chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Pain in extremity
Clinical narrative: Left arm pain and shoulder and hand pain
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Systemic lupus erythematosus
Clinical narrative: Lupus
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: ADMINSTRATION ERROR- PATIENT CAME IN FOR HER 10 MONTH WELL EXAM.  AFTER GIVING VACCINES TO THE PATIENTS, FOUND OUT THAT ALL DOSES HAD ADMINISTERED PRIOR RO TODAY'S VISIT.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Respiratory tract congestion
Clinical narrative: I took my son to the doctor after he experienced pink eye, and he was prescribed eye drops to treat the condition. He also had congestion in the days following up to getting pink eye.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE REACTION (SWELLING, HOT TO TOUCH, PAIN, HARD BUMP UNDER SKIN) APPEARED THE DAY FOLLOWING INJECTING AND PERSISTS AT DAY 6. SEVERE FATIGUE FOR 2 DAYS FOLLOWING VACCINATION.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Chest pain, Cough, Echocardiogram abnormal, Heart valve incompetence
Clinical narrative: PT STATED THAT SHE HAD A REACTION TO BIVALENT MODERNA. NEXT DAY STABING BURNING PAIN UNDERNEATH THE LEDT BREAST IN THE LUNG, WITH THROBBING. FOR 2 MONTHS PT WAS UNABLE TO LAY ON LEFT SIDE. PT WAS COUGHING THROUGH OUT EXPERIENCE. MD ODER BLOOD TEST FOR HEART AND AN ECHOCARDIOGRAM WHICH SHOWS NARROWING AND MITRAL VALVE LEAKING. PT WILL NEED A HEART CATH TO SEE WHAT IS HAPPENING.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mitral valve stenosis, Mobility decreased, Pain, Pulmonary pain
Clinical narrative: PT STATED THAT SHE HAD A REACTION TO BIVALENT MODERNA. NEXT DAY STABING BURNING PAIN UNDERNEATH THE LEDT BREAST IN THE LUNG, WITH THROBBING. FOR 2 MONTHS PT WAS UNABLE TO LAY ON LEFT SIDE. PT WAS COUGHING THROUGH OUT EXPERIENCE. MD ODER BLOOD TEST FOR HEART AND AN ECHOCARDIOGRAM WHICH SHOWS NARROWING AND MITRAL VALVE LEAKING. PT WILL NEED A HEART CATH TO SEE WHAT IS HAPPENING.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: no adverse events noted yet, patient's mother was instructed to notify us of any symptoms
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt. was a routine checkup to have his physical form signed for college. The nurse practitioner told him that he had only received one dose of the chicken pox vaccine (varicella) and told him he needed another dose.  This information is not accurate. The dr's office has record that pt. received his first dose of varicella on 10/14/05 and his second dose of varicella on 4/29/09 as recommended by the CDC. The dose that was administered by the nurse practitioner on 4/19/23 was pt.'s third dose of the varicella vaccine.  The dr was called concerning the third dosage.  The nurse took a message and said she would pass it on to the dr to see if there was anything we should do since pt. was administered a third dosage of varicella.  The dr never called back as of 9:30pm on 4/19/23.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abnormal loss of weight, Dizziness, Dysstasia, Exercise tolerance decreased
Clinical narrative: HR soaring to 200, 187, 166, 141 depending on the day or night, sweating, hot and cold intolerance, dizzy, extreme weight loss, swelling in legs and abdomen, heart palpitations, exercise intolerance, difficulty standing or walking, vision distortion, splotchy arms and legs, shaking, numbness in feet, fainted three times.  All of this is still going on.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: HR soaring to 200, 187, 166, 141 depending on the day or night, sweating, hot and cold intolerance, dizzy, extreme weight loss, swelling in legs and abdomen, heart palpitations, exercise intolerance, difficulty standing or walking, vision distortion, splotchy arms and legs, shaking, numbness in feet, fainted three times.  All of this is still going on.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Metamorphopsia, Palpitations, Peripheral swelling, Rash macular
Clinical narrative: HR soaring to 200, 187, 166, 141 depending on the day or night, sweating, hot and cold intolerance, dizzy, extreme weight loss, swelling in legs and abdomen, heart palpitations, exercise intolerance, difficulty standing or walking, vision distortion, splotchy arms and legs, shaking, numbness in feet, fainted three times.  All of this is still going on.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Temperature intolerance, Tremor
Clinical narrative: HR soaring to 200, 187, 166, 141 depending on the day or night, sweating, hot and cold intolerance, dizzy, extreme weight loss, swelling in legs and abdomen, heart palpitations, exercise intolerance, difficulty standing or walking, vision distortion, splotchy arms and legs, shaking, numbness in feet, fainted three times.  All of this is still going on.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: dad called that daugher had developed a 2 inch red, warm slightly raised circle below injection site.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient said her doctor told her to come in and get a tetanus shot.  claim processed through the insurance.  After discussing shingrix with patient discovered she had an adacel dose in 7/2022
Age: 1.17
Sex: M
Vaccine: DTAP, HIBV, PNC15
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Patient started vaccine at age of six months, and DTaP vaccination was his fourth dose. So it should  have been given at 18 months. Patient is only Fourteen months old, vaccine was given 4 months too early.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: red/swollen
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Pt was given a double dose of IPV polio.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint range of motion decreased, Pain in extremity
Clinical narrative: After 2nd vaccine, cannot still move her arm; It still hurts when she moves her arm; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6198) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot EM5318, Left arm), administration date: 04Feb2021, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "After 2nd vaccine, cannot still move her arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It still hurts when she moves her arm"; HEADACHE (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300159823 Same patient/product, different AE/dose;
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, CSF test normal, Chest X-ray, Chest discomfort, Computerised tomogram head
Clinical narrative: After the injection:  left arm numbness that extended to left shoulder,  base of neck bilaterally, base of skull/occiput bilaterally, headache and pain extending around to right eye.  10/22/2021 treated four sinus infection with doxycycline for 7 days. 11/1/21 symptoms become constant.  Severe sharp stabbing headaches at the base of skull, unable to work for 3 days.  On 11/13/21 left sided chest pressure, palpitations, nausea, worsening of above symptoms and disequilibrium.  EKG normal
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Electrocardiogram normal, Eye pain, Headache, Hypoaesthesia
Clinical narrative: After the injection:  left arm numbness that extended to left shoulder,  base of neck bilaterally, base of skull/occiput bilaterally, headache and pain extending around to right eye.  10/22/2021 treated four sinus infection with doxycycline for 7 days. 11/1/21 symptoms become constant.  Severe sharp stabbing headaches at the base of skull, unable to work for 3 days.  On 11/13/21 left sided chest pressure, palpitations, nausea, worsening of above symptoms and disequilibrium.  EKG normal
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test, Magnetic resonance imaging head, Magnetic resonance imaging neck, Nausea
Clinical narrative: After the injection:  left arm numbness that extended to left shoulder,  base of neck bilaterally, base of skull/occiput bilaterally, headache and pain extending around to right eye.  10/22/2021 treated four sinus infection with doxycycline for 7 days. 11/1/21 symptoms become constant.  Severe sharp stabbing headaches at the base of skull, unable to work for 3 days.  On 11/13/21 left sided chest pressure, palpitations, nausea, worsening of above symptoms and disequilibrium.  EKG normal
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Sinusitis
Clinical narrative: After the injection:  left arm numbness that extended to left shoulder,  base of neck bilaterally, base of skull/occiput bilaterally, headache and pain extending around to right eye.  10/22/2021 treated four sinus infection with doxycycline for 7 days. 11/1/21 symptoms become constant.  Severe sharp stabbing headaches at the base of skull, unable to work for 3 days.  On 11/13/21 left sided chest pressure, palpitations, nausea, worsening of above symptoms and disequilibrium.  EKG normal
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/30/2023. I contacted my provider and got a prescription Paxlovid. I got rebound COVID-19 and I filed a report with the manufacturer.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, No adverse event, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/30/2023. I contacted my provider and got a prescription Paxlovid. I got rebound COVID-19 and I filed a report with the manufacturer.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: covid testdate=05Jan2022, covid test result=Positive; covid testdate=05Jan2022, covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 17:00 as dose 1, single (Lot number: EN6200) and on 16Mar2021 at 17:00 as dose 2, single (Lot number: EN6207) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "PsA" (unspecified if ongoing), notes: Since that time I have also been diagnosed with PsA, Fibromyalgia.; "Fibromyalgia" (unspecified if ongoing), notes: Since that time I have also been diagnosed with PsA, Fibromyalgia. Concomitant medication(s) included: NORTRIPTYLINE; LISINOPRIL; LANSOPRAZOLE; OXYBUTIN. Past drug history included: Demerol, reaction(s): "known allergies: Demerol". The patient didn't have Covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "covid testdate=05Jan2022, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157753 same patient/vaccine, diff dose/event;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid testdate=05Jan2022, covid test result=Positive; covid testdate=05Jan2022, covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 17:00 as dose 1, single (Lot number: EN6200) and on 16Mar2021 at 17:00 as dose 2, single (Lot number: EN6207) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "PsA" (unspecified if ongoing), notes: Since that time I have also been diagnosed with PsA, Fibromyalgia.; "Fibromyalgia" (unspecified if ongoing), notes: Since that time I have also been diagnosed with PsA, Fibromyalgia. Concomitant medication(s) included: NORTRIPTYLINE; LISINOPRIL; LANSOPRAZOLE; OXYBUTIN. Past drug history included: Demerol, reaction(s): "known allergies: Demerol". The patient didn't have Covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "covid testdate=05Jan2022, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157753 same patient/vaccine, diff dose/event;
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; VARIVAX was administered after temperature excursion; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On unknown dates, varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion with 6 Fahrenheit degrees up to 14 Fahrenheit degrees for (12.5 Fahrenheit degrees) for 1 hours 0 minutes 0 seconds and 14 Fahrenheit degrees up to 46 Fahrenheit degrees for (19.7 Fahrenheit degrees) for 1 hours 0 minutes 0 seconds. There was no previous temperature excursion.    On 10-MAR-2023, after temperature excursion, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (1 time dose, lot # W012166, expiration date 12-APR-2024; strength, route of administration, anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was accidently administered an expired dose of MMR II on Apr 17, 2023.; This spontaneous report was received from Pharmacist and refers to a patient of an unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  17-APR-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II)  once, lot #U011149, expiration date: 08-APR-2023, administered for prophylaxis (strength, and route of administration were not provided (Expired vaccine used). No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient who is currently 4 years old received the first dose of RECOMBIVAX in 2019 and did not receive the second dose yet.; No additional AEs were reported; This spontaneous report was received from a medical assistant and refers to a 4-years-old patient of an unknown or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and the patient did not receive the second dose yet (Inappropriate schedule of vaccine administered). No additional adverse event were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: terrible hives mostly from waist up soon even feet and hands / milder, smaller patches; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (terrible hives mostly from waist up soon even feet and hands / milder, smaller patches) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Mar-2023, the patient experienced URTICARIA (terrible hives mostly from waist up soon even feet and hands / milder, smaller patches). At the time of the report, URTICARIA (terrible hives mostly from waist up soon even feet and hands / milder, smaller patches) was resolving.            No concomitant products reported.  It was reported that patient got the new booster on March 2nd. Ten days later, started having terrible hives mostly from waist up, soon even feet and hands. Patient was about to start sixth week with the problem. patient questioned was there any antidote and how long it was going to last for. The only good news was that the last 2 weeks it had been milder, smaller patches and less time. Patient went from 2 hours at a time to about 20 minutes.  No treatment products reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2023: Non Significant follow up appended
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. .     On 08-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine).    No concomitant medications were reported.  It was reported that the patient went to Pharmacy for 1st dose of primary vaccine and received the booster dose. Patient was tired and weak after first dose, she was informed that the booster and the vaccine were same. Patient was offered with a second dose of the booster to complete the vaccine. Patient wanted to know if it was okay to receive a second bivalent dose in order to complete the vaccination series.  No treatment details were reported.   This case was linked to MOD-2023-719731 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 4/15; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID 4/15) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. GJ6742) for COVID-19 prophylaxis.     Prior to vaccination patient was not diagnosed with COVID-19.  Concurrent medical conditions included Drug allergy (Name of Drug Reported as: No).    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Apr-2023, the patient experienced COVID-19 (Tested positive for COVID 4/15). At the time of the report, COVID-19 (Tested positive for COVID 4/15) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2023, SARS-CoV-2 test: Positive.         Date of birth of patient reported.  No concomitant medications were reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also not received any other medications within 2 weeks of vaccination.  Patient did not receive any treatment medications.
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 4/15; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID 4/15) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. GJ6742) for COVID-19 prophylaxis.     Prior to vaccination patient was not diagnosed with COVID-19.  Concurrent medical conditions included Drug allergy (Name of Drug Reported as: No).    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Apr-2023, the patient experienced COVID-19 (Tested positive for COVID 4/15). At the time of the report, COVID-19 (Tested positive for COVID 4/15) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2023, SARS-CoV-2 test: Positive.         Date of birth of patient reported.  No concomitant medications were reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also not received any other medications within 2 weeks of vaccination.  Patient did not receive any treatment medications.
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 15Apr; Tested positive for COVID 15Apr; Pfizer / Moderna Vaccine Bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No covid prior vaccination. covid tested post vaccination. No known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Oct2022, outcome "recovering", described as "Pfizer / Moderna Vaccine Bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Apr2023, outcome "recovering" and all described as "Tested positive for COVID 15Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 15Apr; Tested positive for COVID 15Apr; Pfizer / Moderna Vaccine Bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No covid prior vaccination. covid tested post vaccination. No known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Oct2022, outcome "recovering", described as "Pfizer / Moderna Vaccine Bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Apr2023, outcome "recovering" and all described as "Tested positive for COVID 15Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022) 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 (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022).    No concomitant medication was reported.  Patient was over 65 years old. Patient got bivalent on 19-Sep-2022 and were at higher risk. No treatment information was reported.  This case contains information for patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-720117 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720117:Patient 1
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: weak after first dose; Was tired; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak after first dose) and FATIGUE (Was tired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak after first dose) and FATIGUE (Was tired). At the time of the report, ASTHENIA (weak after first dose) and FATIGUE (Was tired) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2023-719728 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)) 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 EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)).    The vial size was 5.5 ml. The vial was initially stored in the refrigerator was 3APR2023  The vial did not undergo any temperature excursions. Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2023: Live Follow-up received include reference section updated.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023; No adverse event; two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023).    No concomitant medication details was reported. The patient did not report any adverse reaction. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022). 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 the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022) 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 the Moderna vaccine monovalent on 30Oct2021 and second on 30Mar2022).  The concomitant medication was not reported by reporter. Patient received bivalent on 19-Sep-2022. Patient was over 65 years old, so patient was at higher risk.  The treatment medication was not reported by reporter. This case contains information for the 1st patient out of 2 patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2023-720119 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720119:Patient 2.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: The patient had their 1st dose one year ago; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year ago) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year ago) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year 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 PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year ago).    No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044c22a) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine) 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 EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine).    No concomitant medications were provided. No adverse events were reported by the patient after the administration.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available) 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 PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available).    Concomitant medications were not reported.  Patient took the 1st dose of Moderna COVID primary series in mid-March. For the administration of 2nd dose of Moderna COVID primary series is not available.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2023: Live follow up received is non significant.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she had broke out in hives from tip of her fingers and all over; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (she had broke out in hives from tip of her fingers and all over) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 031F21, 019B21A and 010A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product AMOXICILLIN for an unknown indication.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started AMOXICILLIN (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (she had broke out in hives from tip of her fingers and all over). At the time of the report, URTICARIA (she had broke out in hives from tip of her fingers and all over) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient did not take maintenance medication.   On Sep-2022 for dental appointment and for many years the patient took amoxicillin before dental appointment.  The patient received 3rd booster dose on 26-Oct-2022, lot number 021H22A.  No treatment medications were reported.   Reporter did not allow further contact
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 13-APR-2023 at 10:00 AM had drawn up monovalent primary series of Moderna, on 14-APR-2023 morning at 10:58 was administered and vaccine held in syringe in refrigerator overnight.; No adverse event; Thursday 13-APR-2023 at 10:00 AM had drawn up/ Friday 14-APR-2023 morning at 10:58 was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Thursday 13-APR-2023 at 10:00 AM had drawn up/ Friday 14-APR-2023 morning at 10:58 was administered), PRODUCT STORAGE ERROR (On 13-APR-2023 at 10:00 AM had drawn up monovalent primary series of Moderna, on 14-APR-2023 morning at 10:58 was administered and vaccine held in syringe in refrigerator overnight.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1415B) for COVID-19 prophylaxis.     It was reported that patient received any other vaccines in the 4 weeks prior to COVID-19.     On 14-Apr-2023 at 10:58 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2023 at 10:58 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Thursday 13-APR-2023 at 10:00 AM had drawn up/ Friday 14-APR-2023 morning at 10:58 was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 13-APR-2023 at 10:00 AM had drawn up monovalent primary series of Moderna, on 14-APR-2023 morning at 10:58 was administered and vaccine held in syringe in refrigerator overnight.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Thursday 13-APR-2023 at 10:00 AM had drawn up/ Friday 14-APR-2023 morning at 10:58 was administered), PRODUCT STORAGE ERROR (On 13-APR-2023 at 10:00 AM had drawn up monovalent primary series of Moderna, on 14-APR-2023 morning at 10:58 was administered and vaccine held in syringe in refrigerator overnight.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Thursday 13-APR-2023 at 10:00 AM had drawn up/ Friday 14-APR-2023 morning at 10:58 was administered) and PRODUCT STORAGE ERROR (On 13-APR-2023 at 10:00 AM had drawn up monovalent primary series of Moderna, on 14-APR-2023 morning at 10:58 was administered and vaccine held in syringe in refrigerator overnight.).    No concomitant medications was reported. No symptoms was reported. It was reported that o the same day when vaccine was administered Rotovirus, Prednar vaccine, Flu vaccine, Vaccelus vaccine as routine vaccines was given to individuals age group. No additional dose medications or reatmet drug details was reported.