chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia
Clinical narrative: Diarrhea; Everything hurts in her body; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and MYALGIA (Everything hurts in her body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included VITAMINS NOS for Supplementation therapy, LISINOPRIL, METOPROLOL, SERTRALINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced MYALGIA (Everything hurts in her body). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown and MYALGIA (Everything hurts in her body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my neighbor is experiencing lower leg pain that is debilitating; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (my neighbor is experiencing lower leg pain that is debilitating) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my neighbor is experiencing lower leg pain that is debilitating). At the time of the report, PAIN IN EXTREMITY (my neighbor is experiencing lower leg pain that is debilitating) outcome was unknown.            No concurrent and treatment medication was reported by patient.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9-7-2021 contains significant information. patient demographic updated.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only first dose was received/not been able to take the second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only first dose was received/not been able to take the second dose) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (only first dose was received/not been able to take the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only first dose was received/not been able to take the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears keeps coming and going; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears keeps coming and going) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced TINNITUS (Ringing in ears keeps coming and going). At the time of the report, TINNITUS (Ringing in ears keeps coming and going) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Swelling
Clinical narrative: Golf ball size swelling on Left armpit,Bubbling and cyst; Missed 2nd dose of Moderna vaccine on recommended interval; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Golf ball size swelling on Left armpit,Bubbling and cyst) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval). On 08-Apr-2021, the patient experienced SWELLING (Golf ball size swelling on Left armpit,Bubbling and cyst). At the time of the report, SWELLING (Golf ball size swelling on Left armpit,Bubbling and cyst) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) had resolved.            No concomitant medications reported. The patient received second Moderna vaccine on right arm on 18May2021 and no symptom after vaccine administration. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.; Itchy on the head; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.) and PRURITUS (Itchy on the head) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced URTICARIA (Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.) and PRURITUS (Itchy on the head). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and CORTISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.) and PRURITUS (Itchy on the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patients were given vaccine that was stored in refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patients were given vaccine that was stored in refrigerator for more than 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) 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 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patients were given vaccine that was stored in refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patients were given vaccine that was stored in refrigerator for more than 30 days) had resolved.        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.   Patient was  not sure if it was 1st or 2nd dose for patients. The vaccine was given on 03Jun2021 from 1 vial and 07Jun2021 from another vial with same batch number and expiration date.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Myalgia
Clinical narrative: Muscle Soreness; Not feeling herself; being sick; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Soreness), FEELING ABNORMAL (Not feeling herself) and ILLNESS (being sick) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle Soreness), FEELING ABNORMAL (Not feeling herself) and ILLNESS (being sick). At the time of the report, MYALGIA (Muscle Soreness), FEELING ABNORMAL (Not feeling herself) and ILLNESS (being sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Vaccination site bruising
Clinical narrative: bruise at injection site; metallic taste mouth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at injection site) and DYSGEUSIA (metallic taste mouth) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE BRUISING (bruise at injection site) and DYSGEUSIA (metallic taste mouth). At the time of the report, VACCINATION SITE BRUISING (bruise at injection site) and DYSGEUSIA (metallic taste mouth) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-214739 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Head discomfort, Headache
Clinical narrative: Bad flue symptoms; Cough; Nasal congestion; Head congestion; Cheats; Severe headach; Chills; Low fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Bad flue symptoms), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEAD DISCOMFORT (Head congestion) and FEELING ABNORMAL (Cheats) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Bad flue symptoms), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEAD DISCOMFORT (Head congestion), FEELING ABNORMAL (Cheats), HEADACHE (Severe headach), CHILLS (Chills) and PYREXIA (Low fever). At the time of the report, INFLUENZA LIKE ILLNESS (Bad flue symptoms), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEAD DISCOMFORT (Head congestion), FEELING ABNORMAL (Cheats), HEADACHE (Severe headach), CHILLS (Chills) and PYREXIA (Low fever) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Nasal congestion, Pyrexia
Clinical narrative: Bad flue symptoms; Cough; Nasal congestion; Head congestion; Cheats; Severe headach; Chills; Low fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Bad flue symptoms), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEAD DISCOMFORT (Head congestion) and FEELING ABNORMAL (Cheats) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Bad flue symptoms), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEAD DISCOMFORT (Head congestion), FEELING ABNORMAL (Cheats), HEADACHE (Severe headach), CHILLS (Chills) and PYREXIA (Low fever). At the time of the report, INFLUENZA LIKE ILLNESS (Bad flue symptoms), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEAD DISCOMFORT (Head congestion), FEELING ABNORMAL (Cheats), HEADACHE (Severe headach), CHILLS (Chills) and PYREXIA (Low fever) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Night sweats, Pyrexia, Vomiting
Clinical narrative: Thinks she had night sweats after 1st dose; she is so sick after the 1st dose; Threw up all night long after 1st dose/Throwing up everything after 1st dose; Thinks she had fever after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Thinks she had night sweats after 1st dose), ILLNESS (she is so sick after the 1st dose), VOMITING (Threw up all night long after 1st dose/Throwing up everything after 1st dose) and PYREXIA (Thinks she had fever after 1st dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-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 NIGHT SWEATS (Thinks she had night sweats after 1st dose), ILLNESS (she is so sick after the 1st dose), VOMITING (Threw up all night long after 1st dose/Throwing up everything after 1st dose) and PYREXIA (Thinks she had fever after 1st dose). At the time of the report, NIGHT SWEATS (Thinks she had night sweats after 1st dose), ILLNESS (she is so sick after the 1st dose), VOMITING (Threw up all night long after 1st dose/Throwing up everything after 1st dose) and PYREXIA (Thinks she had fever after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she thought she received Johnson and Johnson but later she was informed that she received Moderna COVID 19 vaccine.  No concomitant medications were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Head discomfort
Clinical narrative: burst blood vessels in the left eye / "red spot in the left eye."; felt a loud noise in the head, last night while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (burst blood vessels in the left eye / "red spot in the left eye.") and HEAD DISCOMFORT (felt a loud noise in the head, last night while sleeping) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAD DISCOMFORT (felt a loud noise in the head, last night while sleeping). On 09-Jun-2021, the patient experienced EYE HAEMORRHAGE (burst blood vessels in the left eye / "red spot in the left eye."). At the time of the report, EYE HAEMORRHAGE (burst blood vessels in the left eye / "red spot in the left eye.") and HEAD DISCOMFORT (felt a loud noise in the head, last night while sleeping) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient did not receive any treatment.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-214739, MOD-2021-214735 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A vial of Moderna was opened 30 days prior to administration of the vaccine on the date of 8 August 2021.    The vaccination was given outside the 12-hour use limit on punctured vials per the manufactures recommendations.   Moderna was contacted and the clinic has been informed that the members that received the vaccination is considered vaccinated since the members had the usual reactions to the vaccination.    There was no additional testing or treatment provided.  This is being reported since there was an error in the administration process.  There were no adverse reactions.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A vial of Moderna was opened 30 days prior to administration of the vaccine on the date of 8 August 2021.    The vaccination was given outside the 12-hour use limit on punctured vials per the manufactures recommendations.   Moderna was contacted and the clinic has been informed that the members that received the vaccination is considered vaccinated since the members had the usual reactions to the vaccination.    There was no additional testing or treatment provided.  This is being reported since there was an error in the administration process.  There were no adverse reactions.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Injection site swelling, Lymphadenopathy, Nasal congestion
Clinical narrative: fatigue, stuffy nose, cough, fever, swollen lymph nodes in right armpit, swelling at injection site
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue, stuffy nose, cough, fever, swollen lymph nodes in right armpit, swelling at injection site
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal, Red blood cell sedimentation rate normal
Clinical narrative: chest pain described as burning over all anterior chest area with associated SOB
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: chest pain described as burning over all anterior chest area with associated SOB
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Decreased appetite, Dissociation, Disturbance in attention, Dizziness
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Muscle spasms, Muscle twitching
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Arthralgia, Asthenia, Balance disorder, Blood test
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling abnormal, Feeling drunk
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypersomnia, Hypoaesthesia, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, Paraesthesia, Pruritus, SARS-CoV-2 test negative
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Pfizer-BioTech Covid-19 Vaccine EUA Friday after shot- weak, dizzy, itchy. Nurse gave benadryl. Waited 30 mins and sent home.  Extremely tired and no appetite.  Saturday- left arm sore/swollen, extremely tired, no appetite, feel foggy/disconnected, weak, can't concentrate.  Sunday- foggy/disconnected,  left arm and leg have nerve twitches/numbness/pins and needles/cramps. Right arm and leg numb on and off. No appetite. Muscle spasms in left forearm and leg.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient called store on Saturday August 21 to tell me she had a reaction to the shot. She said it was hot, red and swollen
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: numbness noted around lips/mouth, as well as both hands and arms after receiving the vaccine in the pharmacy by the pharmacist. pt admits to feeling anxious/nervous, likely cause of symptoms. symptoms self resolved within a day.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on groin, behind knees, antecubital fossa, and under arms; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash on groin, behind knees, antecubital fossa, and under arms) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced RASH (Rash on groin, behind knees, antecubital fossa, and under arms). At the time of the report, RASH (Rash on groin, behind knees, antecubital fossa, and under arms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH (Rash on groin, behind knees, antecubital fossa, and under arms) to be possibly related.    No treatment medication was received.  It was reported that, patient had very itchy urticarial rash, at times measles like that is persistent. Worsens with heat.  Patient is on fertility treatment.  In the follow up patient states that she is still suffering from rash.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up received and patient is still having issues with rash
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; PROQUAD temperature excursion; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 23-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T030944, expiration date 09-MAR-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 14 degrees Fahrenheit (F) and 46 degrees Fahrenheit (26.6 F) for the time frame of 3 hours and 20 minutes. There was no previous temperature excursion. Digital Data Logger was not involved. No adverse event was reported.  ; Sender's Comments:  US-009507513-2107USA008378: US-009507513-2107USA008671:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller reported a dose of GARDASIL 9 that experienced a temperature excursion was administered to a patient; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 09-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliters (ml) (vaccination scheme frequency, route and anatomical location of administration were not reported; lot number T029522, expiration date reported as 13-MAR-2022, but upon internal validation established as:13-MAR-2023) as prophylaxis (product storage error).  The involved vaccine underwent, on an unspecified date, a temperature excursion between -4.8 degree Celsius (C) for a time frame of 20 minutes (min). There was not reported previous temperature excursions. It was unknown if the digital data logger was involved. No additional adverse events (AE) were reported.  This was one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA003135: US-009507513-2108USA003288: US-009507513-2108USA003314: US-009507513-2108USA003100: US-009507513-2108USA003267: US-009507513-2108USA003288:
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional aderse event reported; VARIVAX that was administered to a patient a few days before his 12 month; This spontaneous report was received from an office manager and refers to a 11-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-NOV-2007, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). There was no additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Eye pain, Feeling abnormal, Herpes zoster, Incomplete course of vaccination
Clinical narrative: gave me shingles/felt like a stick in my eye; allergic to the shot; scratching and inching my forehead; scar tissue behind my eye; gave me shingles; This case was reported by a consumer via media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), allergy, pruritus, scar and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster, allergy, pruritus, scar and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, allergy, pruritus, scar and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingles shot and experienced shingles it felt like a stick in her/his eye it was awful and allergic to the shot and there's no way patient was having a second dose.  Two years later patient still scratching and inching her/his forehead and now have scar tissue behind her/his eye from it. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pruritus, Scar
Clinical narrative: gave me shingles/felt like a stick in my eye; allergic to the shot; scratching and inching my forehead; scar tissue behind my eye; gave me shingles; This case was reported by a consumer via media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), allergy, pruritus, scar and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster, allergy, pruritus, scar and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, allergy, pruritus, scar and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingles shot and experienced shingles it felt like a stick in her/his eye it was awful and allergic to the shot and there's no way patient was having a second dose.  Two years later patient still scratching and inching her/his forehead and now have scar tissue behind her/his eye from it. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The shot gave me shingles in my face; shingles in my face; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend.  The age at vaccination was not reported. The patient reported that getting the shot was not always the best idea.  After the shot the patient experienced shingles on face. Prior to getting the shot the physician guaranteed the patient about no side effects. After the shot and shingles, the physician said sometimes it happens. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation shingles was not reported. The case has been linked with the case US2021AMR174927 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174927:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said he/she had to take the 2 dose shot, made sick with the side effects. Here conservatively taken 2nd dose as suspect as no contact details were reported for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: these hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date and experienced hurt refer case US2021AMR175049).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the 2nd shot last week from the date of reporting.  The patient could take shots very easy but these hurt.  The patient said he/she would rather have the shots than the Shingles for sure. No contact details were reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175049:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: these hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that after received 1st shot of Shingrix it hurt. No contact details were reported. For tolerance in 2nd dose refer case US2021AMR175027.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175027:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: feels like a train ran over me; This case was reported by a consumer via  interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 2nd shot and felt like train ran over him/her.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body was super achy; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had received first dose of shingles vaccine. The next day the patient's body was super achy. It only lasted for a day.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: mild case of the shingles / was only on my arm; The pain was incredible / was only on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain in arm. On an unknown date, the outcome of the shingles and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shingles and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient experienced a very mild case of the shingles from the first dose of the vaccine.  The patient did not experience any reaction to the second dose, so not regret getting vaccine. The patient reported that he/she could not imagine a full blown case of the shingles. The pain was incredible, and it was only on my arm.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; worst pain; This case was reported by a consumer via interactive digital media ( and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received shingles the shot and still had the shingles. The patient reported that it was worst pain ever. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation shingles was not reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: area / hot to touch; hives at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   Concurrent medical conditions included shingles (patient has had shingles 3 to 4 times throughout her lifetime).   On 28th July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site warmth and injection site hives. On an unknown date, the outcome of the injection site warmth and injection site hives were unknown.   It was unknown if the reporter considered the injection site warmth and injection site hives to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced large area of hives at injection site, the affected area was about 6 inches in diameter and was hot to touch. The reporter consented to follow up.
Age: 32.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 32 year old / received Infanrix; Intended vaccine was Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 32-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported that the 32 years old patient inadvertently received Infanrix  in the right deltoid, which led to inappropriate age at vaccine administration. The Intended vaccine was Boostrix , which led to wrong vaccine administered. The reporter consented to follow up. This is 1 of the 2  linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173224:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than 6 months since I got the first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020, in right deltoid by intramuscular route).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix due to financial constraints , which led to incomplete course of vaccination. The patient just tried to get the second dose at a pharmacy, but they would not give it to her without her calling Glaxosmithkline to find out if she needed to restart the series. The patient stated that, she was going to go back today to get the second dose. Gave medical disclaimer. The reporter consented to follow up.