chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Mammogram, Pain, Rash, Skin lesion
Clinical narrative: on 02Jan2022, she got infected with COVID-19, probably the omicron variant; on 02Jan2022, she got infected with COVID-19, probably the omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Lot number: EW0167), in left arm and on 03Jun2021 at 11:00 as dose 2, single (Lot number: ER8729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID Asymptomatic", start date: Jan2021 (unspecified if ongoing), notes: COVID Asymptomatic did not get any symptoms, she, just did the test because her husband got tested, positive for COVID.; "Menopause" (unspecified if ongoing), notes: Menopause Started like 5-6 years ago. They put her on, low dosage of hormone taking it for 5 years.; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies which of course progressed with, age so instead of 1 medication, started taking 2 then 3, to try to avoid the allergies. Not food allergies, like tree,, grass, pollen; "Iron deficiency" (unspecified if ongoing), notes: Has had this pretty much her whole life., Been on iron pills for this for pretty much like 20-25, years since in her early 40s; "High allergies on multiple unknown medications" (unspecified if ongoing), notes: High allergies on multiple unknown medications for this, for about 10-12 years; condition has been since birth. There were no concomitant medications. Past drug history included: Paxle, reaction(s): "she is allergic to: Paxle", notes: she is allergic to: Paxle. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "on 02Jan2022, she got infected with COVID-19, probably the omicron variant". The event "on 02jan2022, she got infected with covid-19, probably the omicron variant" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) developed Spongiotic dermatitis; Blood test: (unspecified date) Unknown Results; Mammogram: (unspecified date) Unknown Results, notes: small lesion in her left breast; SARS-CoV-2 test: (Jan2021) Unknown results, notes: she just did the test; (02Jan2022) Positive, notes: she also tested positive for COVID Omicron; Ultrasound breast: (unspecified date) Unknown Results, notes: small lesion in her left breast.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Staphylococcal infection, Swelling, Swelling face, Ultrasound breast
Clinical narrative: on 02Jan2022, she got infected with COVID-19, probably the omicron variant; on 02Jan2022, she got infected with COVID-19, probably the omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Lot number: EW0167), in left arm and on 03Jun2021 at 11:00 as dose 2, single (Lot number: ER8729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID Asymptomatic", start date: Jan2021 (unspecified if ongoing), notes: COVID Asymptomatic did not get any symptoms, she, just did the test because her husband got tested, positive for COVID.; "Menopause" (unspecified if ongoing), notes: Menopause Started like 5-6 years ago. They put her on, low dosage of hormone taking it for 5 years.; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies which of course progressed with, age so instead of 1 medication, started taking 2 then 3, to try to avoid the allergies. Not food allergies, like tree,, grass, pollen; "Iron deficiency" (unspecified if ongoing), notes: Has had this pretty much her whole life., Been on iron pills for this for pretty much like 20-25, years since in her early 40s; "High allergies on multiple unknown medications" (unspecified if ongoing), notes: High allergies on multiple unknown medications for this, for about 10-12 years; condition has been since birth. There were no concomitant medications. Past drug history included: Paxle, reaction(s): "she is allergic to: Paxle", notes: she is allergic to: Paxle. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "on 02Jan2022, she got infected with COVID-19, probably the omicron variant". The event "on 02jan2022, she got infected with covid-19, probably the omicron variant" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) developed Spongiotic dermatitis; Blood test: (unspecified date) Unknown Results; Mammogram: (unspecified date) Unknown Results, notes: small lesion in her left breast; SARS-CoV-2 test: (Jan2021) Unknown results, notes: she just did the test; (02Jan2022) Positive, notes: she also tested positive for COVID Omicron; Ultrasound breast: (unspecified date) Unknown Results, notes: small lesion in her left breast.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood test, COVID-19, Mammogram, SARS-CoV-2 test
Clinical narrative: on 02Jan2022, she got infected with COVID-19, probably the omicron variant; on 02Jan2022, she got infected with COVID-19, probably the omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Lot number: EW0167), in left arm and on 03Jun2021 at 11:00 as dose 2, single (Lot number: ER8729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID Asymptomatic", start date: Jan2021 (unspecified if ongoing), notes: COVID Asymptomatic did not get any symptoms, she, just did the test because her husband got tested, positive for COVID.; "Menopause" (unspecified if ongoing), notes: Menopause Started like 5-6 years ago. They put her on, low dosage of hormone taking it for 5 years.; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies which of course progressed with, age so instead of 1 medication, started taking 2 then 3, to try to avoid the allergies. Not food allergies, like tree,, grass, pollen; "Iron deficiency" (unspecified if ongoing), notes: Has had this pretty much her whole life., Been on iron pills for this for pretty much like 20-25, years since in her early 40s; "High allergies on multiple unknown medications" (unspecified if ongoing), notes: High allergies on multiple unknown medications for this, for about 10-12 years; condition has been since birth. There were no concomitant medications. Past drug history included: Paxle, reaction(s): "she is allergic to: Paxle", notes: she is allergic to: Paxle. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "on 02Jan2022, she got infected with COVID-19, probably the omicron variant". The event "on 02jan2022, she got infected with covid-19, probably the omicron variant" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) developed Spongiotic dermatitis; Blood test: (unspecified date) Unknown Results; Mammogram: (unspecified date) Unknown Results, notes: small lesion in her left breast; SARS-CoV-2 test: (Jan2021) Unknown results, notes: she just did the test; (02Jan2022) Positive, notes: she also tested positive for COVID Omicron; Ultrasound breast: (unspecified date) Unknown Results, notes: small lesion in her left breast.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound breast, Vaccination failure
Clinical narrative: on 02Jan2022, she got infected with COVID-19, probably the omicron variant; on 02Jan2022, she got infected with COVID-19, probably the omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Lot number: EW0167), in left arm and on 03Jun2021 at 11:00 as dose 2, single (Lot number: ER8729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID Asymptomatic", start date: Jan2021 (unspecified if ongoing), notes: COVID Asymptomatic did not get any symptoms, she, just did the test because her husband got tested, positive for COVID.; "Menopause" (unspecified if ongoing), notes: Menopause Started like 5-6 years ago. They put her on, low dosage of hormone taking it for 5 years.; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies which of course progressed with, age so instead of 1 medication, started taking 2 then 3, to try to avoid the allergies. Not food allergies, like tree,, grass, pollen; "Iron deficiency" (unspecified if ongoing), notes: Has had this pretty much her whole life., Been on iron pills for this for pretty much like 20-25, years since in her early 40s; "High allergies on multiple unknown medications" (unspecified if ongoing), notes: High allergies on multiple unknown medications for this, for about 10-12 years; condition has been since birth. There were no concomitant medications. Past drug history included: Paxle, reaction(s): "she is allergic to: Paxle", notes: she is allergic to: Paxle. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "on 02Jan2022, she got infected with COVID-19, probably the omicron variant". The event "on 02jan2022, she got infected with covid-19, probably the omicron variant" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) developed Spongiotic dermatitis; Blood test: (unspecified date) Unknown Results; Mammogram: (unspecified date) Unknown Results, notes: small lesion in her left breast; SARS-CoV-2 test: (Jan2021) Unknown results, notes: she just did the test; (02Jan2022) Positive, notes: she also tested positive for COVID Omicron; Ultrasound breast: (unspecified date) Unknown Results, notes: small lesion in her left breast.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus that has not subsided
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Pain in the shoulder, Loss of mobility in the shoulder, started within 48 hours of injection.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in the shoulder, Loss of mobility in the shoulder, started within 48 hours of injection.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Exercise tolerance decreased, Post-acute COVID-19 syndrome
Clinical narrative: Long COVID, dizziness, shortness of breath, chest pain Prior to vaccine able to run 5 miles/day; now unable to run more than 100-200 meters without shortness of breathe
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation delayed, Oropharyngeal pain, Pain, Pharyngitis streptococcal
Clinical narrative: The day after my vaccine, I had a headaches and body aches. A couple of days later I had a sore throat with white spots near my tonsils and I figured it was Strep Throat. I went to the urgent care, and they did a rapid Strep test and verified that it was Strep. They gave me antibiotics but which I took as directed and they didn't seem to help. From there I did a Telehealth appt with my doctor and was advised to back to the urgent care, they did another Strep test, and it was still positive. They switched me to Augmentin, I was told that I should only take this medicine for 7 days as it could start wreaking havoc on my body. After day 7, I still had swelling and redness on my tonsils to I did 10 full days of this medicine. It was only after 10 days that it started subsiding. My next period was irregularly late, I went and got a pregnancy test, and it was negative. I finally got it 15 days later.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test negative, Streptococcus test positive, Tonsillar erythema, Tonsillar hypertrophy
Clinical narrative: The day after my vaccine, I had a headaches and body aches. A couple of days later I had a sore throat with white spots near my tonsils and I figured it was Strep Throat. I went to the urgent care, and they did a rapid Strep test and verified that it was Strep. They gave me antibiotics but which I took as directed and they didn't seem to help. From there I did a Telehealth appt with my doctor and was advised to back to the urgent care, they did another Strep test, and it was still positive. They switched me to Augmentin, I was told that I should only take this medicine for 7 days as it could start wreaking havoc on my body. After day 7, I still had swelling and redness on my tonsils to I did 10 full days of this medicine. It was only after 10 days that it started subsiding. My next period was irregularly late, I went and got a pregnancy test, and it was negative. I finally got it 15 days later.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 141M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose). At the time of the report, PALPITATIONS (Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose) outcome was unknown.            Patient received 4 doses of Moderna COVID-19 vaccine.   Patient stated that after the first 3 doses he did not had any side effects. Patient stated after second booster during night  he started heart pounding and fluttering and while taking a nap in afternoon, heart pounding woke him up.   Patient had no heart disease and never had COVID disease in the past. Patient was healthy   No concomitant medication provided.   No treatment information mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave 3 booster doses  of Lot # that expired on the 12Apr2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 3 booster doses  of Lot # that expired on the 12Apr2022.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 3 booster doses  of Lot # that expired on the 12Apr2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 3 booster doses  of Lot # that expired on the 12Apr2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   The reporter stated that they were administering Moderna COVID-19 vaccines and stated that they gave 3 booster doses that expired on the 12 Apr 2022. The HCP was unable to provide any additional details about the patients except that it was their 2nd booster dose. On 08 Apr 2022 the vial was initially stored in the refrigerator.   Reporter did not allow further contact
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no aditional AE; patient was administered MMR II intramuscularly in the tight instead of subcutaneously; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient.  Information regarding the patient's pertinent medical history, concurrent conditions, drugs reactions or allergies were not provided. Concomitant therapies includes varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis A Vaccine, Inactivated (VAQTA).  On 22-MAR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneous injection, 0.5 milliliter, lot number U013035 has been verified to be valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date: 23-APR-2023, and sterile diluent (MERCK STERILE DILUENT) (lot number, expiry date). However, the vaccine was administered intramuscularly in the right tight instead of subcutaneously (incorrect route of product administration). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Caller is HCP who reported that patient received dose of PROQUAD that has experienced temperature excursion. No additional adverse events/no product quality complaints.; Information has been received from a medical assistant, referring to a 4 year -old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # U028183 and expiration date on 08-MAR-2023 (administration route was not provided) for prophylaxis. No adverse effects were reported.  No additional details regarding the temperature excursion was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE information; Caller reported expired dose of PROQUAD administered to patient.  Product did not experience any temperature excursions.  Read supported statement.  No additional AE information.  No PQC.; Information has been received from an unspecified reporter, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, once, lot # t029104, expiration date on 23-FEB-2022 (administration route was not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: COVID19, VARCEL
Symptoms: Herpes zoster
Clinical narrative: A case of HZ dermatitis after COVID and varicella vaccinations in an immunocompetent person who was previously seronegative and who had no history of chickenpox.  Information has been received from the author's of the published literature article as stated above referring to a 35-year-old healthy male patient. The patient's concurrent conditions and medical history were not reported. There was no concomitant medications reported.  On an unspecified dates, the patient received the first and the second dose (6 weeks before the onset date of event) of covid-19 vaccine (BioNTech-Pfizer)(strength, dose, route, lot number and expiration date were not reported) for prophylaxis. Later, on an unspecified date, the patient received the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route, lot number and expiration date were not reported) also for prophylaxis, because he was a health care worker with no antivaricella IgG antibodies. Subsequently, 3 weeks later he presented with severe stinging pain from the right side of the abdomen to his back. At the time of presentation, the patient denied any recent trauma, medical or cosmetic procedures, or foreign travel. Methocarbamol and topical diclofenac gel were prescribed. Three days later, he developed multiple mildly tender plaques on an erythematous base corresponding to a T5 to T11 dermatomal distribution. He had no history of immunodeficiency, malignancy, or immunosuppressive therapy. He was initiated on valacyclovir at 1 g thrice daily. In 3 days, the erythema began to resolve. Both pain and rash completely resolved after 2 weeks.   Authors report a case of herpez zoster (HZ) dermatitis after BioNTech- Pfizer and varicella vaccinations in an immunocompetent person who was previously seronegative and who had no history of chickenpox. In this case, the COVID-19 vaccination may have influenced the development of HZ after the varicella vaccination. Arguments that support a link among COVID-19 vaccination, varicella vaccination, and HZ include the following: (1) rapid onset of rash after vaccination, (2) eruption on the same side as the vaccinated arm for both vaccines, (3) several previous cases of HZ after COVID-19 vaccination, and (4) cases of HZ reported after various vaccinations.  A copy of the published literature article is attached as further documentation of the patient's experience
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 31-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date was confirmed as: 20-MAY-2023 (reported as 20-MAY-2022; exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 28-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-APR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 06-APR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (9.37 C) for 2 hours and 30 minutes; (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-APR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016061, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: 9.37 degree Celsius for 2 hours and 30 minutes; -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: red hives with central clearing at injection; swelling at the injection site; redness at the injection site; slight itching at the injection site; pain at the injection site; This spontaneous report was received from a medical assistant, referring to a 4-year-old male patient. Drug reactions/allergies included amoxicillin: mild rash. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 30-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (0.5 ml, lot # U039254, expiration date: 09-JUN-2023, vaccination site: left upper thigh, strength was not provided) subcutaneous for prophylaxis (reported as vaccination).   On 31-MAR-2022, the patient had swelling, redness, slight itching, and pain at the injection site. The patient was seen in the office on 01-APR-2022 and the medical assistant read the office notes from that visit "left upper thigh, non tender, red hives with central clearing at injection". The patient sought medical attention. The swelling had progressed when the patient was seen in the office. The outcome of the events was unknown.  The causality assessment between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was not provided.  Additional information had been requested.; Sender's Comments:  US-009507513-2204USA004513:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product administered at inappropriate site
Clinical narrative: no further information provided; 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; This spontaneous report was received from a registered nurse via a pharmacy technician from same facility clinic and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 07-APR-2022, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U024221, expiration date was provided and also validated as 04-AUG-2023; and also with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U028179, expiration date was reported and also validated as 08-MAR-2023; for prophylaxis (exact doses, route of administration and anatomical location were not provided for both vaccines) (overdose). It was unknown to caller if any product confusion occurred that might had contributed to the error. No further information was provided (no adverse event).  This is one of several linked reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005095: US-009507513-2204USA004906: US-009507513-2204USA004990: US-009507513-2204USA005079: US-009507513-2204USA005733:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 07-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U029319, expiration date: 19-MAR-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AEs; using 2 pediatric VAQTA to equal an adult dose of VAQTA administered to a 19 year old; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-APR-2022, the patient was administered 2 pediatric doses of hepatitis A vaccine, inactivated (VAQTA) to equal an adult dose of hepatitis A vaccine, inactivated (VAQTA) (1 ml, for prophylaxis; route of administration, lot # and expiry date were not provided). No additional adverse events were reported.
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse events reported; Caller inquiring about revaccination regarding an expired dose of PROQUAD administered to two different patients on two separate days.; This spontaneous report was received from a registered nurse and a consumer (patient's mother) referring to a male patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with an expired dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength and route were not reported; lot # T029102, expiration date: 23-FEB-2022) for prophylaxis (expired product administered). No other adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 14-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin (rHA)) (M-M-R II) (lot #U006488 was confirmed to be valid, expiration date: 26-FEB-2023) (dose, dose number, site and route of administration were not provided) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccine were improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005826: US-009507513-2204USA005827: US-009507513-2204USA005828: US-009507513-2204USA005829:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 02-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U014992 was confirmed to be valid, expiration date: 29-OCT-2023) (dose, dose number, site and route of administration were not provided) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccine were improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005825: US-009507513-2204USA005827: US-009507513-2204USA005828: US-009507513-2204USA005829:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 11 weeks old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 04-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U014992 was confirmed to be valid, expiration date: 29-OCT-2023) (dose, dose number, site and route of administration were not provided) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccine was improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005825: US-009507513-2204USA005826: US-009507513-2204USA005828: US-009507513-2204USA005829:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 10-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U014992 was confirmed to be valid, expiration date: 29-OCT-2023) (dose, dose number, site and route of administration were not provided) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccine was improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005825: US-009507513-2204USA005826: US-009507513-2204USA005827: US-009507513-2204USA005829:
Age: 1.0
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 12 months old of patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 11-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U014992 was confirmed to be valid, expiration date: 29-OCT-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin (rHA)) (M-M-R II) (lot #U006488 was confirmed to be valid, expiration date: 26-FEB-2023) (dose, dose number, site and route of administration were not provided for both vaccines) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccines were improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005825: US-009507513-2204USA005826: US-009507513-2204USA005827: US-009507513-2204USA005828:
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Gait inability, Monoplegia
Clinical narrative: Temporary paralysis in legs, could not walk; Could not walk; This case was reported by a physician via market research programs and described the occurrence of leg paralysis in a 18-year-old male patient who received Men B NVS (Meningococcal B Recom vaccine + AlOH + OMV) 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 July 2017, the patient received Meningococcal B Recom vaccine + AlOH + OMV and Bexsero Pre-Filled Syringe Device. In July 2017, less than a month after receiving Meningococcal B Recom vaccine + AlOH + OMV and Bexsero Pre-Filled Syringe Device, the patient experienced leg paralysis (serious criteria GSK medically significant) and unable to walk. On an unknown date, the outcome of the leg paralysis and unable to walk were recovered/resolved.   The reporter considered the leg paralysis and unable to walk to be possibly related to Meningococcal B Recom vaccine + AlOH + OMV and Bexsero Pre-Filled Syringe Device. 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: 12-Apr-2022 Reporter's Comments: The reporter stated that the patient could not walk, had temporary paralysis in legs The reporter did not consent to follow up. Additional Supportive Information: This case has been linked to US2022AMR064641 and US2022AMR064642, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064641:Same reporter. Patient 2. US-GLAXOSMITHKLINE-US2022AMR064642:Same reporter. Patient 3.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: Shingles shot gave discomfort for a few days after; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (dad had shingles, he was in so much pain) and pain (Family History) (dad had shingles, he was in so much pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-APR-2022 Reporter's comment: This case was received from consumer via interactive digital media. The case was reported by patient's wife. The reporter stated that the both herself and her hubby got shingles shot and her hubby had discomfort for a few days after. The reporter felt happy to be protected. Additional Supportive Information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066683:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Palpitations; This case was reported by a other health professional via interactive digital media and described the occurrence of palpitation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's comment: This case was reported by other health care professional via interactive digital media. The reporter read different information about not giving and giving 2nd dose of Shingrix vaccine. The reporter asked recommendation for the same. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced swollen lymph node. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose which has been given with 3 months apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a elderly female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   In January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 15th Apr 2022 Reporter's Comments: The registered pharmacist reported that a patient received in January 2022 a second dose of Havrix which was given with 3 months apart instead of 6 months. The reporter consented to follow up.  Additional Supportive Information: The patient received havrix 2nd dose earlier than recommended which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine is later than 6 month after first dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 17th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received shingrix vaccine later than 6 months after 1st dose. Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule.
Age: 38.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was given the Menveo Vial 2 ONLY; Patient was given the Menveo Vial 2 ONLY; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 38-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA687A, expiry date 31st October 2022) for prophylaxis.   On 7th April 2022, the patient received Menveo (intramuscular). On 7th 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: 11-APR-2022  Reporter's Comments: The pharmacist reported that the patient was given the Menveo vial 2 only in the left deltoid. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo vial 2 only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.