chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced can't even sleep in bed because if I roll over on it I wake up because of the pain, and arm still sore like whole upper arm hurts. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still sore like whole upper arm hurts, and can't even sleep in bed because if I roll over on it I wake up because of the pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of CROHN'S DISEASE (Crohn's disease) 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 September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 CROHN'S DISEASE (Crohn's disease). The patient was treated with VEDOLIZUMAB (ENTYVIO) ongoing from January 2022 for Crohn's disease, at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (Crohn's disease) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was respiratory therapist and had questions about the vaccine as he was on biologic medicine. Patient started Entyvio for Crohn's disease in Jan-2022. He took all the Moderna shots and never got sick. His last booster was in Sep-2021. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Upon internal review on 08-Apr-2022, significant correction was performed. The case was updated to valid. Event included (Crohn's disease). Suspect product was recoded with company product dictionary.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oligodendroglioma
Clinical narrative: Diagnosed with brain tumors/ Oligodendroglioma; This spontaneous case was reported by a nurse and describes the occurrence of OLIGODENDROGLIOMA (Diagnosed with brain tumors/ Oligodendroglioma) in a 44-year-old female patient 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 OLIGODENDROGLIOMA (Diagnosed with brain tumors/ Oligodendroglioma) (seriousness criterion medically significant). At the time of the report, OLIGODENDROGLIOMA (Diagnosed with brain tumors/ Oligodendroglioma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  Reporter was enquiring whether it was noted increase of Brain tumors after receiving two shots plus booster vaccine. Reporter was wondering if doctors were reporting this and how would they determine if vaccine was cause or not. Reporter mentioned it was either a rare coincidence or suspicious.  Company Comment: This spontaneous case concerns a 44-year-old female patient with no medical history reported who experienced the unexpected serious (medically significant) event of Oligodendroglioma which occurred unspecified number of days after receiving a dose of mRNA-1273. There is no available information regarding clinical course and treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   This case was linked to MOD-2021-032010, MOD-2022-532773 (Patient Link).; Sender's Comments: This spontaneous case concerns a 44-year-old female patient with no medical history reported who experienced the unexpected serious (medically significant) event of Oligodendroglioma which occurred unspecified number of days after receiving a dose of mRNA-1273. There is no available information regarding clinical course and treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Hyperacusis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and FEELING ABNORMAL (She felt like she was dying) in a 50-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. Concurrent medical conditions included Egg allergy. On 04-Apr-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (She felt like she was dying). On 04-Apr-2022, the patient experienced HYPERACUSIS (Noise sensitivity), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), VOMITING (Vomited 3-5 times a lot/vomiting stopped), HEADACHE (Headache, bad headache) and NAUSEA (Nausea). On 05-Apr-2022, the patient experienced TASTE DISORDER (Could hardly taste). On 05-Apr-2022, PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and VOMITING (Vomited 3-5 times a lot/vomiting stopped) had resolved. At the time of the report, HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), FEELING ABNORMAL (She felt like she was dying), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), HEADACHE (Headache, bad headache) and NAUSEA (Nausea) outcome was unknown. Concomitant product use was not provided by the reporter. On 04-Apr-2022 at 3 PM, patient received her 2nd Moderna COVID-19 booster dose in her left arm. At night, she reported she felt like she was dying. She sat for 5 minutes and started itching but not at the shot site. She reported no hives, but just itching off and on everywhere. She was tired so she went to bed early, woke up with her heart racing, it woke her up. She vomited 3-5 times a lot. Patient reported feeling really dizzy, headache, nausea, light sensitivity, noise sensitivity, bad headache. Patient reported on 05-Apr-2022, she feels a little better, the heart palpitations are down, vomiting stopped. Patient reported the first couple of shots did not affect her like this, just mild reactions: fever, headache, chills. Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Photophobia, Pruritus, Taste disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and FEELING ABNORMAL (She felt like she was dying) in a 50-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. Concurrent medical conditions included Egg allergy. On 04-Apr-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (She felt like she was dying). On 04-Apr-2022, the patient experienced HYPERACUSIS (Noise sensitivity), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), VOMITING (Vomited 3-5 times a lot/vomiting stopped), HEADACHE (Headache, bad headache) and NAUSEA (Nausea). On 05-Apr-2022, the patient experienced TASTE DISORDER (Could hardly taste). On 05-Apr-2022, PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and VOMITING (Vomited 3-5 times a lot/vomiting stopped) had resolved. At the time of the report, HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), FEELING ABNORMAL (She felt like she was dying), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), HEADACHE (Headache, bad headache) and NAUSEA (Nausea) outcome was unknown. Concomitant product use was not provided by the reporter. On 04-Apr-2022 at 3 PM, patient received her 2nd Moderna COVID-19 booster dose in her left arm. At night, she reported she felt like she was dying. She sat for 5 minutes and started itching but not at the shot site. She reported no hives, but just itching off and on everywhere. She was tired so she went to bed early, woke up with her heart racing, it woke her up. She vomited 3-5 times a lot. Patient reported feeling really dizzy, headache, nausea, light sensitivity, noise sensitivity, bad headache. Patient reported on 05-Apr-2022, she feels a little better, the heart palpitations are down, vomiting stopped. Patient reported the first couple of shots did not affect her like this, just mild reactions: fever, headache, chills. Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and FEELING ABNORMAL (She felt like she was dying) in a 50-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. Concurrent medical conditions included Egg allergy. On 04-Apr-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (She felt like she was dying). On 04-Apr-2022, the patient experienced HYPERACUSIS (Noise sensitivity), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), VOMITING (Vomited 3-5 times a lot/vomiting stopped), HEADACHE (Headache, bad headache) and NAUSEA (Nausea). On 05-Apr-2022, the patient experienced TASTE DISORDER (Could hardly taste). On 05-Apr-2022, PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and VOMITING (Vomited 3-5 times a lot/vomiting stopped) had resolved. At the time of the report, HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), FEELING ABNORMAL (She felt like she was dying), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), HEADACHE (Headache, bad headache) and NAUSEA (Nausea) outcome was unknown. Concomitant product use was not provided by the reporter. On 04-Apr-2022 at 3 PM, patient received her 2nd Moderna COVID-19 booster dose in her left arm. At night, she reported she felt like she was dying. She sat for 5 minutes and started itching but not at the shot site. She reported no hives, but just itching off and on everywhere. She was tired so she went to bed early, woke up with her heart racing, it woke her up. She vomited 3-5 times a lot. Patient reported feeling really dizzy, headache, nausea, light sensitivity, noise sensitivity, bad headache. Patient reported on 05-Apr-2022, she feels a little better, the heart palpitations are down, vomiting stopped. Patient reported the first couple of shots did not affect her like this, just mild reactions: fever, headache, chills. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES SIMPLEX (develop a recurrent herpes simplex infection/this happened the very next day, and it was severe and localize, and went away) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 023m20a and 028L20A) for COVID-19 vaccination. Patient has never tested positive or diagnosed with COVID-19. Concurrent medical conditions included Pollen allergy and Blood pressure. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced HERPES SIMPLEX (develop a recurrent herpes simplex infection/this happened the very next day, and it was severe and localize, and went away). At the time of the report, HERPES SIMPLEX (develop a recurrent herpes simplex infection/this happened the very next day, and it was severe and localize, and went away) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was taking concomitant medication (unspecified) for blood pressure. On 25-Sep-2021, patient received the booster dose (lot no: 062E21A) of Moderna vaccine. Patient was wondering about the odds which may happen with second booster, and if it happened can patient take the antiviral medication. It was reported that patient did not seek medical care and did not experienced similar event in past. No treatment medication information was given. This case was linked to MOD-2022-533600 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (after the first dose she had insomnia and a headache for that day and the next day) and HEADACHE (after the first dose she had insomnia and a headache for that day and the next day) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Previously administered products included for Product used for unknown indication: FLUZONE (flu shot 14 days before taking the booster). Past adverse reactions to the above products included No adverse event with FLUZONE. Concurrent medical conditions included Pollen allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INSOMNIA (after the first dose she had insomnia and a headache for that day and the next day.) and HEADACHE (after the first dose she had insomnia and a headache for that day and the next day). At the time of the report, INSOMNIA (after the first dose she had insomnia and a headache for that day and the next day) and HEADACHE (after the first dose she had insomnia and a headache for that day and the next day) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient Concomitant medication reported as blood pressure medicine. No treatment information was provided by the reporter. This case was linked to MOD-2022-533591 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (tiredness) and HEADACHE (headache) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male 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, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had resolved.            No concomitant were reported. No treatment were reported.   Reporter did not allow further contact
Sex: U
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  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 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported.  HCP reported Moderna Covid-19 vaccine vial which was expired on 01-Apr-2022 was administered to four patients on 05-Apr-2022 as a booster. HCP said there was no side effects had been reported.  No treatment medications details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Malaise
Clinical narrative: Did not feel well; He was able to eat something today; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well) and FEEDING DISORDER (He was able to eat something today) 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 March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Did not feel well) and FEEDING DISORDER (He was able to eat something today). On 06-Apr-2022, FEEDING DISORDER (He was able to eat something today) had resolved. At the time of the report, MALAISE (Did not feel well) had not resolved.            No concomitant medication information provided.  Patient received first booster on 01-Dec-2022.  No treatment medication information provided.   This case was linked to MOD-2022-534456 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (kind of a sore spot in her arm/started experiencing a sore spot in her arm where she received) and URTICARIA (started experiencing hives/every day the hives are showing up in different parts of her body) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 025C21A) for COVID-19 vaccination. Patient did not had allergies to medications, food and other products. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient's past medical history included COVID-19. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for an unknown indication. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In March 2022, the patient experienced URTICARIA (started experiencing hives/every day the hives are showing up in different parts of her body). On 16-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (kind of a sore spot in her arm/started experiencing a sore spot in her arm where she received). The patient was treated with PREDNISONE for Adverse reaction, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (kind of a sore spot in her arm/started experiencing a sore spot in her arm where she received) and URTICARIA (started experiencing hives/every day the hives are showing up in different parts of her body) had not resolved. It was reported that, within a day or two post vaccination, the patient started experiencing hives. The hives have gotten so bad at this time that patient had to drive back from one city to another so that patient could have it looked by her doctor. The hives have worsened overtime and have spread all over her body including her legs, chest, neck, and face. Every day the hives are showing up in different parts of her body. Some are the size of a quarter, and some are almost the size of a  softball. The patient did not experience a similar event in the past. AE cause patient to seek urgent care.
Sex: U
Vaccine: COVID19
Symptoms: Product quality issue, Pyrexia, Thrombocytopenia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia after vaccine/thrombocytopenia in patient after using vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia after vaccine/thrombocytopenia in patient after using vaccine) (seriousness criterion medically significant), PYREXIA (fever after vaccine) and PRODUCT QUALITY ISSUE (Defective vaccine). At the time of the report, THROMBOCYTOPENIA (thrombocytopenia after vaccine/thrombocytopenia in patient after using vaccine), PYREXIA (fever after vaccine) and PRODUCT QUALITY ISSUE (Defective vaccine) 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 concomitant medications were reported. No treatment medications were reported. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (important medical event) AESI of Thrombocytopenia, unspecified days after receiving a dose of mRNA-1273 vaccine. Patient also had fever along with the event. Defective vaccine was also reported. No further information on clinical course and management of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up contains product quality complaint number added. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (important medical event) AESI of Thrombocytopenia, unspecified days after receiving a dose of mRNA-1273 vaccine. Patient also had fever along with the event. Defective vaccine was also reported. No further information on clinical course and management of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Ear swelling, Lymphadenopathy, Rash, Tinnitus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling) and LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021b21a and 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient never had COVID-19 Positive test or diagnosis and did not took other vaccines within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Egg allergy and Seafood allergy. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, 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 experienced EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling), LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat), RASH (Got the rash) and VACCINATION SITE LYMPHADENOPATHY (She had swelling of the lymph nodes in the same arm of the injection). At the time of the report, EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling), LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat), RASH (Got the rash) and VACCINATION SITE LYMPHADENOPATHY (She had swelling of the lymph nodes in the same arm of the injection) had not resolved. Patient stated that she had an office visit in order to seek medical care caused due to AE. Patient also stated that she never experienced a similar event in the past and no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. And also reported worsening of symptoms. Treatment information includes doctor gave her antibiotics.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tympanic membrane disorder, Vaccination site lymphadenopathy
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling) and LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021b21a and 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient never had COVID-19 Positive test or diagnosis and did not took other vaccines within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Egg allergy and Seafood allergy. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, 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 experienced EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling), LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat), RASH (Got the rash) and VACCINATION SITE LYMPHADENOPATHY (She had swelling of the lymph nodes in the same arm of the injection). At the time of the report, EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling), LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat), RASH (Got the rash) and VACCINATION SITE LYMPHADENOPATHY (She had swelling of the lymph nodes in the same arm of the injection) had not resolved. Patient stated that she had an office visit in order to seek medical care caused due to AE. Patient also stated that she never experienced a similar event in the past and no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. And also reported worsening of symptoms. Treatment information includes doctor gave her antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Booster dose was given to patient after 24 hr 32 min post puncture. No concomitant medications details were reported. No treatment medications details were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna COVID19 vaccine) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  8 patients received expired doses of the Moderna COVID-19 vaccine. Patient received booster dose on 28Mar2022.  It was reported that vial did not undergo any temperature excursions and the vial was initially stored in the refrigerator on 25-Mar-2022.  No treatment drugs were reported.   This case was linked to MOD-2022-53444.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: Daughter experienced diarrhea; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Daughter experienced diarrhea), NAUSEA (Nausea) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and D37K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Doctor refused to test people. Hence, she did not have a positive test) in March 2020.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, 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 experienced DIARRHOEA (Daughter experienced diarrhea), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, DIARRHOEA (Daughter experienced diarrhea), NAUSEA (Nausea) and CHILLS (Chills) had resolved.            No Concomitant product use was reported.  The reporter stated that their daughter who was the patient had reactions to the second dose of the Moderna Covid-19 vaccine. The reporter said that the patient experienced diarrhea, nausea, and chills and this lasted around 7 weeks when the patient received the second dose of the Moderna Covid 19 vaccine.  The reporter also stated that the patient had Covid-19 in Mar-2020, but doctor refused to test people and for this reason, the patient did not have a positive test. Reportedly, the patient had no allergies.  No treatment information was provided.   This case was linked to MOD-2022-534407 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: with the second booster dose her daughter felt sick,; the second booster dose her daughter had headaches; pain in her right arm in the injection site; First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (with the second booster dose her daughter felt sick,), HEADACHE (the second booster dose her daughter had headaches), VACCINATION SITE PAIN (pain in her right arm in the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 018F21A, 004M20A and D37K20A) for COVID-19 vaccination.     The caller stated that her daughter had no allergies.  The patient's past medical history included COVID-19 (but doctor refused to test people. For this reason she did not have a positive test) in March 2020.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022). On an unknown date, the patient experienced ILLNESS (with the second booster dose her daughter felt sick,), HEADACHE (the second booster dose her daughter had headaches) and VACCINATION SITE PAIN (pain in her right arm in the injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (with the second booster dose her daughter felt sick,), HEADACHE (the second booster dose her daughter had headaches) and VACCINATION SITE PAIN (pain in her right arm in the injection site) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022) outcome was unknown.      No concomitant medication was reported.  It was reported that patient was now feeling better.  This case was linked to MOD-2022-534390 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  On 28-Mar-2022, patient received the booster dose (lot no: 059h21a, Expiration Date: 27-Mar-2022) of Moderna vaccine.  It was reported that 8 Vials were initially stored in the refrigerator on 25-Mar-2022. Doses were administered after manufacturer date of expiry.  The Vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-534443 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Date the vial was initially stored in the refrigerator was 25 March 2022. It was reported that vial did not undergo any temperature excursions.      No treatment medication was provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna COVID19 vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the vial was initially stored in the refrigerator on 25-Mar-2022 and the vial did not undergo any temperature excursions. And the dose was patient's Booster dose.  No treatment medications were reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) 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 vial did not undergo any temperature excursions and the vial was initially stored in the refrigerator on 25-Mar-2022.  No treatment medications were reported.   This case was linked to MOD-2022-534443 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022; dose administered from vial 33 days after stored in fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial did not undergo any temperature excursions.  It was reported that, analysis of the vials associated with storage excursion was complete and likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  Treatment medications were not provided.   This case was linked to MOD-2022-534453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Follow up received included suspect administration date, onset date of event expired vaccine use and updated narrative supplement.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose of the Moderna COVID19 vaccine) in a 95-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that vial did not undergo any temperature excursions and the vial was initially stored in the refrigerator on 25-Mar-2022.   This case was linked to MOD-2022-533291, MOD-2022-534346, MOD-2022-534411, MOD-2022-534418, MOD-2022-534426, MOD-2022-534434, MOD-2022-534458.