chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Retinal disorder, Vaccination complication
Clinical narrative: Terrible reaction; My retina is ruined from your booster shot; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Terrible reaction) and RETINAL DISORDER (My retina is ruined from your booster shot) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Terrible reaction) and RETINAL DISORDER (My retina is ruined from your booster shot). At the time of the report, VACCINATION COMPLICATION (Terrible reaction) and RETINAL DISORDER (My retina is ruined from your booster shot) outcome was unknown.            Concomitant drugs were not reported. Treatment details were not given   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Follow up information received on 10-Dec-2021 contains no new information to add. On 11-Dec-2021: Follow up information received on 11-Dec-2021 -A new event was added.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Botox (Botox started Botox therapeutic for migraine on an unknown date. Patient believes she's sick.). Past adverse reactions to the above products included No adverse event with Botox.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medication was provided. No treatment medication was provided. Received an email from SCC with SD AGN280226 on 06-Dec-2021. Syneos Health Form was attached on the email received for BOTOX THERAPEUTIC. A Botox Complete Support Specialist called on 06Dec2021 at 12:39 PM to warm transfer a patient to report adverse events. Patient's information obtained and permission to follow up granted. Medical history and concomitant medications obtained. HCP information obtained and permission to follow up granted. Botox started Botox therapeutic for migraine on an unknown date. Botox therapeutic wasn't working the first time she received it. Patient's migraines come back 3 weeks before her injections are due. Patient believes she's sick (continued). from COVID-19. She got tested today but hasn't received her results yet. Patient started to experience a headache that's different than a migraine. The headache is not in the same spot as her migraine. Started yesterday.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Illness, Myalgia, Pyrexia
Clinical narrative: Abnormal vaginal bleeding; Severe abdominal pain; very very very sick; Puking; Fever; Muscle aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding), ABDOMINAL PAIN (Severe abdominal pain), ILLNESS (very very very sick), VOMITING (Puking) and PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding), ABDOMINAL PAIN (Severe abdominal pain), ILLNESS (very very very sick), VOMITING (Puking), PYREXIA (Fever), MYALGIA (Muscle aches) and CHILLS (Chills). At the time of the report, VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding), ABDOMINAL PAIN (Severe abdominal pain), ILLNESS (very very very sick), VOMITING (Puking), PYREXIA (Fever), MYALGIA (Muscle aches) and CHILLS (Chills) had resolved.            Patient reported that some adverse events lasted for 24 hours and some for few weeks.  No concomitant medication reported.  No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vomiting
Clinical narrative: Abnormal vaginal bleeding; Severe abdominal pain; very very very sick; Puking; Fever; Muscle aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding), ABDOMINAL PAIN (Severe abdominal pain), ILLNESS (very very very sick), VOMITING (Puking) and PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding), ABDOMINAL PAIN (Severe abdominal pain), ILLNESS (very very very sick), VOMITING (Puking), PYREXIA (Fever), MYALGIA (Muscle aches) and CHILLS (Chills). At the time of the report, VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding), ABDOMINAL PAIN (Severe abdominal pain), ILLNESS (very very very sick), VOMITING (Puking), PYREXIA (Fever), MYALGIA (Muscle aches) and CHILLS (Chills) had resolved.            Patient reported that some adverse events lasted for 24 hours and some for few weeks.  No concomitant medication reported.  No treatment information was provided.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Chills, Fatigue, Headache
Clinical narrative: pains in her upper back; headache, 3 to 4 days later she started experiencing headaches again; tiredness; shingles pain has gone away since she received the booster shot; she has not been feeling well since she received the booster shot; chills running down her back; sweating/ sweating so much at night that she had to take her top off to sleep; legs burning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), BURNING SENSATION (legs burning), MALAISE (she has not been feeling well since she received the booster shot), BACK PAIN (pains in her upper back) and HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shingles (which was misdiagnosed) since 2018 and Post herpetic neuralgia (from the back of her shoulder down to her waist due to Shingles).    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), BURNING SENSATION (legs burning) and CHILLS (chills running down her back). On 26-Nov-2021, the patient experienced MALAISE (she has not been feeling well since she received the booster shot) and THERAPEUTIC RESPONSE UNEXPECTED (shingles pain has gone away since she received the booster shot). On 27-Nov-2021, the patient experienced BACK PAIN (pains in her upper back), HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) and FATIGUE (tiredness). On 26-Nov-2021, THERAPEUTIC RESPONSE UNEXPECTED (shingles pain has gone away since she received the booster shot) had resolved. On 29-Nov-2021, BACK PAIN (pains in her upper back) and FATIGUE (tiredness) had resolved. At the time of the report, HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) and CHILLS (chills running down her back) had not resolved and BURNING SENSATION (legs burning) and MALAISE (she has not been feeling well since she received the booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she does not know if this was due to her age or the vaccination.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-038136 (Patient Link).
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Therapeutic response unexpected
Clinical narrative: pains in her upper back; headache, 3 to 4 days later she started experiencing headaches again; tiredness; shingles pain has gone away since she received the booster shot; she has not been feeling well since she received the booster shot; chills running down her back; sweating/ sweating so much at night that she had to take her top off to sleep; legs burning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), BURNING SENSATION (legs burning), MALAISE (she has not been feeling well since she received the booster shot), BACK PAIN (pains in her upper back) and HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shingles (which was misdiagnosed) since 2018 and Post herpetic neuralgia (from the back of her shoulder down to her waist due to Shingles).    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), BURNING SENSATION (legs burning) and CHILLS (chills running down her back). On 26-Nov-2021, the patient experienced MALAISE (she has not been feeling well since she received the booster shot) and THERAPEUTIC RESPONSE UNEXPECTED (shingles pain has gone away since she received the booster shot). On 27-Nov-2021, the patient experienced BACK PAIN (pains in her upper back), HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) and FATIGUE (tiredness). On 26-Nov-2021, THERAPEUTIC RESPONSE UNEXPECTED (shingles pain has gone away since she received the booster shot) had resolved. On 29-Nov-2021, BACK PAIN (pains in her upper back) and FATIGUE (tiredness) had resolved. At the time of the report, HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) and CHILLS (chills running down her back) had not resolved and BURNING SENSATION (legs burning) and MALAISE (she has not been feeling well since she received the booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she does not know if this was due to her age or the vaccination.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-038136 (Patient Link).
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the Booster shot before 6 month from having the primary series of vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Booster shot before 6 month from having the primary series of vaccine.) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Booster shot before 6 month from having the primary series of vaccine.). On 08-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Booster shot before 6 month from having the primary series of vaccine.) 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 medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site mass, Paraesthesia, Vaccination site reaction
Clinical narrative: site reaction is diameter of coffee mug; It is tickling; It is a red hard lump,that has a goosebumps on it; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (site reaction is diameter of coffee mug), PARAESTHESIA (It is tickling), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INJECTION SITE MASS (It is a red hard lump,that has a goosebumps on it) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE ((2nd dose)  normal lump from the injection.) and PFIZER BIONTECH COVID-19 VACCINE ((1st dose) normal lump from the injection.). Past adverse reactions to the above products included Injection site lump with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VACCINATION SITE REACTION (site reaction is diameter of coffee mug), PARAESTHESIA (It is tickling) and INJECTION SITE MASS (It is a red hard lump,that has a goosebumps on it). On 07-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE REACTION (site reaction is diameter of coffee mug), PARAESTHESIA (It is tickling) and INJECTION SITE MASS (It is a red hard lump,that has a goosebumps on it) outcome was unknown.            Treatment included Compress and icepack
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Skin discolouration
Clinical narrative: black and blue mark that was red and  left; black and blue mark that was red and  left; was tired   after the Booster of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (black and blue mark that was red and  left), ERYTHEMA (black and blue mark that was red and  left) and FATIGUE (was tired   after the Booster of Moderna) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (black and blue mark that was red and  left), ERYTHEMA (black and blue mark that was red and  left) and FATIGUE (was tired   after the Booster of Moderna). At the time of the report, SKIN DISCOLOURATION (black and blue mark that was red and  left), ERYTHEMA (black and blue mark that was red and  left) and FATIGUE (was tired   after the Booster of Moderna) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: facial herpes outbreaks; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (facial herpes outbreaks) 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 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced HERPES ZOSTER (facial herpes outbreaks). At the time of the report, HERPES ZOSTER (facial herpes outbreaks) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Her side effects from the Moderna COVID-19 vaccine are worse than described on the handout given to her.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Her side effects from the Moderna COVID-19 vaccine are worse than described on the handout given to her.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Her side effects from the Moderna COVID-19 vaccine are worse than described on the handout given to her.). At the time of the report, VACCINATION COMPLICATION (Her side effects from the Moderna COVID-19 vaccine are worse than described on the handout given to her.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Sneezing
Clinical narrative: sneezing like crazy; not feeling well for 1-2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing like crazy) and MALAISE (not feeling well for 1-2 weeks) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced SNEEZING (sneezing like crazy) and MALAISE (not feeling well for 1-2 weeks). At the time of the report, SNEEZING (sneezing like crazy) and MALAISE (not feeling well for 1-2 weeks) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.  Reporter mentioned that the patient may have had delta (COVID-19). Did not get tested for COVID-19 but patient said, from what found in the internet, symptoms were similar to delta's.  Symptoms as sneezing like crazy and not feeling well for 1-2 weeks.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: felt sick; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) for COVID-19 vaccination.     Concomitant products included LATANOPROST and DORZOLAMIDE for Glaucoma, GABAPENTIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-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 ILLNESS (felt sick) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (felt sick) and FATIGUE (tired) outcome was unknown.     This case was linked to MOD-2021-408614, MOD-2021-408622 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a full dose of Moderna COVID-19 vaccine after 3 doses of Pfizer COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a full dose of Moderna COVID-19 vaccine after 3 doses of Pfizer COVID-19 vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (the first one on 06-Mar-2021 and the second one on 03-Apr-2021 and the third on 20-Aug-2021.) from 06-Mar-2021 to 20-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.    On 10-Dec-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a full dose of Moderna COVID-19 vaccine after 3 doses of Pfizer COVID-19 vaccine). On 10-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a full dose of Moderna COVID-19 vaccine after 3 doses of Pfizer COVID-19 vaccine) 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 medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 28 patient received expired vaccine; dose 1 and dose 2 were Pfizer and booster was moderna; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1 and dose 2 were Pfizer and booster was moderna) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 26-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE on 17-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE; and No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1 and dose 2 were Pfizer and booster was moderna). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1 and dose 2 were Pfizer and booster was moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported.On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant information was not provided. Treatment information was not provided.This case was linked to MOD-2021-408551 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer (First dose and second dose) from 24-Mar-2021 to 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medication information was provided. 28 patient received expired vaccine. No treatment medication information was provided. This case was linked to MOD-2021-408649, MOD-2021-409288 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-408551 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (First dose) on 15-May-2021 and PFIZER BIONTECH COVID-19 VACCINE (Second dose) on 05-Jun-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; high fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (aches) and PYREXIA (high fever) 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 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 PAIN (aches) and PYREXIA (high fever). At the time of the report, PAIN (aches) and PYREXIA (high fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that  got 3rd moderna shot on 10-DEC-2021 also stated that  had no adverse reactions with the first dose,but did have a strong reaction to the second dose  No concomitant medications were reported   No treatment information was provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Swollen tongue
Clinical narrative: Face is swollen; Neck is swollen; Tongue is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen), SWELLING (Neck is swollen) and SWOLLEN TONGUE (Tongue is swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face is swollen), SWELLING (Neck is swollen) and SWOLLEN TONGUE (Tongue is swollen). At the time of the report, SWELLING FACE (Face is swollen), SWELLING (Neck is swollen) and SWOLLEN TONGUE (Tongue is swollen) outcome was unknown.            On Dec-2021 Patient experienced her face, neck and tongue is swollen. No concomitant medication details was reported. No treatment medication details was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy head then spreading down neck and further down my back/ itchiness persisted), URTICARIA (with bumps appearing where I scratched / Hives/ Urticaria) and ERYTHEMA (Redness/ erythema) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 007C21A) for COVID-19 vaccination. No medical history was provided. Concurrent medical conditions included Food allergy (rawpumpkin, Straw berrie, carrots and peaches.), Gluten sensitivity (Which manifeste GI tract issues, not itches or hives) and Food allergy (Indian foods/Tamarind- Head to toe hives, itching with in 8 hours of meal.) since 2015.Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) from 09-Sep-2005 to an unknown date for Birth control. On 18-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021 at 11:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PRURITUS (itchy head then spreading down neck and further down my back/ itchiness persisted) and URTICARIA (with bumps appearing where I scratched / Hives/ Urticaria). On 13-Nov-2021 at 9:00 AM, the patient experienced ERYTHEMA (Redness/ erythema). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 15-Nov-2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) ongoing from 15-Nov-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy head then spreading down neck and further down my back/ itchiness persisted), URTICARIA (with bumps appearing where I scratched / Hives/ Urticaria) and ERYTHEMA (Redness/ erythema) had not resolved. On 04 Nov morning, patient had event itching. Patient took shower to relieve the symptoms but persisted. The next morning, symptoms including bumps persisted. There had been no changes to his food, cosmetics or laundry products. No environmental changes either. Patient continued treatment medications. This case was linked to MOD-2021-404961, MOD-2021-404946 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vomiting
Clinical narrative: recieved the Moderna covid booster yesterday and is week; recieved the Moderna covid booster yesterday and throwing up; This spontaneous case was reported by a pharmacist and describes the occurrence of ASTHENIA (recieved the Moderna covid booster yesterday and is week) and VOMITING (recieved the Moderna covid booster yesterday and throwing up) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced ASTHENIA (recieved the Moderna covid booster yesterday and is week) and VOMITING (recieved the Moderna covid booster yesterday and throwing up). At the time of the report, ASTHENIA (recieved the Moderna covid booster yesterday and is week) and VOMITING (recieved the Moderna covid booster yesterday and throwing up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain in extremity, Somnolence
Clinical narrative: Slept for 13 hours; Arm hurt after the booster; 7 weeks since booster dose and lymph node was tender; Lymph node was still swollen; She was tired; Lymph node was size of golf ball in the underarm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for 13 hours), PAIN IN EXTREMITY (Arm hurt after the booster), LYMPH NODE PAIN (7 weeks since booster dose and lymph node was tender), LYMPHADENOPATHY (Lymph node was still swollen) and FATIGUE (She was tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept for 13 hours), PAIN IN EXTREMITY (Arm hurt after the booster), LYMPH NODE PAIN (7 weeks since booster dose and lymph node was tender), LYMPHADENOPATHY (Lymph node was still swollen), FATIGUE (She was tired) and LYMPHADENOPATHY (Lymph node was size of golf ball in the underarm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept for 13 hours), PAIN IN EXTREMITY (Arm hurt after the booster), FATIGUE (She was tired) and LYMPHADENOPATHY (Lymph node was size of golf ball in the underarm) outcome was unknown and LYMPH NODE PAIN (7 weeks since booster dose and lymph node was tender) and LYMPHADENOPATHY (Lymph node was still swollen) had not resolved.            No concomitant medication were reported. It was reported that the patient visited healthcare professional about 2 weeks ago and encouraged patient to get mammogram.   Reporter did not allow further contact
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-408922 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hypoaesthesia, Illness, Pyrexia
Clinical narrative: I have been sick; Weak; Chills; Fever; Lips and gums go numb for 30 min; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (I have been sick), ASTHENIA (Weak), HYPOAESTHESIA (Lips and gums go numb for 30 min), CHILLS (Chills) and PYREXIA (Fever) 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 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I have been sick), ASTHENIA (Weak), HYPOAESTHESIA (Lips and gums go numb for 30 min), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ILLNESS (I have been sick), ASTHENIA (Weak), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and HYPOAESTHESIA (Lips and gums go numb for 30 min) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Splinter haemorrhages
Clinical narrative: eczema; red streaks underneath the fingernail; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema) and SPLINTER HAEMORRHAGES (red streaks underneath the fingernail) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Emphysema and Arthritis.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ECZEMA (eczema) and SPLINTER HAEMORRHAGES (red streaks underneath the fingernail). At the time of the report, ECZEMA (eczema) and SPLINTER HAEMORRHAGES (red streaks underneath the fingernail) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs were not reported.  Treatment medications included topical cream.  In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. It was reported that patient was receiving care from a veteran.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I began having shortness of breath two days after the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (I began having shortness of breath two days after the booster) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (I began having shortness of breath two days after the booster). At the time of the report, DYSPNOEA (I began having shortness of breath two days after the booster) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experienced shortness of breath after booster shot and it was over a month and patient had been struggling with the event.  No concomitant medications were reported  No treatment medications were reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (did not put the needle all the way in and some vaccine trickled down her arm) and DEVICE CONNECTION ISSUE (when she pulled out the needle some of the vaccine trickled down her arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (did not put the needle all the way in and some vaccine trickled down her arm) and DEVICE CONNECTION ISSUE (when she pulled out the needle some of the vaccine trickled down her arm). On 10-Dec-2021, ACCIDENTAL UNDERDOSE (did not put the needle all the way in and some vaccine trickled down her arm) and DEVICE CONNECTION ISSUE (when she pulled out the needle some of the vaccine trickled down her arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Symptoms: It was reported that the patient received booster dose of Moderna vaccine and reported that the pharmacist was in a hurry and she did not insert needle completely and when she pulled out the syringe, some amount of vaccine dose was trickled down her arm, patient wanted to know if she could get another booster dose.No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.  Concomitant products included IBUPROFEN, ASPIRIN [ACETYLSALICYLIC ACID] and METFORMIN for an unknown indication. On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dysstasia, Pain
Clinical narrative: Got very weak and achy, could hardly stand up for the next two days after about 10 after the shot . My hips still ache and never had this problem before
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood culture positive, Cardiac output, Cardio-respiratory arrest, Chest pain
Clinical narrative: Admitted on 12/8/2021 with chest pain that woke her from her sleep.  STEMI protocol initiated.  HC - cors clear.  Code blue arrest x2 following - intubated, pressors required.  CT found splenic ruptures - providers do not feel this was related to CPR at this time.  AKI.  Liver failure.  Now on multiple pressors, ETT, CRRT running, GI bleeding, and now also has positive blood cultures.