chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 7/24/2019, 2nd dose 10/6/2021; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th July 2019).   On 6th October 2021, the patient received the 2nd dose of Shingrix. On 6th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient did not get his/her second dose of Shingrix until 6th October 2021, which led to lengthening of vaccination schedule. The reporter also asked would he/she need a 3rd dose. No contact details were available.
Age: 5.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Boostrix, received Boostrix instead of Flu vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 9th November 2021, the patient received Boostrix .5 ml. On an unknown date, the patient started Boostrix Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse stated that, the child received Boostrix vaccine instead of Flu vaccine which led to inappropriate age at vaccine administration and wrong vaccine administered The reporter transferred to medical information team for guidance The reporter consented to follow up. This is 1 of the 4 linked cases, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231231:SAME REPORTER US-GLAXOSMITHKLINE-US2021231232:SAME REPORTER US-GLAXOSMITHKLINE-US2021231230:SAME REPORTER
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Pallor, Somnolence
Clinical narrative: REALLY PALE; FELT LIKE HAD GOT THE FLU, HEADACHE, TIRED, EXHAUSTED AND HIGH FEVER; DROWSY; VERY SORE ARM TO THE TOUCH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 11-NOV-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced really pale. On 11-NOV-2021, the patient experienced felt like had got the flu, headache, tired, exhausted and high fever. On 11-NOV-2021, the patient experienced drowsy. On 11-NOV-2021, the patient experienced very sore arm to the touch. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from really pale, felt like had got the flu, headache, tired, exhausted and high fever, very sore arm to the touch, and drowsy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Biopsy lymph gland, Epstein-Barr virus infection reactivation, Lymphadenopathy, Positron emission tomogram
Clinical narrative: RE-activated EBV; lasting lymphadenopathy "all over '' the body in different areas; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lasting lymphadenopathy "all over '' the body in different areas) and EPSTEIN-BARR VIRUS INFECTION REACTIVATION (RE-activated EBV) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymphoma in 2019, EBV infection and Stem cell transplant in 2019. Previously administered products included for Vaccination: Pfizer vaccine; for an unreported indication: Lymphoma in 2014. Past adverse reactions to the above products included Lymphadenopathy with Pfizer vaccine.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LYMPHADENOPATHY (lasting lymphadenopathy "all over '' the body in different areas). On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (RE-activated EBV). At the time of the report, LYMPHADENOPATHY (lasting lymphadenopathy "all over '' the body in different areas) and EPSTEIN-BARR VIRUS INFECTION REACTIVATION (RE-activated EBV) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) relapse of EBV+ Classical Hodgkin. In 2021, Biopsy lymph gland: no cancer (normal) No cancer. In 2021, Positron emission tomogram: abnormal (abnormal) Lymphadenopathy.         Caller stated that ,EBV was positive before auto transplant but vanished after it. It seemed to have deactivated after the vaccine. Caller had a FNA biopsy that showed a relapse of EBV+ Classical Hodgkin; But another subsequent "excisional" biopsy of another lymph node showing no Cancer. No concomitant medication were given. No treatment information were given.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant Follow-up received on 08-Nov-2021: Contains historical vaccine details .Updated new event.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chromaturia, Digestive enzyme normal, Lymphadenopathy, Nausea
Clinical narrative: orange urine; digestive; stomach pain with nausea; swollen lymph nodes of neck; stomach pain with nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (orange urine), DIGESTIVE ENZYME NORMAL (digestive), ABDOMINAL PAIN UPPER (stomach pain with nausea), LYMPHADENOPATHY (swollen lymph nodes of neck) and NAUSEA (stomach pain with nausea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 025b21a and 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma, Drug allergy (allergic to amoxicillin.), Drug allergy (allergy to tetracycline.) and  macroglobulinaemia since 11-Jan-2018.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced CHROMATURIA (orange urine), DIGESTIVE ENZYME NORMAL (digestive) and LYMPHADENOPATHY (swollen lymph nodes of neck). 28-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain with nausea) and NAUSEA (stomach pain with nausea). At the time of the report, CHROMATURIA (orange urine), DIGESTIVE ENZYME NORMAL (digestive), ABDOMINAL PAIN UPPER (stomach pain with nausea), LYMPHADENOPATHY (swollen lymph nodes of neck) and NAUSEA (stomach pain with nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient weight reported  as 150 unknown units. The patient reported that he is about to do the blood test, CAT scans for the issues. No treatment details were reported. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow-up received on 06-Nov-2021 contains demographic details, patient history  and product information, new events added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 73-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 018B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-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 PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had not resolved.            Concomitant drugs were not reported. Treatment medications were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Influenza
Clinical narrative: first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021; sore arm; mild flu; sweat; maybe a headache; really tired; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache) and FATIGUE (really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021). In 2021, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache), FATIGUE (really tired) and PYREXIA (little bit of fever). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache), FATIGUE (really tired) and PYREXIA (little bit of fever) outcome was unknown.            Patient concomitant mediation included thyroid medication which is used for product use for an unknown indication. Treatment information was not provided. Patient received the Moderna booster on 30-Oct-2021 with Lot No:25D21A and expiration date on 25-Jan-2022 Via IM route. And patient reported that she did not have any side effect for booster dose.   This case was linked to MOD-2021-377223 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021; sore arm; mild flu; sweat; maybe a headache; really tired; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache) and FATIGUE (really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021). In 2021, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache), FATIGUE (really tired) and PYREXIA (little bit of fever). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache), FATIGUE (really tired) and PYREXIA (little bit of fever) outcome was unknown.            Patient concomitant mediation included thyroid medication which is used for product use for an unknown indication. Treatment information was not provided. Patient received the Moderna booster on 30-Oct-2021 with Lot No:25D21A and expiration date on 25-Jan-2022 Via IM route. And patient reported that she did not have any side effect for booster dose.   This case was linked to MOD-2021-377223 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye swelling, Ocular hyperaemia, Periorbital swelling, Pyrexia
Clinical narrative: in the night eyes started to get puffy; Right eyelid is red and swollen, on the top of the eye and underneath; left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath; feeling feverish since last night,at the moment states having 100, 101 temperature; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (in the night eyes started to get puffy), OCULAR HYPERAEMIA (Right eyelid is red and swollen, on the top of the eye and underneath), EYE SWELLING (left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath) and PYREXIA (feeling feverish since last night,at the moment states having 100, 101 temperature) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 016B21A and 025AZ8) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PERIORBITAL SWELLING (in the night eyes started to get puffy), OCULAR HYPERAEMIA (Right eyelid is red and swollen, on the top of the eye and underneath), EYE SWELLING (left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath) and PYREXIA (feeling feverish since last night,at the moment states having 100, 101 temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PERIORBITAL SWELLING (in the night eyes started to get puffy), OCULAR HYPERAEMIA (Right eyelid is red and swollen, on the top of the eye and underneath) and EYE SWELLING (left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath) outcome was unknown and PYREXIA (feeling feverish since last night,at the moment states having 100, 101 temperature) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: high (High) 100, 101 temperature.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   This case was linked to MOD-2021-377259 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm also hurts; there is still a lot of discomfort; arm became hot and red and raised/swollen near the injection site; arm has begun to itch in that area; around the injection site arm became hot and red; swollen near the injection site/ The red/raised area is about the size of my palm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm also hurts), LIMB DISCOMFORT (there is still a lot of discomfort), VACCINATION SITE WARMTH (arm became hot and red and raised/swollen near the injection site), VACCINATION SITE PRURITUS (arm has begun to itch in that area) and VACCINATION SITE ERYTHEMA (around the injection site arm became hot and red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Nov-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (arm also hurts), LIMB DISCOMFORT (there is still a lot of discomfort), VACCINATION SITE WARMTH (arm became hot and red and raised/swollen near the injection site), VACCINATION SITE PRURITUS (arm has begun to itch in that area), VACCINATION SITE ERYTHEMA (around the injection site arm became hot and red) and VACCINATION SITE SWELLING (swollen near the injection site/ The red/raised area is about the size of my palm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm also hurts) outcome was unknown and LIMB DISCOMFORT (there is still a lot of discomfort), VACCINATION SITE WARMTH (arm became hot and red and raised/swollen near the injection site), VACCINATION SITE PRURITUS (arm has begun to itch in that area), VACCINATION SITE ERYTHEMA (around the injection site arm became hot and red) and VACCINATION SITE SWELLING (swollen near the injection site/ The red/raised area is about the size of my palm) had not resolved.            No concomitant medication was reported by the reporter. Treatment included cold compresses
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm also hurts; there is still a lot of discomfort; arm became hot and red and raised/swollen near the injection site; arm has begun to itch in that area; around the injection site arm became hot and red; swollen near the injection site/ The red/raised area is about the size of my palm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm also hurts), LIMB DISCOMFORT (there is still a lot of discomfort), VACCINATION SITE WARMTH (arm became hot and red and raised/swollen near the injection site), VACCINATION SITE PRURITUS (arm has begun to itch in that area) and VACCINATION SITE ERYTHEMA (around the injection site arm became hot and red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Nov-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (arm also hurts), LIMB DISCOMFORT (there is still a lot of discomfort), VACCINATION SITE WARMTH (arm became hot and red and raised/swollen near the injection site), VACCINATION SITE PRURITUS (arm has begun to itch in that area), VACCINATION SITE ERYTHEMA (around the injection site arm became hot and red) and VACCINATION SITE SWELLING (swollen near the injection site/ The red/raised area is about the size of my palm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm also hurts) outcome was unknown and LIMB DISCOMFORT (there is still a lot of discomfort), VACCINATION SITE WARMTH (arm became hot and red and raised/swollen near the injection site), VACCINATION SITE PRURITUS (arm has begun to itch in that area), VACCINATION SITE ERYTHEMA (around the injection site arm became hot and red) and VACCINATION SITE SWELLING (swollen near the injection site/ The red/raised area is about the size of my palm) had not resolved.            No concomitant medication was reported by the reporter. Treatment included cold compresses
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Tremor
Clinical narrative: Starting at 10pm I felt shaking, tremors; Headache is really bad, like a band was wrapped around my head; Chills/Starting at 10pm I felt shivering; Have fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Starting at 10pm I felt shaking, tremors), HEADACHE (Headache is really bad, like a band was wrapped around my head), CHILLS (Chills/Starting at 10pm I felt shivering) and FATIGUE (Have fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson vaccine on 16-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included GABAPENTIN, LEVOTHYROXINE SODIUM (SYNTHROID), PRAVASTATIN SODIUM (PRAVACHOL) and FAMOTIDINE for an unknown indication.    On 06-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced TREMOR (Starting at 10pm I felt shaking, tremors), HEADACHE (Headache is really bad, like a band was wrapped around my head) and FATIGUE (Have fatigue). 06-Nov-2021, the patient experienced CHILLS (Chills/Starting at 10pm I felt shivering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Starting at 10pm I felt shaking, tremors), CHILLS (Chills/Starting at 10pm I felt shivering) and FATIGUE (Have fatigue) outcome was unknown and HEADACHE (Headache is really bad, like a band was wrapped around my head) had not resolved.            Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, Blister, Dyspnoea, Heart rate increased, Hypersensitivity
Clinical narrative: Having hives; Itching; Blisters; They got in their pubic area, like an bacterial infection; Shortness of breath; Rapid heart bit; Experienced a allergic reaction that is still going on to these day; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection) and DYSPNOEA (Shortness of breath) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 804f21a and 091d21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL, APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), HYPERSENSITIVITY (Experienced a allergic reaction that is still going on to these day) and HYPERSENSITIVITY (Allergic reaction). 09-Sep-2021, the patient experienced BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection), DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Rapid heart bit). At the time of the report, URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), HYPERSENSITIVITY (Experienced a allergic reaction that is still going on to these day) and HYPERSENSITIVITY (Allergic reaction) had not resolved and BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection), DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Rapid heart bit) outcome was unknown.            Treatment included they have been prescribed with two types of antibiotics and nothing has work for an allergic reaction.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Having hives; Itching; Blisters; They got in their pubic area, like an bacterial infection; Shortness of breath; Rapid heart bit; Experienced a allergic reaction that is still going on to these day; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection) and DYSPNOEA (Shortness of breath) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 804f21a and 091d21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL, APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), HYPERSENSITIVITY (Experienced a allergic reaction that is still going on to these day) and HYPERSENSITIVITY (Allergic reaction). 09-Sep-2021, the patient experienced BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection), DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Rapid heart bit). At the time of the report, URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), HYPERSENSITIVITY (Experienced a allergic reaction that is still going on to these day) and HYPERSENSITIVITY (Allergic reaction) had not resolved and BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection), DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Rapid heart bit) outcome was unknown.            Treatment included they have been prescribed with two types of antibiotics and nothing has work for an allergic reaction.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: "2nd dose 150 days after the first dose,still can working; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ("2nd dose 150 days after the first dose,still can working) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ("2nd dose 150 days after the first dose,still can working). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ("2nd dose 150 days after the first dose,still can working) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Illness
Clinical narrative: I was violently sick, had pain; Felt way above discomfort; Felt woozy, no appetite, bathroom every 15 minutes; Pain; Cold; Dizziness; Diarrhea; Had trouble sleeping; Chills; Felt nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain) and NASOPHARYNGITIS (Cold) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDRALAZINE, DILTIAZEM, LEVOTHYROXINE SODIUM (SYNTHROID), DIGOXIN, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BIOTIN and APIXABAN (ELIQUIS) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-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 ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting). At the time of the report, ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Nasopharyngitis, Nausea, Pain
Clinical narrative: I was violently sick, had pain; Felt way above discomfort; Felt woozy, no appetite, bathroom every 15 minutes; Pain; Cold; Dizziness; Diarrhea; Had trouble sleeping; Chills; Felt nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain) and NASOPHARYNGITIS (Cold) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDRALAZINE, DILTIAZEM, LEVOTHYROXINE SODIUM (SYNTHROID), DIGOXIN, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BIOTIN and APIXABAN (ELIQUIS) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-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 ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting). At the time of the report, ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I was violently sick, had pain; Felt way above discomfort; Felt woozy, no appetite, bathroom every 15 minutes; Pain; Cold; Dizziness; Diarrhea; Had trouble sleeping; Chills; Felt nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain) and NASOPHARYNGITIS (Cold) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDRALAZINE, DILTIAZEM, LEVOTHYROXINE SODIUM (SYNTHROID), DIGOXIN, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BIOTIN and APIXABAN (ELIQUIS) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-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 ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting). At the time of the report, ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: full body urticaria
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Severe Illness
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Chills, Cough, Injection site pain, Muscle spasms
Clinical narrative: Severe injection site pain Severe chills throughout night not controlled with tylenol/ibuprofen Vaginal bleeding/spotting 2 days after injection- I am breastfeeding and have not had a mensural cycle or bleeding until I received the shot. Lasted for about 12 hours on and off spotting with slight cramping Cough and Sore throat Chest congestion
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Vaginal haemorrhage
Clinical narrative: Severe injection site pain Severe chills throughout night not controlled with tylenol/ibuprofen Vaginal bleeding/spotting 2 days after injection- I am breastfeeding and have not had a mensural cycle or bleeding until I received the shot. Lasted for about 12 hours on and off spotting with slight cramping Cough and Sore throat Chest congestion
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Eczema, Otitis externa, Pyrexia, Skin reaction
Clinical narrative: Chronic swimmers ear that still shows up every 5 days. Large abcess on stomach that caused 104 degree fever, happened once but smaller ones pop up randomly.  3 year old tattoo and 6 month old tattoo started to reject and currently a large open sore. Large patches of "eczema" on arms and parts of the upper body.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tattoo
Clinical narrative: Chronic swimmers ear that still shows up every 5 days. Large abcess on stomach that caused 104 degree fever, happened once but smaller ones pop up randomly.  3 year old tattoo and 6 month old tattoo started to reject and currently a large open sore. Large patches of "eczema" on arms and parts of the upper body.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had a vaccine and still got them/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he/she had seen shingles, and they looked worse than leprosy and he/she knew a person (patient) who got the Shingle vaccine and still got shingles sometime later. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, never received the 2nd.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in 2018 (did not have exact date)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter would like to know if shingrix series need to be restarted. The patient had consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 101 FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced 101 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 101 fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache
Clinical narrative: Minor stroke; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Minor stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Minor stroke) (seriousness criterion medically significant). an unknown date, the patient experienced HEADACHE (really bad headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Minor stroke) and HEADACHE (really bad headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The patient stated that the side effect was not a really bad headache. She had a minor stroke 7 days after she received her second Moderna vaccination. She was not sure that if it was the vaccination or just coincidence. Company comment: This case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious adverse event of special interest of cerebrovascular accident. The event occurred approximately 7 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-159768 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Case is upgraded to serious (Medically significant). Reporter added, patient initials added, dose number added (action taken with drug updated as per dose Number), event added: cerebrovascular accident.; Sender's Comments: This case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious adverse event of special interest of cerebrovascular accident. The event occurred approximately 7 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.