chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: The Shingrix vaccine comes in a powder form that needs to be reconstituted with a diluent. When the vaccine arrives in the department the vial with the powdered vaccine and the vial with the diluent are banded together to remind staff to reconstitute prior to administration. An LPN was preparing give Shingrix to a member when she noted that the last vial coupling in the box was two vaccine powder vials banded together. Because this was the last of the vaccine, out of 10, left in the box, it can be assumed that two diluents were also banded together and it is likely that one of the 9 patients who received Shingrix vaccine from this box received a diluent only injection.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: The Shingrix vaccine comes in a powder form that needs to be reconstituted with a diluent. When the vaccine arrives in the department the vial with the powdered vaccine and the vial with the diluent are banded together to remind staff to reconstitute prior to administration. An LPN was preparing give Shingrix to a member when she noted that the last vial coupling in the box was two vaccine powder vials banded together. Because this was the last of the vaccine, out of 10, left in the box, it can be assumed that two diluents were also banded together and it is likely that one of the 9 patients who received Shingrix vaccine from this box received a diluent only injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: The Shingrix vaccine comes in a powder form that needs to be reconstituted with a diluent. When the vaccine arrives in the department the vial with the powdered vaccine and the vial with the diluent are banded together to remind staff to reconstitute prior to administration. An LPN was preparing give Shingrix to a member when she noted that the last vial coupling in the box was two vaccine powder vials banded together. Because this was the last of the vaccine, out of 10, left in the box, it can be assumed that two diluents were also banded together and it is likely that one of the 9 patients who received Shingrix vaccine from this box received a diluent only injection.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose #3  given too early. Dose #1 was given on 7/28/2022.  Dose #2 was given on 8/25/2022.  Parent aware. No adverse effects reported.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: The Shingrix vaccine comes in a powder form that needs to be reconstituted with a diluent. When the vaccine arrives in the department the vial with the powdered vaccine and the vial with the diluent are banded together to remind staff to reconstitute prior to administration. An LPN was preparing give Shingrix to a member when she noted that the last vial coupling in the box was two vaccine powder vials banded together. Because this was the last of the vaccine, out of 10, left in the box, it can be assumed that two diluents were also banded together and it is likely that one of the 9 patients who received Shingrix vaccine from this box received a diluent only injection.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Body temperature increased, Fatigue, Headache, Myalgia, SARS-CoV-2 test negative
Clinical narrative: Severe headache x 4 days despite Tylenol Temperature high of 101.5 x 3 days Sore muscles even teeth hurt Fatigued
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Toothache
Clinical narrative: Severe headache x 4 days despite Tylenol Temperature high of 101.5 x 3 days Sore muscles even teeth hurt Fatigued
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Oropharyngeal pain, Pyrexia
Clinical narrative: Dose #3  given too early. Dose #1 was given on 7/28/2022.  Dose #2 was given on 8/25/2022.  Parent aware. Mom reported that patient had a sore throat and fever the night of 9/15/22.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: The Shingrix vaccine comes in a powder form that needs to be reconstituted with a diluent. When the vaccine arrives in the department the vial with the powdered vaccine and the vial with the diluent are banded together to remind staff to reconstitute prior to administration. An LPN was preparing give Shingrix to a member when she noted that the last vial coupling in the box was two vaccine powder vials banded together. Because this was the last of the vaccine, out of 10, left in the box, it can be assumed that two diluents were also banded together and it is likely that one of the 9 patients who received Shingrix vaccine from this box received a diluent only injection.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Injection site erythema
Clinical narrative: Patient's appointment was for a fluarix vaccine and a Pfizer COVID booster.  The patient was accidentally given two fluarix vaccines, both in left arm.  It was discussed with patient and her parents that were also present in the room with her.  After discussion, she was given the COVID vaccine she was expecting as well. Patient was advised to watch for increased symptoms/side effects from the flu vaccine.  Contacted patient today to check in, only reported redness at the injection site.  I told patient to contact me if it worsened or any other issues.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: The patient was given 0.2ml dose of an undiluted Pediatric Pfizer vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Blood cholesterol increased, Blood test abnormal, Condition aggravated
Clinical narrative: Painful and stiff joints in fingers, thumbs, hands, elbows, knees, feet and toes beginning approximately 09/01/2021 to 09/18/2022 and ongoing. Previously reported in 2021 was numbness on left side of face from eyebrow to neck, psoriasis flare on left ear and both sides of scalp and hair loss all which have improved since reported. Told Dr about painful and stiff joints never before until had Covid shot and doctor did not want to blame the symptoms on the shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint stiffness, Psoriasis
Clinical narrative: Painful and stiff joints in fingers, thumbs, hands, elbows, knees, feet and toes beginning approximately 09/01/2021 to 09/18/2022 and ongoing. Previously reported in 2021 was numbness on left side of face from eyebrow to neck, psoriasis flare on left ear and both sides of scalp and hair loss all which have improved since reported. Told Dr about painful and stiff joints never before until had Covid shot and doctor did not want to blame the symptoms on the shot.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Foreign travel, Gait disturbance, General physical health deterioration, Impaired work ability
Clinical narrative: Janssen COVID-19 Vaccine EUA. This is a report for Patient. Subject was an otherwise healthy and physically active individual with no notable medical history prior to receiving the Janssen Covid-19 vaccine. He received his first dose of the vaccine (Lot # 1855194) at the pharmacy on 11/11/2021. Several days after receiving the vaccine, Subject experienced pain in his right leg joints and had to leave work. He was seen at Urgent Care on 12/27/2021. Subject was prescribed Naproxen (NAPROSYN). Subject received a second dose of the Janssen COVID-19 vaccine (Lot # 211D217) at the pharmacy on 01/29/22. Subject traveled outside of the country and while away, he experienced increased pain on his right leg joints and had to return home. The pain eventually spread to his left leg joints and then to other parts of the body. Subject visited his primary care physician at local Medical facility several times. Subject's joints became swollen and he experienced difficulties walking. He went to the Emergency Room on 6/25/2022. He was prescribed oxyCODONE-acetaminophen (PERCOCET) and released. Subject's condition severely deteriorated. He experienced severe pain on multiple joints and could barely walk at that point. He was transported by ambulance to local Hospital on 7/12/2022. He remained hospitalized at Hospital until 07/27/2022 when he was released to Rehab. While at County Hospital, several tests were conducted on the subject. He was diagnosed with Inflammatory Polyarthritis and was prescribed several medications which included: cyclobenzaprine (FLEXERIL) famotidine (PEPCID) ferrous sulfate (IRON) oxyCODONE-acetaminophen (PERCOCET) polyethylene glycol (MIRALAX) predniSONE (DELTASONE) rifAMPIN (RIFADIN) Senna (SENOKOT) Subject stayed at Rehab after his release from County Hospital on 07/27/2022 for rehabilitation until 08/20/2022. While at Rehab, he was followed by a physical, Dr. He is now staying in his apartment. He is regularly visited by nurses, and currently follows several drug regimens. He is still experiencing pain on several joints with intermittent joint swelling. He is followed by his primary care physician, Dr. at local Medical Associates, and a Rheumatologist physician, Dr. of the Rheumatology and Arthritis Care Center.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Laboratory test, Polyarthritis
Clinical narrative: Janssen COVID-19 Vaccine EUA. This is a report for Patient. Subject was an otherwise healthy and physically active individual with no notable medical history prior to receiving the Janssen Covid-19 vaccine. He received his first dose of the vaccine (Lot # 1855194) at the pharmacy on 11/11/2021. Several days after receiving the vaccine, Subject experienced pain in his right leg joints and had to leave work. He was seen at Urgent Care on 12/27/2021. Subject was prescribed Naproxen (NAPROSYN). Subject received a second dose of the Janssen COVID-19 vaccine (Lot # 211D217) at the pharmacy on 01/29/22. Subject traveled outside of the country and while away, he experienced increased pain on his right leg joints and had to return home. The pain eventually spread to his left leg joints and then to other parts of the body. Subject visited his primary care physician at local Medical facility several times. Subject's joints became swollen and he experienced difficulties walking. He went to the Emergency Room on 6/25/2022. He was prescribed oxyCODONE-acetaminophen (PERCOCET) and released. Subject's condition severely deteriorated. He experienced severe pain on multiple joints and could barely walk at that point. He was transported by ambulance to local Hospital on 7/12/2022. He remained hospitalized at Hospital until 07/27/2022 when he was released to Rehab. While at County Hospital, several tests were conducted on the subject. He was diagnosed with Inflammatory Polyarthritis and was prescribed several medications which included: cyclobenzaprine (FLEXERIL) famotidine (PEPCID) ferrous sulfate (IRON) oxyCODONE-acetaminophen (PERCOCET) polyethylene glycol (MIRALAX) predniSONE (DELTASONE) rifAMPIN (RIFADIN) Senna (SENOKOT) Subject stayed at Rehab after his release from County Hospital on 07/27/2022 for rehabilitation until 08/20/2022. While at Rehab, he was followed by a physical, Dr. He is now staying in his apartment. He is regularly visited by nurses, and currently follows several drug regimens. He is still experiencing pain on several joints with intermittent joint swelling. He is followed by his primary care physician, Dr. at local Medical Associates, and a Rheumatologist physician, Dr. of the Rheumatology and Arthritis Care Center.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Janssen COVID-19 Vaccine EUA. This is a report for Patient. Subject was an otherwise healthy and physically active individual with no notable medical history prior to receiving the Janssen Covid-19 vaccine. He received his first dose of the vaccine (Lot # 1855194) at the pharmacy on 11/11/2021. Several days after receiving the vaccine, Subject experienced pain in his right leg joints and had to leave work. He was seen at Urgent Care on 12/27/2021. Subject was prescribed Naproxen (NAPROSYN). Subject received a second dose of the Janssen COVID-19 vaccine (Lot # 211D217) at the pharmacy on 01/29/22. Subject traveled outside of the country and while away, he experienced increased pain on his right leg joints and had to return home. The pain eventually spread to his left leg joints and then to other parts of the body. Subject visited his primary care physician at local Medical facility several times. Subject's joints became swollen and he experienced difficulties walking. He went to the Emergency Room on 6/25/2022. He was prescribed oxyCODONE-acetaminophen (PERCOCET) and released. Subject's condition severely deteriorated. He experienced severe pain on multiple joints and could barely walk at that point. He was transported by ambulance to local Hospital on 7/12/2022. He remained hospitalized at Hospital until 07/27/2022 when he was released to Rehab. While at County Hospital, several tests were conducted on the subject. He was diagnosed with Inflammatory Polyarthritis and was prescribed several medications which included: cyclobenzaprine (FLEXERIL) famotidine (PEPCID) ferrous sulfate (IRON) oxyCODONE-acetaminophen (PERCOCET) polyethylene glycol (MIRALAX) predniSONE (DELTASONE) rifAMPIN (RIFADIN) Senna (SENOKOT) Subject stayed at Rehab after his release from County Hospital on 07/27/2022 for rehabilitation until 08/20/2022. While at Rehab, he was followed by a physical, Dr. He is now staying in his apartment. He is regularly visited by nurses, and currently follows several drug regimens. He is still experiencing pain on several joints with intermittent joint swelling. He is followed by his primary care physician, Dr. at local Medical Associates, and a Rheumatologist physician, Dr. of the Rheumatology and Arthritis Care Center.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red swollen around the vax site, itchy. No trouble breathing or angioedema
Age: 1.75
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was given an extra dose of Prevnar. In the chart, it showed that the patient had only received 3 doses of Prevnar, but 2 were after the age of 1 so therefore the patient did not need the fourth one that was given on 9/14/22. Provider spoke with parent and patient is doing well.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given the fourth dose of prevnar too early. Pt had received 3 doses but received 4th one 2 months too early and will have to receive another dose in 6 months.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Headache, Nausea, Vomiting
Clinical narrative: Severe splitting headache, nausea and vomiting, loss of appetite, aches in joints
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gingival pain, Gingival swelling
Clinical narrative: One day after my Moderna bivalent booster my gums started having extreme sensitivity and swelling. At first it was only the bottom left of my mouth but now has migrated to both the bottom left AND right. For now it is just minor pain and swelling, maybe a 3 out of 10.
Age: 6.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Contusion, Dysphonia, Erythema, Fatigue
Clinical narrative: Huge localized reaction - painful, hot to the touch, swollen, red, bruised, about 4 inches in diameter 2 days after injection. Fever (101.2), congestion, sore throat, hoarseness, fatigue, irritability and stomach pain 5 days after injection
Age: 6.0
Sex: M
Vaccine: PNC13
Symptoms: Irritability, Local reaction, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Huge localized reaction - painful, hot to the touch, swollen, red, bruised, about 4 inches in diameter 2 days after injection. Fever (101.2), congestion, sore throat, hoarseness, fatigue, irritability and stomach pain 5 days after injection
Age: 6.0
Sex: M
Vaccine: PNC13
Symptoms: Respiratory tract congestion, Skin warm, Swelling
Clinical narrative: Huge localized reaction - painful, hot to the touch, swollen, red, bruised, about 4 inches in diameter 2 days after injection. Fever (101.2), congestion, sore throat, hoarseness, fatigue, irritability and stomach pain 5 days after injection
Age: 79.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria - hives, itching for 48 hours, treated with Benadryl
Age: 79.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Rash
Clinical narrative: Urticaria - hives, itching for 48 hours, treated with Benadryl
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pruritus, Injection site swelling
Clinical narrative: The day after the vaccination patient had severe bruising around injection site and swelling.  The injection site also was very itchy
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Asthenia, Chills, Computerised tomogram abdomen, Computerised tomogram thorax
Clinical narrative: Fevers, Chills, Sweating, Nausea, Upper GI discomfort and pain, Headaches, Malaise, Loss of Appetite, Dehydration for a FULL 8 days and then weakness and muscle pain have continued over the past two days.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Dehydration, Fibrin D dimer increased, Gastrointestinal pain, Headache
Clinical narrative: Fevers, Chills, Sweating, Nausea, Upper GI discomfort and pain, Headaches, Malaise, Loss of Appetite, Dehydration for a FULL 8 days and then weakness and muscle pain have continued over the past two days.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Malaise, Myalgia, Nausea, Protein urine present
Clinical narrative: Fevers, Chills, Sweating, Nausea, Upper GI discomfort and pain, Headaches, Malaise, Loss of Appetite, Dehydration for a FULL 8 days and then weakness and muscle pain have continued over the past two days.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Ultrasound biliary tract
Clinical narrative: Fevers, Chills, Sweating, Nausea, Upper GI discomfort and pain, Headaches, Malaise, Loss of Appetite, Dehydration for a FULL 8 days and then weakness and muscle pain have continued over the past two days.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea for 12 hours
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral, Dehydration, Dizziness, Laboratory test, Magnetic resonance imaging head
Clinical narrative: Severe vertigo/vomiting that  started  2-3 days after vacccination, and lasted 2-3 days, resulting in severe dehydration and required taking an ambulance to the hospital.  Long term sequelae lasted a number of months and included dizziness, nystagmus, and brain/vision ?asymchrony?
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nystagmus, Vertigo, Visual impairment, Vomiting
Clinical narrative: Severe vertigo/vomiting that  started  2-3 days after vacccination, and lasted 2-3 days, resulting in severe dehydration and required taking an ambulance to the hospital.  Long term sequelae lasted a number of months and included dizziness, nystagmus, and brain/vision ?asymchrony?
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Heavy menstrual bleeding 4-5 months post vaccination. Break through bleeding throughout entire cycle.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Nausea, Vertigo, Vomiting
Clinical narrative: Vertigo, Diarrhea, Nausea, Vomiting
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Acne, Fatigue, Feeling hot, Nausea, Paraesthesia
Clinical narrative: Upon getting the vaccine I sat waiting in a chair just like everyone else; out of no where I became increasingly hot. I started fanning myself and my lips and hands started tingling. I became so hot it became noticeable to the nurses where I felt very alot of nausea. After theh rushed me an ice pack, water and fan to blow on me I slowly regained my normal  senses. I left on my own and drove home; was later ultra fatigued all weekend. Further swelling of secondary pimples intensified but under control. .. one of the worst vaccines I've ever gotten and I've never had such reaction. Shot was given just under the skin on my inner left forearm.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Paraesthesia oral, Swelling
Clinical narrative: Upon getting the vaccine I sat waiting in a chair just like everyone else; out of no where I became increasingly hot. I started fanning myself and my lips and hands started tingling. I became so hot it became noticeable to the nurses where I felt very alot of nausea. After theh rushed me an ice pack, water and fan to blow on me I slowly regained my normal  senses. I left on my own and drove home; was later ultra fatigued all weekend. Further swelling of secondary pimples intensified but under control. .. one of the worst vaccines I've ever gotten and I've never had such reaction. Shot was given just under the skin on my inner left forearm.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Basophil count normal, Basophil percentage, Blood iron decreased, Eosinophil count normal, Eosinophil percentage increased
Clinical narrative: heavy menstrual bleeding, break through bleeding throughout cycle, ongoing as of 9/18/22
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haematocrit normal, Haemoglobin normal, Heavy menstrual bleeding, Iron binding capacity total normal, Lymphocyte count normal
Clinical narrative: heavy menstrual bleeding, break through bleeding throughout cycle, ongoing as of 9/18/22
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Menstruation irregular
Clinical narrative: heavy menstrual bleeding, break through bleeding throughout cycle, ongoing as of 9/18/22
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Monocyte count normal, Monocyte percentage increased, Neutrophil count normal, Neutrophil percentage, Platelet count normal
Clinical narrative: heavy menstrual bleeding, break through bleeding throughout cycle, ongoing as of 9/18/22
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Red blood cell count normal, Red cell distribution width normal, Serum ferritin, Transferrin saturation, White blood cell count normal
Clinical narrative: heavy menstrual bleeding, break through bleeding throughout cycle, ongoing as of 9/18/22
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Error Scenario   Dose Administration Date   Lot Number   Recipient Date of Birth   Location Name   Patient Age at Administration Date   Adult Vaccine given to Child   1/21/2022   Health   5  Nothing happened. Child ok.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Impaired work ability, Malaise, Pyrexia
Clinical narrative: patient had fever 100 F cough "feeling" sick, he had to call in sick from work for a few days, he will be back to work on 9/18/22
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Patient is a 76 y.o. female with history of stage IV metastatic adenocarcinoma of the lung (s/p resection, radiation, chemotherapy), T2DM, CAD, prior PE (March 2022) on Eliquis, and asthma admitted to the hospital on 7/16/2022 for worsening SOB s/p COVID+ diagnosis on 7/12.  Patient was placed on heated high flow, pulmonology and infectious disease consulted.  She was started on Decadron 6 mg for total of 10 days, continue on home Symbicort, Spiriva, albuterol. Infectious disease recommended monoclonal antibodies, however patient declined at that time.  Patient continually improved throughout the clinical course, and was eventually weaned down to 4L supplemental oxygen via nasal cannula.  Patient was discharged w/ steroid taper per pulmonology
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had a positive home test/felt like a bad cold/ sick for 3 days; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had a positive home test/felt like a bad cold/ sick for 3 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 019871A and 027A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hemochromatosis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced COVID-19 (had a positive home test/felt like a bad cold/ sick for 3 days). In March 2022, COVID-19 (had a positive  home test/felt like a bad cold/ sick for 3 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: (Positive) About 4-5 months after the first booster, the patient had a positive home test.         No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  It was reported that about 4-5 months after the first booster, the patient had a positive home test. The patient was getting ready to go for the 2nd booster but he also had to draw blood once a month for his Hemochromatosis.  Company Comment: This spontaneous case concerns a 63-year-old male patient with concurrent Hemochromatosis who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 5 months after receiving the first booster dose of mRNA-1273. The patient has completed the primary series of vaccination with mRNA-1273 taken within the recommended dosing interval of 28 days prior to the booster dose. He developed cold for 3 days and tested positive for COVID-19 using a  home kit. Treatment information was not provided. At the time of report, COVID-19 has recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to (Patient Link). Sender's Comments: This spontaneous case concerns a 63-year-old male patient with concurrent Hemochromatosis who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 5 months after receiving the first booster dose of mRNA-1273. The patient has completed the primary series of vaccination with mRNA-1273 taken within the recommended dosing interval of 28 days prior to the booster dose. He developed cold for 3 days and tested positive for COVID-19 using a home kit. Treatment information was not provided. At the time of report, COVID-19 has recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had a positive home test/felt like a bad cold/ sick for 3 days; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had a positive home test/felt like a bad cold/ sick for 3 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 019871A and 027A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hemochromatosis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced COVID-19 (had a positive home test/felt like a bad cold/ sick for 3 days). In March 2022, COVID-19 (had a positive  home test/felt like a bad cold/ sick for 3 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: (Positive) About 4-5 months after the first booster, the patient had a positive home test.         No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  It was reported that about 4-5 months after the first booster, the patient had a positive home test. The patient was getting ready to go for the 2nd booster but he also had to draw blood once a month for his Hemochromatosis.  Company Comment: This spontaneous case concerns a 63-year-old male patient with concurrent Hemochromatosis who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 5 months after receiving the first booster dose of mRNA-1273. The patient has completed the primary series of vaccination with mRNA-1273 taken within the recommended dosing interval of 28 days prior to the booster dose. He developed cold for 3 days and tested positive for COVID-19 using a  home kit. Treatment information was not provided. At the time of report, COVID-19 has recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to (Patient Link). Sender's Comments: This spontaneous case concerns a 63-year-old male patient with concurrent Hemochromatosis who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 5 months after receiving the first booster dose of mRNA-1273. The patient has completed the primary series of vaccination with mRNA-1273 taken within the recommended dosing interval of 28 days prior to the booster dose. He developed cold for 3 days and tested positive for COVID-19 using a home kit. Treatment information was not provided. At the time of report, COVID-19 has recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; an expired PNEUMOVAX 23 vaccine was administered to a patient; This spontaneous report has been received from a pharmacist referring to a patient of unknown gender and age. The patient's medical history, current condition, and concomitant therapy were not provided.   On 22-AUG-2022, the patient was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (formulation: formulation syringe, valid lot #T032003 with reported expiration date 08-MAY-2022) (strength, dose description, and route of administration were not provided) for prophylaxis (expired product administered). There was no additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no adverse event; an expired MMR-II was in advertently administered to twins; This spontaneous report as received from a medical assistant refers to a twin patient of an unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions, were not provided. On 07-SEP-2022, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live ((M-M-R II) rHA (dose and route not reported) (lot number T029549 expiration date reported as 01-SEP-2022, but upon internal validation established as 10-SEP-2022) (conflicting information). Concomitant therapies included  sterile diluent.; Sender's Comments:  US-009507513-2209USA003202:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; an improperly stored VARIVAX was inadvertently administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 14-SEP-2022, the patient was inadvertently administered an improperly dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot# W016747 with an expiration date on 23-MAY-2024) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The administered dose of the vaccine was stored at a temperature of 8.4 degrees Fahrenheit (F) during a time frame of 34 minutes. There was no previous temperature excursion reported. No additional adverse events were reported.         ?
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Received first dose more than 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In January 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose more than 35 days ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose more than 35 days ago).    No concomitant medications were reported. No treatment details were reported.   This case was linked to MODERNATX, INC. (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.Patient-2 case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given instead of Bivalent
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given instead of Bivalent
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given instead of Bivalent
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given instead of Bivalent
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given instead of Bivalent
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Monovalent given instead of Bivalent
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE (EXPIRED 9 DAYS PRIOR) 08/31/2022
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt sleepy; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (felt sleepy) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Lidocaine).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (felt sleepy). At the time of the report, SOMNOLENCE (felt sleepy) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that patient received first and second dose as full dose. The patient had also received 2 boosters of Moderna Covid-19 vaccine (Monovalent).  The adverse event had not caused patient to seek medical care. It was unknown if the patient experienced a similar event in the past. The patient was advised by doctor that they should not take the Moderna Covid-19 vaccine as patient had allergies and hence queried if it was okay to receive Moderna Covid Vaccine, Bivalent. No treatment drug was reported.   This case was linked to MOD-2021-293413 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: COVID-19; MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Caffeine consumption (caffeinated beverages less than 3 per day), Alcohol use (1 to 9 drinks per week), Non-smoker (smoke cigarettes- no) and Non-tobacco user. Concomitant products included SERTRALINE, ASCORBIC ACID, CALCIUM, CHOLECALCIFEROL, CYANOCOBALAMIN, FERROUS FUMARATE, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, THIAMINE, VITAMIN A NOS, VITAMIN E NOS, ZINC OXIDE and PANTOPRAZOLE for an unknown indication.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY). In 2022, the patient experienced COVID-19 (COVID-19). The delivery occurred  on 12-Oct-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. In 2021, MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Patient had symptoms and was tested to see she was currently infected.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient did not needed to be hospitalized because of COVID-19 infection. Patient didn't consumed marijuana or recreational drugs since your last questionnaire.  Treatment medication was not provided. Company Comment: This retrospective spontaneous case of maternal exposure during pregnancy concerns an unknown-year-old female patient with no relevant medical history who experienced the unexpected events of COVID-19 and maternal exposure during pregnancy unknown days after a dose of mRNA-1273.  In 2022, SARS-CoV-2 test Positive At the time of the report, COVID-19 (COVID-19) outcome was unknown The benefit-risk relationship of product is not affected by this report   This case was linked to (Patient Link). Sender's Comments: This retrospective spontaneous case of maternal exposure during pregnancy concerns an unknown-year-old female patient with no relevant medical history who experienced the unexpected events of COVID-19 and maternal exposure during pregnancy unknown days after a dose of mRNA-1273.  In 2022, SARS-CoV-2 test Positive At the time of the report, COVID-19 (COVID-19) outcome was unknown The benefit-risk relationship of product is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Pyrexia
Clinical narrative: very very sick; fever of 102.5°F; chills; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (very very sick), PYREXIA (fever of 102.5°F) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Shingles and flu vaccine, Shingles and flu vaccine and Shingles and flu vaccine. Past adverse reactions to the above products included Chills with Shingles and flu vaccine; Fever with Shingles and flu vaccine; and Sickness with Shingles and flu vaccine. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa allergy), Multiple sclerosis and Blood pressure high. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high, TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very very sick), PYREXIA (fever of 102.5°F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (very very sick), PYREXIA (fever of 102.5°F) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 degree F.         It was reported that patient had never tested with COVID positive. Patient was not given other vaccines one month prior to Moderna COVID-19 vaccine. It was reported that these adverse events did not cause patient to seek medical care. It was reported that patient had experienced the similar events in the past but the reaction to the Moderna was the worst.   This case was linked to MOD-2021-029394 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First dose greater than 35 days ago; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago).    Concomitant medications were not reported. No treatment information was provided by the reporter. It was reported that the elderly couple at the pharmacy stated that they received first shot back in Jan-2022. They were looking for a follow up shot.  This case contains information for the 2nd patient of that 2 elderly patient described by the reporter.   This case was linked to MOD-, MODERNATX, INC. (E2B Linked Report). Sender's Comments:  MOD-:Patient-1 case -MODERNATX, INC.-MOD-:Patient-1 case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: dry mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DRY MOUTH (dry mouth) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced DRY MOUTH (dry mouth). At the time of the report, DRY MOUTH (dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient was pregnant.  The patient complained of a dry mouth after the first dose in their primary series.  No treatment details were reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Malaise, Nausea, Pyrexia
Clinical narrative: sweats; I woke to extreme nausea; low grade fever; malaise; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional  This case involves a 57 years old female patient who experienced sweats,  woke to extreme nausea, low grade fever and malaise after receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2007 followed by dose o 11-Sep-2022, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported at an unknown dose via intramuscular route in unknown administration site as flu vaccination.  It was reported  that the patient have received a flu vaccination for the past 15 years. Early morning of Sept 12, the patient  woke to extreme nausea, low grade fever (pyrexia), sweats (hyperhidrosis)and malaise.(latency: 1 day for dose on 11-Sep-2022) . The rest of the day, of Sept 12, the patient could barely stay awake and had to lay on the couch for support. The symptoms finally lessened at approximately 2pm on Sept 12, that the patient  could perform some of my daily activities. By the morning of Sept 13, there were no lingering symptoms.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: recovered for all events
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the ACTHIB with no adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 2 months old male patient who was administered acthib diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the acthib with no adverse event w, after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 24-Aug-2022, the patient received a  dose number 1 of suspect HIB (PRP/T) VACCINE( lot UJ650AAA and expiration date: 05-Mar-2023) at a dose of 0.5ml once via intramuscular route in the right vastus lateralis for immunization.  On 24-Aug-2022(Latency: same day), the patient was administered acthib diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the acthib with no adverse event (product preparation error).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .   Outcome: unknown     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.