chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Product dose omission issue
Clinical narrative: Pregnant; Didnt make it to your second appointment (fir second shot); This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)) in an elderly female patient (gravida 1) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (more than 35 days from 1st vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (more than 35 days from 1st vaccination). At the time of the report, inappropriate schedule of product administration (more than 35 days from 1st vaccination) resolved. No concomitant medications, laboratory details or treatment information provided. The patient was actually scheduled for 2nd dose on Jun 1, 2021. Action taken with mRNA-1273 in response to the events:  not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: slight fever; nausea; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-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) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired). At the time of the report, PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired) had resolved.            no treatment and concomitant medication reported.   This case was linked to MOD-2021-004903, MOD-2021-004903 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea every time I eat anything; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea every time I eat anything) 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 DIARRHOEA (Diarrhea every time I eat anything). At the time of the report, DIARRHOEA (Diarrhea every time I eat anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication
Clinical narrative: covid arm; hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle) and VACCINATION COMPLICATION (covid arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle). On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm). On 01-Mar-2021, URTICARIA (hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle) had resolved. At the time of the report, VACCINATION COMPLICATION (covid arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication: The doctor prescribed Benadryl and hydrocortisone cream.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test positive
Clinical narrative: Joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.     This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test positive: positive (Positive) Patient had COVID-19.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Neck meets the back of the head on both sides; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-222262 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea every time I eat anything; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea every time I eat anything) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea every time I eat anything). At the time of the report, DIARRHOEA (Diarrhea every time I eat anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   This case was linked to MOD-2021-223096 (Parent-Child Link).   See case MOD-2021-223096 for details regarding the child case.  Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: i have chills now and have a light jacket on; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (i have chills now and have a light jacket on) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (i have chills now and have a light jacket on). At the time of the report, CHILLS (i have chills now and have a light jacket on) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Decreased appetite, Dysgeusia
Clinical narrative: metallic taste in mouth; steel made fork and nail cutter stick to her body (chest and right arm); abdominal pain; pain in my joints; Decrease in appetite/loss of appetite; intesnse freezing cold chils for 2 days/third day moderate chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decrease in appetite/loss of appetite), DYSGEUSIA (metallic taste in mouth), STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)), ABDOMINAL PAIN (abdominal pain) and CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced DECREASED APPETITE (Decrease in appetite/loss of appetite). 29-Mar-2021, the patient experienced CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills). On an unknown date, the patient experienced DYSGEUSIA (metallic taste in mouth), STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints). On 31-Mar-2021, CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills) had resolved. At the time of the report, DECREASED APPETITE (Decrease in appetite/loss of appetite), DYSGEUSIA (metallic taste in mouth) and STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)) outcome was unknown and ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints) had not resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up Information Received on 16-JUN-2021  contains No NewInformation. On 29-Jun-2021: Added new Events such as Joint pain and Abdominal pain.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sticky skin
Clinical narrative: metallic taste in mouth; steel made fork and nail cutter stick to her body (chest and right arm); abdominal pain; pain in my joints; Decrease in appetite/loss of appetite; intesnse freezing cold chils for 2 days/third day moderate chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decrease in appetite/loss of appetite), DYSGEUSIA (metallic taste in mouth), STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)), ABDOMINAL PAIN (abdominal pain) and CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced DECREASED APPETITE (Decrease in appetite/loss of appetite). 29-Mar-2021, the patient experienced CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills). On an unknown date, the patient experienced DYSGEUSIA (metallic taste in mouth), STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints). On 31-Mar-2021, CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills) had resolved. At the time of the report, DECREASED APPETITE (Decrease in appetite/loss of appetite), DYSGEUSIA (metallic taste in mouth) and STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)) outcome was unknown and ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints) had not resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up Information Received on 16-JUN-2021  contains No NewInformation. On 29-Jun-2021: Added new Events such as Joint pain and Abdominal pain.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Two patients have not received the second dose of the vaccine after 42 days of the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Incorrect route of product administration, Myalgia, Nausea
Clinical narrative: Sensitivity to light; Inappropriate route of vaccination; Body aches; Headache; Chills; Fever; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 19-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 Streptococcal infection (Tonsils and adenoids removed due to chronic strep throat.) in 2007, Tonsillectomy in 2007 and Tonsillectomy & Adenoidectomy in 2007.    On 28-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 28-May-2021, the patient experienced PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). On 28-May-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, PHOTOPHOBIA (Sensitivity to light), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, Vomiting
Clinical narrative: Sensitivity to light; Inappropriate route of vaccination; Body aches; Headache; Chills; Fever; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 19-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 Streptococcal infection (Tonsils and adenoids removed due to chronic strep throat.) in 2007, Tonsillectomy in 2007 and Tonsillectomy & Adenoidectomy in 2007.    On 28-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 28-May-2021, the patient experienced PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). On 28-May-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, PHOTOPHOBIA (Sensitivity to light), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Transaminases
Clinical narrative: low platelets; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (low platelets) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Elevated Transaminase Level, Fatty Liver, Lumbar Adrenal Mass, Kidney Stone, Essential Hypertension, Hyperlipidemia, Vitamin D Deficiency, Gastroesophageal Reflux disease with out esophagitis, Rosacea, Migraines, Asthma, PTSD, Panic attacks, Anxiety, Low grade Bells palsy (from recent face surgery), pre diabetes.  Gallbladder Surgery 10/2016  Uterine Ablation 1/2013 Parotid Gland 3/15/21  Allergies: Doxycycline, Nitrofurantoin, Lisinopril, Sulfa antibiotics, Sumatriptan.  The patient's past medical history included Gallbladder operation NOS in October 2016 and Uterine ablation in January 2013. Concurrent medical conditions included Fatty liver, Adrenal mass (Lumbar Adrenal Mass), Kidney stone (Kidney Stone), Essential hypertension, Hyperlipidemia, Vitamin D deficiency, Gastroesophageal reflux disease (with out esophagitis), Rosacea, Migraine, Asthma, Post-traumatic stress disorder, Panic attacks, Bell's palsy (Low grade Bells palsy from recent facial surgery), Parotid gland enlargement of (Parotid Gland) since 15-Mar-2021, Allergic reaction to antibiotics (Doxycycline), Allergic reaction to antibiotics (Nitrofurantoin), Allergic reaction to antibiotics (Lisinopril), Allergic reaction to antibiotics (Sulfa) and Allergic reaction to drug (Sumatriptan).   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (low platelets). At the time of the report, PLATELET COUNT DECREASED (low platelets) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Transaminases: other (High) Elevated Transaminase Level.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad rash all over my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bad rash all over my body) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced RASH (Bad rash all over my body). At the time of the report, RASH (Bad rash all over my body) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. There's no evidence of seriousness from a clinical or regulatory standpoint.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. There's no evidence of seriousness from a clinical or regulatory standpoint.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Intermenstrual bleeding, Menstrual disorder, Mood altered, Oligomenorrhoea
Clinical narrative: On April 7 and and 9, day 11 and 13 of my menstrual cycle I experienced spotting. That cycle ended up being only 26 days with me beginning to bleed on April 23rd, and during my menses I had a headache for 3 days in a row and greater moodiness. My next cycle was 36 days, then 30, the 26, and currently waiting for my period and on day 34. So it is unclear whether my cycle has re regulated.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: On April 7 and and 9, day 11 and 13 of my menstrual cycle I experienced spotting. That cycle ended up being only 26 days with me beginning to bleed on April 23rd, and during my menses I had a headache for 3 days in a row and greater moodiness. My next cycle was 36 days, then 30, the 26, and currently waiting for my period and on day 34. So it is unclear whether my cycle has re regulated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Chest X-ray, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Shortness of breath Leg swelling Hypertension Diarrhea Cough
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Metabolic function test, Peripheral swelling, SARS-CoV-2 RNA, SARS-CoV-2 test
Clinical narrative: Shortness of breath Leg swelling Hypertension Diarrhea Cough
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest pain, Diarrhoea, Dizziness
Clinical narrative: 12 - 18 hours after getting the second dose of the vaccine, my mother started feeling dizzy, nauseous, severe headache and full body pains. Then it moved to chest pains, reflux and heartburn, spasms in her neck and pain in her joints. Shortness of breath, hand shakes (trembling), then stomach cramps started as well with some diarrhea. it is now day 6 of these side effects, and only starting to subside now.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Dyspnoea, Gastrooesophageal reflux disease, Headache, Muscle spasms
Clinical narrative: 12 - 18 hours after getting the second dose of the vaccine, my mother started feeling dizzy, nauseous, severe headache and full body pains. Then it moved to chest pains, reflux and heartburn, spasms in her neck and pain in her joints. Shortness of breath, hand shakes (trembling), then stomach cramps started as well with some diarrhea. it is now day 6 of these side effects, and only starting to subside now.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Tremor
Clinical narrative: 12 - 18 hours after getting the second dose of the vaccine, my mother started feeling dizzy, nauseous, severe headache and full body pains. Then it moved to chest pains, reflux and heartburn, spasms in her neck and pain in her joints. Shortness of breath, hand shakes (trembling), then stomach cramps started as well with some diarrhea. it is now day 6 of these side effects, and only starting to subside now.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Cough Congestion Runny nose Sore throat
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Headaches Sore throat
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: My husband got the shot and still got a terrible case of shingles. /Suspected Vaccination Failure; My husband got the shot and still got a terrible case of shingles.; They are horrible to deal with and very painful.; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, her husband got the shot and still got a terrible case of shingles. They were horrible to deal with and very painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Compression garment application, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: Within one week of both Moderna Covid vaccination shots I began to develop left leg pain and swelling. I was checked by my doctor on both events. Both times I was sent to the hospital to have my leg ultrasound. Following the first shot there was no finding of blood clots. I was able to treat my leg swelling with compression socks and rest. Following my second dose of the Moderna Covid vaccine a blood clot was discovered. My doctor has been treating it with Eliquis. Both events of leg swelling happened within a 10 day period of the vaccine. No prior history of like swelling or blood clots prior to the vaccine shots.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Within one week of both Moderna Covid vaccination shots I began to develop left leg pain and swelling. I was checked by my doctor on both events. Both times I was sent to the hospital to have my leg ultrasound. Following the first shot there was no finding of blood clots. I was able to treat my leg swelling with compression socks and rest. Following my second dose of the Moderna Covid vaccine a blood clot was discovered. My doctor has been treating it with Eliquis. Both events of leg swelling happened within a 10 day period of the vaccine. No prior history of like swelling or blood clots prior to the vaccine shots.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Eye pruritus, Myalgia, Paraesthesia
Clinical narrative: Beginning immediately after the injection I began feeling a tingly or itchy sensation in the forearm of the arm I received the vaccine. The sensation has come and went sende receiving the vaccine. There is not any kind of physical action that triggers the sensation. 6 days after the vaccine I have started feeling discomfort in my left armpit - the sensation almost feels like a sore Or tender muscle Sensation and is more tender to touch. I have also had a slightly heavy Or tight feeling in my chest since receiving the vaccine. I plan to both call Walgreens pharmacy where I received the vaccine as well as visit a health care provider should the symptoms persist past a week of receiving the vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nasal congestion, Pain
Clinical narrative: Headache     started thursday  ? Chills ? Cough ? Nasal Congestion ? Generalized Body Aches
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Headache     started thursday  ? Chills ? Cough ? Nasal Congestion ? Generalized Body Aches
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat cough chills
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ammonia normal, Blood test normal, Blood thyroid stimulating hormone normal, Cognitive disorder, Dizziness
Clinical narrative: Approximately 15 hours after injection, felt very mild dizziness and sore arm.  Arm soreness went away within 24 hours, but dizziness progressively worsened.   By Day 3 dizziness was accompanied by cognitive impairment/ brain fog, profuse sweating with temp of 99.0 - 99.5 deg F and tachycardia to 120s upon standing with no change in blood pressure and resting HR in the 60s.  As a Registered Nurse, I was unable to care for patients in this condition.  Contacted PCP.  Symptoms intensified on Days 4-5.  Blood work done, pending results. Follow up care to be provided by PCP.  Will not be receiving second vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count normal, Hyperhidrosis, Liver function test normal, Metabolic function test
Clinical narrative: Approximately 15 hours after injection, felt very mild dizziness and sore arm.  Arm soreness went away within 24 hours, but dizziness progressively worsened.   By Day 3 dizziness was accompanied by cognitive impairment/ brain fog, profuse sweating with temp of 99.0 - 99.5 deg F and tachycardia to 120s upon standing with no change in blood pressure and resting HR in the 60s.  As a Registered Nurse, I was unable to care for patients in this condition.  Contacted PCP.  Symptoms intensified on Days 4-5.  Blood work done, pending results. Follow up care to be provided by PCP.  Will not be receiving second vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tachycardia, Urine analysis normal, Vitamin B12 normal, Vitamin D
Clinical narrative: Approximately 15 hours after injection, felt very mild dizziness and sore arm.  Arm soreness went away within 24 hours, but dizziness progressively worsened.   By Day 3 dizziness was accompanied by cognitive impairment/ brain fog, profuse sweating with temp of 99.0 - 99.5 deg F and tachycardia to 120s upon standing with no change in blood pressure and resting HR in the 60s.  As a Registered Nurse, I was unable to care for patients in this condition.  Contacted PCP.  Symptoms intensified on Days 4-5.  Blood work done, pending results. Follow up care to be provided by PCP.  Will not be receiving second vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Tinnitus
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: fever, fatigue, nasal congestion, sore throat, headache and cough
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: fever, fatigue, nasal congestion, sore throat, headache and cough
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Confusional state, Dizziness, Fatigue
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: stomach discomfort / upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of stomach discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th August 2021, the patient received Shingles vaccine. In August 2021, 4 days after receiving Shingles vaccine, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was not recovered/not resolved.   It was unknown if the reporter considered the stomach discomfort to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the vaccine for shingles on Monday and four days after getting shingles vaccine, the patient had stomach upset. The patient enquired what he/she could do about this.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingrix has not been as effective / suspected vaccination failure; Shingrix has not been as effective; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received on unknown date).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The Shingrix has not been as effective as the previous shingles vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedulelaboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. Note: The case has been conservatively kept valid as no further information can be obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The shingles shot gave me the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and gave him/her the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Didnt feel good.; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got second shot a few days ago and did not feel good. The patient was better on day of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and still got shingles / Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patients family member. The age at vaccination was not reported. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had two shots,got the shingles anyway / Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had two shots of vaccine and got the shingles anyway. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles vaccine and then got the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient had shingles one year after receiving shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after she got the shot/ Suspected Vaccination Failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got shingles after she got the shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 23.0
Sex: F
Vaccine: HPVX, TTOX
Symptoms: Exposure during pregnancy
Clinical narrative: received 2 vaccines on July 24, 2021 / found out 2 weeks ago that  she is 6 weeks pregnant; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   Co-suspect products included Tetanus NVS (Tetanus vaccine) for prophylaxis.   On 24th July 2021, the patient received HPV vaccine and Tetanus vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received HPV vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving HPV vaccine and Tetanus vaccine, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.  Additional case details were reported as follows: The case was reported by the patient. The patient received 2 vaccines on 24th July 2021. She could not remember the names of the vaccines but stated one was for HPV and the other for tetanus.  She found out 2 weeks before the date of reporting that she was 6 weeks pregnant.