chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Got less than 0.5ml, the needle fell out by error; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 3527M, expiry date 3rd June 2023) for prophylaxis.   On 20th April 2022, the patient received the 1st dose of Shingrix. On 20th April 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.       Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: The patient received a Shingrix first dose less than 0.5ml because the needle fell out by error. The reporter consented to follow up by email. Additional Supportive Information: The patient received shingrix dose less than recommended which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, second not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: Pharmacist reported a patient receiving the first dose of Shingrix on 2018 and the second dose was not administered yet.  That was all the information that the health care professional (HCP) had.  Patient was vaccinated in another facility.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Note: details pertains to 1st dose of Shingrix in product tab.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POTENTIALLY OUT OF TEMPERATURE RANGE PRODUCT GIVEN TO PATIENTS/THERE HAVE BEEN 7 EXCURSIONS SINCE JANUARY; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, and expiry: 27-MAR-2022) dose was not reported, administered on JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On JAN-2022, the patient experienced potentially out of temperature range product given to patients/there have been 7 excursions since january, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potentially out of temperature range product given to patients/there have been 7 excursions since january and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, 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 consumer concerned a 32 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 12-APR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered for prophylactic vaccination. On 05-FEB-2022, the patient received non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2022, the patient experienced covid-19 symptom of headache (suspected covid-19 infection) (dose number in series: 2). On the same day, the patient then tested positive in a covid-19 Binax Now home test kit (suspected clinical vaccination failure) (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number was requested.; Sender's Comments: V0: 20220438211-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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Adverse event, Dyspnoea exertional, Oedema peripheral, Pain
Clinical narrative: RIGHT SIDE ABDOMINAL SWELLING; BILATERAL FOOT SWELLING; BILATERAL LOWER LEG SWELLING TO KNEES; SHORT OF BREATH WITH EXERTION; PAIN FROM SWELLING; BLEEDING SORES ON BACK OF LEGS; ADVERSE EVENT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hip injury (Hip injury from work), and concurrent conditions included: codeine allergy, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 62 years old.  No concomitant medications were reported.  On an unspecified date, the patient experienced right side abdominal swelling, bilateral foot swelling, bilateral lower leg swelling to knees, short of breath with exertion, pain from swelling, bleeding sores on back of legs, and adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from short of breath with exertion, had not recovered from right side abdominal swelling, bilateral foot swelling, bilateral lower leg swelling to knees, pain from swelling, and bleeding sores on back of legs, and the outcome of adverse event was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin ulcer haemorrhage
Clinical narrative: RIGHT SIDE ABDOMINAL SWELLING; BILATERAL FOOT SWELLING; BILATERAL LOWER LEG SWELLING TO KNEES; SHORT OF BREATH WITH EXERTION; PAIN FROM SWELLING; BLEEDING SORES ON BACK OF LEGS; ADVERSE EVENT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hip injury (Hip injury from work), and concurrent conditions included: codeine allergy, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 62 years old.  No concomitant medications were reported.  On an unspecified date, the patient experienced right side abdominal swelling, bilateral foot swelling, bilateral lower leg swelling to knees, short of breath with exertion, pain from swelling, bleeding sores on back of legs, and adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from short of breath with exertion, had not recovered from right side abdominal swelling, bilateral foot swelling, bilateral lower leg swelling to knees, pain from swelling, and bleeding sores on back of legs, and the outcome of adverse event was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered \some vaccine that were expired a week ago. It was kept in the fridge.; Patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered \some vaccine that were expired a week ago. It was kept in the fridge.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered \some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered \some vaccine that were expired a week ago. It was kept in the fridge.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided.  It was reported that the vaccines expired a week ago. The vial did not undergo any temperature excursions. Vials were stored in the refrigerator on 28-Feb-2022.  Patient was administered with second booster dose.  No treatment information was provided.   This case was linked to MOD-2022-543481 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got Covid after getting 3 Moderna Covid-19 vaccine shots; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid after getting 3 Moderna Covid-19 vaccine shots) and DRUG INEFFECTIVE (Lack of drug effect) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006M20A and 007M20A) for COVID-19 vaccination.     Patient does not have any allergies and concomitant medical conditions.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Got Covid after getting 3 Moderna Covid-19 vaccine shots) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Got Covid after getting 3 Moderna Covid-19 vaccine shots) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            No concomitant medications were reported. It was reported that the patient had her flu vaccination sometime in Jan2022 or Feb2022. It was unknown that the patient was on any treatment.  This is a spontaneous case concerning  a  77-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Covid-19, Drug ineffective. The events occurred approximately 6 months day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.    This case was linked to MOD-2022-544485 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  77-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Covid-19, Drug ineffective. The events occurred approximately 6 months day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: tiredness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported. The patient reported that he had regular symptoms tiredness, fever, chills, those kind of things. Treatment information was unknown.   This case was linked to MOD-2022-543630, MOD-2022-543627 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feel tired) and LYMPHADENOPATHY (Developed swelling of his lymph nodes next to his left ear and towards the jaw and the bottom of his chin which hurt, He says the pain is bad still) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced FATIGUE (Feel tired) and LYMPHADENOPATHY (Developed swelling of his lymph nodes next to his left ear and towards the jaw and the bottom of his chin which hurt, He says the pain is bad still). At the time of the report, FATIGUE (Feel tired) outcome was unknown and LYMPHADENOPATHY (Developed swelling of his lymph nodes next to his left ear and towards the jaw and the bottom of his chin which hurt, He says the pain is bad still) had not resolved. No concomitant medications was reported. No treatment was reported. This case was linked to MOD-2022-543615, MOD-2022-543563, MOD-2022-543627 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), PYREXIA (high fever) and LYMPHADENOPATHY (had lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick), PYREXIA (high fever) and LYMPHADENOPATHY (had lymph nodes). At the time of the report, ILLNESS (really sick), PYREXIA (high fever) and LYMPHADENOPATHY (had lymph nodes) outcome was unknown. No concomitant medication was provided by the reporter. Patient had extreme reactions to every shot. No treatment medication was provided by the reporter. This case was linked to MOD-2022-543607, MOD-2022-543738 (Patient Link). Reporter did not allow further contact.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna booster to someone when the temperature was not in range) and POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna booster to someone when the temperature was not in range) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination. The patient had no allergies to medication, food, and other products. The patient had no Covid-19 positive test or diagnosis. The patient had no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine. On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna booster to someone when the temperature was not in range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna booster to someone when the temperature was not in range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna booster to someone when the temperature was not in range) and POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna booster to someone when the temperature was not in range) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that, the vial underwent an excursion of potentially 5 days since the 13-Apr-2022, until 18-Apr-2022 at 65 Degree Fahrenheit. 2 vials of ten doses each were involved. The vial was initially stored in refrigerator on 10-Apr-2022. At the time of this report the vial was stored in refrigerator. There was no visual inspection noting any vaccine state change. The AE did not cause patient to seek medical care. The patient did not experience similar events in the past. No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. Patient has never been diagnosed or tested positive for COVID-19. Allergies to medications, food, and other products none. Patient had no acute illness at the time of vaccination and up to one month before. Concurrent medical conditions included Deaf, Hypertension, Diabetes mellitus and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, GLIMEPIRIDE and METFORMIN for Diabetes mellitus, LISINOPRIL and AMLODIPINE for Hypertension. On 06-Apr-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The date of the vial was initially stored in the refrigerator was unknown. It was reported that the vial had no temperature excursion  It was reported that the patient was deaf and through typing back and forth, described zero adverse events to the booster on 06-Apr-2022. No treatment information was provided by the reporter. This case was linked to MOD-2022-541343 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after 30-day use by date or after manufacture date of expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. Concurrent medical conditions included Clot blood (Clotting). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Clot blood. On 06-Apr-2022 at 11:05 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 11:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after 30-day use by date or after manufacture date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after 30-day use by date or after manufacture date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had no known drug allergy. It was reported that the patient did not have any acute illness at the time of vaccination and up to one month before. The patient had never been diagnosed with/ tested positive for COVID-19. The patient had no chronic or long-standing health conditions. It was reported that, 28 doses were administered after 30-day use by date or after manufacture date of expiry. The expiry date for the vaccine was given as 18-Mar-2022. The date of vial initially stored in refrigerator was unknown and vials were transferred from another store. The vial did not undergo any temperature excursion. The patient reported no adverse events from the vaccine. No issues or complaint. No information on treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (slightly sore arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No known allergies to food, medication and other products was reported. Patient was not diagnosed or tested positive for COVID-19. There was no diagnosed acute illness at the time of vaccination and up to one month before. There was no chronic or long-standing health conditions. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Clot blood. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slightly sore arm). At the time of the report, PAIN IN EXTREMITY (slightly sore arm) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment information was reported. This case was linked to MOD-2022-544354 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had the flu) and RASH ERYTHEMATOUS (had a big red rash/Moderna arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-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 INFLUENZA LIKE ILLNESS (felt like had the flu). On unknown date, the patient experienced RASH ERYTHEMATOUS (had a big red rash/Moderna arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (felt like had the flu) and RASH ERYTHEMATOUS (had a big red rash/Moderna arm) outcome was unknown. No concomitant medication were reported. Patient took the first booster dose of the Moderna COVID-19 vaccine and felt like had the flu. Also reported that, 4 days later, patient had a big red rash. Patient googled that, and referenced it as Moderna arm.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: He was the only one who did not get covid while four of us did (we all had 2 shots of moderna); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He was the only one who did not get covid while four of us did (we all had 2 shots of moderna)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (He was the only one who did not get covid  while four of us did (we all had 2 shots of moderna)). At the time of the report, COVID-19 (He was the only one who did not get covid  while four of us did (we all had 2 shots of moderna)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.  It was reported that the patient's son did not contract covid while whole family did in Aug-2021. They were all together, staying in the same house and eating traveling together. Patient's son was the only one who did not get covid  while four of family members did (all had 2 shots of moderna).   Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. The patient received 2 doses of mRNA-1273 vaccine with unspecified dose number and unknown dosage interval. The event occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-187034, US-MODERNATX, INC.-MOD-2021-187049, US-MODERNATX, INC.-MOD-2022-544867 (E2B Linked Report). Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19 (delta). The patient received 2 doses of mRNA-1273 vaccine with unspecified dose number and unknown dosage interval. The event occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2021-187034:MOD-2021-187034 (Dose 1) case for (son) US-MODERNATX, INC.-MOD-2021-187049:MOD-2021-187049 (Dose 2) case for (Son) US-MODERNATX, INC.-MOD-2022-544867:MOD-2022-544867  (Case for other 3 family members)
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on his arm, legs and other parts of body since taking shot) and ERYTHEMA (Redness on his arm, legs and other parts of body since taking shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00011A) for COVID-19 vaccination. It was reported as patient did not have any pre-existing condition and allergy. On 22-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness on his arm, legs, and other parts of body since taking shot) and ERYTHEMA (Redness on his arm, legs, and other parts of body since taking shot). At the time of the report, PRURITUS (itchiness on his arm, legs and other parts of body since taking shot) and ERYTHEMA (Redness on his arm, legs, and other parts of body since taking shot) outcome was unknown. No concomitant medications were reported by the reporter. Patient said he seen this reactions for the first time. Antihistamine medication was taken per HCP advise meanwhile.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (got a little stronger diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced DIARRHOEA (got a little stronger diarrhea). At the time of the report, DIARRHOEA (got a little stronger diarrhea) outcome was unknown. No concomitant medications were reported. Patient did not want to provide further  details and ended the call. No treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose was administered to patient from a vial that was opened yesterday 19Apr2022) and PRODUCT STORAGE ERROR (vial was stored in Refrigerator post puncture) in an 83-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 002M21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose was administered to patient from a vial that was opened yesterday 19Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in Refrigerator post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose was administered to patient from a vial that was opened yesterday 19Apr2022) and PRODUCT STORAGE ERROR (vial was stored in Refrigerator post puncture) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided. It was reported that the vial was stored in refrigerator post puncture and was received at the facility as refrigerated storage. The manufactured expiry date was reported as 11-Jul-2022. The vial was first punctured on 19-Apr-2022 at 08:45 am and was administered at 20-Apr-2022 at 10:00 am. It was also reported that the vial did not undergo any temperature excursion neither was stored at room temperature, only was exposed to room temperature at the time in between to pull up doses from the vial, at the most 10 minutes per HCP.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Body temperature, Headache, Illness, Malaise
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)). On 19-Apr-2022, the patient experienced ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 20-Apr-2022 for Adverse event, at an unspecified dose and frequency. On 20-Apr-2022, ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2022, Body temperature: 99.4 (High) low-grade fever (99.4 F). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. It was reported that, patient did not have any allergies, never had COVID positive test or diagnosis and AE did not cause patient to seek medical care. This case was linked to MOD-2022-545276, MOD-2022-545277, MOD-2022-545278 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Terminal insomnia
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)). On 19-Apr-2022, the patient experienced ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 20-Apr-2022 for Adverse event, at an unspecified dose and frequency. On 20-Apr-2022, ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2022, Body temperature: 99.4 (High) low-grade fever (99.4 F). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. It was reported that, patient did not have any allergies, never had COVID positive test or diagnosis and AE did not cause patient to seek medical care. This case was linked to MOD-2022-545276, MOD-2022-545277, MOD-2022-545278 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)). On 19-Apr-2022, the patient experienced ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 20-Apr-2022 for Adverse event, at an unspecified dose and frequency. On 20-Apr-2022, ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2022, Body temperature: 99.4 (High) low-grade fever (99.4 F). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. It was reported that, patient did not have any allergies, never had COVID positive test or diagnosis and AE did not cause patient to seek medical care. This case was linked to MOD-2022-545276, MOD-2022-545277, MOD-2022-545278 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Body temperature, Headache, Illness, Malaise
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (each time soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient had none allergies. The patient was not diagnosed or tested positive for COVID-19. On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (each time soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (each time soreness at the injection site) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It was not reported if the patient had other vaccines within 1 month prior to Moderna COVID-19 vaccine. The event did not cause the patient to seek medical care. The patient received the Moderna primary series doses and first booster dose and each time she experienced soreness at the injection site. No treatment information was reported. This case was linked to MOD-2022-545265, MOD-2022-545277, MOD-2022-545278 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Terminal insomnia
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (each time soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient had none allergies. The patient was not diagnosed or tested positive for COVID-19. On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (each time soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (each time soreness at the injection site) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It was not reported if the patient had other vaccines within 1 month prior to Moderna COVID-19 vaccine. The event did not cause the patient to seek medical care. The patient received the Moderna primary series doses and first booster dose and each time she experienced soreness at the injection site. No treatment information was reported. This case was linked to MOD-2022-545265, MOD-2022-545277, MOD-2022-545278 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (each time soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient had none allergies. The patient was not diagnosed or tested positive for COVID-19. On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (each time soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (each time soreness at the injection site) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It was not reported if the patient had other vaccines within 1 month prior to Moderna COVID-19 vaccine. The event did not cause the patient to seek medical care. The patient received the Moderna primary series doses and first booster dose and each time she experienced soreness at the injection site. No treatment information was reported. This case was linked to MOD-2022-545265, MOD-2022-545277, MOD-2022-545278 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed). At the time of the report, PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Reportedly, a thawed shipment of vials of the Moderna COVID-19 vaccine were received. Once received, they placed the shipment in the refrigerator except for 1 vial, that was stored on the freezer. The vial was again thawed and then administered to 4 patients in the facility. The doses applied were 2 second boosters and 2 first boosters on the 16Apr2022. No treatment details were reported. This case was linked to MOD-2022-545269, MOD-2022-545270, MOD-2022-545272 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced severe reactions following vaccination and it was very unpleasant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced severe reactions following vaccination and it was very unpleasant). At the time of the report, VACCINATION COMPLICATION (experienced severe reactions following vaccination and it was very unpleasant) outcome was unknown. It was reported that the patient was of a senior age group and had received two doses of the Moderna COVID-19 vaccine and then booster dose of the vaccine. No concomitant medications were reported. It was also reported by the patient that the patient did not want to report about the event as the patient already had reported it in VAERS (vaccine adverse event reporting system). No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received a refreeze vaccine once thawed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a refreeze vaccine once thawed). At the time of the report, PRODUCT STORAGE ERROR (Patient received a refreeze vaccine once thawed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was reported. At first, a thawed shipment of vials of the Moderna Covid-19 vaccine was received at the facility. Once received, the shipment was placed on the refrigerator except for 1 vial, that was stored in the freezer. This particular vial was again thawed and then administered to the patient. On 07-Apr-2022, the vial was initially stored in the refrigerator at 41.6 degree Fahrenheit. Then the vial was moved to the freezer at -8.1 degree Fahrenheit but the healthcare provider did not know when it was moved to the freezer. Then, the vial was taken out from the freezer on the date when the dose was administered. The patient would have received either the first booster dose or the second booster dose. No treatment information was provided. This case was linked to MOD-2022-545266, MOD-2022-545272, MOD-2022-545270 (Patient Link).