chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old patient accidentally received Kinrix; 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 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2854, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: The medical assistant reported that a patient accidentally received Kinrix. The reporter consented to follow up. Additional Supportive Information: 2 year old patient received kinrix which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Colonoscopy, Pain, Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned a white, not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic constipation, and other pre-existing medical conditions included: patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, dose number in series 1, 01 total, administered on 10-MAR-2021 on right arm for prophylactic vaccination. On 13-MAR-2021, initially three days later, the patient experienced strong left thumb pain (dose number in series 1). On an unspecified date, later patient started, right wrist pain could be osteoarthritis, pain continues, burning pain (right arm, wrist and shoulder) and arthritis (dose number in series 1). She went to see her doctor and seeing other doctors as well. The action taken with Covid-19   vaccine ad26.cov2.s was not applicable. The patient had not recovered from strong left thumb pain, right wrist pain could be osteoarthritis, and burning pain (right arm, wrist and shoulder), and the outcome of arthritis was not reported. The patient additionally received Moderna Covid-19 vaccine (form of administration, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series 2, administered on 10-NOV-2021 for prophylactic vaccination. No adverse events were reported after vaccination with Moderna vaccine (dose number in series 2). Concomitant medications included MiraLAX (macrogol 3350) for chronic constipation. On 14-MAR-2022, Laboratory data included: Colonoscopy which resulted in chronic constipation. 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 51 year old  female. Initial information processed with additional information received from reporter on 25-MAR-2022. The patient's height, and weight were not reported. The patient's past medical history included: non alcohol user, and concurrent conditions included: non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. There was no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered at right arm on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-OCT-2021, the patient received booster non-company suspect Moderna covid19 vaccine (Spikevax) (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination.  On 21-MAR-2022, the patient started with headache and on the next day (22-MAR-2022) she was not feeling well and her symptoms progressed to wet cough, congestion and sore throat which all seem to be getting worse and patient experienced Suspected covid-19 infection (dose number in series 2). The patient had not taken any medication for her symptoms and she was planning to consult a doctor virtually for her symptoms as she did not want to visit the doctor's office at that point. On 24-MAR-2022, the patient experienced Suspected clinical vaccination failure (dose number in series 1). The laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Suspected covid-19 infection and the outcome of Suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220357912. This report was associated with a product quality complaint: 90000223502.; Sender's Comments: V0-20220354365-Covid-19 vaccine ad26.CoV-2.s-Suspected Clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: VACCINE WAS NOT EFFECTIVE AT ALL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. Initial information was processed along with the additional information received on 28-MAR-2022: 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, and batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced that the vaccine was not effective at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was not effective at all was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000223705.; Sender's Comments: V0: 20220354677-COVID-19 VACCINE AD26.COV2.S-vaccine was not effective at all. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Death, Intracardiac thrombus, Pulmonary thrombosis, Thrombosis
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced legs filled with clots, heart with clots, and lungs with clots. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lungs with clots, filled legs with clots and heart with clots was not reported. This report was serious (Death, and Other Medically Important Condition). Sender's Comments: V0- 20220354771- Covid-19 vaccine ad26.cov2.s  Death, lungs with clots, legs filled with clots and heart with clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Skin odour abnormal, Urine odour abnormal
Clinical narrative: STRONG SMELLING URINE; STRONG SMELLING SWEAT; DARK URINE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy (rash at age 11/12 years old), hyperlipidemia, attention deficit hyperactivity disorder (adhd), post-traumatic stress disorder (ptsd), drinks 4 glasses of beer once a week, and non-smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. Patient's water intake was normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced strong smelling urine, strong smelling sweat, and dark urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from strong smelling urine, strong smelling sweat, and dark urine. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: AMAZING REACTION AND FEELING OF NO PAIN AS THOUGH WAS A YOUNG PERSON AFTER 4 HOURS OF THE SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced amazing reaction and feeling of no pain as though was a young person after 4 hours of the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from amazing reaction and feeling of no pain as though was a young person after 4 hours of the shot. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: ENLARGED/SWELLING OF HEART; This spontaneous report received from a consumer via a company representative concerned an adult male of probably about 27 years old. 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, and batch number were not reported) dose was not reported, 1 total administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in SEP-2021, patient lived across the street, probably about 27 or so. A few days later patient was in hospital in intensive care section because of heart problems, swelling or enlarged heart. Patient spent 4 days there, then patient was sent home with medications. Patient visited emergency department and was hospitalized for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from enlarged/swelling of heart on SEP-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220306547.; Sender's Comments: V0: 20220360257-COVID-19 VACCINE AD26.COV2.S -Enlarged/swelling of heart. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Since he got first shot when he goes on treadmill his heart rate goes up and down; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Since he got first shot when he goes on treadmill his heart rate goes up and down) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (Since he got first shot when he goes on treadmill his heart rate goes up and down). At the time of the report, HEART RATE IRREGULAR (Since he got first shot when he goes on treadmill his heart rate goes up and down) had not resolved.            No concomitant medications were provided. Patient received 3 full doses of the Moderna vaccine. It was reported that the patient wore chest strap and it was linked to phone where he could see heart rate and doctors could not find anything wrong. The patient did not had chest pain. No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022; administered with the vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. Vial was initially stored in the refrigerator on 16-Mar-2022 at 8:00am and at 8:02 am the vial was first punctured. Post puncture the vial was stored in refrigerator and 2nd dose from the same vial was administered to patient on 22-Mar-2022 around noon time. The vial did not undergo any temperature excursions and for 15 minutes time the vial was exposed to room temperature range (8 Degree to 25 Degree Celsius = 46 Degree to 77 Degree Fahrenheit). No information on treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Hyperhidrosis, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (broke into a sweat with no fever, like pushing something out of the body), DECREASED APPETITE (very little appetite), PAIN (a lot of pain) and COUGH (coughing) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (broke into a sweat with no fever, like pushing something out of the body), DECREASED APPETITE (very little appetite), PAIN (a lot of pain) and COUGH (coughing). The patient was treated with MENTHOL (VICKS COUGH [MENTHOL]) for Coughing, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (broke into a sweat with no fever, like pushing something out of the body), DECREASED APPETITE (very little appetite), PAIN (a lot of pain) and COUGH (coughing) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was provided. It was reported that the patient's mother answered the phone and replied that the patient had left for work, but the patient would have asked two questions. The patient's mother was instructed to ask the two questions and was adamant that the patient's mother did not want to provide any other information. The patient had experienced symptoms for two days and wanted to know whether it was normal to have such symptoms after the vaccination or not. The patient wanted to know if receiving the booster shot might affect the patient's mother or not. Reporter did not allow further contact
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Fever; sore right injection site arm; knocked me out for the whole day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm), FATIGUE (knocked me out for the whole day) and PYREXIA (Fever) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 003F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had asymptomatic infection).   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). 09-Sep-2021, the patient experienced FATIGUE (knocked me out for the whole day). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm), FATIGUE (knocked me out for the whole day) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Had asymptomatic infection.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The patient had no adverse reactions after the first dose of vaccination. The patient was not diagnosed with myocarditis  or pericarditis. No history of Myocarditis or pericarditis The patient had history of COVID-19 infection however patient does not know when he caught COVID-19 and said that he had an asymptomatic infection. Date when the symptoms began was unknown.Patient stated that he had COVID-19 antibodies prior to receiving the COVID-19 vaccine and that was evidence of a COVID-19 infection.  Patient was not  hospitalized due to COVID-19 and did not  receive any treatment .  No treatment information was reported.   This case was linked to MOD-2022-523390 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow up information was  received and  included no new information.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Heart started racing/rapid heart beat; Trouble breathing/shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Heart started racing/rapid heart beat) and DYSPNOEA (Trouble breathing/shortness of breath) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 003F21A) for COVID-19 vaccination.     The patient's past medical history included Asymptomatic COVID-19 (Patient had an asymptomatic infection.). Concurrent medical conditions included Stress and Anxiety.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, the patient experienced PALPITATIONS (Heart started racing/rapid heart beat) and DYSPNOEA (Trouble breathing/shortness of breath). At the time of the report, PALPITATIONS (Heart started racing/rapid heart beat) and DYSPNOEA (Trouble breathing/shortness of breath) outcome was unknown.            No concomitant information was reported.  The patient had history of COVID-19 infection however patient did not know when patient caught COVID-19 infection and said that he had an asymptomatic infection. Patient had COVID-19 antibodies prior to receiving the COVID-19 vaccine and that was evidence of a COVID-19 infection. No hospitalization occurred due to COVID-19. The patient went to the Emergency Room due to events.  The patient had a rapid heartbeat and shortness of breath on 21-Feb-2022 after booster dose. The patient was told at the hospital that adverse events were because of stress and anxiety and  booster dose. The patient had not diagnosed with myocarditis or pericarditis.  No treatment information was reported.   This case was linked to MOD-2022-523369 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up received and included no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Swelling, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (little swelling), TINNITUS (humming in ears) and DIZZINESS (swimmy headed) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (little swelling), TINNITUS (humming in ears) and DIZZINESS (swimmy headed). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE; PARACETAMOL; SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), SWELLING (little swelling), TINNITUS (humming in ears) and DIZZINESS (swimmy headed) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No  concomitant medications were reported. This case was linked to MOD-2022-524056 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: feeling something on shoulder pushing down; corner of her mouth feels numb; heat where the lump is; She is not dizzy or nauseous, it is just weird; bells ringing in her ear; swimmy headed; part of left side of her face numb; pinching at the wrist; swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird) and TINNITUS (bells ringing in her ear) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 078C21A and 052B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird), TINNITUS (bells ringing in her ear), DIZZINESS (swimmy headed), HYPOAESTHESIA (part of left side of her face numb), ARTHRALGIA (pinching at the wrist) and VACCINATION SITE SWELLING (swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm). At the time of the report, MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird), TINNITUS (bells ringing in her ear), DIZZINESS (swimmy headed), HYPOAESTHESIA (part of left side of her face numb), ARTHRALGIA (pinching at the wrist) and VACCINATION SITE SWELLING (swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm) outcome was unknown.            No concomitant medication information provided. No treatment information provided.   This case was linked to MOD-2022-524037 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Tinnitus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: feeling something on shoulder pushing down; corner of her mouth feels numb; heat where the lump is; She is not dizzy or nauseous, it is just weird; bells ringing in her ear; swimmy headed; part of left side of her face numb; pinching at the wrist; swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird) and TINNITUS (bells ringing in her ear) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 078C21A and 052B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird), TINNITUS (bells ringing in her ear), DIZZINESS (swimmy headed), HYPOAESTHESIA (part of left side of her face numb), ARTHRALGIA (pinching at the wrist) and VACCINATION SITE SWELLING (swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm). At the time of the report, MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird), TINNITUS (bells ringing in her ear), DIZZINESS (swimmy headed), HYPOAESTHESIA (part of left side of her face numb), ARTHRALGIA (pinching at the wrist) and VACCINATION SITE SWELLING (swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm) outcome was unknown.            No concomitant medication information provided. No treatment information provided.   This case was linked to MOD-2022-524037 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever) and CHILLS (Chills). At the time of the report, PYREXIA (Slight fever) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. This case was linked to MOD-2022-524348 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow up received contain no new information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in his knees after his Moderna Covid-19 booster dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (Joint pain in his knees after his Moderna Covid-19 booster dose.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain in his knees after his Moderna Covid-19 booster dose.). At the time of the report, ARTHRALGIA (Joint pain in his knees after his Moderna Covid-19 booster dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter was calling regarding their son who was the patient. The patient received the booster dose in Dec-2021. The reporter stated that the patient reported joint pain in their knees after the Moderna Covid-19 booster dose.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Product was administered past the expiration date/Expired vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion/vaccine was above 46 F for 10 minutes while stored in the fridge) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 21-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Product was administered past the expiration date/Expired vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion/vaccine was above 46 F for 10 minutes while stored in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Product was administered past the expiration date/Expired vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion/vaccine was above 46 F for 10 minutes while stored in the fridge) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. An overview of temperatures while stored in the fridge was provided as Min 36.6 F  Max 47.3 F Average 38.3 F.. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022 at 3:06 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022 at 3:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up document received contains no new information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Tinnitus
Clinical narrative: developed tinnitus after the booster shot.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (developed tinnitus after the booster shot.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Benign prostatic hyperplasia. Concurrent medical conditions included Asthma.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 TINNITUS (developed tinnitus after the booster shot.). At the time of the report, TINNITUS (developed tinnitus after the booster shot.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 57 index Antibody test read 57 index. No concomitant medications were reported.  It was reported that the vaccination facility had stated that since the patient had asthma, they considered the patient as immunocompromised and suggested the patient had to get third full dose. However, the patient had stated that he did not consider himself as immunocompromised and was also never officially diagnosed as so. The patient stated that he had refused the full third dose and decided to get a booster half shot.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Rash
Clinical narrative: Severe rash covering pubic area not arm; Patient had second Moderna Covid-19 Vaccine booster shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Severe rash covering pubic area not arm) and EXTRA DOSE ADMINISTERED (Patient had second Moderna Covid-19 Vaccine booster shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient had second Moderna Covid-19 Vaccine booster shot). On an unknown date, the patient experienced RASH (Severe rash covering pubic area not arm). At the time of the report, RASH (Severe rash covering pubic area not arm) and EXTRA DOSE ADMINISTERED (Patient had second Moderna Covid-19 Vaccine booster shot) outcome was unknown.            Patient had no known allergies. Patient not had any concomitant medications and did not take any treatment medications.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: swelling at the injection site (1st dose); slight temperature (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2022-525568 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain with the previous 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain with the previous 3 doses) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain with the previous 3 doses). At the time of the report, PAIN IN EXTREMITY (Arm pain with the previous 3 doses) outcome was unknown.            No concomitant medications was reported. No treatment information was reported. It was reported that patient received 1st two doses were full dose.   This case was linked to MOD-2022-525546, MOD-2022-525609, MOD-2022-525616 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Patient reports blood in urine; This spontaneous case was reported by a pharmacist and describes the occurrence of HAEMATURIA (Patient reports blood in urine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No medical history was reported.  Concomitant products included WARFARIN for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATURIA (Patient reports blood in urine). At the time of the report, HAEMATURIA (Patient reports blood in urine) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. It was reported patient on warfarin experienced blood in urine approximately 3 weeks after Moderna Vaccine. No treatment medication was reported. This case was linked to MOD-2022-525821 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Patient reports blood in urine; This spontaneous case was reported by a pharmacist and describes the occurrence of HAEMATURIA (Patient reports blood in urine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included WARFARIN for an unknown indication.   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, 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 HAEMATURIA (Patient reports blood in urine). At the time of the report, HAEMATURIA (Patient reports blood in urine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was reported.   This case was linked to MOD-2022-525792 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood pressure measurement, Cough, Dizziness, Oedema, Throat irritation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): UNT-2022-004274 (Regulatory Authority). A 75 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for Covid-19 immunisation; influenza vaccine (FLU), administration date Feb2022 (Batch/Lot number: unknown) as unknown, single for antiviral prophylaxis; Treprostinil sodium (TYVASO), first regimen since 29Jan2022 (Batch/Lot number: unknown) at 36 ug 4x/day, second regimen since Feb2022 (Batch/Lot number: unknown) at 18 ug 4x/day and third regimen (ongoing) (Batch/Lot number: unknown) at 36 ug 4x/day for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension", start date: Feb2022 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; manufacturer unknown), for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset Feb2022, outcome "not recovered", described as "Continued baseline cough associated with IH TYVASO treatments"; THROAT IRRITATION (non-serious) with onset Feb2022, outcome "unknown", described as "Throat irritation"; OEDEMA (non-serious) with onset Feb2022, outcome "unknown", described as "Edema"; DIZZINESS (non-serious) with onset Feb2022, outcome "unknown", described as "Was not moving around well and was getting dizzy". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for Treprostinil sodium was dosage not changed. Additional information: The male patient began therapy with IH TYVASO (Treprostinil sodium, concentration of 0.6 mg/ml) delivered by TYVASO Inhalation Device (TD-300/A), on an unspecified date in Feb2022 for pulmonary arterial hypertension. The current dose was reported as 18 µg (3 breaths) four times a day (QID), via inhalation (IH) route. On an unspecified date in Feb 2022 (late last week), the patient got her third Covid vaccination and flu shot. Her blood pressure and weight remained stable. She was overall feeling better after that day with the vaccination. It was unknown if the physician was aware. The reporter's causality for the event cough with IH TYVASO was considered to be possibly related. The reporter did not provide causality for the events of throat irritation and oedema. The reporter did not provide causality for the event of dizziness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.