chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Herpes zoster, Pyrexia
Clinical narrative: Outbreak of Shingles; Weakness; Chills; Fever; headache; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles approximately 5 years ago.).   In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a day after receiving Shingrix, the patient experienced chills, fever and headache. On an unknown date, the patient experienced shingles and weakness. On an unknown date, the outcome of the shingles, chills, fever and weakness were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the shingles, chills, fever, headache and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comment: The case was reported by the husband for her wife. Patient had three outbreaks of shingles before the shot. Then the outbreak was in close proximity to the shot. The reporter stated that the patient received Shingrix vaccine. Patient experienced chills, fever and weakness initially for four days and then had outbreak of shingles. Within 24 hours she developed fever, chills and a headache. Then five days later she had a visible outbreak of shingles. The lot and expiration date of Shingrix vaccine was unavailable. No additional details available at time of medical information communication. The reporter consented to follow up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Pain in hip when moves to stand, sit, or walk; Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 24th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain. On 25th July 2022, the patient experienced pain in hip. On an unknown date, the outcome of the injection site pain and pain in hip were recovering/resolving.   It was unknown if the reporter considered the injection site pain and pain in hip to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: The reporter was the patient who reported that received her Shingrix vaccine on the right arm.  The patient reported that right after receiving the Shingrix vaccine, felt soreness at the injection site, which was normal for her.  The patient had began to experience pain in her right hip when she moves to stand, sit, or walk. The 1 day after receiving Shingrix, the patient experienced pain in hip.   The reporter was not sure if this was related to the Shingrix vaccine or not.  The patient reported the pain was a little better this morning.  The reporter did not consent to follow-up.  The caller did not give permission to contact HCP, since had not contacted him yet.  The caller would like to know if other patients had reported this to GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke/Patient suffered a stroke before 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of stroke in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 26th July 2022, unknown after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was not recovered/not resolved.   It was unknown if the reporter considered the stroke to be related to Shingrix.  Additional Information: GSK Receipt Date: 25-Jul-2022. Reporter's Comments: The case was reported by the pharmacist. The reporter reported that the patient had a stroke since his first dose/ patient suffered a stroke before 2nd dose of Shingrix or between doses. The reporter reported that the patient was due to receive his second dose of Shigrix on 26th July 2022. No additional details were available. The reporter did not consent to follow up. Additional Supportive Information: The case US2022111230 was identified as duplicate of case US2022111231. The case US2022111230 was deleted and all future correspondence will be added in the present case US2022111231 which stands as case of record.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Injection site rash, Injection site urticaria, Pain, Swelling
Clinical narrative: Mild Swelling; Soreness; Fatigue; Rash around injection site; Hives extending / spread out  about 8cm x 9cm; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Covid-19 vaccine (the patient had a Covid-19 vaccine in the last year).   In July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In July 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced swelling, pain, fatigue, injection site rash and injection site hives. The patient was treated with allergy medication {nos} (Allergy Medication). On an unknown date, the outcome of the swelling, pain and fatigue were unknown and the outcome of the injection site rash and injection site hives were not recovered/not resolved.   It was unknown if the reporter considered the swelling, pain, fatigue, injection site rash and injection site hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comment: The reporter had a medical question about a patient with an unusual side effect. So he just received his first Meningococcal B vaccine last week.  He had some initial mild swelling, soreness and fatigue.  The day before reporting, 6 days after getting the vaccine, he developed a rash around the vaccine site.  It looked like hives extending from where the injection was.  That skin was clear and the hives spread out from it about 8cm by 9cm.  He was already on daily allergy medications but the rash was not itchy or painful.  The patient did not see report of rash so was wondering on it since it was a delayed appearance.  The reporter wanted to know also would there be any reasons he could not get the 2nd dose.  The patient's mother was extremely anxious and worried about it.  She was afraid it was related to also having a covid vaccine in the last year. The reporter attempted to contact healthcare professional to get the administration site and side and if the symptoms (besides rash and hives) were resolved, but he/she was unable to reach her. The reporter consented to follow up via postal.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Vaccination site rash
Clinical narrative: Mild Swelling; Soreness; Fatigue; Rash around injection site; Hives extending / spread out  about 8cm x 9cm; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Covid-19 vaccine (the patient had a Covid-19 vaccine in the last year).   In July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In July 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced swelling, pain, fatigue, injection site rash and injection site hives. The patient was treated with allergy medication {nos} (Allergy Medication). On an unknown date, the outcome of the swelling, pain and fatigue were unknown and the outcome of the injection site rash and injection site hives were not recovered/not resolved.   It was unknown if the reporter considered the swelling, pain, fatigue, injection site rash and injection site hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comment: The reporter had a medical question about a patient with an unusual side effect. So he just received his first Meningococcal B vaccine last week.  He had some initial mild swelling, soreness and fatigue.  The day before reporting, 6 days after getting the vaccine, he developed a rash around the vaccine site.  It looked like hives extending from where the injection was.  That skin was clear and the hives spread out from it about 8cm by 9cm.  He was already on daily allergy medications but the rash was not itchy or painful.  The patient did not see report of rash so was wondering on it since it was a delayed appearance.  The reporter wanted to know also would there be any reasons he could not get the 2nd dose.  The patient's mother was extremely anxious and worried about it.  She was afraid it was related to also having a covid vaccine in the last year. The reporter attempted to contact healthcare professional to get the administration site and side and if the symptoms (besides rash and hives) were resolved, but he/she was unable to reach her. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aches; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 22nd March 2022, received 1st dose of 0.5 ml by intramuscular route).   On 26th July 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th July 2022, less than a day after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comments: The patient called and stated that she got her second Shingrix vaccine and was experiencing body aches. The reporter did not consent to follow-up. No health care professional for follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Oral herpes, Pain, Pain in extremity
Clinical narrative: experiencing arm soreness; fever blister on the lip; fever blister was hard and painful; fever blister was hard and painful; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fever blister (prior to getting a different, earlier Shingles vaccine). Previously administered products included Shingles vaccine (received in 2004).   On 18th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a week after receiving Shingrix, the patient experienced fever blister, pain and induration. In 2018, the patient experienced pain in arm. The patient was treated with valaciclovir hydrochloride (Valtrex Cream) and valaciclovir (Valacyclovir). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fever blister, pain and induration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever blister, pain and induration to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR112021, US2022AMR112249   Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comments: The patient called and reported that he received vaccine in the left, upper arm.  The patient reported had experienced fever blisters prior to getting a different, earlier Shingles vaccine that only required one dose (caller was unsure of the name of earlier vaccine received) in what they believe was 2004.  The patient had not experienced anymore fever blisters in the years following the administration of the first, unknown Shingles vaccine until he received his first dose of Shingrix.  The patient reported experiencing a fever blister on the lip within a week of receiving first dose of Shingrix.  The fever blister was hard and painful.  The patient reported that he was using Valtex cream to treat the fever blister.  The patient was continuing to experience fever blisters, which were managed with a generic form a valacyclovir.  The patient experienced arm soreness after receipt of both doses of Shingrix. In 2018, less than 6 months after receiving Shingrix, the patient experienced pain in arm. The reporter consented to follow up. Additional Supportive Information: for tolerance of 2nd dose refer linked case US2022AMR112021.; Sender's Comments:  US-GSK-US2022AMR112021:Same case US-GSK-US2022AMR112249:Same patient, split case
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Sore arm/unable to lay on it; Fever of 100.4-100.5; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date and experienced pain in arm, refer case US2022AMR112652).   On 27th July 2022, the patient received the 2nd dose of Shingrix. On 27th July 2022, less than a day after receiving Shingrix, the patient experienced pain in arm and fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR112652   Additional Information: GSK receipt date: 28-Jul-2022 Reporter comment: The case was self reported by the patient.  The patient received second dose of Shingrix yesterday (from the day of reporting) in left arm. Last night, the patient experienced a fever of 100.4 to 100.5. The patient also experienced sore arm in which patient was unable to lay on it. The patient took the Tylenol to alleviate symptoms. Patient gave consent to follow up with HCP (pharmacy).; Sender's Comments:  US-GSK-US2022AMR112652:Same reporter, same case
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received two doses of Bexsero two weeks apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device , the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's comment: Nurse Practitioner reported a patient inadvertently received two doses of Bexsero two weeks apart. HCP did not have vaccine lot or expiry details, only had gender and age of patient (she called from her car to report). The reporter gave consent to follow up via email. Additional Supportive Information: Inadvertently received two doses of Bexsero two weeks apart, which led to drug dose administration interval too short.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and drug allergy (Name of drug not reported), and other pre-existing medical conditions included: patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 in left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 2) (form of admin, and route of admin were not reported, batch number: 071F21A expiry: Unknown,) dose was not reported, administered on 27-OCT-2021 in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination Moderna covid-19 vaccine (elasomeran, dose number in series 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 3) (form of admin, and route of admin were not reported, batch number: 005M51A expiry: Unknown) dose was not reported, administered on 13-MAY-2022 in left arm for covid-19 prophylaxis.  On an unspecified date in 2022, the patient experienced suspected covid-19 infection (dose number in series 3) The patient was prescribed with non-company suspect drug Paxlovid (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose not reported, administered first dose on 09-JUL-2022 and last dose on 14-JUL-2022 for covid-19 treatment. No concomitant medications were reported.  On 16-JUL-2022, 2 days after completing Paxlovid the patient experienced runny nose, cough, and weakness (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and elasomeran was not applicable and was discontinued for paxlovid. The patient had not recovered from suspected covid-19 infection. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DRUG DOSE ADMINISTRATION INTERVAL TOO SHORT; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was unknown whether the adverse event were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect drug included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number: 1160836, expiry: unknown) 40 mg, 1 time every 2 weeks, (1 in 1 Once) from 22-JUL-2022 for rheumatoid arthritis. The patient received Moderna covid-19 vaccine(elasomeran) (dose number in series 2) (form of admin not reported, route of admin: intramuscular, batch number: unknown, expiry: unknown) dose not reported, once, administered on an unspecified date for covid-19 prophylaxis. On 22-JUL-2022, the patient experienced drug dose administration interval too short (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; dose of adalimumab was not changed; and action taken with elasomeran was not reported. The patient recovered from drug dose administration interval too short on 22-JUL-2022. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient via a company representative via social media  concerned a patient of unspecified age, sex, race, ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. On an unspecified date, the patient was diagnosed with cancer (unspecified) and lupus (Dose number in series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 27-JUL-2022, the patient got covid (Dose number in series 2). It was reported that "Hey guess what. Cancer diagnosis. Lupus diagnosis. Fully vaccinated And boosted. Today I got Covid. Care to comment. Do anything about it. Guidance at all. Guarantee I will not here from you." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000244167. This case, involving the same patient is linked to 20220759828 (Dose number in series 1).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Cardiac discomfort, Disturbance in attention, Electrocardiogram, Fatigue
Clinical narrative: LEFT ARM STARTED HURTING THAT IT DETERIORATED AND WENT DOWN TO ELBOW; FATIGUE; HARD TIME FOCUSING; TIGHTNESS IN THE HEART; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported.  The patient's past medical history included: covid-19, and concurrent conditions included: allergies to antibiotic (an antibiotic and could not remember the name), allergic to a dye (dye in a MRI scan (could not remember the name)), non-alcoholic, and non-smoker, and other pre-existing medical conditions included: There was no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-JUN-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested.  Age at time of vaccination 62 years old. No concomitant medications were reported.  On 2022, the patient experienced hard time focusing, tightness in the heart, and fatigue. Laboratory data included: EKG Normal. On MAY-2022, Laboratory data included: Antibody test 7.8. On 14-JUN-2022, the patient experienced left arm started hurting that it deteriorated and went down to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, left arm started hurting that it deteriorated and went down to elbow, tightness in the heart and hard time focusing was not reported. This report was non-serious. This case is a duplicate of 20220761847.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEFT ARM STARTED HURTING THAT IT DETERIORATED AND WENT DOWN TO ELBOW; FATIGUE; HARD TIME FOCUSING; TIGHTNESS IN THE HEART; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported.  The patient's past medical history included: covid-19, and concurrent conditions included: allergies to antibiotic (an antibiotic and could not remember the name), allergic to a dye (dye in a MRI scan (could not remember the name)), non-alcoholic, and non-smoker, and other pre-existing medical conditions included: There was no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-JUN-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested.  Age at time of vaccination 62 years old. No concomitant medications were reported.  On 2022, the patient experienced hard time focusing, tightness in the heart, and fatigue. Laboratory data included: EKG Normal. On MAY-2022, Laboratory data included: Antibody test 7.8. On 14-JUN-2022, the patient experienced left arm started hurting that it deteriorated and went down to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, left arm started hurting that it deteriorated and went down to elbow, tightness in the heart and hard time focusing was not reported. This report was non-serious. This case is a duplicate of 20220761847.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22; doses given after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to antibiotic (Bactrim).    On 19-Jul-2022 at 12:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jul-2022 at 12:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 22 and administered on 19 Jul 22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was reported.      Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Follow up  received contains significant information: Updated report type from invalid case to spontaneous (received patient details in follow up). Added patient's details, medical history, suspect details and start date of event.; Sender's Comments:
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up; This spontaneous case was reported by a non-health professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Cyst, Obsessive-compulsive personality disorder, Knee injury (chronic knee injuries), Anterior cruciate ligament tear (ACL), Ligament tear (MCL) and Pain. Concurrent medical conditions included Allergy.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient reported unintended benefits which she got from Moderna vaccines and booster shots. The patient also mentioned that the 1st vaccine shot and the 2nd booster were the most beneficial to her.  The patient already had a connect with her PCPs, rheumatologist and pulmonologist about her situation.  No treatment information was provided by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site erythema, Vaccination site pain
Clinical narrative: flu like symptoms; sore injection site arm; red area around the injection site.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red area around the injection site.) in a 29-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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red area around the injection site.). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red area around the injection site.) outcome was unknown.            No concomitant medications were reported. The reporter stated that the patient received the vaccine and had not got COVID-19, believes this was because his daughter received the Moderna COVID-19 primary series and her two booster doses. The caller did not have any information on his daughters vaccinations. No lot numbers dates of vaccination or other adverse reactions were known.  Treatment information was unknown.   This case was linked to MOD-2022-614419, MOD-2022-614955, MOD-2022-614959 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got mild COVID disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Got mild COVID disease) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got mild COVID disease). At the time of the report, COVID-19 (Got mild COVID disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2022, SARS-CoV-2 test: (Positive) Had Positive PCR test.         No concomitant medications were reported. No treatment details were reported. Patient had mild symptoms of COVID-19 disease, 9 months after first booster dose, PCP refused to see the patient because of symptoms so patient went to urgent care.  Company Comment:This spontaneous case concerns an 89-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 9 months after receiving the first booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination within the recommended dosing interval with last dose taken approximately six months before the booster dose. There was no information regarding adverse event with previous COVID-19 vaccinations. The patient developed mild COVID-19 symptoms and tested positive for COVID-19 PCR test. Emergency room consultation was done but findings and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 89-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 9 months after receiving the first booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination within the recommended dosing interval with last dose taken approximately six months before the booster dose. There was no information regarding adverse event with previous COVID-19 vaccinations. The patient developed mild COVID-19 symptoms and tested positive for COVID-19 PCR test. Emergency room consultation was done but findings and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients received the vaccine pass 30 days in the fridge; patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   All patients was on medication (unspecified). Patients was not immunocompromised. Patients received their 2nd booster of the vaccine. No patients reported any side effects. Some patients was allergic to penicillin and sulfa and one was allergic to statin drugs like Lipitor. Physician reported that 3 patients received the vaccine on 24Jun2022 and 1 patient received the vaccine on 01Jul2022.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-615208, US-MODERNATX, INC.-MOD-2022-615212, US-MODERNATX, INC.-MOD-2022-615213 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615208:patient 1- elderly female 1 US-MODERNATX, INC.-MOD-2022-615212:patient 3- elderly male 1 US-MODERNATX, INC.-MOD-2022-615213:patient 4- elderly male 2
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Seizure
Clinical narrative: Fever; Sore arm; Two seizes; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Two seizes) in a 4-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. AS1416B and AS1416B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient born 24 weeks BPD.  Concurrent medical conditions included Latex allergy and Asthma.   On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced SEIZURE (Two seizes) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SEIZURE (Two seizes), PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Patient was taking other medication. The patient had two seizes on 26-Jul-2022 back-to-back. He also had a fever and sore arm. The ambulance picked him up on 26-Jul-2022 to bring him to the hospital. No treatment information was provided.  Company comment: This is a spontaneous case concerning  a  4-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) AESI event of Seizure and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The event Seizure occurred 1 day after the second dose of mRNA-1273 Vaccine. On an unknown date events Pain in extremity and Pyrexia occurred. The patient had two seizures, fever and sore arm. It was reported patient was taking other medication. Patient was picked up by the ambulance and brought to the hospital. No treatment information was provided. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  4-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) AESI event of Seizure and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The event Seizure occurred 1 day after the second dose of mRNA-1273 Vaccine. On an unknown date events Pain in extremity and Pyrexia occurred. The patient had two seizures, fever and sore arm. It was reported patient was taking other medication. Patient was picked up by the ambulance and brought to the hospital. No treatment information was provided. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Had a little bit of a back trouble prior to getting the 1st booster dose of the vaccine) had not resolved.            No concomitant product use was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-615240 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615240:1st booster dose
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Unknown if any recent change in status such as improvement or worsening.).    On 27-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jul-2022, the patient experienced UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap). At the time of the report, UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. The reporter stated that the patient was administered with a volume of 0.25 ml of Moderna COVID-19 Vaccine booster dose only presentation (vial with blue cap) for a second booster dose. The reporter was not aware of any adverse events after the vaccine was administered for the patient and did not know if any treatment was given, or if the patient was under any regular medication. Treatment details was not reported by the reporter.   This case was linked.; Sender's Comments:Other patient (Same Reporter)
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022; administer the vaccine  from a vial that  was open on 1Jun2022 to  patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to  patient) and PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 045C21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to  patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to  patient) and PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not tested positive for COVOD-19. No medical history reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 1-Jun-2022. HCP administered the vaccine from a vial that was open on 1-Jun-2022 to 6 patients. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to MOD-2022-615628 (Patient Link).