chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Cognitive disorder, Diplegia, Gait disturbance, Hypoaesthesia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Aug2021 (Lot number: FC3181) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient took concomitant medications (not reported). No other vaccine in four weeks. The following information was reported: PARAESTHESIA (hospitalization, disability), HYPOAESTHESIA (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "Tingling and numbness in toes"; DIPLEGIA (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "temporary bilateral leg paralysis"; BALANCE DISORDER (hospitalization, disability), GAIT DISTURBANCE (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "balance and walking issues"; SPEECH DISORDER (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "speech impairment"; MEMORY IMPAIRMENT (hospitalization, disability), COGNITIVE DISORDER (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "memory and cognition impairment". The patient was hospitalized for paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder (hospitalization duration: 1 day(s)). The events "tingling and numbness in toes", "tingling and numbness in toes", "temporary bilateral leg paralysis", "balance and walking issues", "balance and walking issues", "speech impairment", "memory and cognition impairment" and "memory and cognition impairment" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results, notes: Nasal Swab/since the vaccination. Therapeutic measures were taken as a result of paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder. Treatment received for the adverse event included Physical therapy, medication
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Paraesthesia, Speech disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Aug2021 (Lot number: FC3181) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient took concomitant medications (not reported). No other vaccine in four weeks. The following information was reported: PARAESTHESIA (hospitalization, disability), HYPOAESTHESIA (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "Tingling and numbness in toes"; DIPLEGIA (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "temporary bilateral leg paralysis"; BALANCE DISORDER (hospitalization, disability), GAIT DISTURBANCE (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "balance and walking issues"; SPEECH DISORDER (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "speech impairment"; MEMORY IMPAIRMENT (hospitalization, disability), COGNITIVE DISORDER (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "memory and cognition impairment". The patient was hospitalized for paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder (hospitalization duration: 1 day(s)). The events "tingling and numbness in toes", "tingling and numbness in toes", "temporary bilateral leg paralysis", "balance and walking issues", "balance and walking issues", "speech impairment", "memory and cognition impairment" and "memory and cognition impairment" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results, notes: Nasal Swab/since the vaccination. Therapeutic measures were taken as a result of paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder. Treatment received for the adverse event included Physical therapy, medication
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypoxia, Mechanical ventilation, SARS-CoV-2 test positive
Clinical narrative: Received Janssen vaccine on 3/5/21 Tested positive for COVID by PCR on 11/20/21. Hospitalized at Hospital from 11/26-12/14/21 Expired on 12/14/21 due to Pneumonia d/t COVID 19. Underlying HTN, DM2 Previous VAERS report completed,
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, SARS-CoV-2 test positive
Clinical narrative: Received Janssen vaccine on 3/5/21 Tested positive for COVID by PCR on 11/20/21. Hospitalized at Hospital from 11/26-12/14/21 Expired on 12/14/21 due to Pneumonia d/t COVID 19. Underlying HTN, DM2 Previous VAERS report completed,
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea
Clinical narrative: Pfizer vaccines on 2/12/21, 3/9/21 Positive for COVID 19 by PCR on 11/28/21 Hospitalized 11/27-12/10/21. Expired on 12/10/21 due to Acute Respiratory Failure with Hypoxia Previous VAERS report completed, VAERS e-report reference # 729274
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Death, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Pfizer vaccines on 2/12/21, 3/9/21 Positive for COVID 19 by PCR on 11/28/21 Hospitalized 11/27-12/10/21. Expired on 12/10/21 due to Acute Respiratory Failure with Hypoxia Previous VAERS report completed, VAERS e-report reference # 729274
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bursitis, Gait inability, Inflammation, Mobility decreased
Clinical narrative: could not walk or get out of bed; could not walk or get out of bed; Diagnosis was inflammatory reaction; Water on the hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 6 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Nov2021 12:00 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No covid prior to vaccination and no known allergies. There were no concomitant medications.  The following information was reported: GAIT DISTURBANCE (disability), DYSSTASIA (disability) all with onset 29Nov2021 19:00, outcome "recovering" and all described as "could not walk or get out of bed"; INFLAMMATION (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Diagnosis was inflammatory reaction"; BURSITIS (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Water on the hip". The event "could not walk or get out of bed" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results; ultrasound scan: unknown results. Therapeutic measures were taken as a result of gait disturbance, dysstasia, inflammation, bursitis which included an Ultrasound and Blood Work. The patient was not tested for covid post vaccination.  Clinical course: the child could not walk or get out of bed. Took to Hospital for evaluation. Diagnosis was inflammatory reaction, Water on the Hip.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: could not walk or get out of bed; could not walk or get out of bed; Diagnosis was inflammatory reaction; Water on the hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 6 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Nov2021 12:00 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No covid prior to vaccination and no known allergies. There were no concomitant medications.  The following information was reported: GAIT DISTURBANCE (disability), DYSSTASIA (disability) all with onset 29Nov2021 19:00, outcome "recovering" and all described as "could not walk or get out of bed"; INFLAMMATION (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Diagnosis was inflammatory reaction"; BURSITIS (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Water on the hip". The event "could not walk or get out of bed" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results; ultrasound scan: unknown results. Therapeutic measures were taken as a result of gait disturbance, dysstasia, inflammation, bursitis which included an Ultrasound and Blood Work. The patient was not tested for covid post vaccination.  Clinical course: the child could not walk or get out of bed. Took to Hospital for evaluation. Diagnosis was inflammatory reaction, Water on the Hip.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bursitis, Dysstasia, Gait disturbance, Inflammation, Investigation
Clinical narrative: could not walk or get out of bed; could not walk or get out of bed; Diagnosis was inflammatory reaction; Water on the hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 6 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Nov2021 12:00 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No covid prior to vaccination and no known allergies. There were no concomitant medications.  The following information was reported: GAIT DISTURBANCE (disability), DYSSTASIA (disability) all with onset 29Nov2021 19:00, outcome "recovering" and all described as "could not walk or get out of bed"; INFLAMMATION (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Diagnosis was inflammatory reaction"; BURSITIS (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Water on the hip". The event "could not walk or get out of bed" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results; ultrasound scan: unknown results. Therapeutic measures were taken as a result of gait disturbance, dysstasia, inflammation, bursitis which included an Ultrasound and Blood Work. The patient was not tested for covid post vaccination.  Clinical course: the child could not walk or get out of bed. Took to Hospital for evaluation. Diagnosis was inflammatory reaction, Water on the Hip.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: could not walk or get out of bed; could not walk or get out of bed; Diagnosis was inflammatory reaction; Water on the hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 6 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Nov2021 12:00 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No covid prior to vaccination and no known allergies. There were no concomitant medications.  The following information was reported: GAIT DISTURBANCE (disability), DYSSTASIA (disability) all with onset 29Nov2021 19:00, outcome "recovering" and all described as "could not walk or get out of bed"; INFLAMMATION (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Diagnosis was inflammatory reaction"; BURSITIS (disability) with onset 29Nov2021 19:00, outcome "recovering", described as "Water on the hip". The event "could not walk or get out of bed" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results; ultrasound scan: unknown results. Therapeutic measures were taken as a result of gait disturbance, dysstasia, inflammation, bursitis which included an Ultrasound and Blood Work. The patient was not tested for covid post vaccination.  Clinical course: the child could not walk or get out of bed. Took to Hospital for evaluation. Diagnosis was inflammatory reaction, Water on the Hip.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Heart rate, Heart rate decreased, Investigation
Clinical narrative: Covid test result - Positive / Covid test date 27Sep2021; Covid test result - Positive / Covid test date 27Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot ER8733 expiry information not reported) as a single dose in the left arm on 05Apr2021 (at 55-years-old) and the second dose of intramuscular BNT162B2 (solution for injection; Lot EW0169 expiry information not reported) as a single dose in the left arm on 26Apr2021 (at 55-years-old). Relevant medical history included known sulfonamide and shellfish allergies; the patient described other medical history as multiple. The patient denied receiving any other vaccine within four weeks of this vaccine; It was unknown if the patient was diagnosed with COVID prior to vaccination; and the patient was not pregnant at the time of vaccination. Concomitant medications included omeprazole (PRILOSEC); topiramate (TOPAMAX); escitalopram oxalate (LEXAPRO); ropinirole; and buspirone hydrochloride (BUSPAR). The patient previously received treatment for unspecified indications with oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET), codeine, prochlorperazine maleate (COMPAZINE), and metoclopramide (REGLAN) and experienced a drug allergy with each. On 27Sep2021 the patient tested positive for COVID via nasal swab. The outcome of events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Syncope, Vaccination failure
Clinical narrative: Covid test result - Positive / Covid test date 27Sep2021; Covid test result - Positive / Covid test date 27Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot ER8733 expiry information not reported) as a single dose in the left arm on 05Apr2021 (at 55-years-old) and the second dose of intramuscular BNT162B2 (solution for injection; Lot EW0169 expiry information not reported) as a single dose in the left arm on 26Apr2021 (at 55-years-old). Relevant medical history included known sulfonamide and shellfish allergies; the patient described other medical history as multiple. The patient denied receiving any other vaccine within four weeks of this vaccine; It was unknown if the patient was diagnosed with COVID prior to vaccination; and the patient was not pregnant at the time of vaccination. Concomitant medications included omeprazole (PRILOSEC); topiramate (TOPAMAX); escitalopram oxalate (LEXAPRO); ropinirole; and buspirone hydrochloride (BUSPAR). The patient previously received treatment for unspecified indications with oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET), codeine, prochlorperazine maleate (COMPAZINE), and metoclopramide (REGLAN) and experienced a drug allergy with each. On 27Sep2021 the patient tested positive for COVID via nasal swab. The outcome of events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result - Positive / Covid test date 27Sep2021; Covid test result - Positive / Covid test date 27Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot ER8733 expiry information not reported) as a single dose in the left arm on 05Apr2021 (at 55-years-old) and the second dose of intramuscular BNT162B2 (solution for injection; Lot EW0169 expiry information not reported) as a single dose in the left arm on 26Apr2021 (at 55-years-old). Relevant medical history included known sulfonamide and shellfish allergies; the patient described other medical history as multiple. The patient denied receiving any other vaccine within four weeks of this vaccine; It was unknown if the patient was diagnosed with COVID prior to vaccination; and the patient was not pregnant at the time of vaccination. Concomitant medications included omeprazole (PRILOSEC); topiramate (TOPAMAX); escitalopram oxalate (LEXAPRO); ropinirole; and buspirone hydrochloride (BUSPAR). The patient previously received treatment for unspecified indications with oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET), codeine, prochlorperazine maleate (COMPAZINE), and metoclopramide (REGLAN) and experienced a drug allergy with each. On 27Sep2021 the patient tested positive for COVID via nasal swab. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives and it was coming up his arm, the arm where he got inoculated on and it started on the site where needle went in; site where he got inoculated started itching; allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The following information was reported: VACCINATION SITE RASH (non-serious) with onset 30Nov2021, outcome "recovering", described as "hives and it was coming up his arm, the arm where he got inoculated on and it started on the site where needle went in"; INJECTION SITE PRURITUS (non-serious) with onset 30Nov2021, outcome "recovering", described as "site where he got inoculated started itching"; HYPERSENSITIVITY (non-serious) with onset 30Nov2021, outcome "unknown", described as "allergic reaction". Therapeutic measures were taken as a result of vaccination site rash, injection site pruritus, hypersensitivity.  Additional Information: It was reported that after the shot when patient got the hives and he took Benadryl pill and its subsided. Onset latency for the events was 20 mins.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site pruritus, Vaccination site rash
Clinical narrative: hives and it was coming up his arm, the arm where he got inoculated on and it started on the site where needle went in; site where he got inoculated started itching; allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The following information was reported: VACCINATION SITE RASH (non-serious) with onset 30Nov2021, outcome "recovering", described as "hives and it was coming up his arm, the arm where he got inoculated on and it started on the site where needle went in"; INJECTION SITE PRURITUS (non-serious) with onset 30Nov2021, outcome "recovering", described as "site where he got inoculated started itching"; HYPERSENSITIVITY (non-serious) with onset 30Nov2021, outcome "unknown", described as "allergic reaction". Therapeutic measures were taken as a result of vaccination site rash, injection site pruritus, hypersensitivity.  Additional Information: It was reported that after the shot when patient got the hives and he took Benadryl pill and its subsided. Onset latency for the events was 20 mins.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Haemoptysis, Headache, Nasal congestion, Pain
Clinical narrative: Coughing up blood with mucus for a week, SOB for 7+ days, swollen throat/lymph nodes (difficulty swallowing) ongoing, difficulty eating and sleeping ongoing, slight hearing loss in both ears ongoing, severe headache with neck pain/stiff neck ongoing, coughing up mucus/ difficulty breathing with fatigue ongoing, heart palpitations ongoing.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Coughing up blood with mucus for a week, SOB for 7+ days, swollen throat/lymph nodes (difficulty swallowing) ongoing, difficulty eating and sleeping ongoing, slight hearing loss in both ears ongoing, severe headache with neck pain/stiff neck ongoing, coughing up mucus/ difficulty breathing with fatigue ongoing, heart palpitations ongoing.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Dyspnoea, Fatigue, Feeding disorder, Haemoptysis
Clinical narrative: Coughing up blood with mucus for a week, SOB for 7+ days, swollen throat/lymph nodes (difficulty swallowing) ongoing, difficulty eating and sleeping ongoing, slight hearing loss in both ears ongoing, severe headache with neck pain/stiff neck ongoing, coughing up mucus/ difficulty breathing with fatigue ongoing, heart palpitations ongoing.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza virus test negative, Insomnia, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Coughing up blood with mucus for a week, SOB for 7+ days, swollen throat/lymph nodes (difficulty swallowing) ongoing, difficulty eating and sleeping ongoing, slight hearing loss in both ears ongoing, severe headache with neck pain/stiff neck ongoing, coughing up mucus/ difficulty breathing with fatigue ongoing, heart palpitations ongoing.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Palpitations, Pharyngeal swelling, Productive cough, SARS-CoV-2 test negative
Clinical narrative: Coughing up blood with mucus for a week, SOB for 7+ days, swollen throat/lymph nodes (difficulty swallowing) ongoing, difficulty eating and sleeping ongoing, slight hearing loss in both ears ongoing, severe headache with neck pain/stiff neck ongoing, coughing up mucus/ difficulty breathing with fatigue ongoing, heart palpitations ongoing.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test negative
Clinical narrative: Coughing up blood with mucus for a week, SOB for 7+ days, swollen throat/lymph nodes (difficulty swallowing) ongoing, difficulty eating and sleeping ongoing, slight hearing loss in both ears ongoing, severe headache with neck pain/stiff neck ongoing, coughing up mucus/ difficulty breathing with fatigue ongoing, heart palpitations ongoing.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Peripheral swelling, Vision blurred
Clinical narrative: Within 10 minutes: Dizzy, sharp pain in left eye with blurring vision, numbness/tingling on left side of face, pressure base of skull and down spine, numbness/tingling down left arm, intercostal muscles left rib cage spasm, numbness/tingling down left left leg, mild swelling in left hand  Next morning: Swelling of right side of face, extreme fatigue, numbness not subsided  No fever
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Eye pain, Fatigue, Head discomfort, Hypoaesthesia
Clinical narrative: Within 10 minutes: Dizzy, sharp pain in left eye with blurring vision, numbness/tingling on left side of face, pressure base of skull and down spine, numbness/tingling down left arm, intercostal muscles left rib cage spasm, numbness/tingling down left left leg, mild swelling in left hand  Next morning: Swelling of right side of face, extreme fatigue, numbness not subsided  No fever
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Paraesthesia, Peripheral swelling, Swelling face, Vision blurred
Clinical narrative: Within 10 minutes: Dizzy, sharp pain in left eye with blurring vision, numbness/tingling on left side of face, pressure base of skull and down spine, numbness/tingling down left arm, intercostal muscles left rib cage spasm, numbness/tingling down left left leg, mild swelling in left hand  Next morning: Swelling of right side of face, extreme fatigue, numbness not subsided  No fever
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Previous   Moderna vaccines resulted in the 2nd dose with rash allover body. Recieved  the Jansen today 12/6  AT APPROX. 4::05 pm  and starting itchiness and scratching after 15-20 min from time of inject . rox. 5:35-5:45 my throat started closing on the left side which made it difficult to swollow. Ended un in emegency for a few hours.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Pruritus, Throat tightness
Clinical narrative: Previous   Moderna vaccines resulted in the 2nd dose with rash allover body. Recieved  the Jansen today 12/6  AT APPROX. 4::05 pm  and starting itchiness and scratching after 15-20 min from time of inject . rox. 5:35-5:45 my throat started closing on the left side which made it difficult to swollow. Ended un in emegency for a few hours.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 3 patients received their Moderna Covid-19 vaccine and later caught Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19). At the time of the report, COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications details were provided. No Treatment Medications details were provided. Case summary: The patient reports that her son and daughter in law takes care of 2 people who are residents of their "home". The 2 residents received the Moderna covid-19 vaccine and recently tested Positive for Covid-19. None had received their Moderna Covid-19 booster doses.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced the unexpected event of COVID-19 (AESI) after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. It was reported that the patient had not received they booster dose. No further information is available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 3 patients received their Moderna Covid-19 vaccine and later caught Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19). At the time of the report, COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications details were provided. No Treatment Medications details were provided. Case summary: The patient reports that her son and daughter in law takes care of 2 people who are residents of their "home". The 2 residents received the Moderna covid-19 vaccine and recently tested Positive for Covid-19. None had received their Moderna Covid-19 booster doses.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced the unexpected event of COVID-19 (AESI) after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. It was reported that the patient had not received they booster dose. No further information is available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) tested positive for Covid-19.         No concomitant medication was reported. The caller reported that his daughter in law, who had received the Moderna Covid-19 vaccine, caught Covid-19 recently. No treatment medication was reported. It was reported that she had not received her Moderna Covid-19 booster dose.  This spontaneous case concerns a female patient of unknown age with no details on relevant medical history, who experienced the unexpected non serious events of COVID-19 (AESI) after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available regarding clinical manifestations and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) tested positive for Covid-19.         No concomitant medication was reported. The caller reported that his daughter in law, who had received the Moderna Covid-19 vaccine, caught Covid-19 recently. No treatment medication was reported. It was reported that she had not received her Moderna Covid-19 booster dose.  This spontaneous case concerns a female patient of unknown age with no details on relevant medical history, who experienced the unexpected non serious events of COVID-19 (AESI) after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available regarding clinical manifestations and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: coworkers' daughter became pregnant after receiving Moderna; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (coworkers' daughter became pregnant after receiving Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (coworkers' daughter became pregnant after receiving Moderna). At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (coworkers' daughter became pregnant after receiving Moderna) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications list was not provided. Treatment information was not provided.  Med Info Agent Crosslinked to cases MOD21-MOD21-167090 and MOD21-167131. Caller stated that one of her coworkers' daughter had been trying to get pregnant for a while. She finally became pregnant after receiving the Moderna vaccine. Consent for Safety follow-up was not obtained for this case.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced Vaccine exposure before pregnancy. The patient received the dose of the vaccine (dose number unknown) at an unknown date before pregnancy. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced Vaccine exposure before pregnancy. The patient received the dose of the vaccine (dose number unknown) at an unknown date before pregnancy. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out for a total of three times; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for a total of three times) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out for a total of three times) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for a total of three times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine) (unknown route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The patient received the Moderna COVID-19 vaccine and exactly two days later the patient passed out. The patient passed out for a total of three times after receiving the Moderna vaccine.  Company comment: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced the serious unexpected event of Loss of consciousness. Reportedly, the event occurred two days following the administration of the mRNA-1273 vaccine. At the time of this report, it was stated that the patient passed out for a total of three times. The dose of the vaccine and the exact dates were not specified. The outcome of the event was also not provided. The re-challenge is not applicable since no information about the dose number was disclosed and the outcome of the event was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced the serious unexpected event of Loss of consciousness. Reportedly, the event occurred two days following the administration of the mRNA-1273 vaccine. At the time of this report, it was stated that the patient passed out for a total of three times. The dose of the vaccine and the exact dates were not specified. The outcome of the event was also not provided. The re-challenge is not applicable since no information about the dose number was disclosed and the outcome of the event was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 05-NOV-2021, the patient was vaccinated with Measles, Mumps and Rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) lot # T016352 was confirmed to be valid, expiration date 12-MAY-2022 (exact dose, route of administration, anatomical location were not reported). On 08-NOV-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # U007471 was confirmed to be valid, expiration date 08-MAR-2023 (exact dose, route of administration, anatomical location were not reported) for prophylaxis ( inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No additional AEs reported. No additional information available or provided.; VARIVAX was reconstituted and then stored in the refrigerator for 2 or 3 hours before being administered to a patient.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-NOV-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # U007472, expiration date: 08-MAR-2023 (dose number and route of administration were not reported) for prophylaxis.  The dose of the vaccine was reconstituted and then stored in the refrigerator for 2 or 3 hours before being administered to the patient (wrong technique in product usage process). No additional adverse events were reported (no adverse event). No additional information available or provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No side effects reported from patient; accidentally given PROQUAD and VARIVAX; accidentally given PROQUAD and VARIVAX instead of MMR-II and VARIVAX; This initial spontaneous report was received from a physician concerning a 16-month-old patient. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were unknown by reporter.   On 15-NOV-2021, the patient was accidentally vaccinated with a 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Lot # T037956 and expiration date: 09-MAY-2022, per subcutaneous route for prophylaxis, and on the same day, the patient also received a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) Lot # T028302 and expiration date reported as 20-AUG-2022 (accidental overdose and wrong vaccine administered), instead of measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3) (MMR II). No side effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This initial spontaneous report was received from a Medical Assistant concerning a 2-month-old patient. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported. On 16-NOV-2021, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (oka-merck) virus vaccine live (PROQUAD) Lot # U009259 and expiration date: 19-SEP-2022, for prophylaxis (inappropriate age at vaccine administration). No adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Hand-foot-and-mouth disease, Rash papular
Clinical narrative: This initial spontaneous report as received from a nurse concerning a 6-year-old child of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were unknown per reporter. On 28-OCT-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route, Lot # and expiration date not reported) for prophylaxis. It was reported that later, on an unspecified date in 2021, the patient developed spots that appeared as papules and not vesicles and had "5 chicken pox like spots that were not open and healed as of 11-NOV-2021". It was stated that after speaking with the nurses that day it was verified that the child did not seek medical attention and there was never a confirmed case of chicken pox. The nurse's supervisor stated that she did not think it was chicken pox and instead Hand-foot-mouth disease. The nurse also reported that they had spoken to the state immunization advisor about this situation and that the advisor was not considering this to be a confirmed case of varicella as there was not Polymerase Chain Reaction (PCR) testing performed. At the time of the report, the outcome of rash papular and hand-foot-and-mouth disease was unknown and the outcome of rash macular was recovered as of 11-NOV-2021. The causal relationship between the events and vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. This is one of several cases from the same source. Sender's Comments: US-009507513-2112USA005506: US-009507513-2112USA005507.
Sex: F
Vaccine: HEP
Symptoms: Acquired plagiocephaly, Product storage error
Clinical narrative: Flattening of the skull from positioning; This spontaneous report was received from a medical assistant referring to a currently 10-weeks-old female patient.  Information regarding the patient's concurrent conditions or concomitant medications was not provided. The patient's medical history included growth restriction with a birth weight of 2.49 Kg.     On 15-SEP-2021 the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).   On an unspecified date in 2021, the patient experienced flattening of the skull from positioning (acquired plagiocephaly). On 17-NOV-2021 the patient was administered vaccines with temperature excursion (captured in # 2111USA006585).  The outcome of the event acquired plagiocephaly and the causal relationship between the event and therapy with hepatitis B vaccine (recombinant) (manufacturer unknown) were not reported.; Sender's Comments:  US-009507513-2111USA006585:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; administered a separate dose of this Case's improperly stored GARDASIL 9 to Patient; This spontaneous report as received from a physician assistant and healthcare business professional refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-NOV-2021, the patient was vaccinated with a separate dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T025370, expiry date 01-DEC-2022 (exact dose, route and anatomical location of administration were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) on 04-NOV-2021 (53.0 degrees F for 3 hours and 30 minutes), on 11-NOV-2021 (59.7 degrees F for 6 hours), and on 15-NOV-2021 (48.2 degrees F for 1 hour and 30 minutes). No additional adverse event details were provided (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA002418:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 05-NOV-2021, Hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion with temperature excursion of 47.1 Fahrenheit degrees for 36 minutes. No previous temperature excursion On 20-NOV-2021, the patient was vaccinated with the improperly stored Hepatitis A vaccine, inactivated (VAQTA) (1 time dose, lot # T031202, expiration date 14-JUN-2022; strength and route not reported) for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported. This is one of several reports received from the same reporter; Sender's Comments: US-009507513-2111USA005243: US-009507513-2112USA000879: US-009507513-2112USA000882: US-009507513-2112USA000883: