chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Significant arm pain first day after vaccine, followed by large swollen lymph nodes under armpit the next day.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Syncope, Tremor, Vomiting
Clinical narrative: Passed out, Puking, Sweating, Shaking
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Within 24 hours of vaccine, injection site is red, swollen, painful, warm to touch, enlarged knot/bump. Rash started to spread on arm. 10/3/21 - injection site swelling and redness is even larger
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Pain, Pyrexia
Clinical narrative: Shot received 10/01/21. Symptoms of muscle aches started that night. The next day, slight fever, some body aches, and painful swelling of a lymph under my left arm pit. Painful swelling continues.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: chest pain, headache, soreness, nausea, fatigue, high fever over 101, fuzziness missed 3 days of work went to doctor took painkillers, anti-inflammatories, and antihistamines
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: chest pain, headache, soreness, nausea, fatigue, high fever over 101, fuzziness missed 3 days of work went to doctor took painkillers, anti-inflammatories, and antihistamines
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Urticaria
Clinical narrative: Hives all over body about 8 weeks after vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site mass, Lymphadenopathy, Rash
Clinical narrative: Lump in arm, rash that is growing , swelling of lymph nodes under arm pit, elbow pain, rash happened right away and is continuing to grow
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular periods each month, experiencing a 3 day period 6 days before my regular 5 day cycle
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Painful respiration
Clinical narrative: No issue until 3 weeks later. Sudden pain in chest. Hurts if any pressure is applied. Worse when lay down or take deep breaths. Seems to be worse right behind sternum.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Headache, Joint stiffness, Tinnitus
Clinical narrative: Constant humming in Left ear that has not stopped like tinnitus (MD appointment pending ) , headache - constant, joint stiffness in neck, Left eye twitching several times / day
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide normal, Chest pain, Hypersensitivity, Injection site erythema, Injection site induration
Clinical narrative: Local mild allergic reaction with immediate induration and redness near injection site; not typical local injection site reaction because of robust induration.  No other symptoms; no shortness of breath, chest pain, etc at that time.  Later on Sept 29, the patient presented with chest pain that reportedly got worse since having the vaccination; however, workup was completely negative (BNP and Troponin within normal limits).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Local mild allergic reaction with immediate induration and redness near injection site; not typical local injection site reaction because of robust induration.  No other symptoms; no shortness of breath, chest pain, etc at that time.  Later on Sept 29, the patient presented with chest pain that reportedly got worse since having the vaccination; however, workup was completely negative (BNP and Troponin within normal limits).
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Hypersomnia, Nausea, Tremor
Clinical narrative: Extremely fatigued. Slept sixteen hours on Fri day/Saturday. Woke up for three hours, and slept four hours. Woke up again, staying up for five hours, and slept another seventeen hours. After only two hours, I was fatigued once more. I feel too nauseous to eat, and am shaking as if I'm cold.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Dysarthria, Dyspnoea, Hypoaesthesia
Clinical narrative: The first Pfizer vaccine shot was administered on Sunday, September 19, 2021. On Monday, September 27, 2021, I started feeling dizzy and lightheaded at around 4:10 pm. During the next couple of minutes, the symptoms continued to worsen and my complexion changed to very pale. By 4:30 pm, I started suffering from fast heart palpitations; strong pain in nape of my neck; I felt tingling and numbness all over my body; I had slurred speech; and shortness of breath resulting in difficulty breathing. My family called 911. The paramedics arrived and administered oxygen and determined that I needed to be taken to the hospital. During the hospital trip, the tingling and numbness throughout my body persisted along with muscle spasm. Once I was at the hospital, I was placed on an IV and had X-rays and blood drawn 3 times. I was told my white blood cell count was low, hence the reason for multiple bloodwork exams. I was discharged after my white blood cell count returned to normal. Symptoms best described as similar to a stroke or myocarditis. I was advised to follow-up with my primary doctor, which I have contacted and given an appointment for October 13, 2021. I was told to return to the ER if I felt the symptoms returning.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Neck pain, Pallor, Palpitations, Paraesthesia
Clinical narrative: The first Pfizer vaccine shot was administered on Sunday, September 19, 2021. On Monday, September 27, 2021, I started feeling dizzy and lightheaded at around 4:10 pm. During the next couple of minutes, the symptoms continued to worsen and my complexion changed to very pale. By 4:30 pm, I started suffering from fast heart palpitations; strong pain in nape of my neck; I felt tingling and numbness all over my body; I had slurred speech; and shortness of breath resulting in difficulty breathing. My family called 911. The paramedics arrived and administered oxygen and determined that I needed to be taken to the hospital. During the hospital trip, the tingling and numbness throughout my body persisted along with muscle spasm. Once I was at the hospital, I was placed on an IV and had X-rays and blood drawn 3 times. I was told my white blood cell count was low, hence the reason for multiple bloodwork exams. I was discharged after my white blood cell count returned to normal. Symptoms best described as similar to a stroke or myocarditis. I was advised to follow-up with my primary doctor, which I have contacted and given an appointment for October 13, 2021. I was told to return to the ER if I felt the symptoms returning.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased, X-ray
Clinical narrative: The first Pfizer vaccine shot was administered on Sunday, September 19, 2021. On Monday, September 27, 2021, I started feeling dizzy and lightheaded at around 4:10 pm. During the next couple of minutes, the symptoms continued to worsen and my complexion changed to very pale. By 4:30 pm, I started suffering from fast heart palpitations; strong pain in nape of my neck; I felt tingling and numbness all over my body; I had slurred speech; and shortness of breath resulting in difficulty breathing. My family called 911. The paramedics arrived and administered oxygen and determined that I needed to be taken to the hospital. During the hospital trip, the tingling and numbness throughout my body persisted along with muscle spasm. Once I was at the hospital, I was placed on an IV and had X-rays and blood drawn 3 times. I was told my white blood cell count was low, hence the reason for multiple bloodwork exams. I was discharged after my white blood cell count returned to normal. Symptoms best described as similar to a stroke or myocarditis. I was advised to follow-up with my primary doctor, which I have contacted and given an appointment for October 13, 2021. I was told to return to the ER if I felt the symptoms returning.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Muscle spasms, Syncope, Tachycardia, Tongue discolouration
Clinical narrative: The first Pfizer vaccine shot was administered on Sunday, September 19, 2021. On Monday, September 27, 2021, I started feeling dizzy and lightheaded at around 4:10 pm. During the next couple of minutes, the symptoms continued to worsen and my complexion changed to very pale. By 4:30 pm, I started suffering from fast heart palpitations; strong pain in nape of my neck; I felt tingling and numbness all over my body; I had slurred speech; and shortness of breath resulting in difficulty breathing. My family called 911. The paramedics arrived and administered oxygen and determined that I needed to be taken to the hospital. During the hospital trip, the tingling and numbness throughout my body persisted along with muscle spasm. Once I was at the hospital, I was placed on an IV and had X-rays and blood drawn 3 times. I was told my white blood cell count was low, hence the reason for multiple bloodwork exams. I was discharged after my white blood cell count returned to normal. Symptoms best described as similar to a stroke or myocarditis. I was advised to follow-up with my primary doctor, which I have contacted and given an appointment for October 13, 2021. I was told to return to the ER if I felt the symptoms returning.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Dysarthria, Dyspnoea, Hypoaesthesia
Clinical narrative: on 9/27/2021, around 3:30pm, patient had shortness of breath, tachycardia, blue tongue, muscle cramps that led family member to call paramedics and he later was hospitalized for syncope as diagnosis
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Neck pain, Pallor, Palpitations, Paraesthesia
Clinical narrative: on 9/27/2021, around 3:30pm, patient had shortness of breath, tachycardia, blue tongue, muscle cramps that led family member to call paramedics and he later was hospitalized for syncope as diagnosis
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased, X-ray
Clinical narrative: on 9/27/2021, around 3:30pm, patient had shortness of breath, tachycardia, blue tongue, muscle cramps that led family member to call paramedics and he later was hospitalized for syncope as diagnosis
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Muscle spasms, Syncope, Tachycardia, Tongue discolouration
Clinical narrative: on 9/27/2021, around 3:30pm, patient had shortness of breath, tachycardia, blue tongue, muscle cramps that led family member to call paramedics and he later was hospitalized for syncope as diagnosis
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hyperhidrosis, Myoclonus, Nausea, Pain
Clinical narrative: Fever up to 102.7, body aches, chills, sweats, myoclonus, and nausea
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever up to 102.7, body aches, chills, sweats, myoclonus, and nausea
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer
Clinical narrative: Breast Cancer
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Disorientation, Headache, Pain
Clinical narrative: Fever, chills, severe body aches, headache, weakness, disoriented.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, severe body aches, headache, weakness, disoriented.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Epistaxis, Headache, Injection site warmth, Nervousness
Clinical narrative: I received my second dose last Thursday, September 30, 2021. That evening, my arm swelled up and was hot at the injection site. The swelling has gone half way down my arm and is burning hot the touch. Tomorrow will be day 4 since I've gotten the vaccine. My temperature has not been below 101.1, I'm shaky, have chills, headache, and a nosebleed several times. My fever continues to worsen, as does my body aches.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: I received my second dose last Thursday, September 30, 2021. That evening, my arm swelled up and was hot at the injection site. The swelling has gone half way down my arm and is burning hot the touch. Tomorrow will be day 4 since I've gotten the vaccine. My temperature has not been below 101.1, I'm shaky, have chills, headache, and a nosebleed several times. My fever continues to worsen, as does my body aches.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Heart rate increased, Pain in extremity, Peripheral swelling
Clinical narrative: Woke up to rapid heart beat (114 bpm), my normal resting heart rate is between 59-75 bpm.  Heart stayed elevated for an hour and continued to be higher than normal throughout the day.  Arm was excessively painful and hot, with minor swelling.  After 24 hours, a dose of ibuprofen was taken and relieved the pain, heart rate continued to be elevated but lingered around 90 bpm.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: My kidneys failed
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neck pain
Clinical narrative: Chronic neck muscle pain and daily recurring headaches.  Been over a month and still get them daily
Age: 81.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. Vaccine administered on 11 days after first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 29-Sep-2021 and contains no new information.; Sender's Comments: This is a case of expired product administered for this 81 year-old patient, unknown gender, with no medical history reported, with no associated adverse event reported at this time. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine  is not affected by this report.
Age: 15.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No additional adverse events were reported; Inappropriate route of vaccination; This spontaneous case report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On 28-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); lot # T001214 has been verified as valid and expiration date established as 12-JAN-2022 and varicella virus vaccine live (oka/merck)(VARIVAX); lot # T010309 has been verified as valid lot number and expiration date reported as established as 24-MAR-2022) (strengths, doses, vaccination schemes, anatomical location of administration were not reported) both for prophylaxis.     Nurse reported the patient was inadvertently administered Both vaccines intramuscularly instead of the approved route of administration; subcutaneously. No more information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Inappropriate route of vaccination; No additional adverse events were reported; This spontaneous case report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On 28-SEP-2021, the patient was vaccinated with single dose (unspecified) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD); lot # T015261 has been verified as valid and expiration date established as 31-OCT-2021 (strength, dose, vaccination scheme, anatomical location of administration were not reported) for prophylaxis.     Nurse reported the patient was inadvertently administered the vaccine intramuscularly instead of the approved route of administration; subcutaneously.  No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: tiredness; stomach; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   In September 2021, the patient received Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 2 weeks after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced tiredness and stomach discomfort. On an unknown date, the outcome of the tiredness and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the tiredness and stomach discomfort to be related to Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a shot of Shingles and Flu shot at the same time almost 2 weeks ago of reporting date, it was though not recommended. The patient experienced stomach discomfort and some tiredness and still felt some of the effects of them both. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Parosmia, Taste disorder
Clinical narrative: taste issue; smell issue; This case was reported by a consumer via interactive digital media and described the occurrence of taste disorder 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 taste disorder and parosmia. On an unknown date, the outcome of the taste disorder and parosmia were unknown.   It was unknown if the reporter considered the taste disorder and parosmia to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and believed that, it injured the patient as he/she could not stand the smell of many things or taste many foods he/she once loved. The case is linked with the case US2021AMR203502, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203502:same patient, different event
Sex: U
Vaccine: VARZOS
Symptoms: Formication, Paraesthesia
Clinical narrative: feel a bug crawling on me; This case was reported by a consumer via interactive digital media and described the occurrence of paresthesia 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 paresthesia. On an unknown date, the outcome of the paresthesia was unknown.   It was unknown if the reporter considered the paresthesia to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received one of the Shingles vaccine and felt like bug crawling on him/her. The patient said there was nothing.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives 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 hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and broke out in hives. The patient did not know if he/she could take the other one or not. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: breakout with shingles; This case was reported by a consumer via (Shingrix) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingrix vaccine and experienced Shingles. The patient enquired if a person could experience breakout with shingles after 1st dose or not. Follow-up would not be possible as no contact details available,.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose after a year of the first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date one and half years ago).   On 28th September 2021, the patient received the 2nd dose of Shingrix. On 28th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist reported that patient was administered second dose later than the recommended interval, which led to lengthening of vaccine schedule. The pharmacist reported that between first and second dose a year and half was passed. The health care professional did not know the date of administration of first dose. No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR LOSS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20211001154.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Wrong technique in product usage process
Clinical narrative: PUNCTURED VIAL DOSE ADMINISTERED; WRONG TECHNIQUE IN DRUG USAGE PROCESS; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced punctured vial dose administered. On 30-SEP-2021, the patient experienced wrong technique in drug usage process. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial dose administered and wrong technique in drug usage process was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fungal infection, Nasopharyngitis, Polymerase chain reaction
Clinical narrative: upper respiratory/sinus (non-covid) Cold; Yeast infection of all things on my face/genital area; upper respiratory/sinus (non-covid) Cold; on/off joint pain; This spontaneous case was reported by a patient and describes the occurrence of the second episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold), FUNGAL INFECTION (Yeast infection of all things on my face/genital area), the first episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) and ARTHRALGIA (on/off joint pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Jun-2020. Concomitant products included LANSOPRAZOLE and FAMOTIDINE (PEPCID [FAMOTIDINE]) for GERD, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced the first episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) and ARTHRALGIA (on/off joint pain). On 21-Jun-2021, the patient experienced FUNGAL INFECTION (Yeast infection of all things on my face/genital area). On 16-Sep-2021, the patient experienced the second episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold). In 2021, last episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) had resolved. At the time of the report, FUNGAL INFECTION (Yeast infection of all things on my face/genital area) and ARTHRALGIA (on/off joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Polymerase chain reaction: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-331767 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant Follow up-events added
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Patient Stated I have never tested positive. No concomitant medication were reported.  No treatment medication was reported. This case was linked to MOD-2021-276367 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant followup received contains dose 1 start date,anatomical location; Sender's Comments: This case concerns a 50years-old, female with no relevant medical history, who experienced the unexpected event of SARS-CoV-2 test positive. As per SD The event occurred  after being fully vaccinated with mRNA-1273 Moderna vaccine. (date of vaccination was not provided). The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses were administered from one expired vial; Administered improperly stored vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD21-128181, MOD21-128210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up includes No New Information. On 09-Aug-2021: Follow up includes No New Information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nasal discomfort, Rhinorrhoea, Tinnitus
Clinical narrative: Tinnitus; General malaise; Mend nebular nose; Runny nose; Feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 031L20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Upper respiratory disorder, Hypertension (amlodipine, losartan was used as concomitant) and Diabetes (Tresiba insulin). Concomitant products included INSULIN DEGLUDEC (TRESIBA) for Diabetes, AMLODIPINE and LOSARTAN for Hypertension, ADALIMUMAB (HUMIRA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LORAZEPAM (ATIVAN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable) outcome was unknown.            This case was linked to MOD-2021-324030 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Therapeutic response unexpected, Weight decreased
Clinical narrative: lost 3 pounds, she lost weight after her first dose; tates the vaccine helped the fatigue, she felt much better; worried.; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.). The patient was treated with LISINOPRIL for Blood pressure high, at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-325633 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Nonsignificant followup appended.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Influenza, Influenza like illness
Clinical narrative: nauseous/felt like throwing up; Overall felt like she had the flu; flu symptoms; weak/can't get up; couldn't sleep; sneezing a lot; tired; feeling so sick; breathing was affected not as easily as normal; very itchy on face; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up) and INFLUENZA LIKE ILLNESS (Overall felt like she had the flu) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity and Asthma. Concomitant products included CEFPODOXIME PROXETIL, CLAVULANATE POTASSIUM (FORENZA) for Allergy, MONTELUKAST for Asthma, IRBESARTAN for Blood pressure management, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Chronic sinusitis and Nasal polyps, BUDESONIDE for Nasal polyp and Chronic sinusitis, PRAVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and DENOSUMAB (PROLIA) for an unknown indication.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal) and PRURITUS (very itchy on face). On 22-Sep-2021, the patient experienced NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Stomach ache, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Stomach ache, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired) outcome was unknown.            This case was linked to MOD-2021-328121 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Poor quality sleep, Pruritus, Sneezing
Clinical narrative: nauseous/felt like throwing up; Overall felt like she had the flu; flu symptoms; weak/can't get up; couldn't sleep; sneezing a lot; tired; feeling so sick; breathing was affected not as easily as normal; very itchy on face; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up) and INFLUENZA LIKE ILLNESS (Overall felt like she had the flu) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity and Asthma. Concomitant products included CEFPODOXIME PROXETIL, CLAVULANATE POTASSIUM (FORENZA) for Allergy, MONTELUKAST for Asthma, IRBESARTAN for Blood pressure management, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Chronic sinusitis and Nasal polyps, BUDESONIDE for Nasal polyp and Chronic sinusitis, PRAVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and DENOSUMAB (PROLIA) for an unknown indication.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal) and PRURITUS (very itchy on face). On 22-Sep-2021, the patient experienced NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Stomach ache, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Stomach ache, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired) outcome was unknown.            This case was linked to MOD-2021-328121 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Menometrorrhagia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of MENOMETRORRHAGIA (she still had irregular bleeding. As of 18MAY2021 she started bleeding more heavily) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination. The patient's past medical history included Colonoscopy on 18-Jan-2021. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced MENOMETRORRHAGIA (she still had irregular bleeding. As of 18MAY2021 she started bleeding more heavily). At the time of the report, MENOMETRORRHAGIA (she still had irregular bleeding. As of 18MAY2021 she started bleeding more heavily) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. In May she did a biopsy which was benign, but her uterus was swollen. They can see that is probably where it (the bleeding) is coming from. She had to do a sonogram or xray for her uterus. Now it's (the bleeding) still getting worse. No concomitant medication information was provided. No treatment medication information was provided. This case was linked to MOD-2021-328691 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Sleep disorder, Vomiting
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of sleep disorder (wakes out of deep sleep), palpitations (pounding heart) and vomiting in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 091D21A) for COVID-19 immunization. The patient's past medical history included a tumor. Concurrent medical conditions included celiac disease. On Jul 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced sleep disorder (wakes out of deep sleep), palpitations (pounding heart) and vomiting. At the time of the report, sleep disorder (wakes out of deep sleep), palpitations (pounding heart) and vomiting outcome: unknown.  Concomitant medication and treatment information not provided. This case linked to MOD-2021-328145 (patient link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Loss of personal independence in daily activities, Mobility decreased, Nasopharyngitis
Clinical narrative: could barely walk 6 feet to her bathroom; flu like symptoms; everything in her body hurt; was cold; could barely walk 6 feet to her bathroom; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could barely walk 6 feet to her bathroom), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (everything in her body hurt), NASOPHARYNGITIS (was cold) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could barely walk 6 feet to her bathroom) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2020, the patient experienced FATIGUE (exhausted). On 26-Feb-2021, the patient experienced MOBILITY DECREASED (could barely walk 6 feet to her bathroom), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (everything in her body hurt), NASOPHARYNGITIS (was cold) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could barely walk 6 feet to her bathroom). On 28-Feb-2021, MOBILITY DECREASED (could barely walk 6 feet to her bathroom), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (everything in her body hurt), NASOPHARYNGITIS (was cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could barely walk 6 feet to her bathroom) and FATIGUE (exhausted) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: could barely walk 6 feet to her bathroom; flu like symptoms; everything in her body hurt; was cold; could barely walk 6 feet to her bathroom; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could barely walk 6 feet to her bathroom), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (everything in her body hurt), NASOPHARYNGITIS (was cold) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could barely walk 6 feet to her bathroom) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2020, the patient experienced FATIGUE (exhausted). On 26-Feb-2021, the patient experienced MOBILITY DECREASED (could barely walk 6 feet to her bathroom), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (everything in her body hurt), NASOPHARYNGITIS (was cold) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could barely walk 6 feet to her bathroom). On 28-Feb-2021, MOBILITY DECREASED (could barely walk 6 feet to her bathroom), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (everything in her body hurt), NASOPHARYNGITIS (was cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could barely walk 6 feet to her bathroom) and FATIGUE (exhausted) had resolved.            No concomitant medications were reported. No treatment medications were reported.