lumpectomy. The patient's concomitant medications were not reported. Vaccination history included: Flu, administration date: Oct2021, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid 19". The patient underwent the following laboratory tests and procedures: Blood glucose: (24May2022) 100, notes: Glucose H-100; Blood test: (24May2022) Normal, notes: 24May2022-Bloods normal; Globulin: (24May2022) 4.2, notes: Globulin H 4.2; Iron binding capacity total: (24May2022) 226, notes:  panel Iron binding capacity L 226; Magnetic resonance imaging: (Jan2021) 100% positive, notes: Test: MRI with contrast. Comments: 100% positive. No kidney issues as of Jan2021 tests; (Jan2021) Confirm Breast lump, notes: Test: MRI with Contrast. Result: Confirm breast lump. Comments: Pre surgery; Metabolic function test: (unspecified date) Unknown results, notes: She took blood+ comprehensive metabolic panel; Positron emission tomogram: (Jan2021) All good investigation left lung, notes: Test: PET/CT. Result: All good investigation left lung. Comments: Pre surgery; Protein total: (24May2022) 8.3, notes: Protein total- H 8.3; Red blood cell sedimentation rate: (24May2022) 86, notes: SED rate H 86; SARS-CoV-2 test: (24Jan2021) Negative, notes: Result: Ng. Comments: Pre surgery 26Jan2021; (Apr2022) Positive, notes: I also had tested positive for Covid 19 with only symptom chest rash sometime in April; Transferrin saturation: (24May2022) 54, notes: Saturation H 54. Clinical course: Other vaccinations within four weeks prior to the first administration date of the suspect vaccine included Flu vaccine in Oct2021. No Concomitant drugs were administered more than two weeks before the event, and No drug was used to treat the event or taken after event onset. Since 24May2022 plus massage/by water melon/Root boosted. Patient's left back kidney from is almost 100% well. She also had tested positive for Covid 19 with only symptom chest rash sometime in April.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Iron binding capacity total, Magnetic resonance imaging, Metabolic function test, Positron emission tomogram, Protein total
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3302) intramuscular, in left arm, on 04Mar2021 as dose 2, single (Lot number: EL3302) intramuscular, in left arm, on 22Sep2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular, in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years for covid-19 immunization. The patient's relevant medical history included: "1ST vaccine post lumpectomy" (not ongoing), notes: Illness/AE: 1st vaccine post lumpectomy. The patient's concomitant medications were not reported. Vaccination history included: Flu, administration date: Oct2021, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid 19". The patient underwent the following laboratory tests and procedures: Blood glucose: (24May2022) 100, notes: Glucose H-100; Blood test: (24May2022) Normal, notes: 24May2022-Bloods normal; Globulin: (24May2022) 4.2, notes: Globulin H 4.2; Iron binding capacity total: (24May2022) 226, notes:  panel Iron binding capacity L 226; Magnetic resonance imaging: (Jan2021) 100% positive, notes: Test: MRI with contrast. Comments: 100% positive. No kidney issues as of Jan2021 tests; (Jan2021) Confirm Breast lump, notes: Test: MRI with Contrast. Result: Confirm breast lump. Comments: Pre surgery; Metabolic function test: (unspecified date) Unknown results, notes: She took blood+ comprehensive metabolic panel; Positron emission tomogram: (Jan2021) All good investigation left lung, notes: Test: PET/CT. Result: All good investigation left lung. Comments: Pre surgery; Protein total: (24May2022) 8.3, notes: Protein total- H 8.3; Red blood cell sedimentation rate: (24May2022) 86, notes: SED rate H 86; SARS-CoV-2 test: (24Jan2021) Negative, notes: Result: Ng. Comments: Pre surgery 26Jan2021; (Apr2022) Positive, notes: I also had tested positive for Covid 19 with only symptom chest rash sometime in April; Transferrin saturation: (24May2022) 54, notes: Saturation H 54. Clinical course: Other vaccinations within four weeks prior to the first administration date of the suspect vaccine included Flu vaccine in Oct2021. No Concomitant drugs were administered more than two weeks before the event, and No drug was used to treat the event or taken after event onset. Since 24May2022 plus massage/by water melon/Root boosted. Patient's left back kidney from is almost 100% well. She also had tested positive for Covid 19 with only symptom chest rash sometime in April.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 test, Transferrin saturation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3302) intramuscular, in left arm, on 04Mar2021 as dose 2, single (Lot number: EL3302) intramuscular, in left arm, on 22Sep2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular, in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years for covid-19 immunization. The patient's relevant medical history included: "1ST vaccine post lumpectomy" (not ongoing), notes: Illness/AE: 1st vaccine post lumpectomy. The patient's concomitant medications were not reported. Vaccination history included: Flu, administration date: Oct2021, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid 19". The patient underwent the following laboratory tests and procedures: Blood glucose: (24May2022) 100, notes: Glucose H-100; Blood test: (24May2022) Normal, notes: 24May2022-Bloods normal; Globulin: (24May2022) 4.2, notes: Globulin H 4.2; Iron binding capacity total: (24May2022) 226, notes:  panel Iron binding capacity L 226; Magnetic resonance imaging: (Jan2021) 100% positive, notes: Test: MRI with contrast. Comments: 100% positive. No kidney issues as of Jan2021 tests; (Jan2021) Confirm Breast lump, notes: Test: MRI with Contrast. Result: Confirm breast lump. Comments: Pre surgery; Metabolic function test: (unspecified date) Unknown results, notes: She took blood+ comprehensive metabolic panel; Positron emission tomogram: (Jan2021) All good investigation left lung, notes: Test: PET/CT. Result: All good investigation left lung. Comments: Pre surgery; Protein total: (24May2022) 8.3, notes: Protein total- H 8.3; Red blood cell sedimentation rate: (24May2022) 86, notes: SED rate H 86; SARS-CoV-2 test: (24Jan2021) Negative, notes: Result: Ng. Comments: Pre surgery 26Jan2021; (Apr2022) Positive, notes: I also had tested positive for Covid 19 with only symptom chest rash sometime in April; Transferrin saturation: (24May2022) 54, notes: Saturation H 54. Clinical course: Other vaccinations within four weeks prior to the first administration date of the suspect vaccine included Flu vaccine in Oct2021. No Concomitant drugs were administered more than two weeks before the event, and No drug was used to treat the event or taken after event onset. Since 24May2022 plus massage/by water melon/Root boosted. Patient's left back kidney from is almost 100% well. She also had tested positive for Covid 19 with only symptom chest rash sometime in April.
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Adverse food reaction, Ageusia, Blood test, Chapped lips, Dry mouth
Clinical narrative: Dry eyes; Dry mouth; burning mouth; sores in mouth; Loss of taste; This case was reported by a consumer via call center representative and described the occurrence of eye dryness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several hours after receiving Shingrix, the patient experienced eye dryness, dry mouth, burning mouth, sore mouth and taste loss. On an unknown date, the outcome of the eye dryness, dry mouth, burning mouth, sore mouth and taste loss were not recovered/not resolved.   It was unknown if the reporter considered the eye dryness, dry mouth, burning mouth, sore mouth and taste loss to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The patient was self-reported case.  The patient received first dose in Shingrix vaccine in right arm. The patient stated that few hours later, she started with dry eyes, dry mouth, burning mouth, sores in her mouth, and loss of taste. She stated that these symptoms had not gone away and had gotten worse since they started. She did not have any specific information about the vaccine itself. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Dyspnoea, Eye irritation, Feeling abnormal, Hypophagia, Loss of personal independence in daily activities
Clinical narrative: Dry eyes; Dry mouth; burning mouth; sores in mouth; Loss of taste; This case was reported by a consumer via call center representative and described the occurrence of eye dryness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several hours after receiving Shingrix, the patient experienced eye dryness, dry mouth, burning mouth, sore mouth and taste loss. On an unknown date, the outcome of the eye dryness, dry mouth, burning mouth, sore mouth and taste loss were not recovered/not resolved.   It was unknown if the reporter considered the eye dryness, dry mouth, burning mouth, sore mouth and taste loss to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The patient was self-reported case.  The patient received first dose in Shingrix vaccine in right arm. The patient stated that few hours later, she started with dry eyes, dry mouth, burning mouth, sores in her mouth, and loss of taste. She stated that these symptoms had not gone away and had gotten worse since they started. She did not have any specific information about the vaccine itself. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Pain, Stomatitis, Thirst, Throat irritation, Tongue discomfort
Clinical narrative: Dry eyes; Dry mouth; burning mouth; sores in mouth; Loss of taste; This case was reported by a consumer via call center representative and described the occurrence of eye dryness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several hours after receiving Shingrix, the patient experienced eye dryness, dry mouth, burning mouth, sore mouth and taste loss. On an unknown date, the outcome of the eye dryness, dry mouth, burning mouth, sore mouth and taste loss were not recovered/not resolved.   It was unknown if the reporter considered the eye dryness, dry mouth, burning mouth, sore mouth and taste loss to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The patient was self-reported case.  The patient received first dose in Shingrix vaccine in right arm. The patient stated that few hours later, she started with dry eyes, dry mouth, burning mouth, sores in her mouth, and loss of taste. She stated that these symptoms had not gone away and had gotten worse since they started. She did not have any specific information about the vaccine itself. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: Dry eyes; Dry mouth; burning mouth; sores in mouth; Loss of taste; This case was reported by a consumer via call center representative and described the occurrence of eye dryness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several hours after receiving Shingrix, the patient experienced eye dryness, dry mouth, burning mouth, sore mouth and taste loss. On an unknown date, the outcome of the eye dryness, dry mouth, burning mouth, sore mouth and taste loss were not recovered/not resolved.   It was unknown if the reporter considered the eye dryness, dry mouth, burning mouth, sore mouth and taste loss to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The patient was self-reported case.  The patient received first dose in Shingrix vaccine in right arm. The patient stated that few hours later, she started with dry eyes, dry mouth, burning mouth, sores in her mouth, and loss of taste. She stated that these symptoms had not gone away and had gotten worse since they started. She did not have any specific information about the vaccine itself. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Ageusia, Dry eye, Dry mouth, Oral discomfort, Oral pain
Clinical narrative: Dry eyes; Dry mouth; burning mouth; sores in mouth; Loss of taste; This case was reported by a consumer via call center representative and described the occurrence of eye dryness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several hours after receiving Shingrix, the patient experienced eye dryness, dry mouth, burning mouth, sore mouth and taste loss. On an unknown date, the outcome of the eye dryness, dry mouth, burning mouth, sore mouth and taste loss were not recovered/not resolved.   It was unknown if the reporter considered the eye dryness, dry mouth, burning mouth, sore mouth and taste loss to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The patient was self-reported case.  The patient received first dose in Shingrix vaccine in right arm. The patient stated that few hours later, she started with dry eyes, dry mouth, burning mouth, sores in her mouth, and loss of taste. She stated that these symptoms had not gone away and had gotten worse since they started. She did not have any specific information about the vaccine itself. The reporter did not consent to follow up.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Body temperature increased, Injection site pain, Malaise, Nausea
Clinical narrative: temperature 101; Stomach pain; threw up; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2022 at 09:15 as dose 1, single (Lot number: FT9142) at the age of 3 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 07Jul2022, outcome "not recovered", described as "Stomach pain"; BODY TEMPERATURE INCREASED (non-serious) with onset 07Jul2022, outcome "not recovered", described as "temperature 101"; VOMITING (non-serious) with onset 07Jul2022, outcome "not recovered", described as "threw up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature increased, abdominal pain upper, vomiting.  Additional information: The patient had no other conditions (including medical history/ any illness at time of vaccination), investigations (relevant test) and did not receive any other products. The patient had no previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. The patient did not have any prior vaccinations (within 4 weeks) and no events following them. Family history included father was diabetic. Reporter stated that her son and their family of 5 all had the Pfizer vaccines and had not had any problems at all. The patient seemed perfectly fine the morning when he got up. On the day of the report, her husband had to pick up their son from day care because he had a temperature 101 and was complaining of stomach pain and threw up. He seems to be progressing as the day goes on. Husband just went to pick son up and reporter had not actually seen him yet. Hasn't actually seen him throwing up. The events did not require a visit to emergency room or Physician office.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: temperature 101; Stomach pain; threw up; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2022 at 09:15 as dose 1, single (Lot number: FT9142) at the age of 3 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 07Jul2022, outcome "not recovered", described as "Stomach pain"; BODY TEMPERATURE INCREASED (non-serious) with onset 07Jul2022, outcome "not recovered", described as "temperature 101"; VOMITING (non-serious) with onset 07Jul2022, outcome "not recovered", described as "threw up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature increased, abdominal pain upper, vomiting.  Additional information: The patient had no other conditions (including medical history/ any illness at time of vaccination), investigations (relevant test) and did not receive any other products. The patient had no previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. The patient did not have any prior vaccinations (within 4 weeks) and no events following them. Family history included father was diabetic. Reporter stated that her son and their family of 5 all had the Pfizer vaccines and had not had any problems at all. The patient seemed perfectly fine the morning when he got up. On the day of the report, her husband had to pick up their son from day care because he had a temperature 101 and was complaining of stomach pain and threw up. He seems to be progressing as the day goes on. Husband just went to pick son up and reporter had not actually seen him yet. Hasn't actually seen him throwing up. The events did not require a visit to emergency room or Physician office.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, Body temperature increased, Vomiting
Clinical narrative: temperature 101; Stomach pain; threw up; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2022 at 09:15 as dose 1, single (Lot number: FT9142) at the age of 3 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 07Jul2022, outcome "not recovered", described as "Stomach pain"; BODY TEMPERATURE INCREASED (non-serious) with onset 07Jul2022, outcome "not recovered", described as "temperature 101"; VOMITING (non-serious) with onset 07Jul2022, outcome "not recovered", described as "threw up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature increased, abdominal pain upper, vomiting.  Additional information: The patient had no other conditions (including medical history/ any illness at time of vaccination), investigations (relevant test) and did not receive any other products. The patient had no previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. The patient did not have any prior vaccinations (within 4 weeks) and no events following them. Family history included father was diabetic. Reporter stated that her son and their family of 5 all had the Pfizer vaccines and had not had any problems at all. The patient seemed perfectly fine the morning when he got up. On the day of the report, her husband had to pick up their son from day care because he had a temperature 101 and was complaining of stomach pain and threw up. He seems to be progressing as the day goes on. Husband just went to pick son up and reporter had not actually seen him yet. Hasn't actually seen him throwing up. The events did not require a visit to emergency room or Physician office.
Age: 62.0
Sex: F
Vaccine: COVID19, PNC20, PNC20
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Additional Details: Patient stated had shortness of breath overnight as well as a fever
Age: 62.0
Sex: F
Vaccine: COVID19, PNC20, PNC20
Symptoms: Dizziness, Dyspnoea, Pyrexia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Additional Details: Patient stated had shortness of breath overnight as well as a fever
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: My husband and myself went for our 2 booster, which we got. Later that day pharmacy call and said they only gave us half of the dose and we need to come back when they call us. I need to know if this is going to be safe for us and how long should we wait? I am 72 and my husband is 77.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: My husband and myself went for our 2 booster, which we got. Later that day pharmacy call and said they only gave us half of the dose and we need to come back when they call us. I need to know if this is going to be safe for us and how long should we wait? I am 72 and my husband is 77.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Burning sensation, Electromyogram normal, Erythema, Hypoaesthesia
Clinical narrative: Peripheral neuropathy; I had a CNS reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: 330130BA) and on 21May2022 as dose 4 (booster), single (Lot number: FJ4991, Batch number: RA11133) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "do not have the problem with the first two"; Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "do not have the problem with the first two". The following information was reported: NERVOUS SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I had a CNS reaction"; NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "Peripheral neuropathy". Therapeutic measures were not taken as a result of neuropathy peripheral, nervous system disorder.  Clinical course: The patient had a CNS reaction very severe and resulted in peripheral neuropathy. The patient wants to make sure they understand that the vaccine has caused some serious problem. The patient does not have the problem with the first two, but the two boosters have lastly peripheral neuropathy. Second one which really almost killed me was administered on 21May2022. The patient believed it was my left arm. The patient has nothing other than thyroid medication and the only med and disease.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Peripheral neuropathy; I had a CNS reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: 330130BA) and on 21May2022 as dose 4 (booster), single (Lot number: FJ4991, Batch number: RA11133) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "do not have the problem with the first two"; Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "do not have the problem with the first two". The following information was reported: NERVOUS SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I had a CNS reaction"; NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "Peripheral neuropathy". Therapeutic measures were not taken as a result of neuropathy peripheral, nervous system disorder.  Clinical course: The patient had a CNS reaction very severe and resulted in peripheral neuropathy. The patient wants to make sure they understand that the vaccine has caused some serious problem. The patient does not have the problem with the first two, but the two boosters have lastly peripheral neuropathy. Second one which really almost killed me was administered on 21May2022. The patient believed it was my left arm. The patient has nothing other than thyroid medication and the only med and disease.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervous system disorder, Neuropathy peripheral
Clinical narrative: Peripheral neuropathy; I had a CNS reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: 330130BA) and on 21May2022 as dose 4 (booster), single (Lot number: FJ4991, Batch number: RA11133) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "do not have the problem with the first two"; Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "do not have the problem with the first two". The following information was reported: NERVOUS SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I had a CNS reaction"; NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "Peripheral neuropathy". Therapeutic measures were not taken as a result of neuropathy peripheral, nervous system disorder.  Clinical course: The patient had a CNS reaction very severe and resulted in peripheral neuropathy. The patient wants to make sure they understand that the vaccine has caused some serious problem. The patient does not have the problem with the first two, but the two boosters have lastly peripheral neuropathy. Second one which really almost killed me was administered on 21May2022. The patient believed it was my left arm. The patient has nothing other than thyroid medication and the only med and disease.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered after temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, concurrent condition and drug reactions/allergies were not reported.  On 25-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml subcutaneously (SQ) for prophylaxis (lot # U022321, expiration date: 15-JUL-2023; strength was not provided) after a temperature excursion (temperature: 6 Fahrenheit (F); time frame: 30 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).