chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Severe hives on lower body, face and arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: FJ8762) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: sulfa; "pears" (unspecified if ongoing), notes: pears. The patient took concomitant medications. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Known allergies: ampicillin, reaction(s): "Known allergies: ampicillin", notes: Known allergies: ampicillin; Known allergies: baxtra, reaction(s): "Known allergies: Baxtra", notes: Known allergies: Baxtra. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 04Apr2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 14Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Severe hives on lower body, face and arms.". The event "severe hives on lower body, face and arms." was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria. No follow-up attempts are possible. No further information is expected.  Follow-Up (20Jan2022): Follow-up attempts are completed. No further information is expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID and a week later he died; contracted COVID and a week later he died.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), outcome "fatal", described as "contracted COVID and a week later he died"; COVID-19 (death, medically significant), outcome "fatal", described as "contracted COVID and a week later he died.". The patient date of death was unknown. The reported cause of death was covid-19, drug ineffective. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: contracted COVID and a week later he died.; contracted COVID and a week later he died
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive on Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program (159558). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 06Jan2022, outcome "unknown", described as "tested positive on Covid". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Enlarged lymph node by clavical; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jan2022 (Lot number: FJ5682) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8735; Route of administration: Unspecified; Anatomical location: Right arm), administration date: 08May2021, when the patient was 16 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0178; Route of administration: Unspecified; Anatomical location: Right arm), administration date: 29May2021, when the patient was 16 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Jan2022, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 17Jan2022, outcome "recovering", described as "Enlarged lymph node by clavical". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Significant hair loss on day 9 since receiving vaccine; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 at 09:15 (Lot number: 33025BD) at the age of 46 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication included: VIT D.  The following information was reported: ALOPECIA (non-serious) with onset 19Jan2022 at 08:00, outcome "unknown", described as "Significant hair loss on day 9 since receiving vaccine". Therapeutic measures were not taken as a result of alopecia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Influenza like illness, Lymphadenopathy
Clinical narrative: Fever of up to 103; General flu-like symptoms; fatigue - from hour 12-36; Dose received: 3; Swollen lymph nodes under left arm- from day of and resolved in approximately 2 weeks; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 (Lot number: FF2590) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: IRON and B12. Past drug history included: Diflucan, reaction: "Drug allergy", notes: Known allergies: Diflucan and Benzoyl peroxide, reaction: "Drug allergy", notes: Known allergies: Benzoyl Peroxide. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL9266, Route of administration: unspecified, Anatomical site: left arm), administration date: 14Feb2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EN6206, Route of administration: unspecified, Anatomical site: left arm), administration date: 07Mar2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 14Oct2021, outcome "recovered" (an unknown date in Oct2021), described as "Swollen lymph nodes under left arm- from day of and resolved in approximately 2 weeks"; PYREXIA (non-serious) with onset 15Oct2021 at 09:00, outcome "recovered" (an unknown date in Oct2021), described as "Fever of up to 103"; INFLUENZA LIKE ILLNESS (non-serious) with onset 15Oct2021 at 09:00, outcome "recovered" (an unknown date in Oct2021), described as "General flu-like symptoms"; FATIGUE (non-serious) with onset 15Oct2021 at 09:00, outcome "recovered" (an unknown date in Oct2021), described as "fatigue - from hour 12-36". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, pyrexia, influenza like illness and fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of up to 103; General flu-like symptoms; fatigue - from hour 12-36; Dose received: 3; Swollen lymph nodes under left arm- from day of and resolved in approximately 2 weeks; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 (Lot number: FF2590) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: IRON and B12. Past drug history included: Diflucan, reaction: "Drug allergy", notes: Known allergies: Diflucan and Benzoyl peroxide, reaction: "Drug allergy", notes: Known allergies: Benzoyl Peroxide. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL9266, Route of administration: unspecified, Anatomical site: left arm), administration date: 14Feb2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EN6206, Route of administration: unspecified, Anatomical site: left arm), administration date: 07Mar2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 14Oct2021, outcome "recovered" (an unknown date in Oct2021), described as "Swollen lymph nodes under left arm- from day of and resolved in approximately 2 weeks"; PYREXIA (non-serious) with onset 15Oct2021 at 09:00, outcome "recovered" (an unknown date in Oct2021), described as "Fever of up to 103"; INFLUENZA LIKE ILLNESS (non-serious) with onset 15Oct2021 at 09:00, outcome "recovered" (an unknown date in Oct2021), described as "General flu-like symptoms"; FATIGUE (non-serious) with onset 15Oct2021 at 09:00, outcome "recovered" (an unknown date in Oct2021), described as "fatigue - from hour 12-36". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, pyrexia, influenza like illness and fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 01Jan2022 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 09Jan2022, outcome "unknown", described as "tested positive for Covid". Relevant laboratory tests and procedures are available in the appropriate section. Action taken with respect to suspected vaccine is Not applicable.  Additional information: Investigation Assessment is not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: after her second Pfizer covid vaccination, in Sep2021, she developed Bell's Palsy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "after her second Pfizer covid vaccination, in Sep2021, she developed Bell's Palsy.".  Additional information: After her second Pfizer covid vaccination, in Sep2021, she developed Bells Palsy. The reporter seriousness was reported as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: Brain clot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown, Expiration date: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL THROMBOSIS (death, medically significant), outcome "fatal", described as "Brain clot". The patient date of death was unknown. The reported cause of death was cerebral thrombosis. It was not reported if an autopsy was performed. It was reported that 2 men was died from a brain clot after receiving Pfizer Covid Vaccine. One of the patients died on the way to the emergency department before they got to the hospital, but reporter was unable to clarify which of those 2 patients that was. Reporter did not know if patient died last night, several days ago or when.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200108937 same reporter, different patient; Reported Cause(s) of Death: Brain clot
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: Sore swollen right arm pit; Sore swollen right arm pit; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 (Lot number: FJ5683) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing) and "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: LISINOPRIL; ANASTROZOLE; CALCIUM, CLARITON and VITAMIN D3. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ELA262; Anatomical site: Right arm; Route of administration: Unspecified), administration date: 09Feb2021, when the patient was 48 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ENG199; Anatomical site: Right arm; Route of administration: Unspecified), administration date: 04Mar2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022, outcome "unknown", described as "Dose received: 3"; AXILLARY PAIN (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Sore swollen right arm pit"; SWELLING (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Sore swollen right arm pit". Therapeutic measures were not taken as a result of axillary pain and swelling.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Injection related reaction, Neoplasm, Vomiting
Clinical narrative: "puking violently"; severe reaction to the injections; CAPTURING THE STORY   This is a non-interventional study report.  A 58 year-old female patient received bnt162b2 (COMIRNATY), on Aug2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation; talimogene laherparepvec (TALIMOGENE LAHERPAREPVEC/ (T-VEC)) (Batch/Lot number: unknown). Relevant medical history included: "Melanoma", start date: Jan2015 (ongoing), notes: Surgery - Feb2015, Subsequent radiation therapy, pembrolizumab (KEYTRUDA), binimetinib (MEKTOVI), encorafenib (BRAFTOVI) 2015-2020, T-VEC - 2021. The patient's concomitant medications were unknown. The following information was reported: VOMITING (hospitalization) with onset Aug2021, outcome "recovered" (Aug2021), described as ""puking violently""; INJECTION RELATED REACTION (hospitalization) with onset Aug2021. During an interview about the patient's experiences before and throughout the COVID-19 pandemic, patient described receiving T-VEC injections in early 2021 (12 injections between Jan 2021 and April 2021) without serious side effects. Patient then received notification that the injections had effectively treated the existing tumors. However, in early August 2021 patient was notified that a new tumor was present, and would need to receive additional T-VEC injections. Patient then came down with COVID-19 in early August 2021 and had to postpone treatment. Patient's doctor then advised patient to receive the COVID-19 vaccine (patient was previously unvaccinated), which patient did so approximately 2 weeks after recovering from COVID-19. Patient then returned to received T-VEC injections approximately 10 days after receiving the first dose of the Pfizer COVID-19 vaccine, and had a severe reaction to the injections, including "puking violently" that required hospitalization. Patient's oncologist attempted T-VEC injections two additional times after that, and patient had a similar reaction each time. Additionally, approximately 13 new tumors had formed following receiving the COVID-19 vaccine. Patient attributes both the reactions and growth of new tumors to receiving the Pfizer COVID-19 vaccine. The action taken for study drug BNT162B2 was not applicable, while for talimogene laherparepvec was unknown. The outcome of events were recovered on Aug2021.  The investigator considered there was not a reasonable possibility that the events "puking violently" and "severe reaction to the injections" was related to bnt162b2. The causality assessment for interacting product talimogene laherparepvec was not provided.; Sender's Comments: Based on the current available information, a causal association between the suspect product BNT162B2 and the reported events vomiting, injection related reaction were considered as unrelated.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted COVID-19 from his wife/confirmed on the 5th by rapid test; contracted COVID-19 from his wife/confirmed on the 5th by rapid test; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right, administration date 02Nov2021 09:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 01Mar2021 13:00 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm right, administration date 09Feb2021 13:00 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: ATORVASTATIN; OZEMPIC; TRISIBAM; LISINOPRIL; SYNJARDY XR; LEVOTHYROXINE; VITAMIN E [TOCOPHERYL ACETATE]; ASPIRIN [ACETYLSALICYLIC ACID], and an unspecified multivitamin. Past drug history included: Hydromorphine, reaction(s): "known allergies: Hydromorphine". The following information was reported: IMMUNISATION (medically significant) with onset 02Nov2021 09:00, described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022 17:00, outcome "recovered" (Jan2022) and all described as "contracted COVID-19 from his wife/confirmed on the 5th by rapid test". The patient contracted COVID-19 from his wife on 05Jan2022. His wife was confirmed by PCR on 04Jan2022, while he was confirmed on 05Jan2022 by rapid test (positive). The events were reported as serious; however, it did not result in death, were not life-threatening, did not cause/prolonged hospitalization, were not disabling/incapacitating, nor resulted in congenital anomaly/birth defect. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 and was symptomatic after my doses and booster.; Tested positive for COVID-19 and was symptomatic after my doses and booster.; Tested positive for COVID-19 and was symptomatic after my doses and booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Jan2021 (Lot number: EL3247) at the age of 22 years as dose 1, single, administration date 04Feb2021 (Lot number: EL3247) as dose 2, single and administration date 29Sep2021 (Lot number: FE3592) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Wool" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 28Sep2021. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021, outcome "unknown", DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown" and all described as "Tested positive for COVID-19 and was symptomatic after my doses and booster."; ASYMPTOMATIC COVID-19 (medically significant) with onset 03Jan2022, outcome "recovered with sequelae", described as "Tested positive for COVID-19 and was symptomatic after my doses and booster.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, asymptomatic covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID 19; tested positive for COVID 19; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 28Oct2021 (Lot number: FF8839) at the age of 24 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 05Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 15Jan2021 (Lot number: EL3247) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient had no prior COVID-19 vaccination. The patient had no known allergies. The patient was not pregnant at time of vaccination. Concomitant medication(s) included: BLISOVI FE; SERTRALINE HCL; LORATADINE; FLU VACCINE VII. The following information was reported: IMMUNISATION (medically significant) with onset 28Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "recovered" and all described as "tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: Nasal swab: (28Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular, Swelling
Clinical narrative: Rash that lookedand felt like chicken pox on left upper part of my body; In addition another rash broke out on all other parts of my body that is still present; it is itchy; swelling; allergic to ingredients in the Shingrix vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced varicella-like rash, generalized rash, itchy rash, swelling and allergy to vaccine. On an unknown date, the outcome of the varicella-like rash and allergy to vaccine were unknown and the outcome of the generalized rash, itchy rash and swelling were not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash, generalized rash, itchy rash, swelling and allergy to vaccine to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received a dose of Shingrix and a day or two days after receiving the Shingrix vaccination, the patient was broken out with a rash that looked and felt like chicken pox on the left upper part of my body. In addition, another rash broke out on all other parts of his/her body that was still present. The patient stated that rash was itchy, and some swelling was present. The patient never had these types of breakouts but apparently allergic to ingredients in the Shingrix vaccine.  The patient asked that what were the ingredients.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Neck pain, Pain, Pain in jaw
Clinical narrative: fair bit of pain, including her glutes; has pain up the back of her neck; has pain all the way down to her lower back; pain in the jaw.; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2022 09:00, the patient received Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced pain, neck pain, back pain and jaw pain. On an unknown date, the outcome of the pain, neck pain, back pain and jaw pain were not recovered/not resolved.   The reporter considered the pain, neck pain, back pain and jaw pain to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient was in a fair bit of pain on the day of reporting. The reporter do not know exactly when the pain started. It was communicated to reporter that she had pain up the back of her neck, all the way down to her lower back including her glutes. The patient was also experiencing pain in the jaw. The patient reported of no redness or discoloration in the areas of reported pain. Consent to follow up was not possible as no contact details were available. The reporter thought the events were directly related to the Shingles shot she received last week.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered Shingrix with Merck diluent; administered Shingrix with Merck diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) (batch number 729PH, expiry date 9th April 2023) for prophylaxis.   On 27th December 2021, the patient received Shingrix. On 27th December 2021, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix where Merck diluent was used which led to the inappropriate reconstitution technique and incorrect dose administered. Consent to follow up was granted.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 27 year old male of unspecified race. Initial information was processed along with the additional information received on 21-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included: ankle surgery, and concurrent conditions included: alcoholic, and weed smoker, and other pre existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s(dose number in series:1) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, 1 total, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JAN-2022, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection( runny nose got a little heavier, a little bit of cough). Laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) rapid diagnostic test (NR: not provided) positive.(dose number in series:1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected clinical vaccination failure and suspected covid-19 infection. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000213496.  Additional information was received on 21-JAN-2022. The following information was updated and incorporated into the case narrative: product quality complaint number.; Sender's Comments: V0: 20220133740- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Breakthrough COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (breakthrough COVID-19 infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Antibody Response six months after SARS-CoV-2 mRNA Vaccination in patients with inflammatory bowel disease. Clinical Gastroenterology and Hepatology. Concurrent medical conditions included Inflammatory bowel disease. Concomitant products included IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) and MESALAMINE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (breakthrough COVID-19 infection) (seriousness criterion medically significant). At the time of the report, COVID-19 (breakthrough COVID-19 infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (breakthrough COVID-19 infection) to be related. Concomitant medication included glucocorticoids. Treatment information were not reported. One patient had breakthrough COVID-19 infection two months after Moderna vaccine was on immunosuppressive regimen. Company comment: This is a literature case concerning a patient of unknown age and gender, with concomitant treatment with immunosuppressive regimen, who experienced the serious (due to medically important condition) unexpected, AESI of COVID-19. The event occurred approximately 2 months after the mRNA-1273 vaccine, dose number not provided. The outcome of the event was not reported. The rechallenge was not applicable. The concomitant treatment with immunosuppressive regimen remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a literature case concerning a patient of unknown age and gender, with concomitant treatment with immunosuppressive regimen, who experienced the serious (due to medically important condition) unexpected, AESI of COVID-19. The event occurred approximately 2 months after the mRNA-1273 vaccine, dose number not provided. The outcome of the event was not reported. The rechallenge was not applicable. The concomitant treatment with immunosuppressive regimen remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Back pain, Gait disturbance
Clinical narrative: it felt like I got the flu bad.; could not sleep (kept tossing and turning for hours; had nightmares; felt wobbly when walking; I feel weak; my neck hurts; my back hurts; vaccine may have kicked up my arthritis symptoms; my shoulders hurt; I also felt like I had a fever; feel achy all over her body; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking) and ASTHENIA (I feel weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A and 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine in December 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Arthritis.   On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022 at 6:30 AM, the patient experienced INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body). At the time of the report, INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-455461 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Insomnia, Myalgia, Neck pain, Nightmare
Clinical narrative: it felt like I got the flu bad.; could not sleep (kept tossing and turning for hours; had nightmares; felt wobbly when walking; I feel weak; my neck hurts; my back hurts; vaccine may have kicked up my arthritis symptoms; my shoulders hurt; I also felt like I had a fever; feel achy all over her body; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking) and ASTHENIA (I feel weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A and 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine in December 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Arthritis.   On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022 at 6:30 AM, the patient experienced INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body). At the time of the report, INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-455461 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: it felt like I got the flu bad.; could not sleep (kept tossing and turning for hours; had nightmares; felt wobbly when walking; I feel weak; my neck hurts; my back hurts; vaccine may have kicked up my arthritis symptoms; my shoulders hurt; I also felt like I had a fever; feel achy all over her body; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking) and ASTHENIA (I feel weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A and 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine in December 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Arthritis.   On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022 at 6:30 AM, the patient experienced INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body). At the time of the report, INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-455461 (Patient Link).
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator; Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator). On 18-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vial was initially stored in refrigerator on 17-Dec-2021 and the vial did not undergo any temperature excursions.   This case was linked to MOD-2022-456307 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccine Injury has caused serious problems / flipped my life upside down; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine Injury has caused serious problems / flipped my life upside down) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine Injury has caused serious problems / flipped my life upside down). At the time of the report, VACCINATION COMPLICATION (Vaccine Injury has caused serious problems / flipped my life upside down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. No treatment medications are provided.