chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Put into the refrigerator on 7OCT2021 and given on 8NOV2021 and 9NOV2021) 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.In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT STORAGE ERROR (Put into the refrigerator on 7OCT2021 and given on 8NOV2021 and 9NOV2021). In November 2021, PRODUCT STORAGE ERROR (Put into the refrigerator on 7OCT2021 and given on 8NOV2021 and 9NOV2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Multiple patients received doses of the Moderna  COVID-19 vaccine after it had spent greater than 30 days  in the refrigerator on 8 -NOV-2021 and  9-NOV-2021.The vaccine was first moved from the freezer to the refrigerator on 7-OCT-2021. The contact believed that most if not all of these doses were booster doses administered. None  have reported any known symptoms or side effects to the contact, and no treatment measures have been attempted.Concomitant medication use was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received a booster dose instead of a full dose; 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 INCORRECT DOSE ADMINISTERED (Received a booster dose instead of a full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received a booster dose instead of a full dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a booster dose instead of a full dose) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Immune-mediated hepatic disorder
Clinical narrative: Immune system started attacking liver; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE-MEDIATED HEPATIC DISORDER (Immune system started attacking liver) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Liver cirrhosis since 2010.    On 22-Jan-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 IMMUNE-MEDIATED HEPATIC DISORDER (Immune system started attacking liver) (seriousness criterion medically significant). The patient was treated with BUDESONIDE for Immune-mediated hepatic disorder, at a dose of 3 mg. At the time of the report, IMMUNE-MEDIATED HEPATIC DISORDER (Immune system started attacking liver) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Alanine aminotransferase: 62 (abnormal) 62. On 17-Feb-2021, Aspartate aminotransferase: 63 (abnormal) 63. On 17-Feb-2021, Blood alkaline phosphatase: 273 (abnormal) 273.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. 01-Nov-2021: AST was 35, Immunoglobulin was at 1800. Dr said: Patient's immune system started attacking his liver.  Company's comment: This case concerns a 66-year-old, male patient with a history of liver cirrhosis, who experienced the unexpected serious AESI event of Immune-mediated hepatic disorder. The event occurred at an unknown time after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events were ongoing. The medical history of cirrhosis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-389025 (Patient Link).; Sender's Comments: This case concerns a 66-year-old, male patient with a history of liver cirrhosis, who experienced the unexpected serious AESI event of Immune-mediated hepatic disorder. The event occurred at an unknown time after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events were ongoing. The medical history of cirrhosis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: she felt "blegh," but otherwise fine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she felt "blegh," but otherwise fine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal, Osteoporosis and Blood pressure abnormal. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, DENOSUMAB (PROLIA) for Osteoporosis.    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 FEELING ABNORMAL (she felt "blegh," but otherwise fine). At the time of the report, FEELING ABNORMAL (she felt "blegh," but otherwise fine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient also included blood pressure medication.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-069787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: First dose date was added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Electrocardiogram, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness), TACHYCARDIA (Tachycardia/fast heart rate), HYPERTENSION (Hypertension/elevated Blood pressure) and HYPERSENSITIVITY (Allergic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 041L20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021 at 3:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic reaction). On 15-Nov-2021, the patient experienced DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness) and HYPERTENSION (Hypertension/elevated Blood pressure). In November 2021, the patient experienced HEADACHE (Headache). On 15-Nov-2021 at 7:55 AM, the patient experienced TACHYCARDIA (Tachycardia/fast heart rate). At the time of the report, DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and TACHYCARDIA (Tachycardia/fast heart rate), HYPERTENSION (Hypertension/elevated Blood pressure) and HEADACHE (Headache) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 15-Nov-2021, Blood pressure measurement: 200/100 (High) High.On 15-Nov-2021, Electrocardiogram: normal (normal) normal.On 15-Nov-2021, Heart rate: 137 (High) High.No concomitant medications were provided.No treatment information were given.This case was linked to MOD-2021-389097, MOD-2021-389098 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypersensitivity, Hypertension, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness), TACHYCARDIA (Tachycardia/fast heart rate), HYPERTENSION (Hypertension/elevated Blood pressure) and HYPERSENSITIVITY (Allergic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 041L20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021 at 3:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic reaction). On 15-Nov-2021, the patient experienced DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness) and HYPERTENSION (Hypertension/elevated Blood pressure). In November 2021, the patient experienced HEADACHE (Headache). On 15-Nov-2021 at 7:55 AM, the patient experienced TACHYCARDIA (Tachycardia/fast heart rate). At the time of the report, DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and TACHYCARDIA (Tachycardia/fast heart rate), HYPERTENSION (Hypertension/elevated Blood pressure) and HEADACHE (Headache) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 15-Nov-2021, Blood pressure measurement: 200/100 (High) High.On 15-Nov-2021, Electrocardiogram: normal (normal) normal.On 15-Nov-2021, Heart rate: 137 (High) High.No concomitant medications were provided.No treatment information were given.This case was linked to MOD-2021-389097, MOD-2021-389098 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was administered at 2:54 PM on 16 NOV 2021 and was initially punctured at 10:30 AM the previous day.; Initially punctured at 10:30 AM the previous day, being left at room temperature for approximately 28.5 hours.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered at 2:54 PM on 16 NOV 2021 and was initially punctured at 10:30 AM the previous day.) and PRODUCT STORAGE ERROR (Initially punctured at 10:30 AM the previous day, being left at room temperature for approximately 28.5 hours.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 014C21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021 at 2:54 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRODUCT STORAGE ERROR (Initially punctured at 10:30 AM the previous day, being left at room temperature for approximately 28.5 hours.). On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered at 2:54 PM on 16 NOV 2021 and was initially punctured at 10:30 AM the previous day.). In November 2021, PRODUCT STORAGE ERROR (Initially punctured at 10:30 AM the previous day, being left at room temperature for approximately 28.5 hours.) had resolved. On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered at 2:54 PM on 16 NOV 2021 and was initially punctured at 10:30 AM the previous day.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the booster dose of the vaccine was administered at 2:54 PM on 16 Nov 2021 and was initially punctured at 10:30 AM the previous day, being left at room temperature for approximately 28.5 hours. No symptoms were reported. No concomitant medications provided. No treatment medications received.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (received more than 0.25 ml booster 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received more than 0.25 ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (received more than 0.25 ml booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided by reporter. No treatment information was provided by reporter.Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Non-Significant Follow-up appended, Email Address added.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: give me half the booster amount; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (give me half the booster amount) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.Concurrent medical conditions included COPD.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (give me half the booster amount). At the time of the report, ACCIDENTAL UNDERDOSE (give me half the booster amount) 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.No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fear, Heart rate, Heart rate irregular
Clinical narrative: I developed an irregular heartbeat; I  am afraid to get the booster; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE IRREGULAR (I developed an irregular heartbeat) and FEAR (I  am afraid to get the booster) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (I developed an irregular heartbeat) and FEAR (I  am afraid to get the booster). At the time of the report, HEART RATE IRREGULAR (I developed an irregular heartbeat) and FEAR (I  am afraid to get the booster) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: irregular (abnormal) Heartbeats irregular. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. This case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious events of Heart rate irregular and Fear. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2021-390506 (Patient Link). Sender's Comments: This case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious events of Heart rate irregular and Fear. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. 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, 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. No concomitant medication reported.No treatment medication reported.This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, expected event of fatigue. The event occurred  on unknown date after the two doses of mRNA 1273 vaccine. The patient states he had episodes of fatigue with various causes after receiving two Moderna vaccines but did not specify which dose. The patient stating that there are various causes to his fatigue remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.Reporter did not allow further contact; Sender's Comments: This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, expected event of fatigue. The event occurred  on unknown date after the two doses of mRNA 1273 vaccine. The patient states he had episodes of fatigue with various causes after receiving two Moderna vaccines but did not specify which dose. The patient stating that there are various causes to his fatigue remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: exaggerated cellulitis; painful arm; really swollen arm; Initial information received on 12-Nov-2021 regarding an unsolicited valid serious case received from an other health professional.   This case involves adult and unknown gender patient who experienced exaggerated cellulitis (Cellulitis), painful arm (Pain in extremity) and really swollen arm (Peripheral swelling) while receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On 08-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number : C5882AA and expiry date not reported] via an intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious exaggerated cellulitis (cellulitis) 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious painful arm (pain in extremity) and really swollen arm (peripheral swelling) 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported pharmacy intern reports 4 patients who received an Adacel vaccine between 08-Nov-2021 and 11-Nov-2021. She states that four vaccines from this box had been administered, and all four patients developed this classic exaggerated cellulitis.   It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  Information on the batch number was requested.; Sender's Comments: This case involves adult and unknown gender patient who experienced cellulitis, peripheral swelling, and pain in extremity after vaccination with ADACEL. The time to onset is compatible. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood test, Chest pain, Computerised tomogram
Clinical narrative: Heart palpitations, chest pain, shortness of breath, headaches, head pressure, ringing in ears, ear aches, loss of appetite, loss of balance, diarrhea, weakness & fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dyspnoea, Ear pain, Echocardiogram
Clinical narrative: Heart palpitations, chest pain, shortness of breath, headaches, head pressure, ringing in ears, ear aches, loss of appetite, loss of balance, diarrhea, weakness & fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Head discomfort, Headache, Palpitations
Clinical narrative: Heart palpitations, chest pain, shortness of breath, headaches, head pressure, ringing in ears, ear aches, loss of appetite, loss of balance, diarrhea, weakness & fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, X-ray
Clinical narrative: Heart palpitations, chest pain, shortness of breath, headaches, head pressure, ringing in ears, ear aches, loss of appetite, loss of balance, diarrhea, weakness & fatigue
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Vertigo
Clinical narrative: Dizziness about two weeks after first shot. Do otro diagnosed vertigo. Vértigo exercises suggested. Still dealing with the dizziness 6 months after full vaccination.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fall, Gait disturbance, Hypoaesthesia
Clinical narrative: Soon after pfizer booster, Pt started have symptoms of neuropoly.   Hands, and lower arms numb & tingly all the time.    He can feel things with his finger - no longer can:  shave, hold silverware correctly, he's spilling drinks, food.   He is getting more and more weak, he has fallen, his lumber & neck hurt.   Hard for him to walk
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Neck pain, Paraesthesia
Clinical narrative: Soon after pfizer booster, Pt started have symptoms of neuropoly.   Hands, and lower arms numb & tingly all the time.    He can feel things with his finger - no longer can:  shave, hold silverware correctly, he's spilling drinks, food.   He is getting more and more weak, he has fallen, his lumber & neck hurt.   Hard for him to walk
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash with pruritus on torso chest back and arms. Improving now appear like dark circular patches on abdomen. No longer pruritic
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; development of rash.; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient presented with shingles and had subsequent office visit on 8th November 2021. No other intel or adverse event reported to office outside of development of rash. Consent to follow up was granted.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Decreased appetite, Dysuria, Haematuria, Headache
Clinical narrative: SEVERE TINNITUS(FEELING OF CONSTANT FIRE ALARMS IN EARS); HEMATURIA(PRESENCE OF BLOOD IN URINE); DISCOMFORTING TO URINATE; SORE THROAT; SEVERE LEG CRAMPS; LOW APPETITE; NAUSEA; HEADACHE; MUSCLE ACHES; FELT FEVERISH; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: Patient had no known drug allergies, no current medication usage, and no previous medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. On 09-OCT-2021, the patient experienced low appetite. On 09-OCT-2021, the patient experienced nausea. On 09-OCT-2021, the patient experienced headache. On 09-OCT-2021, the patient experienced muscle aches. On 09-OCT-2021, the patient experienced felt feverish. On 14-OCT-2021, the patient experienced sore throat. On 14-OCT-2021, the patient experienced severe leg cramps. On 18-OCT-2021, the patient experienced hematuria (presence of blood in urine). On 18-OCT-2021, the patient experienced discomforting to urinate. On 19-OCT-2021, the patient experienced severe tinnitus (feeling of constant fire alarms in ears). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low appetite, nausea, muscle aches, and felt feverish on 13-OCT-2021, and sore throat on OCT-2021, had not recovered from severe tinnitus(feeling of constant fire alarms in ears), and the outcome of headache, hematuria(presence of blood in urine), severe leg cramps and discomforting to urinate was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: SEVERE TINNITUS(FEELING OF CONSTANT FIRE ALARMS IN EARS); HEMATURIA(PRESENCE OF BLOOD IN URINE); DISCOMFORTING TO URINATE; SORE THROAT; SEVERE LEG CRAMPS; LOW APPETITE; NAUSEA; HEADACHE; MUSCLE ACHES; FELT FEVERISH; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: Patient had no known drug allergies, no current medication usage, and no previous medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. On 09-OCT-2021, the patient experienced low appetite. On 09-OCT-2021, the patient experienced nausea. On 09-OCT-2021, the patient experienced headache. On 09-OCT-2021, the patient experienced muscle aches. On 09-OCT-2021, the patient experienced felt feverish. On 14-OCT-2021, the patient experienced sore throat. On 14-OCT-2021, the patient experienced severe leg cramps. On 18-OCT-2021, the patient experienced hematuria (presence of blood in urine). On 18-OCT-2021, the patient experienced discomforting to urinate. On 19-OCT-2021, the patient experienced severe tinnitus (feeling of constant fire alarms in ears). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low appetite, nausea, muscle aches, and felt feverish on 13-OCT-2021, and sore throat on OCT-2021, had not recovered from severe tinnitus(feeling of constant fire alarms in ears), and the outcome of headache, hematuria(presence of blood in urine), severe leg cramps and discomforting to urinate was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Urine analysis
Clinical narrative: SEVERE TINNITUS(FEELING OF CONSTANT FIRE ALARMS IN EARS); HEMATURIA(PRESENCE OF BLOOD IN URINE); DISCOMFORTING TO URINATE; SORE THROAT; SEVERE LEG CRAMPS; LOW APPETITE; NAUSEA; HEADACHE; MUSCLE ACHES; FELT FEVERISH; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: Patient had no known drug allergies, no current medication usage, and no previous medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. On 09-OCT-2021, the patient experienced low appetite. On 09-OCT-2021, the patient experienced nausea. On 09-OCT-2021, the patient experienced headache. On 09-OCT-2021, the patient experienced muscle aches. On 09-OCT-2021, the patient experienced felt feverish. On 14-OCT-2021, the patient experienced sore throat. On 14-OCT-2021, the patient experienced severe leg cramps. On 18-OCT-2021, the patient experienced hematuria (presence of blood in urine). On 18-OCT-2021, the patient experienced discomforting to urinate. On 19-OCT-2021, the patient experienced severe tinnitus (feeling of constant fire alarms in ears). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low appetite, nausea, muscle aches, and felt feverish on 13-OCT-2021, and sore throat on OCT-2021, had not recovered from severe tinnitus(feeling of constant fire alarms in ears), and the outcome of headache, hematuria(presence of blood in urine), severe leg cramps and discomforting to urinate was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: INJECTION SITE WARMTH; NUMBNESS ON THE VACCINATED UPPER RIGHT ARM RADIATING TO THE FINGERS AND HER ARM FELT LIKE IT WAS FALLING ASLEEP; INJECTION SITE REDNESS; FEVER; SWELLING AT INJECTION SITE; CHILLS; WEAKNESS AND FEELING FATIGUED; DIZZINESS; INJECTION SITE LUMP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-NOV-2021, the patient experienced dizziness. On 10-NOV-2021, the patient experienced injection site lump. On 10-NOV-2021, the patient experienced chills. On 10-NOV-2021, the patient experienced weakness and feeling fatigued. On 10-NOV-2021, the patient experienced injection site redness. On 10-NOV-2021, the patient experienced fever. On 10-NOV-2021, the patient experienced swelling at injection site. On 20-NOV-2021, the patient experienced injection site warmth. On 20-NOV-2021, the patient experienced numbness on the vaccinated upper right arm radiating to the fingers and her arm felt like it was falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, injection site warmth, weakness and feeling fatigued, injection site redness, and swelling at injection site on NOV-2021, and chills, and fever on 12-NOV-2021, and had not recovered from injection site lump, and numbness on the vaccinated upper right arm radiating to the fingers and her arm felt like it was falling asleep. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: INJECTION SITE WARMTH; NUMBNESS ON THE VACCINATED UPPER RIGHT ARM RADIATING TO THE FINGERS AND HER ARM FELT LIKE IT WAS FALLING ASLEEP; INJECTION SITE REDNESS; FEVER; SWELLING AT INJECTION SITE; CHILLS; WEAKNESS AND FEELING FATIGUED; DIZZINESS; INJECTION SITE LUMP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-NOV-2021, the patient experienced dizziness. On 10-NOV-2021, the patient experienced injection site lump. On 10-NOV-2021, the patient experienced chills. On 10-NOV-2021, the patient experienced weakness and feeling fatigued. On 10-NOV-2021, the patient experienced injection site redness. On 10-NOV-2021, the patient experienced fever. On 10-NOV-2021, the patient experienced swelling at injection site. On 20-NOV-2021, the patient experienced injection site warmth. On 20-NOV-2021, the patient experienced numbness on the vaccinated upper right arm radiating to the fingers and her arm felt like it was falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, injection site warmth, weakness and feeling fatigued, injection site redness, and swelling at injection site on NOV-2021, and chills, and fever on 12-NOV-2021, and had not recovered from injection site lump, and numbness on the vaccinated upper right arm radiating to the fingers and her arm felt like it was falling asleep. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: A patient was administered a booster dose twice on the same day; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (A patient was administered a booster dose twice on the same day) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013F21A, 004M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced EXTRA DOSE ADMINISTERED (A patient was administered a booster dose twice on the same day). On 15-Nov-2021, EXTRA DOSE ADMINISTERED (A patient was administered a booster dose twice on the same day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. The patient was observed for 30 minutes and showed no symptoms.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: Slight cough for 2weeks; Floundering; Fever; Aching feeling; Difficulty breathing; Chest sore feeling; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling) and DYSPNOEA (Difficulty breathing) in a 78-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.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling), DYSPNOEA (Difficulty breathing) and CHEST PAIN (Chest sore feeling). At the time of the report, COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling), DYSPNOEA (Difficulty breathing) and CHEST PAIN (Chest sore feeling) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Slight cough for 2weeks; Floundering; Fever; Aching feeling; Difficulty breathing; Chest sore feeling; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling) and DYSPNOEA (Difficulty breathing) in a 78-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.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling), DYSPNOEA (Difficulty breathing) and CHEST PAIN (Chest sore feeling). At the time of the report, COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling), DYSPNOEA (Difficulty breathing) and CHEST PAIN (Chest sore feeling) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired Moderna booster; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Moderna booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE NRVV AD26 on 02-Jan-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Moderna booster). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up information received on 16-Nov-2021 contains significant information. Patient gender and DOB were added.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Haemorrhoids, Transfusion
Clinical narrative: bleeding a lot; losing a lot of blood; hemorrhoids; Blood Transfusion; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding a lot) and HAEMORRHAGE (losing a lot of blood) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HAEMORRHAGE (bleeding a lot) (seriousness criterion medically significant), HAEMORRHAGE (losing a lot of blood) (seriousness criterion medically significant), HAEMORRHOIDS (hemorrhoids) and TRANSFUSION (Blood Transfusion). At the time of the report, HAEMORRHAGE (bleeding a lot), HAEMORRHAGE (losing a lot of blood), HAEMORRHOIDS (hemorrhoids) and TRANSFUSION (Blood Transfusion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.  This case concerns a 21 year-old male patient with no reported medical history who experienced the unexpected serious event of hemorrhage. The event occurred approximately 4 months on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 21 year-old male patient with no reported medical history who experienced the unexpected serious event of hemorrhage. The event occurred approximately 4 months on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (POSSIBLE AE receiving a full dose instead of a booster dose by mistake) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (POSSIBLE AE receiving a full dose instead of a booster dose by mistake). At the time of the report, ACCIDENTAL OVERDOSE (POSSIBLE AE receiving a full dose instead of a booster dose by mistake) had resolved.  Concomitant product use was not provided by the reporter.  No treatment information provided. Caller mentioned following vaccination with the booster dose he got a new vaccination card saying he needed to receive a second dose. Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Non significant followup received on 16-Nov -2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (side effect fleur up again/last night the mucus was the thickest its been) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 11J20A and 028L2OA) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included LORAZEPAM, ATENOLOL, VENLAFAXINE, ESOMEPRAZOLE MAGNESIUM, FAMOTIDINE, ATORVASTATIN, BUPROPION, MELOXICAM and ESTRADIOL for an unknown indication.On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SECRETION DISCHARGE (side effect fleur up again/last night the mucus was the thickest its been). The patient was treated with MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SECRETION DISCHARGE (side effect fleur up again/last night the mucus was the thickest its been) had not resolved. Treatment medication include common allergy medication.This case was linked to MOD-2021-387995 (Patient Link).