chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received expired vaccine from the lot  that had beyond use date of 01/20/22.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received expired vaccine from the lot  that had beyond use date of 01/20/22.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received expired vaccine from the lot  that had beyond use date of 01/20/22.). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patients received expired vaccine from the lot  that had beyond use date of 01/20/22.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  On 21-Dec-2021, the vial was initially stored in the refrigerator. The nurse stated that they had a lot  number which has a expiry date written on the box as 28-Mar-2022. However, when the lot  was moved the freezer to refrigerator the beyond use date was 20-Jan-2022. No side effect were reported by patient during the 15 minute observation time. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-457591 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) 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.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No concomitant medications were reported.  The patient asked that was it necessary to get another dose, was the test of COVID free and could he still get a booster.  No treatment information was reported.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination complication
Clinical narrative: kind of quiet; Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (kind of quiet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION COMPLICATION (kind of quiet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021). On 05-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) had resolved. On 07-May-2021, VACCINATION COMPLICATION (kind of quiet) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  Patient did not take any medications or treatments for his symptoms.  Patient got kind of quiet following the first dose which lasted a couple of days before resolving. Patient has a history of immunocompromise, was non-verbal and has a history of clotting factor disorder.  Patient received second dose on 02 Jun 2021 (lot number 026C21A).   This case was linked to MOD-2022-458050 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Product administered to patient of inappropriate age
Clinical narrative: kind of quiet; Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (kind of quiet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION COMPLICATION (kind of quiet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021). On 05-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) had resolved. On 07-May-2021, VACCINATION COMPLICATION (kind of quiet) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  Patient did not take any medications or treatments for his symptoms.  Patient got kind of quiet following the first dose which lasted a couple of days before resolving. Patient has a history of immunocompromise, was non-verbal and has a history of clotting factor disorder.  Patient received second dose on 02 Jun 2021 (lot number 026C21A).   This case was linked to MOD-2022-458050 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was administered after the temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine was administered after the temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, the patient experienced PRODUCT STORAGE ERROR (vaccine was administered after the temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (vaccine was administered after the temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment and concomitant medications were reported   Storage condition at the time of the excursion was Refrigerated storage  Total duration of excursion reported as less than 2°C between 1/6/2022 and 1/20/2022: Lowest temperature recorded 0.5 Celsius only on 1/6/2022 at 0801 for 5 minutes.  Total duration of excursion greater than 8°C between 1/6/2022 and 1/20/2022: Highest temperature recorded was 8.8 Celsius  only on 1/14/2022 at 0800 for a total of 5 minutes
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: Patient received only a tiny amount of the vaccine / the liquid was all down her arm /lower volume administered; The device failed and most of the shot sprayed outside the needle; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received only a tiny amount of the vaccine / the liquid was all down her arm /lower volume administered) and DEVICE CONNECTION ISSUE (The device failed and most of the shot sprayed outside the needle) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 013M20A and 007D21A) for COVID-19 vaccination. No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received only a tiny amount of the vaccine / the liquid was all down her arm /lower volume administered) and DEVICE CONNECTION ISSUE (The device failed and most of the shot sprayed outside the needle). On 21-Jan-2022, ACCIDENTAL UNDERDOSE (Patient received only a tiny amount of the vaccine / the liquid was all down her arm /lower volume administered) and DEVICE CONNECTION ISSUE (The device failed and most of the shot sprayed outside the needle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was not on any concomitant medication. Treatment information was not provided. The dose could not be completely administered to the patient. The patient did not experience any symptoms after receiving the vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 003C21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered an expired Moderna Covid-19 vaccine to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Dose administered after 30-day Use By Date or after manufacturer date of expiry. No vial under went any temperature excursions   This case was linked to MOD-2022-457918 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Arthralgia, Fatigue, Feeding disorder, Headache
Clinical narrative: patient is immunocompromised and received booster dose of vaccine; Inappropriate schedule of vaccine administered; Sweating in bed for 24 hours; Terrible terrible pain; Could not eat; Headache; Nausea so she could not eat; Joint pain; Muscle pain; woke up very tired but still went to work, big mistake; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), HEADACHE (Headache) and NAUSEA (Nausea so she could not eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient felt worse when had COVID.) in October 2021. Previously administered products included for Product used for unknown indication: Johnson and Johnson (Lot Number (206A21A) and Arm of injection: Right) on 11-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concurrent medical conditions included Thyroid disorder, Cancer and Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Antidepressant therapy, CANDESARTAN for Blood pressure, TAMOXIFEN for Cancer, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3 and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), HEADACHE (Headache), NAUSEA (Nausea so she could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (woke up very tired but still went to work, big mistake). On 20-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient is immunocompromised and received booster dose of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 20-Jan-2022, ACCIDENTAL UNDERDOSE (patient is immunocompromised and received booster dose of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (woke up very tired but still went to work, big mistake) had resolved and HEADACHE (Headache) and NAUSEA (Nausea so she could not eat) had not resolved.            Patient got the antibodies which is why Patient waited 90 more days before getting booster.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Myalgia, Nausea, Pain
Clinical narrative: patient is immunocompromised and received booster dose of vaccine; Inappropriate schedule of vaccine administered; Sweating in bed for 24 hours; Terrible terrible pain; Could not eat; Headache; Nausea so she could not eat; Joint pain; Muscle pain; woke up very tired but still went to work, big mistake; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), HEADACHE (Headache) and NAUSEA (Nausea so she could not eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient felt worse when had COVID.) in October 2021. Previously administered products included for Product used for unknown indication: Johnson and Johnson (Lot Number (206A21A) and Arm of injection: Right) on 11-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concurrent medical conditions included Thyroid disorder, Cancer and Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Antidepressant therapy, CANDESARTAN for Blood pressure, TAMOXIFEN for Cancer, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3 and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), HEADACHE (Headache), NAUSEA (Nausea so she could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (woke up very tired but still went to work, big mistake). On 20-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient is immunocompromised and received booster dose of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 20-Jan-2022, ACCIDENTAL UNDERDOSE (patient is immunocompromised and received booster dose of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (woke up very tired but still went to work, big mistake) had resolved and HEADACHE (Headache) and NAUSEA (Nausea so she could not eat) had not resolved.            Patient got the antibodies which is why Patient waited 90 more days before getting booster.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Fluid retention, Peripheral swelling
Clinical narrative: arm swelled up; was so hot that I could hardly it just felt like it was just literally burning; fluid that had build up under my arm; little bit hot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was so hot that I could hardly it just felt like it was just literally burning), FLUID RETENTION (fluid that had build up under my arm) and FEELING HOT (little bit hot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was so hot that I could hardly it just felt like it was just literally burning), FLUID RETENTION (fluid that had build up under my arm) and FEELING HOT (little bit hot). At the time of the report, PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was so hot that I could hardly it just felt like it was just literally burning) and FEELING HOT (little bit hot) had not resolved and FLUID RETENTION (fluid that had build up under my arm) was resolving.            No concomitant medications was reported. Treatment medications was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22; Vaccine moved the freezer to refrigerator the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22) and PRODUCT STORAGE ERROR ( Vaccine moved the freezer to refrigerator the beyond use date ) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22) and PRODUCT STORAGE ERROR ( Vaccine moved the freezer to refrigerator the beyond use date ). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22) and PRODUCT STORAGE ERROR ( Vaccine moved the freezer to refrigerator the beyond use date ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that No side effect was reported by 3 patients during the 15 minute observation time. Expire date based on once the vial was move from freezer was on 20JAN2022. Vial was initially stored in refrigerator on 21DEC2021. Vial did not undergo any temperature excursions.  No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2022-457589, MOD-2022-457576 (Patient Link).
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: made me sick as hell; Initial information received on 01-Jan-2022 regarding an unsolicited valid Social Media non-serious case.  This case involves a patient of unknown demographics who reported event "made me sick as hell", while receiving vaccine INFLUENZA VACCINE.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as flu vaccine.  On an unknown date the patient developed a non-serious event "made me sick as hell" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the "last flu shot I had made me sick as hell. no way no shots, GOD gave me what I need and so far its worked really good., haven't been sick in over 14 years and had NO SHOTS."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (made me sick as hell).  At time of reporting, the outcome was Unknown for the event made me sick as hell.
Sex: U
Vaccine: FLUX
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune diseases; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced autoimmune diseases after receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed autoimmune diseases (autoimmune disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (autoimmune diseases).  At time of reporting, the outcome was Unknown for the event autoimmune diseases.; Sender's Comments: Sanofi Company Comment on 20-Jan-2022: This case involves Adult and unknown gender patient who experienced autoimmune diseases while receiving vaccine INFLUENZA VACCINE.. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: bad case of the flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult male patient who had bad case of the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious bad case of the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (bad case of the flu).  At time of reporting, the outcome was Unknown for the event bad case of the flu.
Age: 18.0
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 15-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 18 years old patient of unknown gender who was sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious  event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"Last time I was sick was after I got a flu shot. I was 18 and now over 50."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced still got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, formulation was unknown)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu).  At time of reporting, the outcome was Unknown for the event still got the flu.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PPV, RVX
Symptoms: Incorrect dose administered, Medication error, No adverse event, Syringe issue
Clinical narrative: part of the vaccine came out of the hub area of the syringe and ran down on the table with o reproted adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who experienced part of the vaccine came out of the hub area of the syringe and ran down on the table with no reported adverse event  while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 14-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ597AAA  and expiry date was 05-Dec-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious part of the vaccine came out of the hub area of the syringe and ran down on the table with o reproted adverse event  (incorrect dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (part of the vaccine came out of the hub area of the syringe and ran down on the table with no reported adverse event ).  At time of reporting, the outcome was Unknown for the event part of the vaccine came out of the hub area of the syringe and ran down on the table with no reported adverse event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Red, swollen lump at injection site, 3cm in diameter. Redness and swelling lasted approximately 3 weeks. Lump palpable 2 months post-vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Ear discomfort, Ear, nose and throat examination, Hyperacusis
Clinical narrative: Started after shot with left ear feeling full and sensitive to noise then turned to tinnitus. Spoke to my doctor who gave me ear drops which seemed to make my tinnitus worse so she said to stop taking the drops. The tinnitus progressed and i went to the ENT doctor for a hearing test. The test showed some hearing loss but at my age that is somewhat normal and that my tinnitus was from loud noise when I was younger? I don't recall having any hearing loss at a younger age went to some concerts have been around some machinery but did wear hearing protection most of the time. The tinnitus progressed and was waking me up at night I was having trouble sleeping and loud noise would set it off very severly for weeks at a time. I called my doctor and they gave me a referral to an audiologist which I am still waiting to hear from. The tinnitus has lowered down some. I have stopped most of my medication which I was taking before the tinnitus started hoping it would help. I still have buzzing in the left side of my head. I am hoping it will go away with time. I am afraid of getting another vaccine because my tinnitus was so bad it was interferring with the quality of my life.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Quality of life decreased, Tinnitus
Clinical narrative: Started after shot with left ear feeling full and sensitive to noise then turned to tinnitus. Spoke to my doctor who gave me ear drops which seemed to make my tinnitus worse so she said to stop taking the drops. The tinnitus progressed and i went to the ENT doctor for a hearing test. The test showed some hearing loss but at my age that is somewhat normal and that my tinnitus was from loud noise when I was younger? I don't recall having any hearing loss at a younger age went to some concerts have been around some machinery but did wear hearing protection most of the time. The tinnitus progressed and was waking me up at night I was having trouble sleeping and loud noise would set it off very severly for weeks at a time. I called my doctor and they gave me a referral to an audiologist which I am still waiting to hear from. The tinnitus has lowered down some. I have stopped most of my medication which I was taking before the tinnitus started hoping it would help. I still have buzzing in the left side of my head. I am hoping it will go away with time. I am afraid of getting another vaccine because my tinnitus was so bad it was interferring with the quality of my life.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Severe insomnia.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: Outcome is MS
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after booster/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for reporter's sister-in-law. The age at vaccination was not reported. The patient got shingles after her booster Shingles vaccine. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had it after my shot around my side/suspected vaccination failure; had it after my shot around my side; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice, first was on right eyelid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got the Shingles shot and had shingles after his/her shot around his/her side. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting.
Sex: F
Vaccine: HEP
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: Vaginal yeast infection; Approximately two weeks after that, she again developed a yeast infection, and again two weeks after that.; Approximately two weeks after that, she again developed a yeast infection, and again two weeks after that.; This case was reported by a consumer via call center representative and described the occurrence of vaginal yeast infection in a 10-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, between 1 and 2 weeks after receiving Hepatitis B vaccine, the patient experienced vaginal yeast infection, vaginal yeast infection and vaginal yeast infection. The patient was treated with miconazole nitrate (Monistat). On an unknown date, the outcome of the vaginal yeast infection was recovered/resolved and the outcome of the vaginal yeast infection and vaginal yeast infection were unknown.   It was unknown if the reporter considered the vaginal yeast infection, vaginal yeast infection and vaginal yeast infection to be related to Hepatitis B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not unknown. The patient received a dose of Hepatitis B vaccine in 2019 and approximately 1 to 2 weeks after her vaccination, developed a vaginal yeast infection and approximately two weeks after that, she again developed a yeast infection, and again two weeks after that. The patient was 10 years old at the time and had not started her periods. The patient was treated with Monistat. The reporter was not certain of the manufacturer. The reporter was given medical advice disclaimer. The reporter was referred to Heath care professional. The reporter was offered as per package insert. The reporter did not wish to provide last name or address and only provided limited information. The reporter stated that she might be contacted via phone or text but did not consent for health care professional to follow-up. This is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022011309:Same reporter
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: COVID-19; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 60 year old female of an unspecified race and ethnic origin. The patient was enrolled in a non-company sponsored clinical trial. The patient's height and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis. The patient was previously received with covid-19 vaccine ad26. cov2.s. (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on 30-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s. On an unspecified date in 2021, the patient was previously received with covid-19 vaccine ad26. cov2.s. (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26. cov2. s. The patient additionally received covid-19 vaccine ad26.cov2. s (dose number in series 3) (suspension for injection, intramuscular, batch number: Unknown and expiry: unknown) dose was not reported, 01 total, administered on 30-NOV-2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: 1154253 and expiry: unknown) dose, frequency and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On 03-JAN-2022, the patient experienced covid-19 (dose number in series 3). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19, and the outcome of inappropriate schedule of vaccine administered and off label use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000211924. 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 PQC evaluation/investigation performed. This case is a duplicate of 20220124494.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Age: 37.0
Sex: M
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 concerned a 38 year old male. 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 not reported, batch number: 1808980 expiry: UNKNOWN) 1 total, administered on 06-MAY-2021 on unspecified arm for prophylactic vaccination. No concomitant medications were reported. On 18-JAN-2022, the patient reported testing positive for COVID-19 with an at home rapid test kit (suspected covid-19 infection and suspected vaccination failure). The patient had symptoms of cough and headache which started on 18-JAN-2022 and symptoms were very mild and could still taste food and had sense of smell. The patient had not taken a PCR (Polymerase chain reaction) test and denied getting a booster dose. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s 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: 90000212966.; Sender's Comments: V0: 20220133024 -Covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination  failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Joint swelling
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; PAIN; CRAMPING; DIZZINESS; SWELLING JOINTS; WEAKNESS; EXTREME FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. 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 not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-AUG-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced pain, cramping, swelling joints, extreme fatigue, and headaches that went away four days after, and patient also experienced dizziness, weakness and fatigue that lasted for about a month. On 25-DEC-2021, the patient experienced headaches, cough, itchy throat and weakness (suspected clinical vaccination failure, and suspected covid-19 infection). On 20-JAN-2022, the patient tested positive (twice) for a covid-19 using an antigen rapid test (BinaxNOW).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain, cramping, swelling joints, and headaches on 05-SEP-2021, and dizziness, weakness, and extreme fatigue, 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 product quality complaint: 90000213333.; Sender's Comments: V0: 20220139800-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. This event(s) is considered not related. 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