chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Thyroid function test
Clinical narrative: Acid reflux; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 22-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: She has had COVID twice, she had it in 2020 and had it in Nov2021.; "COVID", start date: Nov2021 (unspecified if ongoing), notes: She has had COVID twice, she had it in 2020, and had it in Nov2021.; "migraine sufferer" (unspecified if ongoing), notes: migraine sufferer. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Dec2020, when the patient was 22 years old, for Covid-19 Immunization; Flu, for Immunization, reaction(s): "her arm hurt". The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "Acid reflux". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastrooesophageal reflux disease. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Blood test, Computerised tomogram, Echocardiogram, Gastrooesophageal reflux disease
Clinical narrative: Acid reflux; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 22-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: She has had COVID twice, she had it in 2020 and had it in Nov2021.; "COVID", start date: Nov2021 (unspecified if ongoing), notes: She has had COVID twice, she had it in 2020, and had it in Nov2021.; "migraine sufferer" (unspecified if ongoing), notes: migraine sufferer. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Dec2020, when the patient was 22 years old, for Covid-19 Immunization; Flu, for Immunization, reaction(s): "her arm hurt". The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "Acid reflux". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastrooesophageal reflux disease. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke; thrombocytopenia; exacerbated the cTTP condition; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "ischemic stroke"; THROMBOCYTOPENIA (medically significant), outcome "unknown"; THROMBOTIC THROMBOCYTOPENIC PURPURA (medically significant), outcome "unknown", described as "exacerbated the cTTP condition".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke, Thrombocytopenia, Thrombotic thrombocytopenic purpura
Clinical narrative: ischemic stroke; thrombocytopenia; exacerbated the cTTP condition; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "ischemic stroke"; THROMBOCYTOPENIA (medically significant), outcome "unknown"; THROMBOTIC THROMBOCYTOPENIC PURPURA (medically significant), outcome "unknown", described as "exacerbated the cTTP condition".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Heart rate increased, Immediate post-injection reaction, Injection site pain
Clinical narrative: Shivering; heart rate was high (tachycardia); his oxygen saturation was in the mid 90s; arm soreness at injection site; Myalgia; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2022 09:30, the patient received the 1st dose of Shingrix. On 23rd April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia and headache. On 23rd April 2022 23:30, the patient experienced shivering, tachycardia and oxygen saturation decreased. On 24th April 2022, the outcome of the myalgia, headache, shivering, tachycardia and oxygen saturation decreased were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, myalgia, headache, shivering, tachycardia and oxygen saturation decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix on 23rd April 2022 at 9:30 am. He noted that later that afternoon post vaccination he experienced some arm soreness at injection site as well as some myalgia. On 23rd April 2022, 14 hours after receiving Shingrix, around 11:30 pm he woke up and was shivering, he also noted that his heart rate was high (tachycardia) in the 115s and he noted his oxygen saturation was in the mid 90s since he wears a monitor. He confirmed he did check his temperature and did not have a fever. The patient also reported that evening he experienced a headache. All of the symptoms resolved mid afternoon the following day and the only symptom that persists was the soreness at injection site. The patient refused to provide date of birth. The consent to follow up and to contact the healthcare professional was given.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscle fatigue, Myalgia, Pain in extremity, Tremor
Clinical narrative: Shivering; heart rate was high (tachycardia); his oxygen saturation was in the mid 90s; arm soreness at injection site; Myalgia; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2022 09:30, the patient received the 1st dose of Shingrix. On 23rd April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia and headache. On 23rd April 2022 23:30, the patient experienced shivering, tachycardia and oxygen saturation decreased. On 24th April 2022, the outcome of the myalgia, headache, shivering, tachycardia and oxygen saturation decreased were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, myalgia, headache, shivering, tachycardia and oxygen saturation decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix on 23rd April 2022 at 9:30 am. He noted that later that afternoon post vaccination he experienced some arm soreness at injection site as well as some myalgia. On 23rd April 2022, 14 hours after receiving Shingrix, around 11:30 pm he woke up and was shivering, he also noted that his heart rate was high (tachycardia) in the 115s and he noted his oxygen saturation was in the mid 90s since he wears a monitor. He confirmed he did check his temperature and did not have a fever. The patient also reported that evening he experienced a headache. All of the symptoms resolved mid afternoon the following day and the only symptom that persists was the soreness at injection site. The patient refused to provide date of birth. The consent to follow up and to contact the healthcare professional was given.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Oxygen saturation decreased
Clinical narrative: Shivering; heart rate was high (tachycardia); his oxygen saturation was in the mid 90s; arm soreness at injection site; Myalgia; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2022 09:30, the patient received the 1st dose of Shingrix. On 23rd April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia and headache. On 23rd April 2022 23:30, the patient experienced shivering, tachycardia and oxygen saturation decreased. On 24th April 2022, the outcome of the myalgia, headache, shivering, tachycardia and oxygen saturation decreased were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, myalgia, headache, shivering, tachycardia and oxygen saturation decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix on 23rd April 2022 at 9:30 am. He noted that later that afternoon post vaccination he experienced some arm soreness at injection site as well as some myalgia. On 23rd April 2022, 14 hours after receiving Shingrix, around 11:30 pm he woke up and was shivering, he also noted that his heart rate was high (tachycardia) in the 115s and he noted his oxygen saturation was in the mid 90s since he wears a monitor. He confirmed he did check his temperature and did not have a fever. The patient also reported that evening he experienced a headache. All of the symptoms resolved mid afternoon the following day and the only symptom that persists was the soreness at injection site. The patient refused to provide date of birth. The consent to follow up and to contact the healthcare professional was given.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tachycardia
Clinical narrative: Shivering; heart rate was high (tachycardia); his oxygen saturation was in the mid 90s; arm soreness at injection site; Myalgia; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2022 09:30, the patient received the 1st dose of Shingrix. On 23rd April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia and headache. On 23rd April 2022 23:30, the patient experienced shivering, tachycardia and oxygen saturation decreased. On 24th April 2022, the outcome of the myalgia, headache, shivering, tachycardia and oxygen saturation decreased were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, myalgia, headache, shivering, tachycardia and oxygen saturation decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix on 23rd April 2022 at 9:30 am. He noted that later that afternoon post vaccination he experienced some arm soreness at injection site as well as some myalgia. On 23rd April 2022, 14 hours after receiving Shingrix, around 11:30 pm he woke up and was shivering, he also noted that his heart rate was high (tachycardia) in the 115s and he noted his oxygen saturation was in the mid 90s since he wears a monitor. He confirmed he did check his temperature and did not have a fever. The patient also reported that evening he experienced a headache. All of the symptoms resolved mid afternoon the following day and the only symptom that persists was the soreness at injection site. The patient refused to provide date of birth. The consent to follow up and to contact the healthcare professional was given.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Extreme pain in injection site for 3 days; extreme pain in Lymph nodes under left arm for 3 days; Headache; nauseous; vaginal bleeding; Uterine cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Adenomyosis" (unspecified if ongoing); "Cow's milk" (unspecified if ongoing), notes: known allergies: Cow's milk. Concomitant medication(s) included: LITHIUM; PRISTIQ; KLONOPIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 10Sep2021, when the patient was 42-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 20Aug2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Extreme pain in injection site for 3 days"; HEADACHE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering"; UTERINE SPASM (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Uterine cramps"; LYMPH NODE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "extreme pain in Lymph nodes under left arm for 3 days"; NAUSEA (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "nauseous"; VAGINAL HAEMORRHAGE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "vaginal bleeding". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, lymph node pain, headache, nausea, vaginal haemorrhage, uterine spasm.  Additional information: Patient was taking multivitamins and vitamins. No Other vaccine in four weeks. No COVID prior vaccination.  Follow-up attempts completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Uterine spasm, Vaginal haemorrhage
Clinical narrative: Extreme pain in injection site for 3 days; extreme pain in Lymph nodes under left arm for 3 days; Headache; nauseous; vaginal bleeding; Uterine cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Adenomyosis" (unspecified if ongoing); "Cow's milk" (unspecified if ongoing), notes: known allergies: Cow's milk. Concomitant medication(s) included: LITHIUM; PRISTIQ; KLONOPIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 10Sep2021, when the patient was 42-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 20Aug2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Extreme pain in injection site for 3 days"; HEADACHE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering"; UTERINE SPASM (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Uterine cramps"; LYMPH NODE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "extreme pain in Lymph nodes under left arm for 3 days"; NAUSEA (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "nauseous"; VAGINAL HAEMORRHAGE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "vaginal bleeding". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, lymph node pain, headache, nausea, vaginal haemorrhage, uterine spasm.  Additional information: Patient was taking multivitamins and vitamins. No Other vaccine in four weeks. No COVID prior vaccination.  Follow-up attempts completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymph node pain, Nausea, SARS-CoV-2 test, Uterine spasm
Clinical narrative: Extreme pain in injection site for 3 days; extreme pain in Lymph nodes under left arm for 3 days; Headache; nauseous; vaginal bleeding; Uterine cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Adenomyosis" (unspecified if ongoing); "Cow's milk" (unspecified if ongoing), notes: known allergies: Cow's milk. Concomitant medication(s) included: LITHIUM; PRISTIQ; KLONOPIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 10Sep2021, when the patient was 42-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 20Aug2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Extreme pain in injection site for 3 days"; HEADACHE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering"; UTERINE SPASM (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Uterine cramps"; LYMPH NODE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "extreme pain in Lymph nodes under left arm for 3 days"; NAUSEA (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "nauseous"; VAGINAL HAEMORRHAGE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "vaginal bleeding". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, lymph node pain, headache, nausea, vaginal haemorrhage, uterine spasm.  Additional information: Patient was taking multivitamins and vitamins. No Other vaccine in four weeks. No COVID prior vaccination.  Follow-up attempts completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaginal haemorrhage
Clinical narrative: Extreme pain in injection site for 3 days; extreme pain in Lymph nodes under left arm for 3 days; Headache; nauseous; vaginal bleeding; Uterine cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Adenomyosis" (unspecified if ongoing); "Cow's milk" (unspecified if ongoing), notes: known allergies: Cow's milk. Concomitant medication(s) included: LITHIUM; PRISTIQ; KLONOPIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 10Sep2021, when the patient was 42-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FC3183 , Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 20Aug2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Extreme pain in injection site for 3 days"; HEADACHE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering"; UTERINE SPASM (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "Uterine cramps"; LYMPH NODE PAIN (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "extreme pain in Lymph nodes under left arm for 3 days"; NAUSEA (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "nauseous"; VAGINAL HAEMORRHAGE (non-serious) with onset 27Apr2022 at 09:00, outcome "recovering", described as "vaginal bleeding". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, lymph node pain, headache, nausea, vaginal haemorrhage, uterine spasm.  Additional information: Patient was taking multivitamins and vitamins. No Other vaccine in four weeks. No COVID prior vaccination.  Follow-up attempts completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: sore arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Polyps (bile duct removal by surgery) in October 2019 and Surgery (bile duct removal by surgery (because of polyps in duodenum)) in October 2019. Previously administered products included for Drug use for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Drug allergy (Aleve allergy), Drug allergy (Codeine allergy), Drug allergy (allergic to Opioids), Cholesterol, Anxiety, Restless leg syndrome, Acid reflux (esophageal), Insomnia, Osteoporosis and Hypothyroidism. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for Allergy, CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLESEVELAM for Cholesterol and Bile duct obstruction, LEVOTHYROXINE for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, CLONIDINE for Restless leg syndrome, ZOLPIDEM TARTRATE (AMBIEN) for Sleeplessness.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (Rash). At the time of the report, PAIN IN EXTREMITY (sore arm) and RASH (Rash) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient has completed the vaccination series and has received 2 booster doses. she got her booster dose about 3 weeks ago.  Patient stated no changes in medical history after vaccination.  No treatment information was reported.   This case was linked to MOD-2022-553214, MOD-2022-553294, MOD-2022-553295.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A,) for COVID-19 vaccination.     The patient's past medical history included Gastroesophageal reflux disease. Concurrent medical conditions included Arthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient had not had  diagnosed with COVID-19 previously. No treatment information were provided.   This case was linked to MOD-2022-554727, MOD-2022-554797, MOD-2022-554802 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE HAD EXPIRED
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Basal ganglia stroke, Death, Decreased appetite, Dizziness, Dyspepsia
Clinical narrative: Prior to the major events my dad was having heart burn. Weakness on one side which subsided. Felt dizzy at times,  fatigued and reduced appetite. Ejection fraction went from 70% to 35%. Had small stroke in basal ganglia . My father died 8 days after being discharged from hospital. Father passed over on 9/30/21.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Fatigue, Hemiparesis, Magnetic resonance imaging head abnormal
Clinical narrative: Prior to the major events my dad was having heart burn. Weakness on one side which subsided. Felt dizzy at times,  fatigued and reduced appetite. Ejection fraction went from 70% to 35%. Had small stroke in basal ganglia . My father died 8 days after being discharged from hospital. Father passed over on 9/30/21.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: NONE
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Death, Dizziness, Fall, Intensive care
Clinical narrative: Dizziness, confusion, falling, lungs filled with fluid, ventilator, death
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical ventilation, Pulmonary oedema
Clinical narrative: Dizziness, confusion, falling, lungs filled with fluid, ventilator, death
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Patient was administered a 3rd full dose (0.5ml) instead of 0.25ml and it was administered 1 month after second dose instead of 5 months post 2nd dose.  Patient reported a slight fever but nothing else.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Chest pain, extreme fatigue, shortness of breath on minimal exertion
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: Chest pain, extreme fatigue, shortness of breath on minimal exertion
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Extreme itching, hives, rash,  swelling of hands and feet began 11 days after the shot suddenly starting with itching.  The hives and swelling began the next day. Before these symptoms I had fatigue 2-3 days after the shot, and then a runny nose and sneezed a lot on days 5-8 after the shot.  Due to the allergic reaction I went to health services and received a shot and prednisone to take over the next 6 days. This somewhat relieved my symptoms. Since
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: Extreme itching, hives, rash,  swelling of hands and feet began 11 days after the shot suddenly starting with itching.  The hives and swelling began the next day. Before these symptoms I had fatigue 2-3 days after the shot, and then a runny nose and sneezed a lot on days 5-8 after the shot.  Due to the allergic reaction I went to health services and received a shot and prednisone to take over the next 6 days. This somewhat relieved my symptoms. Since
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anticoagulant therapy, Laboratory test, Pelvic venous thrombosis, Thrombosis
Clinical narrative: On 7/12/21 went to er for stomach pain and they found a blood clot in the iliac vein, no injury, no birth control, don't smoke. They couldn't find a reason for it. Hospitalization and put on blood thinners.   Got pfizer booster 2/10/22 . About died 2/15/22 got a massive blood clot  from my groin to my knee  hospitalized.  Had covid 1x on 12/31/21   No history of any blood clots before getting vaccinated.  I get these shots and now I'm getting them.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL FUMARATE, start date: 20Apr2022, stop date: 25Apr2022; IRBESARTAN, start date: 20Apr2022, stop date: 25Apr2022; ZIAC, start date: 20Apr2022, stop date: 25Apr2022; AVAPRO, start date: 20Apr2022, stop date: 25Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient has administered other medication in 2 weeks. Paxlovid was given as a treatment for COVID 19. Treatment start date: 20Apr2022 and treatment stop date: 25Apr2022. The patient experienced Bad cold-like symptoms on day ten after having started medication. By day Five  the patient was feeling fine. There were no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Product use issue
Clinical narrative: Caller is a pharmacy technician (listed as technician in additional case contacts, as pharmacy technician is not listed) who is reporting that a dose of PROQUAD was administered with VARIVAX for 8 different patients. Caller reports the information; Caller is a pharmacy technician (listed as technician in additional case contacts, as pharmacy technician is not listed) who is reporting that a dose of PROQUAD was administered with VARIVAX for 8 different patients. Caller reports the information; This spontaneous report was received from a pharmacy technician referring to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 29-MAR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (Rha) (PROQUAD) (lot number U028179 has been verified to be valid, expiration date reported and established as 08-MAR-2023). On the same date, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U024221 has been verified to be valid, expiration date reported and established as 04-AUG-2023) (product use issue, inappropriate schedule of product administration). Both vaccines were administered as prophylaxis.; Sender's Comments:  US-009507513-2204USA004906: US-009507513-2204USA005095: US-009507513-2204USA005731: US-009507513-2204USA005733: US-009507513-2204USA005079: US-009507513-2204USA005707: US-009507513-2204USA005707:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; Information has been received from a lawyer and an a patient (pt) of unknown age and ender regarding a case in litigation. Information about the pt's concurrent conditions, medical history and concomitant medication was not reported. In or around October 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine (Date not reported), the pt suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt sustained serious, severe, progressive, permanent, and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; the pt symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX), the pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the condition. The outcome of the event was not recovered. The causality assessment was considered as related. The event was considered as disabling.  Upon internal review, the pt's hearing loss was determined to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: vertigo for a year; This case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was recovered/resolved.   It was unknown if the reporter considered the vertigo to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's comments: This case was reported by consumer via  interactive digital media. The reporter reported that his/her friend received dose of Shingles vaccine and experienced vertigo for a year. The reporter thought vaccine was not worth it. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Have headaches; Fever; Shivering; Muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received the 2nd dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced headache, fever, shivering and muscle pain. On an unknown date, the outcome of the headache, fever, shivering and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, shivering and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had 2nd dose of Shingrix the day prior to the reporting. The patient experienced headache, fever, shivering and muscle pain. The patient asked how long do these effects last.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: didn't have any side effects with either one other than a sore arm.; hurt a lot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles shot with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2022AMR071643).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR071643   Additional Information: GSK Receipt Date: 27-APR-2022  Reporter's comment: This case was reported by a patient via Interactive Digital Media. The patient did not have any side effects with either one other than a sore arm.  The shingles shot hurt a lot more than the Covid shot. Additional supportive information:  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR071643:same reporter
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received liquid portion as first dose; received liquid portion as first dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA642A, expiry date 30th June 2023) for prophylaxis.   On 28th April 2022, the patient received the 1st dose of Menveo. On 28th April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-APR-2022  Reporter's comment: Medical assistant reported that, a patient received by error the liquid portion of Menveo. The reporter consented to follow up. Additional supportive information: A patient received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a patient concerned a 68 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had excellent health and was an athlete. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, therapy start date was not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: unknown) dose was not reported, 1 total administered on 12-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in NOV-2021 (within 1 to 2 weeks after booster), the patient experienced tinnitus (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: FATIGUE EXTREME; This spontaneous report received from a patient concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: The patient has no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 56 years old. No concomitant medications were reported. On an unspecified date, the patient experienced fatigue extreme. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from fatigue extreme. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 18-FEB-2022) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Age at time of vaccination 30 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA (flu symptoms). On 05-Mar-2021, INFLUENZA (flu symptoms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported no concomitant or regular medications. No treatment medications were reported.   This case was linked to MOD-2022-552549 (Patient Link).   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-apr-2022, post expiry date of 01-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 02-Apr-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 02-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The Pharmacist was calling to verify an expiration date for lot number 026L21B. The pharmacist said that when his Pharmacy received this vaccine on 23FEB2022 that a Pharmacy staff member looked up the expiration date and came up with an expiration date of June 2022. However, another Pharmacy Staff member looked up the expiration date of the Moderna Covid-19 vaccine in question and the expiration date is 01APR2022. Number of doses/vials: 80 doses administered. The vial did not undergo any temperature excursions. Caller mentioned 155 patients were vaccinated with expired doses from 2Apr2022 to 19Apr2022. The Pharmacist did not have any other information on the patients currently. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that thought that the vaccine expired in Jun-2022, however it was expired in 01-Apr-2022. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received contains non-significant information: updated reporter contact details.