chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Inflammation, Insomnia, Skin burning sensation
Clinical narrative: Underarm skin burning of his left arm; Lack of sleep in unbearable; Inflammation; Inflammation that involves the harm and pain; This spontaneous case was reported by a patient and describes the occurrence of SKIN BURNING SENSATION (Underarm skin burning of his left arm), INSOMNIA (Lack of sleep in unbearable), INFLAMMATION (Inflammation) and AXILLARY PAIN (Inflammation that involves the harm and pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Underarm skin burning of his left arm), INSOMNIA (Lack of sleep in unbearable), INFLAMMATION (Inflammation) and AXILLARY PAIN (Inflammation that involves the harm and pain). At the time of the report, SKIN BURNING SENSATION (Underarm skin burning of his left arm), INSOMNIA (Lack of sleep in unbearable), INFLAMMATION (Inflammation) and AXILLARY PAIN (Inflammation that involves the harm and pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  It was stated that adverse events impacted the patient for 18 months. The burning  the pain and the lack of sleep was unbearable.  Unusual side effects have come to light, including underarm pain as a result of swollen lymph nodes.  No treatment medication reported.   This case was linked to MOD-2022-651341.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Sore arm; She didn't feel good for a couple of days; The follow up case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on (17Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Time: 7:40AM, Anatomical site of injection : Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN5310), administration date: 13Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Tiem:4:50 PM, Anatomical location :Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN6208), administration date: 13Mar2021, for Covid-19 Immunization; BNT162b2 (Dose 3 (Booster), SIngle, Booster dose (other): Booster Dose (Other): 02Nov2021, FH8020 (744T3)), administration date: 02Nov2021, for Covid-19 Immunization.  The following information was reported: MALAISE (non-serious) with onset 24Sep2022, outcome "recovering", described as "She didn't feel good for a couple of days"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sore arm". The event "she didn't feel good for a couple of days" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise.  Additional information: She called about the Pfizer omicron booster covid vaccine. She had the booster last Thursday and has felt tired ever since. All she wants to do is sleep. She has collagenous colitis which is nothing new. This report is on the retired nurse. One of the people that she talked was a retired nurse. She didn't feel good for a couple of days. She declined to complete report on her. Does not know what product the nurse was referring to. She got it at the same pharmacy. It was scheduled an appt. with Dr office on 30Sep2022 at their suggestion. It was reported her arm (left) id still same at 09Oct2022. Blood count is normal, not anemic. liver and kidney are functioning well. electrolytes are normal. The rate of  kidney clear medications from your body is a little low, we will continue to monitor this. Thyroid is in normal range. Vitamins B12 and D are normal range.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Sore arm; She didn't feel good for a couple of days; The follow up case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on (17Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Time: 7:40AM, Anatomical site of injection : Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN5310), administration date: 13Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Tiem:4:50 PM, Anatomical location :Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN6208), administration date: 13Mar2021, for Covid-19 Immunization; BNT162b2 (Dose 3 (Booster), SIngle, Booster dose (other): Booster Dose (Other): 02Nov2021, FH8020 (744T3)), administration date: 02Nov2021, for Covid-19 Immunization.  The following information was reported: MALAISE (non-serious) with onset 24Sep2022, outcome "recovering", described as "She didn't feel good for a couple of days"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sore arm". The event "she didn't feel good for a couple of days" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise.  Additional information: She called about the Pfizer omicron booster covid vaccine. She had the booster last Thursday and has felt tired ever since. All she wants to do is sleep. She has collagenous colitis which is nothing new. This report is on the retired nurse. One of the people that she talked was a retired nurse. She didn't feel good for a couple of days. She declined to complete report on her. Does not know what product the nurse was referring to. She got it at the same pharmacy. It was scheduled an appt. with Dr office on 30Sep2022 at their suggestion. It was reported her arm (left) id still same at 09Oct2022. Blood count is normal, not anemic. liver and kidney are functioning well. electrolytes are normal. The rate of  kidney clear medications from your body is a little low, we will continue to monitor this. Thyroid is in normal range. Vitamins B12 and D are normal range.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes, Full blood count, Investigation, Liver function test, Malaise
Clinical narrative: Sore arm; She didn't feel good for a couple of days; The follow up case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on (17Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Time: 7:40AM, Anatomical site of injection : Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN5310), administration date: 13Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Tiem:4:50 PM, Anatomical location :Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN6208), administration date: 13Mar2021, for Covid-19 Immunization; BNT162b2 (Dose 3 (Booster), SIngle, Booster dose (other): Booster Dose (Other): 02Nov2021, FH8020 (744T3)), administration date: 02Nov2021, for Covid-19 Immunization.  The following information was reported: MALAISE (non-serious) with onset 24Sep2022, outcome "recovering", described as "She didn't feel good for a couple of days"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sore arm". The event "she didn't feel good for a couple of days" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise.  Additional information: She called about the Pfizer omicron booster covid vaccine. She had the booster last Thursday and has felt tired ever since. All she wants to do is sleep. She has collagenous colitis which is nothing new. This report is on the retired nurse. One of the people that she talked was a retired nurse. She didn't feel good for a couple of days. She declined to complete report on her. Does not know what product the nurse was referring to. She got it at the same pharmacy. It was scheduled an appt. with Dr office on 30Sep2022 at their suggestion. It was reported her arm (left) id still same at 09Oct2022. Blood count is normal, not anemic. liver and kidney are functioning well. electrolytes are normal. The rate of  kidney clear medications from your body is a little low, we will continue to monitor this. Thyroid is in normal range. Vitamins B12 and D are normal range.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; She didn't feel good for a couple of days; The follow up case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on (17Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Time: 7:40AM, Anatomical site of injection : Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN5310), administration date: 13Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Tiem:4:50 PM, Anatomical location :Left Arm, Route of Administration : Intramuscular, Batch/Lot Number : EN6208), administration date: 13Mar2021, for Covid-19 Immunization; BNT162b2 (Dose 3 (Booster), SIngle, Booster dose (other): Booster Dose (Other): 02Nov2021, FH8020 (744T3)), administration date: 02Nov2021, for Covid-19 Immunization.  The following information was reported: MALAISE (non-serious) with onset 24Sep2022, outcome "recovering", described as "She didn't feel good for a couple of days"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sore arm". The event "she didn't feel good for a couple of days" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise.  Additional information: She called about the Pfizer omicron booster covid vaccine. She had the booster last Thursday and has felt tired ever since. All she wants to do is sleep. She has collagenous colitis which is nothing new. This report is on the retired nurse. One of the people that she talked was a retired nurse. She didn't feel good for a couple of days. She declined to complete report on her. Does not know what product the nurse was referring to. She got it at the same pharmacy. It was scheduled an appt. with Dr office on 30Sep2022 at their suggestion. It was reported her arm (left) id still same at 09Oct2022. Blood count is normal, not anemic. liver and kidney are functioning well. electrolytes are normal. The rate of  kidney clear medications from your body is a little low, we will continue to monitor this. Thyroid is in normal range. Vitamins B12 and D are normal range.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient  under vaccinated with less than half Moderna Bivalent Booster; given 0.05ml. No adverse symptoms. CDC advised patient be revaccinated with full dose of vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient  under vaccinated with less than half Moderna Bivalent Booster; given 0.05ml. No adverse symptoms. CDC advised patient be revaccinated with full dose of vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Patient  under vaccinated with less than half Moderna Bivalent Booster; given 0.05ml. No adverse symptoms. CDC advised patient be revaccinated with full dose of vaccine.
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Diarrhoea
Clinical narrative: Chronic diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "not recovered", described as "Chronic diarrhea".  Additional Information: Patient developed Chronic diarrhea shortly after receiving (15Sep2022) the Gray cap, Original/Omicron BA.4/BA.5 (Bivalent) COVID vaccine. Nothing seemed to help. Patient inquired if there was a medical solution to the problem or if it had to run its course. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Nausea, Syncope
Clinical narrative: Feeling a little under the weather; Body ache after each vaccine but not really bad; Fatigue; Nausea; Vomiting; Faint 14 to 16 hours later after dose 1; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Faint 14 to 16 hours later after dose 1) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SYNCOPE (Faint 14 to 16 hours later after dose 1) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Feeling a little under the weather), MYALGIA (Body ache after each vaccine but not really bad), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYNCOPE (Faint 14 to 16 hours later after dose 1), MALAISE (Feeling a little under the weather), MYALGIA (Body ache after each vaccine but not really bad), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient took Tylenol once or twice after vaccine but nothing else.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope, which occurred 14 to 16 hours after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient also had fatigue, nausea, vomiting, a little bit of body ache, and feeling unwell. Patient took paracetamol once or twice after having the vaccine. No further details about the clinical course and diagnostic procedures were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-659978, MOD-2022-659976, MOD-2022-659974 (Patient Link).; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope, which occurred 14 to 16 hours after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient also had fatigue, nausea, vomiting, a little bit of body ache, and feeling unwell. Patient took paracetamol once or twice after having the vaccine. No further details about the clinical course and diagnostic procedures were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Malaise, Myalgia, Nausea, Syncope
Clinical narrative: Feeling a little under the weather; Body ache after each vaccine but not really bad; Fatigue; Nausea; Vomiting; Faint 14 to 16 hours later after dose 1; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Faint 14 to 16 hours later after dose 1) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SYNCOPE (Faint 14 to 16 hours later after dose 1) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Feeling a little under the weather), MYALGIA (Body ache after each vaccine but not really bad), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYNCOPE (Faint 14 to 16 hours later after dose 1), MALAISE (Feeling a little under the weather), MYALGIA (Body ache after each vaccine but not really bad), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient took Tylenol once or twice after vaccine but nothing else.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope, which occurred 14 to 16 hours after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient also had fatigue, nausea, vomiting, a little bit of body ache, and feeling unwell. Patient took paracetamol once or twice after having the vaccine. No further details about the clinical course and diagnostic procedures were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-659978, MOD-2022-659976, MOD-2022-659974 (Patient Link).; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope, which occurred 14 to 16 hours after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient also had fatigue, nausea, vomiting, a little bit of body ache, and feeling unwell. Patient took paracetamol once or twice after having the vaccine. No further details about the clinical course and diagnostic procedures were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Feeling a little under the weather; Body ache after each vaccine but not really bad; Fatigue; Nausea; Vomiting; Faint 14 to 16 hours later after dose 1; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Faint 14 to 16 hours later after dose 1) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SYNCOPE (Faint 14 to 16 hours later after dose 1) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Feeling a little under the weather), MYALGIA (Body ache after each vaccine but not really bad), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYNCOPE (Faint 14 to 16 hours later after dose 1), MALAISE (Feeling a little under the weather), MYALGIA (Body ache after each vaccine but not really bad), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient took Tylenol once or twice after vaccine but nothing else.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope, which occurred 14 to 16 hours after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient also had fatigue, nausea, vomiting, a little bit of body ache, and feeling unwell. Patient took paracetamol once or twice after having the vaccine. No further details about the clinical course and diagnostic procedures were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-659978, MOD-2022-659976, MOD-2022-659974 (Patient Link).; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope, which occurred 14 to 16 hours after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient also had fatigue, nausea, vomiting, a little bit of body ache, and feeling unwell. Patient took paracetamol once or twice after having the vaccine. No further details about the clinical course and diagnostic procedures were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Terrible blistering; rash systemic; ear swelling; nausea; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:15 as dose 3 (booster), single (Lot number: GJ3277) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATIVAN; CYMBALTA; LUNESTA. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Elo140, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 12Jan2022, when the patient was 47-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Elo140, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 21Dec2021, when the patient was 47-year-old, for COVID-19 immunization. The following information was reported: BLISTER (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered", described as "Terrible blistering"; EAR SWELLING (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered"; NAUSEA (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered"; RASH (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered", described as "rash systemic". The events "terrible blistering", "rash systemic", "ear swelling" and "nausea" required emergency room visit. Therapeutic measures were taken as a result of blister, rash, ear swelling, nausea.  Additional information: Facility type of vaccine at Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior vaccination and covid tested post vaccination reported as Yes. Known allergies reported as None.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Ear swelling, Nausea, Rash
Clinical narrative: Terrible blistering; rash systemic; ear swelling; nausea; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:15 as dose 3 (booster), single (Lot number: GJ3277) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATIVAN; CYMBALTA; LUNESTA. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Elo140, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 12Jan2022, when the patient was 47-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Elo140, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 21Dec2021, when the patient was 47-year-old, for COVID-19 immunization. The following information was reported: BLISTER (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered", described as "Terrible blistering"; EAR SWELLING (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered"; NAUSEA (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered"; RASH (non-serious) with onset 14Oct2022 at 16:00, outcome "not recovered", described as "rash systemic". The events "terrible blistering", "rash systemic", "ear swelling" and "nausea" required emergency room visit. Therapeutic measures were taken as a result of blister, rash, ear swelling, nausea.  Additional information: Facility type of vaccine at Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior vaccination and covid tested post vaccination reported as Yes. Known allergies reported as None.
Age: 59.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event
Clinical narrative: Patient given 0.3ml dose of vaccine 14 hrs after vial initially accessed
Age: 59.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient given 0.3ml dose of vaccine 14 hrs after vial initially accessed
Age: 1.33
Sex: F
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patient given adult dosage
Age: 1.33
Sex: F
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient given adult dosage
Age: 68.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Feeling abnormal, Vaccination site pain, Wrong product administered
Clinical narrative: overall bad feeling; Fatigued; My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.; I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (overall bad feeling), FATIGUE (Fatigued), VACCINATION SITE PAIN (My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.) and WRONG PRODUCT ADMINISTERED (I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 12-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced VACCINATION SITE PAIN (My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.) and WRONG PRODUCT ADMINISTERED (I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent). On 13-Oct-2022, the patient experienced FEELING ABNORMAL (overall bad feeling) and FATIGUE (Fatigued). On 14-Oct-2022, FEELING ABNORMAL (overall bad feeling) and FATIGUE (Fatigued) had resolved. At the time of the report, VACCINATION SITE PAIN (My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.) and WRONG PRODUCT ADMINISTERED (I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent) outcome was unknown.            No concomitant medications were reported.  The patient was mistakenly given the pediatric dose of the regular Moderna Covid-19 vaccine [Monovalent], instead of the Moderna Covid-19 Vaccine, Bivalent. It was reported that the patient also got the senior dose of the flu shot in right arm. Soreness at the right arm injection site was worse than the Moderna shot.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659988 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659988:Crosslinked with MOD22-026790 (wife's case) same reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient tested positive for COVID-19) in a 75-year-old female patient 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) (Intramuscular) 1 dosage form. On 24-Sep-2022, the patient experienced COVID-19 (Patient tested positive for COVID-19). On 30-Sep-2022, COVID-19 (Patient tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2022, SARS-CoV-2 test: (Positive) Positive. On 30-Sep-2022, SARS-CoV-2 test: (Negative) Negative.         Patient received booster dose.  Concomitant medications were not reported.  It was reported that patient seeking location to receive his moderna bivalent booster, and was having hard time finding a location in their area. During the conversion, patient stated that she would have to wait 90 days as she was tested positive for Covid.  Lot numbers to moderna primary and boosters were unknown.  Patient did not seeked medical care (office visit, Urgent care, ER, hospitalized).  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660012:MOD22-026797(husband Case)
Age: 81.0
Sex: M
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: COVID-19, Fatigue, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid-19 with home test; I felt nauseated all the time; I felt drug out & tired; I had sore arms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for Covid-19 with home test), PAIN IN EXTREMITY (I had sore arms), FATIGUE (I felt drug out & tired) and NAUSEA (I felt nauseated all the time) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 14-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On 15-Oct-2022, the patient experienced PAIN IN EXTREMITY (I had sore arms). On 16-Oct-2022, the patient experienced FATIGUE (I felt drug out & tired). On 17-Oct-2022, the patient experienced NAUSEA (I felt nauseated all the time). On 18-Oct-2022, the patient experienced COVID-19 (I tested positive for Covid-19 with home test). At the time of the report, COVID-19 (I tested positive for Covid-19 with home test), PAIN IN EXTREMITY (I had sore arms), FATIGUE (I felt drug out & tired) and NAUSEA (I felt nauseated all the time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2022, SARS-CoV-2 test: (Positive) Positive for Covid-19 with home test.         Concomitant product use was not provided by the reporter.  On 14-Oct-2022, the patient received flu shot.   Treatment information was not provided.  Patient received 1st dose: 06Jan2021, Lot: 02520A 2nd dose: 03Feb2021, Lot: 032L20A 1st booster: 19Aug2021, Lot: 091C21A 2nd booster: 24May2022, Lot: 059A22A
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator; No adverse event; Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. o13B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator).    No concomitant medicine were reported. It was reported that on 14-Oct-2022, the temperature went for vial up to 8.2C for 1 minute.  There has not been a previous excursion.  The vial was moved from Freezer to the refrigerator on 13-Oct-2022. The patient received 1 Booster Dose on Monday 17-Oct-2022 and the vial was discarded within 12 hours after first puncture. No treatment medicine were reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Urticaria
Clinical narrative: COVID Disease 6 months after first booster; Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster) and COVID-19 (COVID Disease 6 months after first booster) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 009C21A and 006C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced URTICARIA (Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster). In May 2022, the patient experienced COVID-19 (COVID Disease 6 months after first booster). The patient was treated with CETIRIZINE for Urticaria, at a dose of 10 milligram (2 Cetirizine 10 mg in the Morning); FAMOTIDINE (PEPCID [FAMOTIDINE]) for Urticaria, at a dose of 20 milligram once a day and MONTELUKAST SODIUM (SINGULAIR) for Hives, at a dose of 10 milligram once a day. In May 2022, URTICARIA (Hives all over the body 2 weeks after first booster/Urticaria all over the body 2 weeks after first booster) had resolved. At the time of the report, COVID-19 (COVID Disease 6 months after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-1 test: (Positive) Positive PCR Test.         No concomitant medication was reported. It was reported that the Hives did not stop until MA-2022 when she had a positive PCR test. She stopped the allergy medications after she had COVID disease in MAY-2022..   This case was linked to MOD-2022-660888 (Patient Link).
Age: 44.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a nurse referring a 44-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-SEP-2022, the patient was administered with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W002601 with expiration date 24-JAN-2024, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error), which had a temperature excursion of -11.8 celsius (C) for 1 hour 45 minutes 0 seconds; also, a previous temperature excursion happened. There was no additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a nurse referring a patient of unknown age and gender. Patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-SEP-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W002601 with expiration date: 24-JAN-2024, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided). No additional adverse event reported and there was no previous temperature excursion.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: no additional AE reported; Office manager who is also a registered nurse reporting a patient was administered a dose of GARDASIL 9 after the labeled expiration date. Caller stated the GARDASIL 9 expired on 11-SEP-2022, but was administered on 5-OCT-2022. Caller confirmed the v; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On 05-OCT-2022, the patient was vaccinated with a expired vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot number 687291, expiration date reported and internally validated as 11-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that there was not any temperature excursion and no additional adverse events.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The case was received from the other healthcare professional via interactive digital media. The reporter just given Bexsero vaccine that was expired in July 2022. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used. The follow-up could not be possible as no contact details were available. Based upon the narrative, the vaccination date and onset date for medication was captured as October 2022.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: Shingles on arm (mild case); Burning; Itching; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced shingles, burning sensation, pruritus and pain. The patient was treated with paracetamol (Tylenol), capsaicin (Capsaicin Cream) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the burning sensation, pruritus and pain were unknown.   It was unknown if the reporter considered the shingles, burning sensation, pruritus and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Oct-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient had shingles shot and 2 years later got the shingles on his arm. The physician said that it was a mild case but you could not prove them by him.  Less than 2 years after vaccination, the patient had the burning, itching and pain. The patient got tylenol, capsaicin cream, ice packs but it's been almost a month and it was still not entirely gone. The patient stated that he will get the second shot in 2 months.  The patient did not want to go through that agony. Additional supportive information: The follow-up could not be possible as no contact details were available. Tylenol, capsaicin cream and ice pack were coded as treatment medication as per reported narrative chronology. As it was clearly reported that the patient was recovering from it (it's still not entirely gone), there 2nd shot was not coded as suspect with medication errors. Time to onset for burning, itching and pain was captured as less than 2 years as it was reported that 2 years later after vaccination the patient had shingles i.e., in between this duration the patient had these events.