chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Yawning
Clinical narrative: MICROVASCULAR CORONARY ARTERY DISEASE; LEG CRAMPS; GUT PAIN; LOWER BACK PAIN; CLOTTING PROBLEMS; REPETITIVE YAWNING; BOTH CALVES AFFECTED FOR LEG PAIN; HEADACHE; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes mellitus, hypothyroid, autoimmune condition, and inflammatory disease. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 54 years old. No concomitant medications were reported.  On an unspecified date, about 3 months patient started experiencing chest pain when walking (dose number in series 1). After 6 months the chest pain presented intermittently. Patient was diagnosed with microvascular CAD (microvascular coronary artery disease) and prescribed with Imdur and Hydrochloroquine (dose number in series 1). Patient stated that her both calves were affected for the leg pain (dose number in series 1). Symptoms were most prevalent when she was exerting herself. She also displayed repetitive yawning (dose number in series 1). On an unspecified date, the patient experienced leg cramps, gut pain, lower back pain, clotting problems, and headache (dose number in series 1). The patient received additional non company suspect Moderna vaccine (dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on an unspecified date for prophylactic vaccination.  It was unknown if patient experienced any adverse reactions following administration of Moderna vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the both calves affected for leg pain, headache, leg cramps, gut pain, lower back pain, microvascular coronary artery disease, clotting problems and repetitive yawning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220517380-covid-19 vaccine ad26.cov2.s-Microvascular coronary artery disease. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 64 year old female . Initial information was processed along with the additional information received on 10-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, pollen allergy, dust allergy, and peanuts allergy, and other pre-existing medical conditions included: patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802072, expiry: unknown) dose was not reported, 1 total administered on 11-MAR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 63 years old. Concomitant medications included Citracal (calcium citrate), and Claritin (loratadine).  On 20-APR-2022, patient took ritonavir (Paxlovid) dose and was feeling better. On 28-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 29-APR-2022 at 12:00, the patient reported symptoms return (covid relapse) coded to suspected clinical vaccination failure and suspected covid-19. On 30-APR-2022, patient performed two different COVID-19 antigen test which resulted positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000230236; Sender's Comments: V0: 20220517486-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Malaise
Clinical narrative: FELT SICK; VERY TIRED; ADVERSE EVENT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. Patient was not having any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-MAY-2022, the patient experienced adverse event. On an unspecified date, the patient experienced felt sick, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from adverse event on 09-MAY-2022, and the outcome of very tired and felt sick was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via Pfizer concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: unspecified allergy, and concurrent conditions included: depression, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: Unknown) dose was not reported, 1 total administered to right arm on 15-MAR-2021 for prophylactic vaccination. Age at time of vaccination 49 years old. The patient received additional mon-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, and were not reported batch number: 071F21A expiry: Unknown (dose 1), batch number: 048L21A expiry: Unknown(dose 2)) dose was not reported, administered on 29-OCT-2021 (dose 1), and dose was not reported, administered on 02-APR-2022 11:00 (dose 2) both doses to right arm for prophylactic vaccination. Age at time of vaccination 49 years old. Concomitant medications included Niva (ethinylestradiol/norethisterone) (1-5 MG-MCG).  On 19-APR-2022, the patient experienced symptoms (suspected covid-19 infection) (dose number in series 2) which led to suspected clinical vaccination failure (Dose number in series 1). On 24-APR-2022, (on day 5 after symptoms started) she started treatment with Paxolovid (ritonavir). The patient stated that it was very helpful to her, felt better every day after treatment. On 03-MAY-2022 she was feeling totally well (Dose number in series 2). On 04-MAY-2022 (At 05:30) she woke up feeling congested and having drainage in her sinuses and feeling under the weather (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220518282-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported and expiry: unknown) 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. The batch number was not reported. Per Procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed or not. The reporter stated that, "Unfortunately, my cousin took your Covid vaccine and died right after". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220520946-covid-19 vaccine ad26.cov2.s - died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Feeling abnormal, Gastrooesophageal reflux disease, Heart rate
Clinical narrative: RED BUMPS ON ARMS, LEGS AND CHEST; ITCHY ARMS, LEGS AND CHEST; ACID REFLUX; SKIN TINGLING; CONFIRMED COVID-19 INFECTION; ELEVATED HEART RATE, INTERMITTENT; LIGHT HEADED; FOGGY; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (1 per week, infrequent), and non smoker, and other pre-existing medical conditions included: The patient did not have known drug allergies. The patient did not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: UNKNOWN) dose was not reported, administered on 05-JAN-2022 for prophylactic vaccination. Age at time of vaccination 56 years old. No concomitant medications were reported. On 06-JAN-2022, the patient experienced confirmed covid-19 infection, elevated heart rate, intermittent, light headed, and foggy. Laboratory data included: Heart rate (NR: not provided) Elevated (Elevated heart rate, intermittent). On 08-JAN-2022, the patient experienced skin tingling. On 10-JAN-2022, the patient experienced acid reflux, and itchy arms, legs and chest. On 24-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the patient experienced red bumps on arms, legs and chest. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, was recovering from foggy, light headed, and elevated heart rate, intermittent, and had not recovered from red bumps on arms, legs and chest, itchy arms, legs and chest, acid reflux, and skin tingling. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Paraesthesia, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: RED BUMPS ON ARMS, LEGS AND CHEST; ITCHY ARMS, LEGS AND CHEST; ACID REFLUX; SKIN TINGLING; CONFIRMED COVID-19 INFECTION; ELEVATED HEART RATE, INTERMITTENT; LIGHT HEADED; FOGGY; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (1 per week, infrequent), and non smoker, and other pre-existing medical conditions included: The patient did not have known drug allergies. The patient did not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: UNKNOWN) dose was not reported, administered on 05-JAN-2022 for prophylactic vaccination. Age at time of vaccination 56 years old. No concomitant medications were reported. On 06-JAN-2022, the patient experienced confirmed covid-19 infection, elevated heart rate, intermittent, light headed, and foggy. Laboratory data included: Heart rate (NR: not provided) Elevated (Elevated heart rate, intermittent). On 08-JAN-2022, the patient experienced skin tingling. On 10-JAN-2022, the patient experienced acid reflux, and itchy arms, legs and chest. On 24-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the patient experienced red bumps on arms, legs and chest. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, was recovering from foggy, light headed, and elevated heart rate, intermittent, and had not recovered from red bumps on arms, legs and chest, itchy arms, legs and chest, acid reflux, and skin tingling. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Malaise, Movement disorder
Clinical narrative: VERY LONG, CANNOT MOVE THE BODY; SWEATING LIKE CAME OUT OF A POOL; SUDDENLY STARTED FEELING VERY ILL; NUMBNESS OF BOTH LEGS AND BOTH HANDS; This spontaneous report received from a patient concerned a white male of an unspecified age and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 041A21A, expiry: unknown) dose was not reported, 1 total administered to left arm on 11-APR-2021 for prophylactic vaccination. On 11-APR-2021, 3 to 4 minutes following vaccination with covid-19 vaccine ad26.cov2.s, the patient suddenly started feeling very ill, sweating like came out of a pool, very long, could not move body and numbness of both legs and both hands for 8 weeks (2 months) (Dose number in series 1). The patient recovered from numbness of both legs and both hands on JUN-2021, and was recovering from very long, could not move the body, sweating like came out of a pool, and suddenly started feeling very ill. The patient received booster of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 12-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamin b12 nos for nerve regeneration.  On 12-JAN-2022, 3 to 4 minutes following vaccination with covid-19 vaccine ad26.cov2.s, the patient suddenly started feeling very ill, experienced sweating like came out of a pool, very long, cannot move the body and numbness of both legs and both hands for 8 weeks (2 months) (Dose number in series 2). The patient reports that he had the same reactions with both the shots. The physician is aware of the adverse events that the patient experienced and advised to not to get anymore vaccine nor booster. The patient felt much better currently. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of both legs and both hands on MAR-2022, and was recovering from very long, cannot move the body, sweating like came out of a pool, and suddenly started feeling very ill. This report was non-serious. This case, involving the same patient is linked to 20220518225 (Dose number in series 1).
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN IN LEFT ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injection site pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain in left arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Crying
Clinical narrative: Was in bed all day crying for mama; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Was in bed all day crying for mama) 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 CRYING (Was in bed all day crying for mama). At the time of the report, CRYING (Was in bed all day crying for mama) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-317755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Upon internal review on 12-May-2022, significant correction was performed. The country of incidence was updated from unknown to, recoded the suspect product, events updated, added reporter details and updated the narrative.
Sex: F
Vaccine: COVID19
Symptoms: Crying
Clinical narrative: Patient was crying; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Patient was crying) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRYING (Patient was crying). At the time of the report, CRYING (Patient was crying) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not reported.  Treatment information was not provided.  The reporter stated that mother had side effects a month later but was not aware for whom she was crying for.   This case was linked to MOD-2021-317744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Upon internal review on 12-May-2022, significant correction was performed. The country of incidence was updated from unknown to the, suspect product was recoded, added reporter details and narrative was updated accordingly.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 2nd  booster.  Site of injection has swollen hard lump that is red and  noticeably warm to the touch. Slightly itchy. Started small this morning (12 hours after shot) and continuing to grow at 24 hours after. This was my first Moderna shot. First 3  (initial 2 and first booster) were Pfizer and I did not have this reaction.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Urinary tract infection
Clinical narrative: urinary tract infection; body is sore / his body was sore; had a fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection), MYALGIA (body is sore / his body was sore) and PYREXIA (had a fever) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient had no medications, food and other products allergies. The patient never had COVID. The patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection), MYALGIA (body is sore / his body was sore) and PYREXIA (had a fever). At the time of the report, URINARY TRACT INFECTION (urinary tract infection), MYALGIA (body is sore / his body was sore) and PYREXIA (had a fever) was resolving.            No information on concomitant medication was reported.  It was reported that the patient had all shots and was due for a booster. The patient went to the urgent care and they treated him for urinary tract infection. The event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The symptoms were improving.  No information on treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow-up information received included reporter's details, patient's demographic details (gender and height), events and event related information added.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis) outcome was unknown.            No concomitant medications were reported. It was reported that when the patient got her 3rd Moderna Covid-19 vaccine dose, a week after she experienced: chest pain, left side chest pain, back pain, severe heart pain, and she was not able to lie down. She went to ER and they run studies and was diagnosed with Pericarditis. She contacted her cardiologist but he said that he did not had guidance on how to proceed with her vaccination.  No treatment information was provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the expected serious (medically significant) AESI of Pericarditis which occurred approximately 1 week after administration of third dose of mRNA-1273. Patient experienced left chest pain, back pain, she was not able to lie down, she went to emergency where she was diagnosed with pericarditis after investigations. Details of primary doses of vaccination, medical history, concomitant medications, clinical course, treatment, and investigations were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the expected serious (medically significant) AESI of Pericarditis which occurred approximately 1 week after administration of third dose of mRNA-1273. Patient experienced left chest pain, back pain, she was not able to lie down, she went to emergency where she was diagnosed with pericarditis after investigations. Details of primary doses of vaccination, medical history, concomitant medications, clinical course, treatment, and investigations were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine was given to a patient after 31 days; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine was given to a patient after 31 days) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was given to a patient after 31 days). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine was given to a patient after 31 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: After the second booster more episode and more violent episodes of genital herpes; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (After the second booster more episode and more violent episodes of genital herpes) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 018F21A, 011A21A and 030M20A) for COVID-19 vaccination.     It was reported that patient has never been diagnosed or tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Influvac-Tetra2022 (Influvac-Tetra2022) on 21-Mar-2022 and Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot and Influvac-Tetra2022. Concurrent medical conditions included Genital herpes since 2017.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GENITAL HERPES (After the second booster more episode and more violent episodes of genital herpes). At the time of the report, GENITAL HERPES (After the last booster more episode and more violent episodes of genital herpes) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-563448 (Patient Link).
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 yr. received Moderna dose 1 and 2; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr. received Moderna dose 1 and 2) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr. received Moderna dose 1 and 2). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr. received Moderna dose 1 and 2) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Reporter queried that if a 16 years old patient received Moderna dose 1 and 2, properly spaced and then received a booster at 17 years of age, does this individual need to repeat any of the doses.   This case was linked to MOD-2022-563490 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Live follow-up document received: Reporter's contact number was reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: headache after first booster dose that resolved in a day; fever after first booster dose that resolved in a day; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after first booster dose that resolved in a day) and PYREXIA (fever after first booster dose that resolved in a day) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had a positive SARS-CoV 2 antibody test after his second dose in the primary series of the Moderna Covid-19 vaccine.).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced HEADACHE (headache after first booster dose that resolved in a day) and PYREXIA (fever after first booster dose that resolved in a day). At the time of the report, HEADACHE (headache after first booster dose that resolved in a day) and PYREXIA (fever after first booster dose that resolved in a day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative.         No concomitant medications were reported. Patient had a headache and a fever that resolved in a day. No treatment medications were reported.   This case was linked to MOD-2021-040897, MOD-2022-563509 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received full 0.5mL 4th dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received full 0.5mL 4th dose) 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 09-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2022, the patient experienced ACCIDENTAL OVERDOSE (Received full 0.5mL 4th dose). At the time of the report, ACCIDENTAL OVERDOSE (Received full 0.5mL 4th dose) outcome was unknown.            No concomitant medications were reported. Patient received 4th 0.5mL full dose in March 2022. Patient had no side effects after any vaccine dose. He was not a high risk patient. No treatment medication were provided.   This case was linked to MOD-2021-428648, MOD-2021-428659, MOD-2021-428660 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pain, SARS-CoV-2 test
Clinical narrative: cold; pain; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (pain), CHILLS (chills) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 032M20A) for COVID-19 vaccination.     Patient didn't have allergies but was very sensitive in general.  The patient's past medical history included Mitral valve replacement and Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disease, unspecified since 2008. Concomitant products included APIXABAN (ELIQUIS) for Prophylaxis, FUROSEMIDE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), PAIN (pain), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), PAIN (pain), CHILLS (chills) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         It was reported that patient was always had adverse reactions, but not as longer as this time.  The patient was recovered form events a couple of days after first 3 doses.   This case was linked to MOD-2022-563534 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hiccups, Insomnia
Clinical narrative: Hiccups; couldn't sleep all night; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (Hiccups) and INSOMNIA (couldn't sleep all night) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 007B21A and 032M20A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER (IM left deltoid) on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER. Concurrent medical conditions included Depression (started after father died Condition: No change reported) since 2001 and Migraine (condition: No change reported) since 2012. Concomitant products included SUMATRIPTAN, LEVOTHYROXINE, TOPIRAMATE (TOPAMAX), PROPRANOLOL, VENLAFAXINE, BACLOFEN, CLONAZEPAM (KLONOPIN), MELOXICAM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), IRON, MAGNESIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 09-May-2022, the patient experienced HICCUPS (Hiccups) and INSOMNIA (couldn't sleep all night). At the time of the report, HICCUPS (Hiccups) had not resolved and INSOMNIA (couldn't sleep all night) outcome was unknown.            The concomitant medications reported as Women's Multi-Vitamin.  The patient started experiencing hiccups with the "same pattern". The patient for treatment she tried a spoonful of peanut butter, but it didn't help. The patient also reported that she drank carbonated cherry water very fast, and the hiccups went away for about one hour and then returned. The patient couldn't sleep all night because of the ongoing hiccups.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Gait disturbance, SARS-CoV-2 test, Tremor
Clinical narrative: he was really weak; could hardly walk; very shaky; afraid that he may fall, but he did not; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (he was really weak), GAIT DISTURBANCE (could hardly walk), TREMOR (very shaky) and FEELING ABNORMAL (afraid that he may fall, but he did not) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 027H21B, 045A21A and 012M20A) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Autoimmune disorder (Start Date: 4 years ago, (unknown but related to arthritis), Stable, no relapses in last 4 years), Congestive heart failure (Stable) and Prostate cancer. Concomitant products included FUROSEMIDE for Congestive heart failure, OMEPRAZOLE, TAMSULOSIN, CARVEDILOL, ATORVASTATIN, ENALAPRIL and SERTRALINE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2022, the patient experienced ASTHENIA (he was really weak), GAIT DISTURBANCE (could hardly walk), TREMOR (very shaky) and FEELING ABNORMAL (afraid that he may fall, but he did not). On 10-May-2022, ASTHENIA (he was really weak), GAIT DISTURBANCE (could hardly walk), TREMOR (very shaky) and FEELING ABNORMAL (afraid that he may fall, but he did not) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive in late NOV- early DEC2021.   Concomitant drug included injection for prostate cancer.  The 2nd day, after receiving the 2nd booster dose patient was still weak, but his symptoms were improving. By the 3rd day, patient was much better, and his symptoms had resolved.  AE did not cause patient to seek medical care, patient rested all day.  No treatment medication was reported by the reporter.   This case was linked to MOD-2022-564299 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: having persistent rashes on his chest; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (having persistent rashes on his chest) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (having persistent rashes on his chest). At the time of the report, RASH (having persistent rashes on his chest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has received his second booster dose of the Moderna Covid-19 vaccine. No concomitant medication was reported. Treatment information include patient talked to his HCP who recommended allergy medications and topical steroids and topical creams which have provided temporary relief.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm; It itched and itched and itched; Showed up on her left arm, like a big rectangle of red; It hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm), VACCINATION SITE PRURITUS (It itched and itched and itched), VACCINATION SITE ERYTHEMA (Showed up on her left arm, like a big rectangle of red) and VACCINATION SITE PAIN (It hurts) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 026D21A, 002C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-Jan-2021. Concurrent medical conditions included Allergy to animal (Horses), Allergic to dogs (Dogs), Grass allergy and Allergy to animal (Cat).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2022, the patient experienced VACCINATION SITE DISCOLOURATION (It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm), VACCINATION SITE PRURITUS (It itched and itched and itched), VACCINATION SITE ERYTHEMA (Showed up on her left arm, like a big rectangle of red) and VACCINATION SITE PAIN (It hurts). On 09-May-2022, VACCINATION SITE DISCOLOURATION (It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (It itched and itched and itched) and VACCINATION SITE PAIN (It hurts) was resolving and VACCINATION SITE ERYTHEMA (Showed up on her left arm, like a big rectangle of red) had not resolved.            No concomitant medication was reported. It was reported that the patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine. No treatment medications was reported.   This case was linked to MOD-2022-564453 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose 37 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 37 days after first dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-Jan-2021. Concurrent medical conditions included Allergy to animals (Allergy to horses), Allergy to animals (Allergy to cats), Allergy to animals (Allergy to dogs) and Grass allergy.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 37 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 37 days after first dose) outcome was unknown.            No concomitant product was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2022-564413 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatological examination, Therapeutic response unexpected
Clinical narrative: Improvements in Rheumatory Arthritis after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvements in Rheumatory Arthritis after the first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for RA: Methotrexate (The patient stopped Methotrexate in 2018 because she had cancer) in 2018 and Leflunomide (The patient stopped Leflunomide prior to vaccination) until August 2020. Past adverse reactions to the above products included Cancer with Methotrexate; and No adverse event with Leflunomide. Concurrent medical conditions included Rheumatoid arthritis (The patient was diagnosed with RA in 2014) since 2014 and Cancer.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvements in Rheumatory Arthritis after the first dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Improvements in Rheumatory Arthritis after the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Rheumatological examination: zero positive ra (normal) zero positive RA. The IL6 driven autoimmune disease improve after Moderna COVID-19 vaccine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. Patient stated that COVID-19 vaccine caused a Leukotriene storm. The IL6 driven autoimmune disease improve after Moderna COVID-19 vaccine. Patient stated that after vaccination all positive rheumatoid arthritis numbers went down. All rheumatoid arthritis manifestations went away. Lab test Predictors of rheumatoid arthritis were completely gone. The patient had minimal arthritis symptoms from time to time and it goes away without using any medications. No information on treatment medications was reported.   This case was linked to MOD-2022-564648, MOD-2022-564658, MOD-2022-564650 (Patient Link).