chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's husband had a terrible case of shingles, still had pain 21 months later). Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm 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 got the first shingle shot with no side effects except a sore arm. For tolerance of second dose refer case, US2021AMR226595, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226595:Same reporter US-GLAXOSMITHKLINE-US2021AMR226600:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Vaccinated. Still got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and still got shingles. The patient stated that got vaccine 16 percent chances you could still get the shingles and he/she got shingles just his/her kick. Follow-up would not be performed as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure/I got the shot and later had the shingles; Shingles; Still have a lot of nerve pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and later had shingles; the patient still had a lot of nerve pain. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter denied to provide patient's demographics. There were no additional information to provide. The information regarding consented to follow up was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Took her down; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided are as follows: The case was reported for reporter's husband aunt. The age at vaccination was not reported. The reporter stated that the patient said that the Shingrix vaccine took her down. The reporter could not clarified what the statement meant. The reporter had limited information. The reporter did not consent to follow-up. The case has been linked with case US2021225705 and US2021225710, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021225705:same reporter US-GLAXOSMITHKLINE-US2021225710:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, has not received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date about 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. The reporter did not know the specific date of the 1st dose of Shingrix. No vaccine data was provided. This case was linked with US2021227430, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227430:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, has not received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consented to follow up. No vaccine data was provided. This case was linked with US2021227428, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227428:Same reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Application site pain, Euphoric mood
Clinical narrative: FELT EUPHORIC LIKE I WAS ON A HIGH I WAS VERY HAPPY; SLIGHT TENDERNESS ON THE VACCINATION SITE (ARM); This spontaneous report received from a patient concerned a 78 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced felt euphoric like I was on a high I was very happy. On 03-APR-2021, the patient experienced slight tenderness on the vaccination site (arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt euphoric like i was on a high i was very happy, and was recovering from slight tenderness on the vaccination site (arm). This report was non-serious.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT ISCHAEMIC ATTACK; This spontaneous report received from a consumer concerned a 99 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: transient ischemic attacks (TIA's) but it was less often, it was perhaps once a year and concurrent conditions included: cancer that has metastasized, has 24 hours around the clock care and frail. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on MAR-2021 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. It was reported that, the patient had TIA's occurred in JUN-2021, AUG-2021, SEP-2021 and NOV-2021. She was uncertain if it could be related to the vaccine since she was 99 turning 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of transient ischaemic attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211116517-Covid-19 vaccine ad26.cov2.s- Transient ischemic attack. This event(s) is considered not related. 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Insomnia
Clinical narrative: BODY ACHES; CHILLS; SPLITTING HEADACHE; TEMP 101.5; FEEL LIKE ABSOLUTE CRUD; COULDN'T SLEEP; This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 05-NOV-2021, the patient experienced couldn't sleep. On 06-NOV-2021, the patient experienced feel like absolute crud. On an unspecified date, the patient experienced body aches, chills, splitting headache, and temp 101.5. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Temp 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp 101.5, splitting headache, chills, body aches, couldn't sleep and feel like absolute crud was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; SPLITTING HEADACHE; TEMP 101.5; FEEL LIKE ABSOLUTE CRUD; COULDN'T SLEEP; This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 05-NOV-2021, the patient experienced couldn't sleep. On 06-NOV-2021, the patient experienced feel like absolute crud. On an unspecified date, the patient experienced body aches, chills, splitting headache, and temp 101.5. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Temp 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp 101.5, splitting headache, chills, body aches, couldn't sleep and feel like absolute crud was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: THROBBING/DEEPER PAIN IN HIP JOINT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker. The patient experienced drug allergy when treated with methyldopa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-NOV-2021, the patient experienced throbbing/deeper pain in hip joint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing/deeper pain in hip joint. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: COVID -19/Breakthrough infections; COVID -19/Breakthrough infections; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (COVID -19/Breakthrough infections) and COVID-19 (COVID -19/Breakthrough infections) 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 VACCINE BREAKTHROUGH INFECTION (COVID -19/Breakthrough infections) and COVID-19 (COVID -19/Breakthrough infections). At the time of the report, VACCINE BREAKTHROUGH INFECTION (COVID -19/Breakthrough infections) and COVID-19 (COVID -19/Breakthrough infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided.  Company Comment: This case concerns a patient  of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event s of COVID-19 and Vaccine breakthrough infection. The event occurred an unknown number of days after being fully vaccinated with unspecified dosing schedule for mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from event of COVID-19 based on review of available information in the source document that does not support seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient  of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event s of COVID-19 and Vaccine breakthrough infection. The event occurred an unknown number of days after being fully vaccinated with unspecified dosing schedule for mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from event of COVID-19 based on review of available information in the source document that does not support seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Muscle spasms
Clinical narrative: Paralysis of Face; Leg Muscle Spasm; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Paralysis of Face) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced FACIAL PARALYSIS (Paralysis of Face) (seriousness criterion medically significant) and MUSCLE SPASMS (Leg Muscle Spasm). At the time of the report, FACIAL PARALYSIS (Paralysis of Face) and MUSCLE SPASMS (Leg Muscle Spasm) outcome was unknown.      Concomitant medication was not provided.  Treatment information was not provided.  Company Comment: This case concerns a 30-year-old male patient with no relevant medical history, who experienced the expected event of Facial Paralysis. The event Facial Paralysis occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the second dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 30-year-old male patient with no relevant medical history, who experienced the expected event of Facial Paralysis. The event Facial Paralysis occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the second dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Groin pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: chills; fever of 100.3; aches in his groin area and on both sides of his legs; soreness in his arm; aches in his groin area and on both sides of his legs; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever of 100.3), GROIN PAIN (aches in his groin area and on both sides of his legs), VACCINATION SITE PAIN (soreness in his arm) and PAIN IN EXTREMITY (aches in his groin area and on both sides of his legs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 041L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 100.3), GROIN PAIN (aches in his groin area and on both sides of his legs), VACCINATION SITE PAIN (soreness in his arm) and PAIN IN EXTREMITY (aches in his groin area and on both sides of his legs). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever of 100.3), GROIN PAIN (aches in his groin area and on both sides of his legs), VACCINATION SITE PAIN (soreness in his arm) and PAIN IN EXTREMITY (aches in his groin area and on both sides of his legs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided. It was reported that the patient took 2 Excedrin this morning, and 2 this afternoon.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: Nauseous; Tired; Fever was between 103-105/Fever was at a low 100 for 48 hours/Extreme high temperature; 106 fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (106 fever), NAUSEA (Nauseous), FATIGUE (Tired) and PYREXIA (Fever was between 103-105/Fever was at a low 100 for 48 hours/Extreme high temperature) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERPYREXIA (106 fever). On 26-Mar-2021, the patient experienced NAUSEA (Nauseous) and FATIGUE (Tired). 26-Mar-2021, the patient experienced PYREXIA (Fever was between 103-105/Fever was at a low 100 for 48 hours/Extreme high temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 Tylenol. On 28-Mar-2021, PYREXIA (Fever was between 103-105/Fever was at a low 100 for 48 hours/Extreme high temperature) had resolved. At the time of the report, HYPERPYREXIA (106 fever), NAUSEA (Nauseous) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 106 (High) 106 fever., 103-105 (High) Fever was between 103-105. and high (High) Fever was at a low 100 for 48 hours..         Patient stated that his fever was at a low 100 for 48 hours. Patient was taking other medications which were not reported. Oncologist was aware of the side effects.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Was given 2.5ml of vaccine rather than the prescribed 0.25 ml of Moderna booster vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Was given 2.5ml of vaccine rather than the prescribed 0.25 ml of Moderna booster vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 milliliter. On 01-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Was given 2.5ml of vaccine rather than the prescribed 0.25 ml of Moderna booster vaccine). On 01-Nov-2021, ACCIDENTAL OVERDOSE (Was given 2.5ml of vaccine rather than the prescribed 0.25 ml of Moderna booster vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-370033, MOD-2021-370217, MOD-2021-370033 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Myalgia, Pruritus
Clinical narrative: gastro symptoms like the first time; entire body started itching; ache-y; typical symptoms of fatigue/ tiredness; headache/ little bit dulled headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (gastro symptoms like the first time), PRURITUS (entire body started itching), MYALGIA (ache-y), FATIGUE (typical symptoms of fatigue/ tiredness) and HEADACHE (headache/ little bit dulled headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CANDESARTAN CILEXETIL (ATACAND) for an unknown indication.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (gastro symptoms like the first time), MYALGIA (ache-y), FATIGUE (typical symptoms of fatigue/ tiredness) and HEADACHE (headache/ little bit dulled headache). 31-Oct-2021, the patient experienced PRURITUS (entire body started itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 2 Benadryl. At the time of the report, ABDOMINAL PAIN UPPER (gastro symptoms like the first time), MYALGIA (ache-y), FATIGUE (typical symptoms of fatigue/ tiredness) and HEADACHE (headache/ little bit dulled headache) outcome was unknown and PRURITUS (entire body started itching) had resolved.            Reporter stated she took 2 Benadryl but had a paradoxical reaction that kept her up instead. No medical history was reported.   This case was linked to MOD-2021-370458 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Feeding disorder, Feeling abnormal
Clinical narrative: Didn't eat much; Slept all day; Severe chills; Running a high fever; Headache; Muscle were sore/Achy; Felt weak and Trouble getting up/Felt pretty tough; Couldn't get out of bed by himself and Trouble getting up; Sweaty during the night; Seemed a little confused; Generally felt bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused) and FEELING ABNORMAL (Generally felt bad) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 739904 and 739904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.   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 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy). On 30-Oct-2021, the patient experienced FEEDING DISORDER (Didn't eat much) and SOMNOLENCE (Slept all day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), FEEDING DISORDER (Didn't eat much), SOMNOLENCE (Slept all day), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy) had resolved.            No Concomitant medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Myalgia, Night sweats, Pyrexia
Clinical narrative: Didn't eat much; Slept all day; Severe chills; Running a high fever; Headache; Muscle were sore/Achy; Felt weak and Trouble getting up/Felt pretty tough; Couldn't get out of bed by himself and Trouble getting up; Sweaty during the night; Seemed a little confused; Generally felt bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused) and FEELING ABNORMAL (Generally felt bad) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 739904 and 739904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.   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 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy). On 30-Oct-2021, the patient experienced FEEDING DISORDER (Didn't eat much) and SOMNOLENCE (Slept all day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), FEEDING DISORDER (Didn't eat much), SOMNOLENCE (Slept all day), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy) had resolved.            No Concomitant medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Didn't eat much; Slept all day; Severe chills; Running a high fever; Headache; Muscle were sore/Achy; Felt weak and Trouble getting up/Felt pretty tough; Couldn't get out of bed by himself and Trouble getting up; Sweaty during the night; Seemed a little confused; Generally felt bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused) and FEELING ABNORMAL (Generally felt bad) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 739904 and 739904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.   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 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy). On 30-Oct-2021, the patient experienced FEEDING DISORDER (Didn't eat much) and SOMNOLENCE (Slept all day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), FEEDING DISORDER (Didn't eat much), SOMNOLENCE (Slept all day), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy) had resolved.            No Concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered the vaccine from a vial that experienced excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that experienced excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that experienced excursion). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that experienced excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Hypopnoea, Sleep disorder, Wheezing
Clinical narrative: Chronic cough; Tiny asthma attacks; Shallower breath; When I lay down, there's some wheezing; Couldn't sleep through the night/the coughing kept me up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Chronic cough), ASTHMA (Tiny asthma attacks), HYPOPNOEA (Shallower breath), WHEEZING (When I lay down, there's some wheezing) and SLEEP DISORDER (Couldn't sleep through the night/the coughing kept me up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced COUGH (Chronic cough), ASTHMA (Tiny asthma attacks), HYPOPNOEA (Shallower breath), WHEEZING (When I lay down, there's some wheezing) and SLEEP DISORDER (Couldn't sleep through the night/the coughing kept me up). At the time of the report, COUGH (Chronic cough), ASTHMA (Tiny asthma attacks), HYPOPNOEA (Shallower breath), WHEEZING (When I lay down, there's some wheezing) and SLEEP DISORDER (Couldn't sleep through the night/the coughing kept me up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Inhaler and cough drops and drinking water were reported as treatment.  Concomitant medications were included Inhaler.  Patient were received the Johnson & Johnson COVID-19 Vaccine on 31-Mar-2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Body ache; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 024M20A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, CARVEDILOL, LISINOPRIL, SIMVASTATIN (ZOCOR), CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-371024 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, METFORMIN, PIOGLITAZONE, FENOFIBRATE, LEVOTHYROXINE, ROSUVASTATIN and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site haemorrhage, Product administered at inappropriate site
Clinical narrative: injection site too low (injection site measures 3.5? from shoulder acromion process instead of medical guidelines 2?) on low deltoid and punctured vein  with immediate excess bleeding at vaccine site with resultant 3cm horizontal x3.5cm vertical Bruise Left upper Arm - and especially with concerns  whether the  mMRA-1273 administration was intravenously instead of intramuscular especially w concerns whether the  mMRA-1273 administration was intravenously instead of intramuscular especially with recent research articles highlighting potential harm of inadvertent IV mRNA vaccines causing myocarditis, pericarditis or being rendered less effective or ineffective as would be vulnerable to being inactivated intravascularly
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lymphadenopathy, Menstrual disorder
Clinical narrative: headache, dizziness, severe fatigue, nausea, severely swollen lymph node above left clavicle--painful, onset of menstration after menopause for over a year.  Similar swollen lymph node that took over 6 weeks after second dose to go away
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: headache, dizziness, severe fatigue, nausea, severely swollen lymph node above left clavicle--painful, onset of menstration after menopause for over a year.  Similar swollen lymph node that took over 6 weeks after second dose to go away
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Mobility decreased, Pain in extremity
Clinical narrative: Within 10 minutes of vaccine admission, arm had severe pain and stiffness. Stiffness and pain increased over the next hour to the point of limiting all movement and usage of entire arm from fingers to shoulder. Within 24 hours of vaccination, joints throughout body ached mildly and experienced mild stiffness. These symptoms have fluctuated in severity since date of vaccination, but have not subsided 100%. Small joints of hands & feet are stiff and painful 24/7. Other joints are stiff/painful daily but not constantly. No swelling or redness noticed at the joints.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle disorder, Myalgia
Clinical narrative: Muscle and Joint pain about 24 hours after injection. Especially wrists and knees. Subsided after 6-7 hours but knees remained painful for days. Then a series of events over the last months since vaccine of muscle issues in my left leg and ongoing issues with my knees. I've been doing chiropractic, accupuncture, cryotherapy and massage. started a natural joint supplement and cbd to manage pain. This is all stuff that I've NEVER experienced and then heard another person had very similar issues since vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulation time, Contusion, Full blood count, Liver function test normal, Lymphadenopathy
Clinical narrative: multiple episodes (10+) of atraumatic bruising , lasting 4-5 weeks, began a few days after vaccination. Intermittent itching behind the knees with petechiae, lasting approx 4 weeks, began a few days after vaccination. Axillary lymphadenopathy lasting 1 week immediately following vaccination.  No treatment was required. symptoms resolved on their own after time period described above.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Petechiae, Prothrombin level, Prothrombin time, Pruritus
Clinical narrative: multiple episodes (10+) of atraumatic bruising , lasting 4-5 weeks, began a few days after vaccination. Intermittent itching behind the knees with petechiae, lasting approx 4 weeks, began a few days after vaccination. Axillary lymphadenopathy lasting 1 week immediately following vaccination.  No treatment was required. symptoms resolved on their own after time period described above.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Vertigo two weeks after receiving vaccine Tinnitus  four weeks after receiving vaccine
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Rash vesicular, Skin lesion, Varicella virus test positive
Clinical narrative: Note - patient was vaccinated for chickenpox in childhood with attenuated live vaccine and never infected with chickenpox previously.  On Oct 29, 2021, patient received Moderna COVID booster vaccine. On Oct 30, 2021, patient began experiencing neuropathic pain in R gluteus. On Oct 31, 2021, blistering rash appeared on patient's R gluteal dermatome, and several lesions appears on patient's torso, scalp, and face, accompanied by pain. Lesions continued to appear on patient's torso and extremities (arms, legs) over the next several days (>20 lesions on various, non-gluteal sites). Patient began taking oral valacyclovir treatment on Nov 2, 2021 and was instructed to quarantine beginning on those dates. On Nov 4, 2021, VZV PCR testing on facial and gluteal lesion was positive for VZV, confirming disseminated zoster. As of reporting date (Nov 9, 2021), patient has not recovered