chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: ULTRASOUND DOPPLER ABNORMAL; ARTHRALGIA; CHILLS; PARAESTHESIA; FATIGUE; NAUSEA; PYREXIA; SUPERFICIAL VEIN THROMBOSIS; TREMOR; PERIPHERAL SWELLING; INJECTION SITE MASS; PAIN; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 34-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, route of admin not reported, batch number: 042a21a expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for an unknown indication. Vaccine was given about 1.5 cm below the acromion process per doctor measurement. No concomitant medications were reported. On 08-APR-2021, the patient experienced a small lump at injection site within 15 minutes of vaccination. That night patient had 'pins and needles' (paraesthesia) down her left arm. The patient experienced hand tremors, chills, fever 102.3, nausea, body aches, fatigue and shoulder pain (arthralgia). On 09-APR-2021, The patient took ibuprofen at 4 AM. On 10-APR-2021 patient noticed a lump on her left forearm. On 14-APR-2021, The patient had an Ultrasound Doppler done on her left arm and a supraficial venous thrombosis in the cephalic vein of the left forearm was found. Patient was told to start aspirin 81 mg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arthralgia, chills, fatigue, injection site mass, nausea, pain, paraesthesia, peripheral swelling, pyrexia, superficial vein thrombosis, tremor and ultrasound doppler abnormal was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 30-NOV-2021. Upon review following information was amended: seriousness of event superficial vein thrombosis updated to serious (other medically important).; Sender's Comments: V1. This follow up version was created to update the following information: seriousness of event superficial vein thrombosis updated to serious (other medically important).  20211201391-covid-19 vaccine ad26.cov2.s -superficial vein thrombosis . This event(s) is considered unassessable. 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).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Superficial vein thrombosis, Tremor, Ultrasound Doppler, Ultrasound Doppler abnormal
Clinical narrative: ULTRASOUND DOPPLER ABNORMAL; ARTHRALGIA; CHILLS; PARAESTHESIA; FATIGUE; NAUSEA; PYREXIA; SUPERFICIAL VEIN THROMBOSIS; TREMOR; PERIPHERAL SWELLING; INJECTION SITE MASS; PAIN; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 34-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, route of admin not reported, batch number: 042a21a expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for an unknown indication. Vaccine was given about 1.5 cm below the acromion process per doctor measurement. No concomitant medications were reported. On 08-APR-2021, the patient experienced a small lump at injection site within 15 minutes of vaccination. That night patient had 'pins and needles' (paraesthesia) down her left arm. The patient experienced hand tremors, chills, fever 102.3, nausea, body aches, fatigue and shoulder pain (arthralgia). On 09-APR-2021, The patient took ibuprofen at 4 AM. On 10-APR-2021 patient noticed a lump on her left forearm. On 14-APR-2021, The patient had an Ultrasound Doppler done on her left arm and a supraficial venous thrombosis in the cephalic vein of the left forearm was found. Patient was told to start aspirin 81 mg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arthralgia, chills, fatigue, injection site mass, nausea, pain, paraesthesia, peripheral swelling, pyrexia, superficial vein thrombosis, tremor and ultrasound doppler abnormal was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 30-NOV-2021. Upon review following information was amended: seriousness of event superficial vein thrombosis updated to serious (other medically important).; Sender's Comments: V1. This follow up version was created to update the following information: seriousness of event superficial vein thrombosis updated to serious (other medically important).  20211201391-covid-19 vaccine ad26.cov2.s -superficial vein thrombosis . This event(s) is considered unassessable. 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).
Age: 35.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cardiac flutter
Clinical narrative: HEART FLUTTERS; This spontaneous report received from a patient concerned a 35 year old male. 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, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on SEP-2021 (dose series 1) for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, the patient experienced heart flutters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab (Humira) was unknown. The patient recovered from heart flutters on an unspecified date of 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211215302-COVID-19 VACCINE Ad26.COV2.S- Heart flutters. This event(s) is considered unassessable. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a consumer concerned a 5 decade (approximately 40 or 41 years) old female of unspecified race and ethnicity. 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, batch number: unknown and expiry: unknown) dose, 1 total, dose number in series 1, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter texted to the company representative and reported that the patient which was a neighbor of reporter on an unspecified date suffered from bells palsy three weeks after receiving the JANSSEN covid-19 vaccine. According to reporter exact date of vaccination was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211217733-COVID-19 VACCINE AD26.COV2.S-Bell's palsy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging, Neuralgia
Clinical narrative: BELLS PALSY; This spontaneous report received from a consumer concerned a 5 decade (approximately 40 or 41 years) old female of unspecified race and ethnicity. 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, batch number: unknown and expiry: unknown) dose, 1 total, dose number in series 1, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter texted to the company representative and reported that the patient which was a neighbor of reporter on an unspecified date suffered from bells palsy three weeks after receiving the JANSSEN covid-19 vaccine. According to reporter exact date of vaccination was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211217733-COVID-19 VACCINE AD26.COV2.S-Bell's palsy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler
Clinical narrative: BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned a 59 year old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy, gall bladder removal, varicose veins and underwent surgery, knee replacement surgery, and concurrent conditions included: non alcohol user, and non smoker. The patient had no known drug allergies and no history of bleeding or blood clot disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808980, expiry: 18-SEP-2021) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. Dose number series was 1. No concomitant medications were reported.  After vaccination, on an unspecified date in AUG-2021, the patient went to a doctor and they did a doppler ultrasound for her and found one blood clot in leg. A month later, they checked her again and found another blood clot in her leg. Then a week ago, they found a third blood clot in her leg. She had a total of 3 blood clots, 2 clots in her right leg and 1 clot in her left leg. The patient was doubtful if the vaccine could have caused the blood clots. The patient was receiving treatment from two different doctors for her blood clots at the time of reporting. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots in both legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211217781-COVID-19 VACCINE AD26.COV2.S-blood clots in both legs. This event(s) is considered unassessable. 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).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old female. 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, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211218297, 20211218548 and 20211218731.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 13 year old male. 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, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218548 and 20211218731.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Poor quality product administered, Pyrexia
Clinical narrative: ACHINESS; ADMINISTERED VACCINE 7.5 HOURS AFTER PUNCTURE; FEVER; TIREDNESS; This spontaneous report received from a pharmacist concerned a 34 year old male. 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, batch number: 1855835 expiry: UNKNOWN) dose was not reported, administered on 06-DEC-2021 17:00 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On 06-DEC-2021, the patient experienced achiness. On 06-DEC-2021, the patient experienced administered vaccine 7.5 hours after puncture. On 06-DEC-2021, the patient experienced fever. On 06-DEC-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine 7.5 hours after puncture, fever, tiredness and achiness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced URTICARIA (broke out in hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives) outcome was unknown.            Concomitant medications was not provided by the reporter.  Last week is the first week that patient has been able to go more than 3 days without the Zyrtec without a flare up.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious event of urticaria. The event occurred 9 days after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient broke out in hives. The patient then took Zyrtec (cetirizine), unspecified dose and frequency, which afforded relief of symptoms. The event had resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious event of urticaria. The event occurred 9 days after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient broke out in hives. The patient then took Zyrtec (cetirizine), unspecified dose and frequency, which afforded relief of symptoms. The event had resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021 at 9:44 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Aug-2021 at 9:44 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021 at 9:44 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Felt like when he had COVID, had a hard time breathing; Hands were aching, like arthritis; Had a sore arm at the injection site; Had a high temperature; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Felt like when he had COVID, had a hard time breathing), PAIN IN EXTREMITY (Hands were aching, like arthritis), VACCINATION SITE PAIN (Had a sore arm at the injection site) and PYREXIA (Had a high temperature) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (At the end of February 2021.) in February 2021. Previously administered products included for COVID-19: Oxygen (He was on O2 now because of Covid- 19.) since an unknown date. Past adverse reactions to the above products included No adverse event with Oxygen.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced DYSPNOEA (Felt like when he had COVID, had a hard time breathing), PAIN IN EXTREMITY (Hands were aching, like arthritis), VACCINATION SITE PAIN (Had a sore arm at the injection site) and PYREXIA (Had a high temperature). At the time of the report, DYSPNOEA (Felt like when he had COVID, had a hard time breathing), PAIN IN EXTREMITY (Hands were aching, like arthritis), VACCINATION SITE PAIN (Had a sore arm at the injection site) and PYREXIA (Had a high temperature) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-406178 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: uncomfortable/druggy; achy; could not sleep; throwing up; really tired; real bad headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up) and FATIGUE (really tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up), FATIGUE (really tired), HEADACHE (real bad headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 11-Apr-2021, FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up), FATIGUE (really tired), HEADACHE (real bad headache), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 100.7.         Concomitant medications were not provided.   This case was linked to MOD21-170135 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia, Vomiting
Clinical narrative: uncomfortable/druggy; achy; could not sleep; throwing up; really tired; real bad headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up) and FATIGUE (really tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up), FATIGUE (really tired), HEADACHE (real bad headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 11-Apr-2021, FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up), FATIGUE (really tired), HEADACHE (real bad headache), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 100.7.         Concomitant medications were not provided.   This case was linked to MOD21-170135 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: arm tingling/pins and needles; arm burning; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (arm tingling/pins and needles) and BURNING SENSATION (arm burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (arm tingling/pins and needles) and BURNING SENSATION (arm burning). At the time of the report, PARAESTHESIA (arm tingling/pins and needles) and BURNING SENSATION (arm burning) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: booster given less than 6 months; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months). On 06-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported. No Treatment informations were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Joint swelling, Vaccination site mass, Vaccination site swelling
Clinical narrative: swelling went down to elbow; two big lumps; swelling of the arm on the injection site; it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling went down to elbow), VACCINATION SITE MASS (two big lumps), VACCINATION SITE SWELLING (swelling of the arm on the injection site) and ACCIDENTAL UNDERDOSE (it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 013C20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and MS. Concomitant products included LABETALOL, HYDROCHLOROTHIAZIDE, GABAPENTIN, OXCARBAZEPINE (OXTELLAR XR) and OCRELIZUMAB (OCREVUS) for an unknown indication.   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 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced JOINT SWELLING (swelling went down to elbow), VACCINATION SITE MASS (two big lumps) and VACCINATION SITE SWELLING (swelling of the arm on the injection site). 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 03-Dec-2021, ACCIDENTAL UNDERDOSE (it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition) had resolved. At the time of the report, JOINT SWELLING (swelling went down to elbow), VACCINATION SITE MASS (two big lumps) and VACCINATION SITE SWELLING (swelling of the arm on the injection site) had not resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site rash
Clinical narrative: Constant runny nose; Still has a rash at the injection site that takes up her whole upper arm.; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Constant runny nose) and VACCINATION SITE RASH (Still has a rash at the injection site that takes up her whole upper arm.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced RHINORRHOEA (Constant runny nose) and VACCINATION SITE RASH (Still has a rash at the injection site that takes up her whole upper arm.). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Constant runny nose) and VACCINATION SITE RASH (Still has a rash at the injection site that takes up her whole upper arm.) had not resolved.            It was reported that the treatment medications taken by the patient was not working for the patient.   No concomitant medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia
Clinical narrative: flu-like symptoms; achy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (achy) and FATIGUE (fatigue) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (achy) and FATIGUE (fatigue). In March 2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (achy) and FATIGUE (fatigue) had resolved.            No Concomitant medications were provided. No treatment medications were provided   This case was linked to MOD-2021-406186 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: Skin irritation because of booster; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN IRRITATION (Skin irritation because of 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 28-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (Skin irritation because of booster). At the time of the report, SKIN IRRITATION (Skin irritation because of booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over body/hives are constantly travelling throughout the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over body/hives are constantly travelling throughout the body) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives all over body/hives are constantly travelling throughout the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and CALAMINE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over body/hives are constantly travelling throughout the body) had not resolved.            On 29NOV2021, she started experiencing hives all over her body. She says that it's now been 10-11 days since the hives first started and they have not gone away yet.   She says that the hives seem to appear sporadically on different areas of her body. They are constantly there but appear on different areas of the body. It seems as if the hives are constantly travelling throughout the body. She says that she has taken Zyrtec, Benadryl, and Calamine to treat the symptoms but they don't seem to be helping get rid of the hives. She gets temporary relief from them but the hives just re-appear again.   This case was linked to MOD-2021-406154, MOD-2021-406161, MOD-2021-406162 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling, Pruritus
Clinical narrative: neck is stiff; my arm is swollen; my arm is red; my arm itching; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck is stiff), PERIPHERAL SWELLING (my arm is swollen), ERYTHEMA (my arm is red) and PRURITUS (my arm itching) 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 MUSCULOSKELETAL STIFFNESS (neck is stiff), PERIPHERAL SWELLING (my arm is swollen), ERYTHEMA (my arm is red) and PRURITUS (my arm itching). At the time of the report, MUSCULOSKELETAL STIFFNESS (neck is stiff), PERIPHERAL SWELLING (my arm is swollen), ERYTHEMA (my arm is red) and PRURITUS (my arm itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: light heart palpitations; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (light heart palpitations) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced PALPITATIONS (light heart palpitations). At the time of the report, PALPITATIONS (light heart palpitations) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm hurting for a day or so after the previous shots; probably the 1st hurt more than the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm hurting for a day or so after the previous shots; probably the 1st hurt more than the 2nd dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 010M20A or 016M20A) 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) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (left arm hurting for a day or so after the previous shots; probably the 1st hurt more than the 2nd dose). At the time of the report, VACCINATION SITE PAIN (left arm hurting for a day or so after the previous shots; probably the 1st hurt more than the 2nd dose) outcome was unknown.      No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-405941 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Rash, Urticaria
Clinical narrative: pretty severe hives/acute urticaria; skin rash over his body seem to follow the lymphatic system (groin, creases, neck); This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (pretty severe hives/acute urticaria) and RASH (skin rash over his body seem to follow the lymphatic system (groin, creases, neck)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 039B21A and 011A21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Surgery. Concurrent medical conditions included Drug allergy (Had given Morphine during a surgery in the past and patient had vomiting, nausea and he felt like he was catching his breath).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced URTICARIA (pretty severe hives/acute urticaria) and RASH (skin rash over his body seem to follow the lymphatic system (groin, creases, neck)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Rash, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Hives and Rash, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives and Rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (pretty severe hives/acute urticaria) and RASH (skin rash over his body seem to follow the lymphatic system (groin, creases, neck)) had not resolved.            Patient noticed that the symptoms were aggravated by touch and friction.The patient stated that he is going to see an allergist immunologist on 14 December 2021. No concomitant medications were reported.  Other treatment medications included steroids.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: fairly severe anemia; This spontaneous case was reported by a pharmacist and describes the occurrence of ANAEMIA (fairly severe anemia) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAEMIA (fairly severe anemia). At the time of the report, ANAEMIA (fairly severe anemia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Patient stated she would like to get  Booster dose on 08-Dec-2021.The pharmacist wants to know if she is contraindicated.  Patient had undergone blood transfusions twice for the event.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose administered to 17 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old). On 06-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter who was a nurse reported regarding an administration error to a 17 year old patient. The patient received their 1st dose on 06-Dec-2021 and on 08-Dec-2021 they realized that the patient was 17 years old. No symptoms were reported, and the reporter have not contacted the patient yet.  No medical conditions were reported.  No Concomitant product use was reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Apr-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 PAIN IN EXTREMITY (on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it). At the time of the report, PAIN IN EXTREMITY (on first dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medication details was reported.  It was reported that, when patient tried to move her arm, it would hurt a little more than it should have probably.  This case was linked to MOD-2021-406224, MOD-2021-406226 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001CZ1A, 020B21A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it). At the time of the report, PAIN IN EXTREMITY (On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) outcome was unknown.            No Concomitant medication was reported.   This case was linked to MOD-2021-406211, MOD-2021-406226 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia
Clinical narrative: whole body burns; whole body pain; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (whole body burns) and MYALGIA (whole body pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 027C21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-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 BURNING SENSATION (whole body burns) and MYALGIA (whole body pain). At the time of the report, BURNING SENSATION (whole body burns) and MYALGIA (whole body pain) outcome was unknown.            No concomitant medication information provided. Treatment- boiling tea to alleviate pain  Patient had whole body pain and whole body burns the night after getting her booster shot yesterday 05December.