chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: indicate at which point in the process the medication error occurred; No additional AE/PQC reported.; administered an expired dose of MMRII; This spontaneous report was received from a medical assistant and vaccine provider referring to a 4-year-old male patient. Concomitant vaccinees included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), polio vaccine inact (IPV) and varicella zoster vaccine (VARICELLA VACCINE).  On 16-MAY-2022, the patient was vaccinated with an expired dose of the second dose (previous doses reported as 1) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T016352, expiration date 12-MAY-2022, anatomical location: left thigh; strength and dose were not reported) subcutaneously for prophylaxis (expired product administered). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with not expired and no temperature excursion stored sterile diluent (lot# S037029, expiration date: 30-AUG-2022). The patient had no illness at time of vaccination. The medication error occurred in the process of preparation for administration. It was not occurred as a result of reading from digital data logger. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Peripheral swelling
Clinical narrative: patient developed arm swelling after receiving a dose of either GARDASIL or GARDASIL 9; This spontaneous report has been received from a physician, referring to a female patient of unknown age. The patient's historical condition, current condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with a dose of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), for prophylaxis (unknown which medication patient received). The dose, strength, route, lot number and expiration date were unknown for suspect vaccine.  On an unknown date, the patient developed arm swelling. The reporter reported it occurred "years ago" but did not specify exactly how long ago. The reporter reported the patient did not finish the vaccine series. The outcome of the event was unknown. The causality was not provided.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect were noted; The expired VAQTA that was administered both had the same lot number and expiration date; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) , prefilled syringe, lot #T033304, expiration date: 02-APR-2022 (PT: Expired product administered) (strength, dose and route of administration were not provided) administered as prophylaxis. No adverse effects were noted. No additional information was provided.  This is a case of two from the same reporter. ; Sender's Comments:  US-009507513-2205USA005543:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reports vaccine administered after temperature excursion; This spontaneous report, as received from a Registered Nurse, refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 03-MAY-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant Human albumin) (PROQUAD), lot # U031560 upon internal validation established to be valid, with expiration date 06-APR-2023 (reported as 05-APR-2022), 0,5 ml administered subcutaneously (SQ) (exact anatomical location was not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 10 degrees Fahrenheit for 10 minutes (Incorrect product storage). There were no previous excursions, product quality complaints or additional adverse events reported (No adverse event).
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No further adverse events; administered dose of MMR II using expired diluent; administered dose of MMR II using expired diluent; This spontaneous report was received from a pharmacist and refers to an adult female patient of unknown age (reported as "in her 20s"). There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 21-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was diluted with an expired sterile diluent (lot # S007823 confirmed to be valid with an expiration date: 22-JUN-2021) (product preparation issue) (expired product administered). There was no prior temperature excursion and no further adverse events were reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and referred to a 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAR-2022, the temperature excursion (-14 degree Celsius up to -10 degree Celsius for 3 hours) occurred of varicella virus vaccine live (oka/merck) (VARIVAX). On 27-APR-2022, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis (lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. The reporter contacted company and verified the viability of vaccine; the vaccine was not available for return or evaluation because it was given to the patient.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and refers to a 4-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 27-APR-2022, the patient was vaccinated with improperly stored second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours; -10 degrees C up to 8 degrees C for 1 h, 30 min on 23-MAR-2022 (product storage error). No previous temperature excursion was reported. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007739: US-009507513-2205USA007809: US-009507513-2205USA007957: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008064: US-009507513-2205USA008066: US-009507513-2205USA008100: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA008795: US-009507513-2205USA008800: US-009507513-2205USA008830:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No symptomatic Adverse events; expired dose of VAQTA was administered to a patient inadvertently; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergy, pertinent medical history and concomitant therapy were not reported.  On 23-MAY-2022, inadvertently, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # T033304, expiration date 02-APR-2022 (dose and route were not reported)  for prophylaxis (expired product administered).  Neither symptomatic adverse events and nor product quality were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported.; Medical assistant reported that a patient received an expired PNEUMOVAX 23.     .; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 26-MAY-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (ml), for prophylaxis (lot number t028093 has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent), expiration date reported and established as 24-APR-2022) (strength, route of administration and anatomical location were not provided).  No adverse event reported.
Age: 36.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; patient was accidently administered PROQUAD instead of MMR II; that patient was accidently administered PROQUAD at 36 years old; This spontaneous report has been received from a medical assistant to a 36 years old female patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.     The patient had lab work done and her titers said that she needed measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On 31-MAY-2022, the patient was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U029322, expiration date 19-MAR-2023) instead (wrong vaccine administered and inappropriate age at vaccine administration). No additional adverse events (AE) reported.
Age: 65.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Product administration error
Clinical narrative: got his first shot of HPV vaccine at 65 year old; Product origin unknown; This spontaneous report was received from a 65-year-old male patient and refers to himself via Pfizer. The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On an unknown date, the patient was high-risk category and he got the first shot of human papilloma virus (HPV) vaccine for prophylaxis (formulation, dose, unit, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). However, the manufacturer was unknown, and it was also not sure it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Product origin unknown).
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Blood test, Cardiac stress test, Chest pain, Pain in extremity
Clinical narrative: he went to the ER for chest pain and was admitted overnight; had gone down back of arm and turned into systemic joint pain/pain in his hand; shoulder pain/had gone down back of arm and turned into systemic joint pain/pain in his hand and knees/arthritis pain; This spontaneous report was received from a 59 years old male patient and referred to himself. There was no pertinent medical history. The patient was allergic to pethidine hydrochloride (DEMOROL) (reported as "DEMORAL") (bottoms out and didn't like it). Concomitant medications included atorvastatin, amlodipine, levothyroxine sodium (SYNTHROID) (reported as "SYNTHRIOD"), trazodone, potassium, furosemide (LASIX), omeprazole (PROTONIX), fish oil and magnesium.   On 14-APR-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, dose, route of administration, lot # and expiry date) for preventative.  On an unknown date in 2022 (reported as a few days later), the patient began experiencing shoulder pain.   On 14-MAY-2022 (reported as thirty days later), the patient went back for the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, dose, route of administration, lot # and expiry date).   After the second dose, he was still experiencing shoulder pain that had gone down back of arm and turned into systemic joint pain. The patient received the shot in the left arm, which was the same arm he experienced the pain in. He also experienced pain in his hand and knees after the second shot.   On 26-MAY-2022, he went to the emergency room for chest pain and was admitted overnight to Vanderbuilt (also reported as caused hospitalization) and he received stress test and blood work to rule out heart issues. The patient stated the chest pain he was experiencing was related to the shoulder and arthritis pain. Outcome of the events was reported as not resolved.  The causality assessment was not reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 04-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes; additionally on 26-MAY-2022 experienced an additional temperature excursion of 35.2 F for 56 seconds. If a digital data logger was involved was not reported (product storage error).   Consequently, on 27-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Age: 0.25
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 03-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # U026664, and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot# U029145 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes; additionally on 26-MAY-2022 experienced an additional temperature excursion of 35.2 F for 56 seconds. If a digital data logger was involved was not reported (product storage error).   Consequently, on 31-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally (formulation, strength, dose, vaccination scheme were not provided) and with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB (lot number reported as U029145 confirmed as valid, expiration date reported and stablished as 30-MAR-2024) (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, lot number and expiration date were not provided), both administered as prophylaxis (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, a 2-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes; additionally on 26-MAY-2022 experienced an additional temperature excursion of 35.2 F for 56 seconds. If a digital data logger was involved was not reported (product storage error) (product storage error).   Consequently, on unknown dates 31-MAY-2022, the patients was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling for TE evaluation on frozen products states products have been administered.; No additional AE details.; This spontaneous report has been received from a nurse, concerning an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number W004029 [expiration date 02-AUG-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis, and sterile diluent (dose, vaccination scheme, frequency, lot number, expiration date were not provided), after a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees F (8F) for 0 hours (h), 18 minutes (min) and 0 seconds (sec), 14 F up to 46 F (18.40F) for 0 h, 45 min, 0 sec (product storage error). No previous temperature excursion was reported.   No additional adverse event (AE) details.  Thisis one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA002184: US-009507513-2206USA002208: US-009507513-2206USA002249: US-009507513-2206USA002264: US-009507513-2206USA002383:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling for TE evaluation on frozen products states products have been administered.; No additional AE details.; This spontaneous report has been received from a nurse, concerning an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number W004029 [expiration date 02-AUG-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis, and sterile diluent (dose, vaccination scheme, frequency, lot number, expiration date were not provided), after a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees F (8F) for 0 hours (h), 18 minutes (min) and 0 seconds (sec), 14 F up to 46 F (18.40F) for 0 h, 45 min, 0 sec (product storage error). No previous temperature excursion was reported.   No additional adverse event (AE) details.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA002231: US-009507513-2206USA002184: US-009507513-2206USA002208: US-009507513-2206USA002264: US-009507513-2206USA002249: US-009507513-2206USA002383: US-009507513-2206USA002264:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unknown whether the autopsy was performed. Reporter stated that "I know a lot of people suffering after having your jab, one is dead". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220562523.; Sender's Comments: V0:20220601898-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 55 year old female. Initial information was processed along with additional information received from  RA department on 08-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre diabetic, and mango allergy. The patient was not pregnant at the time of reporting. On 16-APR-2021 12:00, the patient received covid-19 vaccine ad26.cov2.s (first dose) (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered to left arm for prophylactic vaccination. The batch number was not reported and has been requested. On 15-OCT-2021 16:00, the patient received non-company suspect elasomeran (Moderna) (second dose) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. On 15-APR-2022 12:00, the patient received non-company suspect elasomeran (Moderna) (third dose) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. Concomitant medications included levothyroxine sodium (Synthroid). On 25-MAY-2022 07:00, the patient experienced relapse of covid-19 symptoms and positive covid-19 antigen test which indicated suspected covid-19 infection (dose number in series: 2) and suspected clinical vaccination failure (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000233847. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified. based on the evaluation/investigation performed.; Sender's Comments: V0.20220601952-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Malaise, Pyrexia
Clinical narrative: LETHARGIC MORE THAN USUAL; FELT NOT VERY GOOD; FEVER / FELT HEAT LIKE FEVER / FELT HOT BUT NOT LIKE BOILING, WARM FELT IT IN VEIN; TIRED; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic type 2, ibuprofen allergy, alcohol user (Rarely), and nonsmoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. Age at time of vaccination 74 years old. No concomitant medications were reported. On an unspecified date, the patient experienced lethargic more than usual, felt not very good, fever / felt heat like fever / felt hot but not like boiling, warm felt it in vein, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic more than usual, felt not very good, fever / felt heat like fever / felt hot but not like boiling, warm felt it in vein, and tired. This report was non-serious. This case, involving the same patient is linked to 20220606610.
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Endocrine ophthalmopathy, Eye degenerative disorder, Hypometabolism, Lethargy
Clinical narrative: THYROID EYE DISEASE (BLURRY VISION); GAINED 35 POUNDS, UNEXPLAINED; THYROID NO LONGER WORKING; MASSIVE SWELLING IN FEET AND ANKLES; SLOW METABOLISM; EXCRUCIATING PAIN WHEN GOING TO BATHROOM; LETHARGIC; EYE DEGENERATE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included: double pneumonia (Hospitalized in 2020 for double pneumonia (effects of Covid)), and concurrent conditions included: non alcohol user and other pre-existing medical conditions included: Patient was perfectly healthy. Patient was not on any medication, only on unspecified vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered to left arm on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in AUG-2021, the patient experienced thyroid eye disease (blurry vision), gained 35 pounds, unexplained, thyroid no longer working, massive swelling in feet and ankles, slow metabolism, excruciating pain when going to bathroom, lethargic and eye degenerate. The side effects began about 2 weeks after the vaccine and throughout since then. The physician prescribed Tepezza for eye disease since getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gained 35 pounds, unexplained, thyroid no longer working, massive swelling in feet and ankles, slow metabolism, excruciating pain when going to bathroom, lethargic, eye degenerate, and thyroid eye disease (blurry vision). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220606209-covid-19 vaccine ad26.cov2.s-thyroid eye disease (blurry vision). The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thyroid disorder, Weight, Weight increased
Clinical narrative: THYROID EYE DISEASE (BLURRY VISION); GAINED 35 POUNDS, UNEXPLAINED; THYROID NO LONGER WORKING; MASSIVE SWELLING IN FEET AND ANKLES; SLOW METABOLISM; EXCRUCIATING PAIN WHEN GOING TO BATHROOM; LETHARGIC; EYE DEGENERATE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included: double pneumonia (Hospitalized in 2020 for double pneumonia (effects of Covid)), and concurrent conditions included: non alcohol user and other pre-existing medical conditions included: Patient was perfectly healthy. Patient was not on any medication, only on unspecified vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered to left arm on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in AUG-2021, the patient experienced thyroid eye disease (blurry vision), gained 35 pounds, unexplained, thyroid no longer working, massive swelling in feet and ankles, slow metabolism, excruciating pain when going to bathroom, lethargic and eye degenerate. The side effects began about 2 weeks after the vaccine and throughout since then. The physician prescribed Tepezza for eye disease since getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gained 35 pounds, unexplained, thyroid no longer working, massive swelling in feet and ankles, slow metabolism, excruciating pain when going to bathroom, lethargic, eye degenerate, and thyroid eye disease (blurry vision). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220606209-covid-19 vaccine ad26.cov2.s-thyroid eye disease (blurry vision). The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: asthma flares (everyone in immediate family had asthma). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received booster dose of non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin, route of admin, batch number were not reported and expiry: unknown) dose was not reported, administered on an unspecified date in NOV-2021 for prophylactic vaccination.  Around on 20-APR-2022, the patient experienced covid-19 (suspected covid-19 infection (Dose number in series 2) and suspected clinical vaccination failure (Dose number in series 1). The patient recovered at home and was not treated. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from suspected covid-19 infection on an unspecified date in 2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220542436. This report was associated with product quality complaint.; Sender's Comments: V0: 20220606884 -Covid-19 vaccine ad26.cov2.s -SUSPECTED CLINICAL VACCINATION FAILURE. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: UNBEARABLE CHEST PAIN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced unbearable chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unbearable chest pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: TERRIBLE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terrible side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220609909.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious. This case, involving the same patient is linked to 20220610242.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that 173 doses were administered on 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 from batch 070H21A. No information was reported on date of the storage of vaccine in refrigerator.Vaccine was expired on 07-APR-2022. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Follow up received patient and reporter added and narrative updated. On 08-Jun-2022: Follow-up received contains non significant information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022; Receiving doses after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022 at 8:31 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  It was reported that HCP provided doses of the Moderna COVID19 vaccine after the beyond use date as the HCP did not know that the vials should not be used past 30 days from thawing the vials. Vial did not undergo any temperature excursions. Date vials initially stored: 31-Jan-2022. No treatment drug details was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022; Patient received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2022 at 11:51 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-May-2022 at 11:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that the affected Lot 045L21A was initially stored on 31-Jan-2022 and the thaw expired on 02-Mar-2022. Total doses administered was reported as 20 doses and number of vials used was 15. The vial did not undergo any temperature excursion.  Treatment medications were not reported.   This case was linked to MOD-2022-583132 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O15821a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug.). Concomitant products included LORAZEPAM, DULOXETINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from an unknown date to 24-May-2022 and ZOLPIDEM from an unknown date to 24-May-2022 for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            On 02-JUN-2022 at 11:00, the patient had COVID rebound and at the time of reporting it was reported as not recovered.  Device date was reported as 02-Jun-2022.  Company comment- This spontaneous case concerns a 54-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient experienced Covid rebound 4 days after completing the course of paxovid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient experienced Covid rebound 4 days after completing the course of paxovid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Polyp, Vaccination site pain
Clinical narrative: Two polyps; COVID Vaccine caused sore arm; This spontaneous case was reported by a consumer and describes the occurrence of POLYP (Two polyps) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced POLYP (Two polyps) (seriousness criterion medically significant) and VACCINATION SITE PAIN (COVID Vaccine caused sore arm). At the time of the report, POLYP (Two polyps) and VACCINATION SITE PAIN (COVID Vaccine caused sore arm) had resolved.            Concomitant medications were not reported.  The patient had found 2 polyps which were removed and everything was doing fine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient experienced COVID vaccine caused sore arm with HUMIRA (ADLIMUMAB).  Treatment information was not provided.  CC: This spontaneous case concerns a 46-year-old, male patient, with a relevant history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Two polyps, which occurred unknown days after receiving the first dose of mRNA-1273 vaccine. The patient had found 2 polyps which were removed. The outcome of the events was reported as resolved. Underlying history of Crohn's disease remains a confounder for the event Two polyps. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 46-year-old, male patient, with a relevant history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Two polyps, which occurred unknown days after receiving the first dose of mRNA-1273 vaccine. The patient had found 2 polyps which were removed. The outcome of the events was reported as resolved. Underlying history of Crohn's disease remains a confounder for the event Two polyps. The benefit-risk relationship of mRNA-1273 is not affected by this report.