chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Illness, Polymerase chain reaction, Pyrexia
Clinical narrative: Vaccination failure; Reports her daughter is "sick as a dog". Really sick; temp as high 100 for couple of days; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue). The patient was treated with IBUPROFEN from 19-Jul-2021 to 22-Jul-2021 at a dose of UNK, as needed. At the time of the report, VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, Polymerase chain reaction: positive (Positive) source of sample was naso pharyngeal. On 19-Jul-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID on (after being vaccinated). source of sample was naso pharyngeal. On an unknown date, Body temperature: 101.5 (High) duration: 2 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient was symptomatic with allergy like symptoms.  Chills, cough, muscle ache, headache, nasal congestion, loss of taste and loss of smell were reported as symptoms of COVID-19 for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up was received and Patient's race and ethnicity were added. Lab data was updated and the Treatment medication was added.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Reports her daughter is "sick as a dog". Really sick; temp as high 100 for couple of days; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue). The patient was treated with IBUPROFEN from 19-Jul-2021 to 22-Jul-2021 at a dose of UNK, as needed. At the time of the report, VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, Polymerase chain reaction: positive (Positive) source of sample was naso pharyngeal. On 19-Jul-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID on (after being vaccinated). source of sample was naso pharyngeal. On an unknown date, Body temperature: 101.5 (High) duration: 2 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient was symptomatic with allergy like symptoms.  Chills, cough, muscle ache, headache, nasal congestion, loss of taste and loss of smell were reported as symptoms of COVID-19 for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up was received and Patient's race and ethnicity were added. Lab data was updated and the Treatment medication was added.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Possible COVID infection between doses; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Possible COVID infection between doses) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Possible COVID infection between doses). At the time of the report, COVID-19 (Possible COVID infection between doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided. Reporter asking if second vaccine is needed if subject had Covid  Company comment: This spontaneous case concerns a patient, unknown age and gender, with no reported medical history, who experienced the non-serious unexpected event of Possible Covid-infection on unknown date after the unspecified dose of mRNA 1273 vaccine. Subject was asking if a second dose of vaccine is needed if he had Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, unknown age and gender, with no reported medical history, who experienced the non-serious unexpected event of Possible Covid-infection on unknown date after the unspecified dose of mRNA 1273 vaccine. Subject was asking if a second dose of vaccine is needed if he had Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Influenza like illness, Pyrexia, Vaccination site pain
Clinical narrative: covid arm that was swollen and sore arm from shoulder to elbow; swollen covid arm; chills; Flu like symptoms; A covid arm; Inappropriate schedule of vaccine administered; arm had big welt at the injection site and lasted 10 days; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (A covid arm), VACCINATION SITE URTICARIA (arm had big welt at the injection site and lasted 10 days), VACCINATION SITE PAIN (covid arm that was swollen and sore arm from shoulder to elbow) and VACCINATION SITE SWELLING (swollen covid arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot (had similar reaction as COVID-19 vaccination). Past adverse reactions to the above products included Adverse reaction with flu shot. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), ALPRAZOLAM (XANAX), VITAMIN D3, LOVASTATIN and TIZANIDINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (A covid arm), VACCINATION SITE URTICARIA (arm had big welt at the injection site and lasted 10 days), VACCINATION SITE PAIN (covid arm that was swollen and sore arm from shoulder to elbow), VACCINATION SITE SWELLING (swollen covid arm), CHILLS (chills) and PYREXIA (fever). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (A covid arm), VACCINATION SITE PAIN (covid arm that was swollen and sore arm from shoulder to elbow), VACCINATION SITE SWELLING (swollen covid arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown and VACCINATION SITE URTICARIA (arm had big welt at the injection site and lasted 10 days) had resolved.            The patient reported experiencing fever, chills, flu like symptoms and a Covid arm that was swollen and sore from shoulder to elbow. The arm had big welt at the injection site and lasted 10 days. The patient reported of developing a similar reaction after the flu shot as well. The symptoms had resolved, lasting 10 days.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: covid arm that was swollen and sore arm from shoulder to elbow; swollen covid arm; chills; Flu like symptoms; A covid arm; Inappropriate schedule of vaccine administered; arm had big welt at the injection site and lasted 10 days; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (A covid arm), VACCINATION SITE URTICARIA (arm had big welt at the injection site and lasted 10 days), VACCINATION SITE PAIN (covid arm that was swollen and sore arm from shoulder to elbow) and VACCINATION SITE SWELLING (swollen covid arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot (had similar reaction as COVID-19 vaccination). Past adverse reactions to the above products included Adverse reaction with flu shot. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), ALPRAZOLAM (XANAX), VITAMIN D3, LOVASTATIN and TIZANIDINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (A covid arm), VACCINATION SITE URTICARIA (arm had big welt at the injection site and lasted 10 days), VACCINATION SITE PAIN (covid arm that was swollen and sore arm from shoulder to elbow), VACCINATION SITE SWELLING (swollen covid arm), CHILLS (chills) and PYREXIA (fever). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (A covid arm), VACCINATION SITE PAIN (covid arm that was swollen and sore arm from shoulder to elbow), VACCINATION SITE SWELLING (swollen covid arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown and VACCINATION SITE URTICARIA (arm had big welt at the injection site and lasted 10 days) had resolved.            The patient reported experiencing fever, chills, flu like symptoms and a Covid arm that was swollen and sore from shoulder to elbow. The arm had big welt at the injection site and lasted 10 days. The patient reported of developing a similar reaction after the flu shot as well. The symptoms had resolved, lasting 10 days.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: did not feel very well; felt draggy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel very well) and FEELING ABNORMAL (felt draggy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 MALAISE (did not feel very well) and FEELING ABNORMAL (felt draggy). At the time of the report, MALAISE (did not feel very well) and FEELING ABNORMAL (felt draggy) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-419213 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: dull headache/ Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull headache/ Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 935903, 013M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (dull headache/ Headache). At the time of the report, HEADACHE (dull headache/ Headache) had not resolved.            No concomitant medications was reported. No treatment drug detail was reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: Inappropriate schedule of vaccine administered; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MYALGIA (body aches) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MYALGIA (body aches). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved and MYALGIA (body aches) outcome was unknown.            Patient stated that her sister suffered greatly after getting a Pfizer booster after her Moderna Covid-19 Vaccine primary series.  Her sister had body aches after her primary series.  Four hours after her Pfizer booster she had heart palpitations.  She experienced those before due to her blood pressure medicine, but they were accelerated after the Pfizer booster.    Concomitant medications included blood pressure medication. No treatment information provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: Bunch of liquid was dripping; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (Bunch of liquid was dripping) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 027A21A and 023M20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE and LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, 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 experienced INJECTION SITE EXTRAVASATION (Bunch of liquid was dripping). At the time of the report, INJECTION SITE EXTRAVASATION (Bunch of liquid was dripping) outcome was unknown.            No treatment information was provided.  No reported medical history.   The patient stated that she is concerned because her arm was dripping not just wet.doctor who stated they weren't sure what she should do.When she talked to the person who vaccinated her she said if she got at least half she is okay.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Diarrhoea
Clinical narrative: hair loss became more prominent, mother is basically bald now; she has been having diarrhea off and on; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss became more prominent, mother is basically bald now) and DIARRHOEA (she has been having diarrhea off and on) 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 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 ALOPECIA (hair loss became more prominent, mother is basically bald now) and DIARRHOEA (she has been having diarrhea off and on). The patient was treated with BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) for Diarrhea, at a dose of 1 dosage form. At the time of the report, ALOPECIA (hair loss became more prominent, mother is basically bald now) and DIARRHOEA (she has been having diarrhea off and on) had not resolved.            Concomitant medication included unspecified medication for blood pressure.  It was reported that the patient experienced diarrhea once or twice every week, or every other week. It was also reported that when the patient was taking medicine for diarrhea, it was going away but was coming back after sometime.   This case was linked to MOD-2021-419573 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: soreness; redness; itchiness; sometimes arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), ERYTHEMA (redness), PRURITUS (itchiness) and PAIN IN EXTREMITY (sometimes arm hurts) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-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. In December 2021, the patient experienced PAIN (soreness), ERYTHEMA (redness), PRURITUS (itchiness) and PAIN IN EXTREMITY (sometimes arm hurts). At the time of the report, PAIN (soreness), ERYTHEMA (redness), PRURITUS (itchiness) and PAIN IN EXTREMITY (sometimes arm hurts) had not resolved.            Concomitant medications were not provided.  Patient is not taking any treatment medications for the events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness/Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/Achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CITALOPRAM, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Soreness/Achiness). On 25-Feb-2021, PAIN (Soreness/Achiness) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-418822, MOD-2021-419760 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Vaccination site pain
Clinical narrative: in the bed; tiredness; chills; sore arm that is painful when you move it; knocked her out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed), FEELING ABNORMAL (knocked her out), FATIGUE (tiredness), CHILLS (chills) and VACCINATION SITE PAIN (sore arm that is painful when you move it) in an 8-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed) and FATIGUE (tiredness). In 2021, the patient experienced FEELING ABNORMAL (knocked her out), CHILLS (chills) and VACCINATION SITE PAIN (sore arm that is painful when you move it). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed), FEELING ABNORMAL (knocked her out), FATIGUE (tiredness), CHILLS (chills) and VACCINATION SITE PAIN (sore arm that is painful when you move it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. The patient was not on any medication aside from vitamins but was supposed to be on a baby aspirin.   This case was linked to MOD-2021-419412, MOD-2021-419795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Non significant follow up no new information was added
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (After expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (After expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Camptocormia, Dysstasia, Gait disturbance, Headache, Inappropriate schedule of product administration
Clinical narrative: pain in arm; headache; received 1st and 2nd dose of Pfizer; her back was bent over; had to hold on to a furniture to walk; could not stand up straight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (could not stand up straight), PAIN IN EXTREMITY (pain in arm), CAMPTOCORMIA (her back was bent over), GAIT DISTURBANCE (had to hold on to a furniture to walk) and HEADACHE (headache) in a 64-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.     The patient's past medical history included Chemotherapy (has a rare health problem since she had chemo 21 years ago when tamoxifen damaged her neurologic system.). Previously administered products included for COVID-19 vaccination: Pfizer (1st dose) in May 2021 and Pfizer (2nd dose) in June 2021; for Product used for unknown indication: TAMOXIFEN (damaged her neurologic system). Past adverse reactions to the above products included Adverse event with Pfizer and Pfizer; and Neurological disorder NOS with TAMOXIFEN. Concurrent medical conditions included Dysautonomia and Orthostatic hypertension. Concomitant products included GLUCOSAMINE, VITAMINS NOS, CLONIDINE and LISINOPRIL for an unknown indication.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced DYSSTASIA (could not stand up straight), CAMPTOCORMIA (her back was bent over) and GAIT DISTURBANCE (had to hold on to a furniture to walk). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st and 2nd dose of Pfizer). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSSTASIA (could not stand up straight), PAIN IN EXTREMITY (pain in arm), CAMPTOCORMIA (her back was bent over), GAIT DISTURBANCE (had to hold on to a furniture to walk) and HEADACHE (headache) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st and 2nd dose of Pfizer) had resolved.            Other concomitant medication included  Sleep aid.  Moderna booster was given on her left arm and her symptoms were similar to that of Pfizer vaccine including pain in arm and headache. Further the consumer mentioned that she took Tylenol and Ibuprofen as guided by a nurse.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; headache; received 1st and 2nd dose of Pfizer; her back was bent over; had to hold on to a furniture to walk; could not stand up straight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (could not stand up straight), PAIN IN EXTREMITY (pain in arm), CAMPTOCORMIA (her back was bent over), GAIT DISTURBANCE (had to hold on to a furniture to walk) and HEADACHE (headache) in a 64-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.     The patient's past medical history included Chemotherapy (has a rare health problem since she had chemo 21 years ago when tamoxifen damaged her neurologic system.). Previously administered products included for COVID-19 vaccination: Pfizer (1st dose) in May 2021 and Pfizer (2nd dose) in June 2021; for Product used for unknown indication: TAMOXIFEN (damaged her neurologic system). Past adverse reactions to the above products included Adverse event with Pfizer and Pfizer; and Neurological disorder NOS with TAMOXIFEN. Concurrent medical conditions included Dysautonomia and Orthostatic hypertension. Concomitant products included GLUCOSAMINE, VITAMINS NOS, CLONIDINE and LISINOPRIL for an unknown indication.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced DYSSTASIA (could not stand up straight), CAMPTOCORMIA (her back was bent over) and GAIT DISTURBANCE (had to hold on to a furniture to walk). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st and 2nd dose of Pfizer). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSSTASIA (could not stand up straight), PAIN IN EXTREMITY (pain in arm), CAMPTOCORMIA (her back was bent over), GAIT DISTURBANCE (had to hold on to a furniture to walk) and HEADACHE (headache) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st and 2nd dose of Pfizer) had resolved.            Other concomitant medication included  Sleep aid.  Moderna booster was given on her left arm and her symptoms were similar to that of Pfizer vaccine including pain in arm and headache. Further the consumer mentioned that she took Tylenol and Ibuprofen as guided by a nurse.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: increased blood pressure after first 2 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERTENSION (increased blood pressure after first 2 doses) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination.     Family history included Blood pressure high. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LOSARTAN for Blood pressure management.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (increased blood pressure after first 2 doses). At the time of the report, HYPERTENSION (increased blood pressure after first 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased.     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.   No Treatment Medications details were provided.   This case was linked to MOD-2021-420124, MOD-2021-420138 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: Can not lift anything; Swollen right arm; Pain in right arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not lift anything), PERIPHERAL SWELLING (Swollen right arm), PAIN IN EXTREMITY (Pain in right arm) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0G1W21A, 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Dapsone).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not lift anything), PERIPHERAL SWELLING (Swollen right arm), PAIN IN EXTREMITY (Pain in right arm) and HEADACHE (Headache). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not lift anything), PERIPHERAL SWELLING (Swollen right arm), PAIN IN EXTREMITY (Pain in right arm) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tiredness) 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 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. In December 2021, the patient experienced PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose from a FLUZONE QUADRIVALENT multidose vial (MDV) that was opened and exposed to 22 Fahrenheit for 23 hours due to a refrigerator malfunction with no A/E; Initial information was received on 15-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via a physician Inquiry Number: 00899139).  This case involves a 54 years old male patient who received a dose from a INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] multidose vial (mdv) that was opened and exposed to 22 Fahrenheit for 23 hours due to a refrigerator malfunction with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 13-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ713AA and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "The caller reported a temperature excursion on FLUZONE (MULTI-DOSE VIAL, UNPUNCTURED) and wanted to know if the products are still suitable for use. Caller reported she needed to confirm, but a patient may have had received this vaccine and wanted to know if they would need to re-administer. She asks if the dose was valid or needs to be repeated."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Bradykinesia, Chills, Dizziness
Clinical narrative: . I had minor reactions to first two doses of Pfizer in March/April 2021  besides sore arm-and odd arm feeling .   Day 1: Wednesday About 1pm get injection hurts immediately but arm isn?t super sore. Do my ?15 min timeout at Pharmacy? Felt nothing while waiting then walked to car and suddenly felt tingling across top of bottom of my feet.   I went right back in and told pharmacists and one starts talking to me saying she had happen and took two months to go away hers was painful and feet would buckle. She?s asking if I had water I had brought but forgotten to drink so I down the bottle and it stops. I  eat a little granola bar and drive 45 min home praying no more side effects while downing another bottle of water.  3pm-1am I?m feeling normal cleaning and going on then start to feel really tired and left side of body shot side - feels weird -as it did with my very first shot not painful just like aware of it.  Day 2. I tossed and turned all night at some point like 5am my arm was hurting so bad I couldn?t even lay on that side -take pain medicine and keep tossing and turning. I?m super exhausted. Brain kinda slow take cold medicine get spurts of energy then feel crappy. Night time my glands under shot arm swell not visible but painful to move arm because pressing lymph node and I have swollen boils behind one ear and a small skin rash on right hand. Take Benadryl.  Day 3 slept for 9 hours feel the worst back hurts right side of head hurts - lymph nodes under arm still swollen. I can?t hardly move talk feed myself change clothes need help doing everything. Super slow - like staring at my hand and napkin slow - I?m hot and cold off and on not severe chills but annoying. Don?t wanna move. Take couple doses of cold Medicine, pain pill and Benadryl throughout day and eat and now at 9/10pm starting to feel more normal.   Days 4 & 5 feel I am beginning to be back to normal then tingling begins again in big toes eventually to entire bottom of feet. Various aches and pains begin moving around fingers, arms, legs, toes and sometimes head and chest. December 3 rd horrible arm aching pain cannot sleep without 600 ibuprofen  tingling and random aches. Meet with neurologist Dec 3 video visit. Doctor asked me to come to office for neurological exam I did on Dec. 15. Dec 1 st - Dec 5/6th feeling ?off? right side of  head like perhaps I?m going to lose balance or faint. Eventually improves. Still have floating aches that last for usually under one minute and tingling feet intermittently. Also a strange feeling on left side. I also had this with my first two Pfizer vaccines but it did not last as long - like an awareness of left arm and leg a strange feeling can?t be explained.   Symptoms have improved but not disappeared. Heavy tingling in bottoms of feet tonight.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Furuncle, Headache
Clinical narrative: . I had minor reactions to first two doses of Pfizer in March/April 2021  besides sore arm-and odd arm feeling .   Day 1: Wednesday About 1pm get injection hurts immediately but arm isn?t super sore. Do my ?15 min timeout at Pharmacy? Felt nothing while waiting then walked to car and suddenly felt tingling across top of bottom of my feet.   I went right back in and told pharmacists and one starts talking to me saying she had happen and took two months to go away hers was painful and feet would buckle. She?s asking if I had water I had brought but forgotten to drink so I down the bottle and it stops. I  eat a little granola bar and drive 45 min home praying no more side effects while downing another bottle of water.  3pm-1am I?m feeling normal cleaning and going on then start to feel really tired and left side of body shot side - feels weird -as it did with my very first shot not painful just like aware of it.  Day 2. I tossed and turned all night at some point like 5am my arm was hurting so bad I couldn?t even lay on that side -take pain medicine and keep tossing and turning. I?m super exhausted. Brain kinda slow take cold medicine get spurts of energy then feel crappy. Night time my glands under shot arm swell not visible but painful to move arm because pressing lymph node and I have swollen boils behind one ear and a small skin rash on right hand. Take Benadryl.  Day 3 slept for 9 hours feel the worst back hurts right side of head hurts - lymph nodes under arm still swollen. I can?t hardly move talk feed myself change clothes need help doing everything. Super slow - like staring at my hand and napkin slow - I?m hot and cold off and on not severe chills but annoying. Don?t wanna move. Take couple doses of cold Medicine, pain pill and Benadryl throughout day and eat and now at 9/10pm starting to feel more normal.   Days 4 & 5 feel I am beginning to be back to normal then tingling begins again in big toes eventually to entire bottom of feet. Various aches and pains begin moving around fingers, arms, legs, toes and sometimes head and chest. December 3 rd horrible arm aching pain cannot sleep without 600 ibuprofen  tingling and random aches. Meet with neurologist Dec 3 video visit. Doctor asked me to come to office for neurological exam I did on Dec. 15. Dec 1 st - Dec 5/6th feeling ?off? right side of  head like perhaps I?m going to lose balance or faint. Eventually improves. Still have floating aches that last for usually under one minute and tingling feet intermittently. Also a strange feeling on left side. I also had this with my first two Pfizer vaccines but it did not last as long - like an awareness of left arm and leg a strange feeling can?t be explained.   Symptoms have improved but not disappeared. Heavy tingling in bottoms of feet tonight.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Lymphadenopathy, Mobility decreased, Neurological examination
Clinical narrative: . I had minor reactions to first two doses of Pfizer in March/April 2021  besides sore arm-and odd arm feeling .   Day 1: Wednesday About 1pm get injection hurts immediately but arm isn?t super sore. Do my ?15 min timeout at Pharmacy? Felt nothing while waiting then walked to car and suddenly felt tingling across top of bottom of my feet.   I went right back in and told pharmacists and one starts talking to me saying she had happen and took two months to go away hers was painful and feet would buckle. She?s asking if I had water I had brought but forgotten to drink so I down the bottle and it stops. I  eat a little granola bar and drive 45 min home praying no more side effects while downing another bottle of water.  3pm-1am I?m feeling normal cleaning and going on then start to feel really tired and left side of body shot side - feels weird -as it did with my very first shot not painful just like aware of it.  Day 2. I tossed and turned all night at some point like 5am my arm was hurting so bad I couldn?t even lay on that side -take pain medicine and keep tossing and turning. I?m super exhausted. Brain kinda slow take cold medicine get spurts of energy then feel crappy. Night time my glands under shot arm swell not visible but painful to move arm because pressing lymph node and I have swollen boils behind one ear and a small skin rash on right hand. Take Benadryl.  Day 3 slept for 9 hours feel the worst back hurts right side of head hurts - lymph nodes under arm still swollen. I can?t hardly move talk feed myself change clothes need help doing everything. Super slow - like staring at my hand and napkin slow - I?m hot and cold off and on not severe chills but annoying. Don?t wanna move. Take couple doses of cold Medicine, pain pill and Benadryl throughout day and eat and now at 9/10pm starting to feel more normal.   Days 4 & 5 feel I am beginning to be back to normal then tingling begins again in big toes eventually to entire bottom of feet. Various aches and pains begin moving around fingers, arms, legs, toes and sometimes head and chest. December 3 rd horrible arm aching pain cannot sleep without 600 ibuprofen  tingling and random aches. Meet with neurologist Dec 3 video visit. Doctor asked me to come to office for neurological exam I did on Dec. 15. Dec 1 st - Dec 5/6th feeling ?off? right side of  head like perhaps I?m going to lose balance or faint. Eventually improves. Still have floating aches that last for usually under one minute and tingling feet intermittently. Also a strange feeling on left side. I also had this with my first two Pfizer vaccines but it did not last as long - like an awareness of left arm and leg a strange feeling can?t be explained.   Symptoms have improved but not disappeared. Heavy tingling in bottoms of feet tonight.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Rash
Clinical narrative: . I had minor reactions to first two doses of Pfizer in March/April 2021  besides sore arm-and odd arm feeling .   Day 1: Wednesday About 1pm get injection hurts immediately but arm isn?t super sore. Do my ?15 min timeout at Pharmacy? Felt nothing while waiting then walked to car and suddenly felt tingling across top of bottom of my feet.   I went right back in and told pharmacists and one starts talking to me saying she had happen and took two months to go away hers was painful and feet would buckle. She?s asking if I had water I had brought but forgotten to drink so I down the bottle and it stops. I  eat a little granola bar and drive 45 min home praying no more side effects while downing another bottle of water.  3pm-1am I?m feeling normal cleaning and going on then start to feel really tired and left side of body shot side - feels weird -as it did with my very first shot not painful just like aware of it.  Day 2. I tossed and turned all night at some point like 5am my arm was hurting so bad I couldn?t even lay on that side -take pain medicine and keep tossing and turning. I?m super exhausted. Brain kinda slow take cold medicine get spurts of energy then feel crappy. Night time my glands under shot arm swell not visible but painful to move arm because pressing lymph node and I have swollen boils behind one ear and a small skin rash on right hand. Take Benadryl.  Day 3 slept for 9 hours feel the worst back hurts right side of head hurts - lymph nodes under arm still swollen. I can?t hardly move talk feed myself change clothes need help doing everything. Super slow - like staring at my hand and napkin slow - I?m hot and cold off and on not severe chills but annoying. Don?t wanna move. Take couple doses of cold Medicine, pain pill and Benadryl throughout day and eat and now at 9/10pm starting to feel more normal.   Days 4 & 5 feel I am beginning to be back to normal then tingling begins again in big toes eventually to entire bottom of feet. Various aches and pains begin moving around fingers, arms, legs, toes and sometimes head and chest. December 3 rd horrible arm aching pain cannot sleep without 600 ibuprofen  tingling and random aches. Meet with neurologist Dec 3 video visit. Doctor asked me to come to office for neurological exam I did on Dec. 15. Dec 1 st - Dec 5/6th feeling ?off? right side of  head like perhaps I?m going to lose balance or faint. Eventually improves. Still have floating aches that last for usually under one minute and tingling feet intermittently. Also a strange feeling on left side. I also had this with my first two Pfizer vaccines but it did not last as long - like an awareness of left arm and leg a strange feeling can?t be explained.   Symptoms have improved but not disappeared. Heavy tingling in bottoms of feet tonight.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram head, Electrocardiogram
Clinical narrative: Blood Clot to the Brain causing PCA stroke
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Implantable cardiac monitor insertion, Magnetic resonance imaging, Ultrasound abdomen, X-ray
Clinical narrative: Blood Clot to the Brain causing PCA stroke