chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Nitrite urine present, Pain, Prohormone brain natriuretic peptide increased, Pyrexia
Clinical narrative: Pfizer Dose 1 1/25/21 (lot NA) Pfizer Dose 2 2/15/21 (lot NA) Pfizer Dose 3 11/2/21 (301308A) COVID Positive 2/21/22  2/21/22: Patient is a 63 year old female with PMH multiple sclerosis, anemia, chronic osteomyelitis of the pelvis, GERD, heart failure with preserved ejection fraction, neurogenic bladder with chronic suprapubic urinary catheter, chronic G-tube, ileostomy, legally blind who presented to the ED today due to fever and altered mental status.   In the ED she presented with pulse 126, respiratory rate 35 saturating 91% on room air, temperature 99.3°, with BP 128/37.  Labs notable for Na 130, ALP 124, proBNP 718, WBC 18.43, with negative troponin, and normal lactate and lipase.  Urine turbid with large blood, leuk esterase, and positive nitrates with loaded bacteria, many amorphous crystal, and moderate yeast.  Patient was given vancomycin, Zosyn, and 1 L NS.   Upon evaluation patient does not understand why she is in the hospital.  Due to MS limited history was obtained from patient.  Mental status similar from previous admissions. She agrees to fevers, however denies chills.  She notes chronic pain, however no increased pain in her abdomen or at the site of her suprapubic catheter.  She otherwise denies of chest pain, shortness of breath.  Surgical history:  Ileostomy, chronic G-tube, chronic suprapubic catheter  Social history:   FH: Noncontributory  2/26/22: Patient is a 63 year old female with PMH multiple sclerosis, anemia, chronic osteomyelitis of the pelvis, GERD, heart failure with preserved ejection fraction, neurogenic bladder with chronic suprapubic urinary catheter, chronic G-tube, ileostomy, legally blind who had presented to the ER due to fever and altered mental status. Pt was tachycardic with leukocytosis and signs of possible UTI. Pt was admitted for concerns of possible urosepsis. However, blood cultures were negative. Imaging studies showed stable known staghorn calculus of L kidney with inflammatory changes. Urology was consulted and are considering PCNL outpatient, otherwise no procedure while hospitalized. She received several days of ceftriaxone for therapy until urine cultures resulted. These eventually showed MRSA and Enterococcus faecalis, both sensitive to Macrobid. Pt was stabilized during the hospital and had no repeat fevers. Today feeling well with no concerns. She was discharged to complete a full 7 days of Macrobid for treatment of possible UTI. Pt stable and discharged. She has a scheduled f/u with urology in April, but FMC will work to move up this appointment per urology's recommendation.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Staphylococcus test positive, Tachycardia, Troponin, Urine abnormality
Clinical narrative: Pfizer Dose 1 1/25/21 (lot NA) Pfizer Dose 2 2/15/21 (lot NA) Pfizer Dose 3 11/2/21 (301308A) COVID Positive 2/21/22  2/21/22: Patient is a 63 year old female with PMH multiple sclerosis, anemia, chronic osteomyelitis of the pelvis, GERD, heart failure with preserved ejection fraction, neurogenic bladder with chronic suprapubic urinary catheter, chronic G-tube, ileostomy, legally blind who presented to the ED today due to fever and altered mental status.   In the ED she presented with pulse 126, respiratory rate 35 saturating 91% on room air, temperature 99.3°, with BP 128/37.  Labs notable for Na 130, ALP 124, proBNP 718, WBC 18.43, with negative troponin, and normal lactate and lipase.  Urine turbid with large blood, leuk esterase, and positive nitrates with loaded bacteria, many amorphous crystal, and moderate yeast.  Patient was given vancomycin, Zosyn, and 1 L NS.   Upon evaluation patient does not understand why she is in the hospital.  Due to MS limited history was obtained from patient.  Mental status similar from previous admissions. She agrees to fevers, however denies chills.  She notes chronic pain, however no increased pain in her abdomen or at the site of her suprapubic catheter.  She otherwise denies of chest pain, shortness of breath.  Surgical history:  Ileostomy, chronic G-tube, chronic suprapubic catheter  Social history:   FH: Noncontributory  2/26/22: Patient is a 63 year old female with PMH multiple sclerosis, anemia, chronic osteomyelitis of the pelvis, GERD, heart failure with preserved ejection fraction, neurogenic bladder with chronic suprapubic urinary catheter, chronic G-tube, ileostomy, legally blind who had presented to the ER due to fever and altered mental status. Pt was tachycardic with leukocytosis and signs of possible UTI. Pt was admitted for concerns of possible urosepsis. However, blood cultures were negative. Imaging studies showed stable known staghorn calculus of L kidney with inflammatory changes. Urology was consulted and are considering PCNL outpatient, otherwise no procedure while hospitalized. She received several days of ceftriaxone for therapy until urine cultures resulted. These eventually showed MRSA and Enterococcus faecalis, both sensitive to Macrobid. Pt was stabilized during the hospital and had no repeat fevers. Today feeling well with no concerns. She was discharged to complete a full 7 days of Macrobid for treatment of possible UTI. Pt stable and discharged. She has a scheduled f/u with urology in April, but FMC will work to move up this appointment per urology's recommendation.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis abnormal, Urine leukocyte esterase positive, White blood cell count increased
Clinical narrative: Pfizer Dose 1 1/25/21 (lot NA) Pfizer Dose 2 2/15/21 (lot NA) Pfizer Dose 3 11/2/21 (301308A) COVID Positive 2/21/22  2/21/22: Patient is a 63 year old female with PMH multiple sclerosis, anemia, chronic osteomyelitis of the pelvis, GERD, heart failure with preserved ejection fraction, neurogenic bladder with chronic suprapubic urinary catheter, chronic G-tube, ileostomy, legally blind who presented to the ED today due to fever and altered mental status.   In the ED she presented with pulse 126, respiratory rate 35 saturating 91% on room air, temperature 99.3°, with BP 128/37.  Labs notable for Na 130, ALP 124, proBNP 718, WBC 18.43, with negative troponin, and normal lactate and lipase.  Urine turbid with large blood, leuk esterase, and positive nitrates with loaded bacteria, many amorphous crystal, and moderate yeast.  Patient was given vancomycin, Zosyn, and 1 L NS.   Upon evaluation patient does not understand why she is in the hospital.  Due to MS limited history was obtained from patient.  Mental status similar from previous admissions. She agrees to fevers, however denies chills.  She notes chronic pain, however no increased pain in her abdomen or at the site of her suprapubic catheter.  She otherwise denies of chest pain, shortness of breath.  Surgical history:  Ileostomy, chronic G-tube, chronic suprapubic catheter  Social history:   FH: Noncontributory  2/26/22: Patient is a 63 year old female with PMH multiple sclerosis, anemia, chronic osteomyelitis of the pelvis, GERD, heart failure with preserved ejection fraction, neurogenic bladder with chronic suprapubic urinary catheter, chronic G-tube, ileostomy, legally blind who had presented to the ER due to fever and altered mental status. Pt was tachycardic with leukocytosis and signs of possible UTI. Pt was admitted for concerns of possible urosepsis. However, blood cultures were negative. Imaging studies showed stable known staghorn calculus of L kidney with inflammatory changes. Urology was consulted and are considering PCNL outpatient, otherwise no procedure while hospitalized. She received several days of ceftriaxone for therapy until urine cultures resulted. These eventually showed MRSA and Enterococcus faecalis, both sensitive to Macrobid. Pt was stabilized during the hospital and had no repeat fevers. Today feeling well with no concerns. She was discharged to complete a full 7 days of Macrobid for treatment of possible UTI. Pt stable and discharged. She has a scheduled f/u with urology in April, but FMC will work to move up this appointment per urology's recommendation.
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE information; a pediatric dose (0.5 ml) of RECOMBIVAX HB was administered to an adult patient instead of 1 ml; This spontaneous report was received from medical assistance and refers to a 52-year-old female. There were no pre-existing physician diagnosed allergies, birth defects or medical conditions. There were no illness at the time of the vaccination. The patient's concomitant therapies were not reported.   On 07-JUN-2022, the patient was vaccinated with the pediatric dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 ml, intramuscularly, lot #T024551 with expiration date 03-NOV-2022, for prophylaxis (anatomical location was not provided) instead of the adult dose (1 ml). No additional adverse reactions reported. The outcome of the event of product use issue was reported as recovered. The error occurred at the dispensing point.
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: No additional AE information; a pediatric dose (0.5 ml) of RECOMBIVAX HB was administered to an adult patient instead of 1 ml; This spontaneous report was received from medical assistance and refers to a 52-year-old female. There were no pre-existing physician diagnosed allergies, birth defects or medical conditions. There were no illness at the time of the vaccination. The patient's concomitant therapies were not reported.   On 07-JUN-2022, the patient was vaccinated with the pediatric dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 ml, intramuscularly, lot #T024551 with expiration date 03-NOV-2022, for prophylaxis (anatomical location was not provided) instead of the adult dose (1 ml). No additional adverse reactions reported. The outcome of the event of product use issue was reported as recovered. The error occurred at the dispensing point.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: no additional AE details; expired dose of MMR-11 was inadvertently administered.; This spontaneous report was received from a registered nurse and refers to an 1-year-old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant medications included sterile diluent (STERILE DILUENT).   On 27-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot #T020656, expiration date: 16-JUN-2022, verified to be rHA (strength, exact dose and route of administration were not provided) for prophylaxis (Expired product administered). No adverse events were reported (No adverse event).
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE details; expired dose of MMR-11 was inadvertently administered.; This spontaneous report was received from a registered nurse and refers to an 1-year-old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant medications included sterile diluent (STERILE DILUENT).   On 27-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot #T020656, expiration date: 16-JUN-2022, verified to be rHA (strength, exact dose and route of administration were not provided) for prophylaxis (Expired product administered). No adverse events were reported (No adverse event).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyst, Gait disturbance, Headache, Memory impairment, Muscle atrophy
Clinical narrative: she ended up getting a really bad COVID omicron variant; she ended up getting a really bad COVID omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (COMIRNATY), on 12Feb2021 as dose 1, single (Lot number: E19269), in right arm, on 04Mar2021 as dose 2, single (Lot number: GNCR98), in right arm and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "left leg injury years ago and had her kneecap taken out in 1975" (unspecified if ongoing), notes: left leg injury years ago and had her kneecap taken out in 1975; "left leg injury years ago and had her knee cap taken out in 1975" (unspecified if ongoing), notes: left leg injury years ago and had her knee cap taken out in 1975. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "she ended up getting a really bad COVID omicron variant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) she had covid.  Additional information: At the end, caller mentioned that even though she was fully vaccinated and with the booster, she ended up getting a really bad COVID omicron variant. She was a passenger at a drive-thru vaccination site for first and second dose and thinks the doses were administered in right arm. Booster dose was administered at withheld. She has plates and screws in left arm and cannot be injected into the left arm. She wanted to protect her mother that is 89 years old and 6-year-old granddaughter that is autistic and to prevent COVID. They sent off her COVID test, clarifies they tested her after they sent an ambulance to her house and the supervisor took her test. She got COVID really bad even though she was vaccinated, she got the omicron variant. Diagnosed with COVID: First week of Feb2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Ultrasound Doppler
Clinical narrative: she ended up getting a really bad COVID omicron variant; she ended up getting a really bad COVID omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (COMIRNATY), on 12Feb2021 as dose 1, single (Lot number: E19269), in right arm, on 04Mar2021 as dose 2, single (Lot number: GNCR98), in right arm and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "left leg injury years ago and had her kneecap taken out in 1975" (unspecified if ongoing), notes: left leg injury years ago and had her kneecap taken out in 1975; "left leg injury years ago and had her knee cap taken out in 1975" (unspecified if ongoing), notes: left leg injury years ago and had her knee cap taken out in 1975. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "she ended up getting a really bad COVID omicron variant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) she had covid.  Additional information: At the end, caller mentioned that even though she was fully vaccinated and with the booster, she ended up getting a really bad COVID omicron variant. She was a passenger at a drive-thru vaccination site for first and second dose and thinks the doses were administered in right arm. Booster dose was administered at withheld. She has plates and screws in left arm and cannot be injected into the left arm. She wanted to protect her mother that is 89 years old and 6-year-old granddaughter that is autistic and to prevent COVID. They sent off her COVID test, clarifies they tested her after they sent an ambulance to her house and the supervisor took her test. She got COVID really bad even though she was vaccinated, she got the omicron variant. Diagnosed with COVID: First week of Feb2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she ended up getting a really bad COVID omicron variant; she ended up getting a really bad COVID omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (COMIRNATY), on 12Feb2021 as dose 1, single (Lot number: E19269), in right arm, on 04Mar2021 as dose 2, single (Lot number: GNCR98), in right arm and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "left leg injury years ago and had her kneecap taken out in 1975" (unspecified if ongoing), notes: left leg injury years ago and had her kneecap taken out in 1975; "left leg injury years ago and had her knee cap taken out in 1975" (unspecified if ongoing), notes: left leg injury years ago and had her knee cap taken out in 1975. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "she ended up getting a really bad COVID omicron variant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) she had covid.  Additional information: At the end, caller mentioned that even though she was fully vaccinated and with the booster, she ended up getting a really bad COVID omicron variant. She was a passenger at a drive-thru vaccination site for first and second dose and thinks the doses were administered in right arm. Booster dose was administered at withheld. She has plates and screws in left arm and cannot be injected into the left arm. She wanted to protect her mother that is 89 years old and 6-year-old granddaughter that is autistic and to prevent COVID. They sent off her COVID test, clarifies they tested her after they sent an ambulance to her house and the supervisor took her test. She got COVID really bad even though she was vaccinated, she got the omicron variant. Diagnosed with COVID: First week of Feb2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Patient had pain in his left hip and leg and was diagnosed with shingles the following day by the medical center.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Herpes zoster, Pain in extremity
Clinical narrative: Patient had pain in his left hip and leg and was diagnosed with shingles the following day by the medical center.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at injection site, tender, itchy for a couple days with after 1st dose; Redness at injection site, tender, itchy for a couple days with after 1st dose; Redness at injection site, tender, itchy for a couple days with after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Redness at injection site, tender, itchy for a couple days with after 1st dose), VACCINATION SITE ERYTHEMA (Redness at injection site, tender, itchy for a couple days with after 1st dose) and VACCINATION SITE PAIN (Redness at injection site, tender, itchy for a couple days with after 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Restless leg syndrome, Blood pressure high, Hashimoto's thyroiditis, Acid reflux (oesophageal), Drug allergy (Sulfa drugs), Iodine contrast media allergy (Iodine contrast) and Seasonal allergy. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Hashimoto's thyroiditis, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for Restless leg syndrome.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Redness at injection site, tender, itchy for a couple days with after 1st dose), VACCINATION SITE ERYTHEMA (Redness at injection site, tender, itchy for a couple days with after 1st dose) and VACCINATION SITE PAIN (Redness at injection site, tender, itchy for a couple days with after 1st dose). At the time of the report, VACCINATION SITE PRURITUS (Redness at injection site, tender, itchy for a couple days with after 1st dose), VACCINATION SITE ERYTHEMA (Redness at injection site, tender, itchy for a couple days with after 1st dose) and VACCINATION SITE PAIN (Redness at injection site, tender, itchy for a couple days with after 1st dose) had resolved.    mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient did not had COVID positive test or diagnosis. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided. This case was linked to MOD-2022-598106, MOD-2022-598177 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Redness at injection site, tender, itchy for a couple days with after 1st dose; Redness at injection site, tender, itchy for a couple days with after 1st dose; Redness at injection site, tender, itchy for a couple days with after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Redness at injection site, tender, itchy for a couple days with after 1st dose), VACCINATION SITE ERYTHEMA (Redness at injection site, tender, itchy for a couple days with after 1st dose) and VACCINATION SITE PAIN (Redness at injection site, tender, itchy for a couple days with after 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Restless leg syndrome, Blood pressure high, Hashimoto's thyroiditis, Acid reflux (oesophageal), Drug allergy (Sulfa drugs), Iodine contrast media allergy (Iodine contrast) and Seasonal allergy. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Hashimoto's thyroiditis, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for Restless leg syndrome.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Redness at injection site, tender, itchy for a couple days with after 1st dose), VACCINATION SITE ERYTHEMA (Redness at injection site, tender, itchy for a couple days with after 1st dose) and VACCINATION SITE PAIN (Redness at injection site, tender, itchy for a couple days with after 1st dose). At the time of the report, VACCINATION SITE PRURITUS (Redness at injection site, tender, itchy for a couple days with after 1st dose), VACCINATION SITE ERYTHEMA (Redness at injection site, tender, itchy for a couple days with after 1st dose) and VACCINATION SITE PAIN (Redness at injection site, tender, itchy for a couple days with after 1st dose) had resolved.    mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient did not had COVID positive test or diagnosis. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided. This case was linked to MOD-2022-598106, MOD-2022-598177 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: I received vaccine on March 10, 2021, and then received 2nd shot on March 25, 2021 and booster on December 10, 2021. I started receiving pain in upper abdomen shortly after the second shot. I figured it was liver pain so I went to my pcp a few months alter , as pain progressed. I went to hospital for the pain ,a nd they figured it was liver pain but they never checked for blood clots. Got refered to liver specialist, ran series of tests, and stated it was fatty tissue. Then after 3rd shot , not even a week later i caught covid and was having difficult breathing and figured since i was vaccinated it may be normal. However I had to get EAU infusions, and also got hospitized and they found blood clot in lung. I was on blood thinner for 3 months , June 2022, I started having pain again got rehospitalized for blood clots, shortness of breath and chest pain, and was negative for covid. i am on blood thinners again. I never had clotting disorder before vaccines
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, COVID-19, Chest pain, Computerised tomogram abnormal
Clinical narrative: I received vaccine on March 10, 2021, and then received 2nd shot on March 25, 2021 and booster on December 10, 2021. I started receiving pain in upper abdomen shortly after the second shot. I figured it was liver pain so I went to my pcp a few months alter , as pain progressed. I went to hospital for the pain ,a nd they figured it was liver pain but they never checked for blood clots. Got refered to liver specialist, ran series of tests, and stated it was fatty tissue. Then after 3rd shot , not even a week later i caught covid and was having difficult breathing and figured since i was vaccinated it may be normal. However I had to get EAU infusions, and also got hospitized and they found blood clot in lung. I was on blood thinner for 3 months , June 2022, I started having pain again got rehospitalized for blood clots, shortness of breath and chest pain, and was negative for covid. i am on blood thinners again. I never had clotting disorder before vaccines
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Liver scan abnormal, Pain, Pulmonary thrombosis, SARS-CoV-2 test positive
Clinical narrative: I received vaccine on March 10, 2021, and then received 2nd shot on March 25, 2021 and booster on December 10, 2021. I started receiving pain in upper abdomen shortly after the second shot. I figured it was liver pain so I went to my pcp a few months alter , as pain progressed. I went to hospital for the pain ,a nd they figured it was liver pain but they never checked for blood clots. Got refered to liver specialist, ran series of tests, and stated it was fatty tissue. Then after 3rd shot , not even a week later i caught covid and was having difficult breathing and figured since i was vaccinated it may be normal. However I had to get EAU infusions, and also got hospitized and they found blood clot in lung. I was on blood thinner for 3 months , June 2022, I started having pain again got rehospitalized for blood clots, shortness of breath and chest pain, and was negative for covid. i am on blood thinners again. I never had clotting disorder before vaccines
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: I received vaccine on March 10, 2021, and then received 2nd shot on March 25, 2021 and booster on December 10, 2021. I started receiving pain in upper abdomen shortly after the second shot. I figured it was liver pain so I went to my pcp a few months alter , as pain progressed. I went to hospital for the pain ,a nd they figured it was liver pain but they never checked for blood clots. Got refered to liver specialist, ran series of tests, and stated it was fatty tissue. Then after 3rd shot , not even a week later i caught covid and was having difficult breathing and figured since i was vaccinated it may be normal. However I had to get EAU infusions, and also got hospitized and they found blood clot in lung. I was on blood thinner for 3 months , June 2022, I started having pain again got rehospitalized for blood clots, shortness of breath and chest pain, and was negative for covid. i am on blood thinners again. I never had clotting disorder before vaccines
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.; Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.) in a 41-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 003K21-2A) for COVID-19 prophylaxis.     It was unknown if the patient  was allergic to medications, food and other products . It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was  diagnosed acute illness at the time of vaccination and or up to one month before. Chronic or long-standing health conditions was unknown. It was unknown if the patient was on any Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.     On 19-May-2022 at 9:15 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 19-May-2022 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.).    Vials expiration date was reported as 13-May-2022 and were stored in the refrigerator on 17-MAY-2022. It was reported that the events did not cause patient to seek medical care. It was unknown if the patient had experienced a similar event in the past. The vial did not undergo any temperature excursions.  No treatment medications information were reported.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:MCN Number
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022; vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) and PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 038A21A, 040B21A and 013H21B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Blood pressure increased.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 12-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 22-Dec-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 10:00 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022). On 19-May-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) and PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022).    No concomitant medication was reported. The vial expired on 13-May-2022 was placed in refrigerator on 21-Jan-2022.  The event did not cause patient to seek medical care. The reporter did not report any other potential causes. The patient did not experienced a similar event in the past.  Allergies to medications, food, and other products was reported as unknown. Acute illnesses at the time of vaccination and up to one month before was reported as unknown.  No treatment medication was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered post the expiration or beyond use date; The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) in a 55-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 039A21A, 043B21A and 034F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 26-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:21 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022). On 08-Jun-2022 at 10:21 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022).    No concomitant medication was reported.  The patient had no known allergies. It was unknown if the patient was diagnosed or tested positive for COVID-19.Also unknown if the patient had acute illnesses at the time of vaccination and up to one month before and chronic or long-standing health conditions, and unknown if prescriptions, over-the-counter medications, dietary supplements or herbal remedies were taken at time of vaccination and/or at the time of the adverse event. It was also unknown if the patient had experienced a similar event in the past.  The vaccines expired on 13-May-2022 and administered on 19-May-2022. The vials were placed in refrigerator on 17-May-2022.  No treatment drug detail  was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered post the expiration or beyond use date; Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022) in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 022C21A and 032H20A) for COVID-19 prophylaxis.     Allergies to medication, food and other products were unknown. It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 13-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 19-May-2022 at 10:18 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022). On 19-May-2022 at 10:18 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022).    Prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event was unknown. The event did not cause the patient to seek medical care. It was unknown if the patient had experienced any similar event in the past. Treatment information was not provided.   This case was linked to MOD-2022-585601 (E2B Linked Report).; Sender's Comments:  MOD-2022-585601:Master case
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE details.; Medical assistant calling to report expired dose of VARIVAX was administered today.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (valid lot #T016000, expiration date: 08-MAY-2022) (strength, route of administration and anatomical location were not provided), however, the sterile diluent used to reconstitute the vaccine (valid lot #T017425, expiration date: 22-DEC-2022) (strength, route of administration and anatomical location were not provided) was not expired. None of them had any temperature excursions. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered vaccine; No additional AE; This spontaneous report was received from a reporter (other types) and referred to a currently 4-year-old patient of unknown gender.  The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) (strength, dose, and route not provided; valid lot #U022727 with an expiration date: 16-JAN-2023) for prophylaxis. The vaccine was improperly stored, temperature -14 Celsius up to -10 Celsius (-11.6 Celsius) with a time frame of 30 mins (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report administered vaccine temperature excursion on multiple patients. Per caller vaccines went out of range yesterday and it was not discovered until this morning when checking the data logger.; This spontaneous report was received from a medical asssistant (also reported as physician, conflicting information) referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 13-JUN-2022, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) (1 injection; lot #U031911; expiration date: 11-NOV-2022; strength, and route of administration were not provided), administered for prophylaxis (Product storage error).  Administered vaccine experienced the temperature excursion. It was reported that vaccines went out of range on 13-JUN-2022 (reported as yesterday) and it was not discovered until 14-JUN-2022 (reported as this morning) when checking the data logger.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA004337: US-009507513-2206USA004154: US-009507513-2206USA004511: US-009507513-2206USA004187: US-009507513-2206USA004506:
Age: 11.0
Sex: U
Vaccine: PPV
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: An 11 year old patient was administered a PNEUMOVAX 23 vaccine by mistake instead of a T-Dap vaccine.; An 11 year old patient was administered a PNEUMOVAX 23 vaccine by mistake instead of a T-Dap vaccine.; An 11 year old patient was administered a PNEUMOVAX 23 vaccine by mistake instead of a T-Dap vaccine.; No symptomatic AEs. No additional AE details or PQC.; This spontaneous case has been received from a nurse concerning an 11-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On 15-JUN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not provided) (product administered to patient of inappropriate age). This was administered by mistake instead of a diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (reported as T-Dap) vaccine (formulation, indication, dose, and vaccination scheme frequency were not reported) (wrong product administered, interchange of vaccine products). No symptomatic adverse events were reported.
Age: 31.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Exposure during pregnancy, Fatigue, Headache, Injection site pain, Vaccination site pain
Clinical narrative: injection site soreness; headache; fatigue; who is 30 weeks pregnant/ administered GARDASIL 9; was expected to receive TDap, but was administered GARDASIL 9 instead; This spontaneous report has been received from a registered nurse, concerning her granddaughter a 31-year-old female patient who was pregnant with 30 weeks at the time of report. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 15-JUN-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscular (lot #, expiration date and anatomical location were not provided) as prophylaxis, instead of a dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) in her provider's office (exposure during pregnancy, wrong vaccine administered). On the same date, she experienced fatigue, injection site soreness (vaccination site pain) and headache. The outcome for the events of fatigue, vaccination site pain and headache was not reported.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for fatigue, vaccination site pain and headache was not reported.  At the reporting time, the outcome of the pregnancy was unknown.
Age: 31.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Wrong product administered
Clinical narrative: injection site soreness; headache; fatigue; who is 30 weeks pregnant/ administered GARDASIL 9; was expected to receive TDap, but was administered GARDASIL 9 instead; This spontaneous report has been received from a registered nurse, concerning her granddaughter a 31-year-old female patient who was pregnant with 30 weeks at the time of report. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 15-JUN-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscular (lot #, expiration date and anatomical location were not provided) as prophylaxis, instead of a dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) in her provider's office (exposure during pregnancy, wrong vaccine administered). On the same date, she experienced fatigue, injection site soreness (vaccination site pain) and headache. The outcome for the events of fatigue, vaccination site pain and headache was not reported.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for fatigue, vaccination site pain and headache was not reported.  At the reporting time, the outcome of the pregnancy was unknown.