chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain
Clinical narrative: any and all of its sequelae; shingles; Information has been received from a lawyer, concerning a case in litigation and refers to a 70-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not repoted. In 2014 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administraton, lot # and expiration date were not reported) by a physician. Patient was 68 years old when he received zoster vaccine live (ZOSTAVAX) vaccine. As a result of his receipt of zoster vaccine live (ZOSTAVAX), on 02-OCT-2017, patient was caused to suffer shingles, including any and all of its sequelaes. As a result of his receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient  was caused to suffer serious and dangerous side effects including Shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient  requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The outcome of shingles, including any and all of its sequelaes was unknown. The reporter considered shingles, including any and all of its sequelaes to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; Information has been received from a lawyer regarding a case in litigation and  refers to a patient of unknown age and gender. Pt's concurrent conditions, medical history and concomitant therapy were not reported. Pt was inoculated with zoster vaccine live (ZOSTAVAX)  on or about 24-OCT-2010, as prescribed and/or administered by a healthcare provider at a health center for the long-term prevention of herpes zoster or shingles. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider at the health center for shingles and other zoster related injuries. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the events was reported as not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Neurological symptom, Ophthalmic herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster ophthalmicus; loss of vision; postherpetic neuralgia; serious other neurological issues; herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered herpes zoster, herpes zoster ophthalmicus, postherpetic neuralgia, loss of vision and serious other neurological issues. As a result of these symptoms, patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experience mental and emotional distresscdue to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, patient have suffering incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     Upon internal revie events of herpes zoster ophthalmicus, loss of vision and serious other neurological issues were determined to be medically significant. All events were determined to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: mild flu-like reaction; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles before). Previously administered products included Shingles vaccine with an associated reaction of influenza like illness (received 1st dose on an unknown date and had mild flu-like reaction, refer case US2021AMR208487).   In October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had just finished his/her 2nd Shingles shot over the weekend and had a mild flu-like reaction. The patient had shingles before and was hoping to not have it again.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208487:same patient and reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Condition aggravated, Herpes zoster, Injection site pain
Clinical narrative: Pain in her right hip/pain; Blisters in the right hip area; Full-blown case of shingles/blisters, which patient thinks is shingles; Sore arm (at injection site)/sore arm, which is anticipated; This case was reported by a physician via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3S3X7, expiry date 20th March 2023) for prophylaxis.   The patient's past medical history included shingles (patient had shingles episode 26 years ago). Concurrent medical conditions included pain in arm (patient has a normal and regular condition of sore arm).   On 30th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 1st October 2021, the patient experienced pain in hip. In October 2021, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles, pain in arm, pain in hip and blister were not recovered/not resolved.   The reporter considered the shingles, pain in arm, pain in hip and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix shot in the left deltoid and reported sore arm in her left arm  that was anticipated; but had not yet resolved as of the time/date of reporting. On next day after vaccination, the patient started having pain in her right hip Two days after vaccination; in the morning, within 48 hours, she woke up with blisters in the right hip area.  The patient was sure that the blisters were shingles. The patient developed a full-blown case of shingles within 48 hours of Shingrix shot and she did attribute that to Shingrix. The patient consented to follow-up via e-mail.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206983:SAME REPORTER - FU1 - deleted from database
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in her right hip/pain; Blisters in the right hip area; Full-blown case of shingles/blisters, which patient thinks is shingles; Sore arm (at injection site)/sore arm, which is anticipated; This case was reported by a physician via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3S3X7, expiry date 20th March 2023) for prophylaxis.   The patient's past medical history included shingles (patient had shingles episode 26 years ago). Concurrent medical conditions included pain in arm (patient has a normal and regular condition of sore arm).   On 30th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 1st October 2021, the patient experienced pain in hip. In October 2021, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles, pain in arm, pain in hip and blister were not recovered/not resolved.   The reporter considered the shingles, pain in arm, pain in hip and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix shot in the left deltoid and reported sore arm in her left arm  that was anticipated; but had not yet resolved as of the time/date of reporting. On next day after vaccination, the patient started having pain in her right hip Two days after vaccination; in the morning, within 48 hours, she woke up with blisters in the right hip area.  The patient was sure that the blisters were shingles. The patient developed a full-blown case of shingles within 48 hours of Shingrix shot and she did attribute that to Shingrix. The patient consented to follow-up via e-mail.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206983:SAME REPORTER - FU1 - deleted from database
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Pain in extremity
Clinical narrative: Arm soreness; Fatigue; Racing  pulse; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, fatigue and pulse rapid. On an unknown date, the outcome of the pain in arm, fatigue and pulse rapid were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and pulse rapid to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine approximately 4 or 5 months ago (reporter was not sure of exact date) and experienced arm soreness, fatigue, and racing pulse. The patient reported all symptoms resolved after approximately 2 to 3 hours. The reporter did not want to provide more information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: advised her not to get no second dose during the pandemic; This case was reported by a consumer via call center representative and described the occurrence of off label use in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose Intramuscularly on an unknown date in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not applicable for this report. The reporter reported that her health care professional advised her not to get second dose during the pandemic, which led to off label use by the health care professional.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: waited 13/14 months to receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, 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 details were reported as follows: The pharmacist reported that the patient was around 60 years old. The age at vaccination was not reported. The pharmacist was looking for guidance on Havrix schedule if a patient waited 13/14 months to receive second dose, which led to lengthening of vaccination schedule. The pharmacist was in a super rush during the call, no additional info was given. The pharmacist did not consent to follow- up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021 at 2:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. The patient was monitored after Moderna  COVID vaccine was administered for 15 min. Pt was ok and left home after 15 min observation.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Non- Significant Follow-up received on 07-OCT-2021 contains patient condition (patient was monitored after Moderna Covid vaccine was administered for 15 min. Pt was ok and left home after 15 min observation).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: BREAKTHROUGH COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via news report concerned a 70 year old male. The patient's height, and weight were not reported. On an unspecified date in the year 2020 the patient had covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date in SEP-2021, the patient experienced breakthrough covid-19 infection (suspected clinical vaccination failure), was hospitalized (date unspecified) and eventually intubated. At the time of reporting the patient was on ventilation. The family members are seeking for the option of extracorporeal membrane oxygenation treatment for the patient. The number of hospitalization days was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0- 20211014827-covid-19 vaccine ad26.cov2 s- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS 20211014827-covid-19 vaccine ad26.cov2. s Breakthrough covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pain
Clinical narrative: INSOMNIA; WORSE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced insomnia. On 06-OCT-2021, the patient experienced worse pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the insomnia and worse pain was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dry mouth, Fatigue, Feeling abnormal
Clinical narrative: Blowing her nose; Coughing; Sick; She feels she is getting worse; Head started hurting; Really tired; Mouth became dry; Sore throat; Thirsty; She feels like crap (per MCC agent); This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Mouth became dry), OROPHARYNGEAL PAIN (Sore throat), THIRST (Thirsty), RHINORRHOEA (Blowing her nose) and COUGH (Coughing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced DRY MOUTH (Mouth became dry), OROPHARYNGEAL PAIN (Sore throat), THIRST (Thirsty), FEELING ABNORMAL (She feels like crap (per MCC agent)) and FATIGUE (Really tired). On 08-Jul-2021, the patient experienced HEADACHE (Head started hurting). On 09-Jul-2021, the patient experienced RHINORRHOEA (Blowing her nose), COUGH (Coughing), MALAISE (Sick) and CONDITION AGGRAVATED (She feels she is getting worse). At the time of the report, DRY MOUTH (Mouth became dry), OROPHARYNGEAL PAIN (Sore throat), THIRST (Thirsty), RHINORRHOEA (Blowing her nose), COUGH (Coughing), MALAISE (Sick), FEELING ABNORMAL (She feels like crap (per MCC agent)), HEADACHE (Head started hurting) and FATIGUE (Really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient gets a flu shot and pneumonia shot earlier.  No concomitant product use was provided by the reporter.  Treatment medication included doctor told to use Chloro-septic.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: TCR document attached and reporter address updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Oropharyngeal pain, Rhinorrhoea, Thirst
Clinical narrative: Blowing her nose; Coughing; Sick; She feels she is getting worse; Head started hurting; Really tired; Mouth became dry; Sore throat; Thirsty; She feels like crap (per MCC agent); This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Mouth became dry), OROPHARYNGEAL PAIN (Sore throat), THIRST (Thirsty), RHINORRHOEA (Blowing her nose) and COUGH (Coughing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced DRY MOUTH (Mouth became dry), OROPHARYNGEAL PAIN (Sore throat), THIRST (Thirsty), FEELING ABNORMAL (She feels like crap (per MCC agent)) and FATIGUE (Really tired). On 08-Jul-2021, the patient experienced HEADACHE (Head started hurting). On 09-Jul-2021, the patient experienced RHINORRHOEA (Blowing her nose), COUGH (Coughing), MALAISE (Sick) and CONDITION AGGRAVATED (She feels she is getting worse). At the time of the report, DRY MOUTH (Mouth became dry), OROPHARYNGEAL PAIN (Sore throat), THIRST (Thirsty), RHINORRHOEA (Blowing her nose), COUGH (Coughing), MALAISE (Sick), FEELING ABNORMAL (She feels like crap (per MCC agent)), HEADACHE (Head started hurting) and FATIGUE (Really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient gets a flu shot and pneumonia shot earlier.  No concomitant product use was provided by the reporter.  Treatment medication included doctor told to use Chloro-septic.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: TCR document attached and reporter address updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Facial discomfort, Hypoaesthesia, Limb discomfort, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: numbness in left hand side of his face/ numbness in neck/numbness in arm; discomfort in left hand side of his face; discomfort in neck; discomfort in arm; This feeling of numbness quickly became more uncomfortable as the days progressed; He also elected not to take his second dose; The lymph nodes in his neck also swelled to a level which made it uncomfortable for him to swallow; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left hand side of his face/ numbness in neck/numbness in arm), FACIAL DISCOMFORT (discomfort in left hand side of his face), MUSCULOSKELETAL DISCOMFORT (discomfort in neck), LIMB DISCOMFORT (discomfort in arm) and HYPOAESTHESIA (This feeling of numbness quickly became more uncomfortable as the days progressed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left hand side of his face/ numbness in neck/numbness in arm), FACIAL DISCOMFORT (discomfort in left hand side of his face), MUSCULOSKELETAL DISCOMFORT (discomfort in neck), LIMB DISCOMFORT (discomfort in arm), HYPOAESTHESIA (This feeling of numbness quickly became more uncomfortable as the days progressed), PRODUCT DOSE OMISSION ISSUE (He also elected not to take his second dose) and LYMPHADENOPATHY (The lymph nodes in his neck also swelled to a level which made it uncomfortable for him to swallow). At the time of the report, HYPOAESTHESIA (numbness in left hand side of his face/ numbness in neck/numbness in arm), FACIAL DISCOMFORT (discomfort in left hand side of his face), LIMB DISCOMFORT (discomfort in arm), HYPOAESTHESIA (This feeling of numbness quickly became more uncomfortable as the days progressed) and LYMPHADENOPATHY (The lymph nodes in his neck also swelled to a level which made it uncomfortable for him to swallow) outcome was unknown and MUSCULOSKELETAL DISCOMFORT (discomfort in neck) and PRODUCT DOSE OMISSION ISSUE (He also elected not to take his second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: lymph nodes were 22mm by  18mm in size lymph nodes were 22mm by  18mm in size.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Scan
Clinical narrative: numbness in left hand side of his face/ numbness in neck/numbness in arm; discomfort in left hand side of his face; discomfort in neck; discomfort in arm; This feeling of numbness quickly became more uncomfortable as the days progressed; He also elected not to take his second dose; The lymph nodes in his neck also swelled to a level which made it uncomfortable for him to swallow; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left hand side of his face/ numbness in neck/numbness in arm), FACIAL DISCOMFORT (discomfort in left hand side of his face), MUSCULOSKELETAL DISCOMFORT (discomfort in neck), LIMB DISCOMFORT (discomfort in arm) and HYPOAESTHESIA (This feeling of numbness quickly became more uncomfortable as the days progressed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left hand side of his face/ numbness in neck/numbness in arm), FACIAL DISCOMFORT (discomfort in left hand side of his face), MUSCULOSKELETAL DISCOMFORT (discomfort in neck), LIMB DISCOMFORT (discomfort in arm), HYPOAESTHESIA (This feeling of numbness quickly became more uncomfortable as the days progressed), PRODUCT DOSE OMISSION ISSUE (He also elected not to take his second dose) and LYMPHADENOPATHY (The lymph nodes in his neck also swelled to a level which made it uncomfortable for him to swallow). At the time of the report, HYPOAESTHESIA (numbness in left hand side of his face/ numbness in neck/numbness in arm), FACIAL DISCOMFORT (discomfort in left hand side of his face), LIMB DISCOMFORT (discomfort in arm), HYPOAESTHESIA (This feeling of numbness quickly became more uncomfortable as the days progressed) and LYMPHADENOPATHY (The lymph nodes in his neck also swelled to a level which made it uncomfortable for him to swallow) outcome was unknown and MUSCULOSKELETAL DISCOMFORT (discomfort in neck) and PRODUCT DOSE OMISSION ISSUE (He also elected not to take his second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: lymph nodes were 22mm by  18mm in size lymph nodes were 22mm by  18mm in size.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Mouth injury
Clinical narrative: issues with their mouth; blisters under her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MOUTH INJURY (issues with their mouth) and BLISTER (blisters under her mouth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOUTH INJURY (issues with their mouth) and BLISTER (blisters under her mouth). At the time of the report, MOUTH INJURY (issues with their mouth) and BLISTER (blisters under her mouth) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included antivirals, antibiotics, steroids in three four different times.
Sex: M
Vaccine: COVID19
Symptoms: B-cell lymphoma
Clinical narrative: Diagnosed with B-Cell Lymphoma; This spontaneous case was reported by a physician and describes the occurrence of B-CELL LYMPHOMA (Diagnosed with B-Cell Lymphoma) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced B-CELL LYMPHOMA (Diagnosed with B-Cell Lymphoma) (seriousness criterion medically significant). The patient was treated with RITUXIMAB (RITUXAN) for B-cell lymphoma, at an unspecified dose and frequency. At the time of the report, B-CELL LYMPHOMA (Diagnosed with B-Cell Lymphoma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not Applicable.  Company comment: This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of B-cell Lymphoma approximately 2 months after the second dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of B-cell Lymphoma approximately 2 months after the second dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site arm hurt after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm hurt after first vaccination) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm hurt after first vaccination). At the time of the report, VACCINATION SITE PAIN (injection site arm hurt after first vaccination) 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 did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-339177 (Patient Link).   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Numbness from injection site down to fingertips/Vaccination site hypoaesthesia; Tingling from injection site down to fingertips; Sore when it comes back/ soreness is constant; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness from injection site down to fingertips/Vaccination site hypoaesthesia), VACCINATION SITE PARAESTHESIA (Tingling from injection site down to fingertips) and VACCINATION SITE PAIN (Sore when it comes back/ soreness is constant) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dog bite (he was bitten by a dog in the right arm).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness from injection site down to fingertips/Vaccination site hypoaesthesia), VACCINATION SITE PARAESTHESIA (Tingling from injection site down to fingertips) and VACCINATION SITE PAIN (Sore when it comes back/ soreness is constant). At the time of the report, HYPOAESTHESIA (Numbness from injection site down to fingertips/Vaccination site hypoaesthesia), VACCINATION SITE PARAESTHESIA (Tingling from injection site down to fingertips) and VACCINATION SITE PAIN (Sore when it comes back/ soreness is constant) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient said that his numbness & tingling was from injection site down to fingertips. His soreness was constant, but the numbness & tingling are not.   No treatment details were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Frustration tolerance decreased, Hypoaesthesia, Nausea
Clinical narrative: Numbness in hands and Feet feels like carpel tunnel; Frustrated; Chills after second Shot; Tired after second Shot; Nauseous after second Shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands and Feet feels like carpel tunnel), FRUSTRATION TOLERANCE DECREASED (Frustrated), CHILLS (Chills after second Shot), FATIGUE (Tired after second Shot) and NAUSEA (Nauseous after second Shot) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced HYPOAESTHESIA (Numbness in hands and Feet feels like carpel tunnel), FRUSTRATION TOLERANCE DECREASED (Frustrated), CHILLS (Chills after second Shot), FATIGUE (Tired after second Shot) and NAUSEA (Nauseous after second Shot). On 24-Sep-2021, CHILLS (Chills after second Shot) had resolved. On 28-Sep-2021, FATIGUE (Tired after second Shot) and NAUSEA (Nauseous after second Shot) had resolved. At the time of the report, HYPOAESTHESIA (Numbness in hands and Feet feels like carpel tunnel) and FRUSTRATION TOLERANCE DECREASED (Frustrated) outcome was unknown.            The patient has 2 years old baby and still breastfeeding but baby has no issues.  No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-339349 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Interchange of vaccine products
Clinical narrative: Mixed product; Headache; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed product), HEADACHE (Headache) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE ASTRAZENECA on 23-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE ASTRAZENECA.    On 26-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed product), HEADACHE (Headache) and CHILLS (Chills). On 26-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Mixed product) had resolved. On 29-Jun-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Patient received her first dose of AstraZeneca on 23-March-2021 and second dose of Moderna on 26-June 2021. Patient experienced headache and chills for about 2-3 days following the Moderna shot.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Pruritus, Skin mass, Urticaria
Clinical narrative: Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps; itchiness; redness; hives in LEFT side from armpit until above of his chest with clumps; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps), PRURITUS (itchiness), ERYTHEMA (redness), SKIN MASS (hives in LEFT side from armpit until above of his chest with clumps) and INJECTION SITE PAIN (injection site pain) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Environmental allergy (Sneezes when dusty). Concomitant products included MELATONIN for Sleep disorder.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 03-Oct-2021, the patient experienced URTICARIA (Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps), PRURITUS (itchiness), ERYTHEMA (redness) and SKIN MASS (hives in LEFT side from armpit until above of his chest with clumps). On 01-Oct-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, URTICARIA (Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps), PRURITUS (itchiness), ERYTHEMA (redness) and SKIN MASS (hives in LEFT side from armpit until above of his chest with clumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Feeling abnormal, Pain in extremity, Pyrexia, Rash
Clinical narrative: Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.; Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.; Felt awfull; hair loss/last two months symptoms have been only getting worse; intense rash in the scalp/last two months symptoms have been only getting worse; Experienced 101F fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.), SKIN DISCOLOURATION (Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.), FEELING ABNORMAL (Felt awfull), ALOPECIA (hair loss/last two months symptoms have been only getting worse) and RASH (intense rash in the scalp/last two months symptoms have been only getting worse) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Stress. Concomitant products included TRAZODONE for Stress.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Not applicable) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.), SKIN DISCOLOURATION (Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.), FEELING ABNORMAL (Felt awfull), ALOPECIA (hair loss/last two months symptoms have been only getting worse), RASH (intense rash in the scalp/last two months symptoms have been only getting worse) and PYREXIA (Experienced 101F fever). The patient was treated with CLOBETASOL for Dermatitis and Psoriasis, at an unspecified dose and frequency; SODIUM PROPIONATE (PROPIONATE) for Dermatitis and Psoriasis, at an unspecified dose and frequency and CICLOPIROX for Dermatitis and Psoriasis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.), SKIN DISCOLOURATION (Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.), FEELING ABNORMAL (Felt awfull), ALOPECIA (hair loss/last two months symptoms have been only getting worse), RASH (intense rash in the scalp/last two months symptoms have been only getting worse) and PYREXIA (Experienced 101F fever) outcome was unknown.            This case was linked to MOD-2021-339439 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.; Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.; Felt awfull; hair loss/last two months symptoms have been only getting worse; intense rash in the scalp/last two months symptoms have been only getting worse; Experienced 101F fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.), SKIN DISCOLOURATION (Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.), FEELING ABNORMAL (Felt awfull), ALOPECIA (hair loss/last two months symptoms have been only getting worse) and RASH (intense rash in the scalp/last two months symptoms have been only getting worse) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Stress. Concomitant products included TRAZODONE for Stress.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Not applicable) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.), SKIN DISCOLOURATION (Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.), FEELING ABNORMAL (Felt awfull), ALOPECIA (hair loss/last two months symptoms have been only getting worse), RASH (intense rash in the scalp/last two months symptoms have been only getting worse) and PYREXIA (Experienced 101F fever). The patient was treated with CLOBETASOL for Dermatitis and Psoriasis, at an unspecified dose and frequency; SODIUM PROPIONATE (PROPIONATE) for Dermatitis and Psoriasis, at an unspecified dose and frequency and CICLOPIROX for Dermatitis and Psoriasis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)\last two months symptoms have been only getting worse.), SKIN DISCOLOURATION (Covid toes( feet hurting, red/purple colorationlast two months symptoms have been only getting worse.), FEELING ABNORMAL (Felt awfull), ALOPECIA (hair loss/last two months symptoms have been only getting worse), RASH (intense rash in the scalp/last two months symptoms have been only getting worse) and PYREXIA (Experienced 101F fever) outcome was unknown.            This case was linked to MOD-2021-339439 (Patient Link).