chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: shoulder pain gone/shoulder injury and pain didn't have that anymore after; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (shoulder pain gone/shoulder injury and pain didn't have that anymore after) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shoulder injury (didn't have that anymore after the Moderna vaccine.) and Pain (didn't have that anymore after the Moderna vaccine.).    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 THERAPEUTIC RESPONSE UNEXPECTED (shoulder pain gone/shoulder injury and pain didn't have that anymore after). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (shoulder pain gone/shoulder injury and pain didn't have that anymore after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided. Reporter states as the shoulder pain issue was NOT me, but an article I shared with her about another lady.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Significant follow up-Patient identifier gender female provided. i-narrative updated (as the shoulder pain issue was NOT me, but an article I shared with her about another lady).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Polymerase chain reaction
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 036C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19 through PCR test.) on 05-Oct-2020 and Dialysis (Dialysis three times weekly.) since an unknown date. Concurrent medical conditions included Type II diabetes mellitus (Most recent A1C (July 2021), required increase in insulin) since July 2021, Hypertension (Controlled), Depression (No current exacerbation per patient), End stage renal disease (ESRD) (Controlled- Dialysis three times weekly.) and Heart failure (Controlled).   On 24-Sep-2021 at 9:29 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2020, Polymerase chain reaction: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication reported included Insulin for Type II diabetes mellitus. No treatment information was provided.  It was reported that the patient was given 0.5 mL Moderna vaccine out of a vial that had been at room temperature since 1558 hours on 21-Oct-2021. Puncture time of vial was 1558 hours on 21-Oct-2021 with expiration time of 0358 hours in 22-Oct-2021. The dose was given from the same vial to the patient at 0830 hours on 22-Oct-2021. The patient was notified and was advised to monitor for adverse effects. The patient denied of having any side effects at the time of follow up.  The reporter stated that they already reported to agency.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up received contains significant information which included patient demographics, medical history and preexisting conditions, lab information, dosage information of suspect drug, concomitant medication and event description. Updated all the received information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Itchiness on her arm; Major rash; Redness; Swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness on her arm), VACCINATION SITE RASH (Major rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness on her arm), VACCINATION SITE RASH (Major rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE PRURITUS (Itchiness on her arm), VACCINATION SITE RASH (Major rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-362118 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: major rash on arm; redness on arm; swelling on arm; itchiness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (major rash on arm), VACCINATION SITE ERYTHEMA (redness on arm), VACCINATION SITE SWELLING (swelling on arm) and VACCINATION SITE PRURITUS (itchiness on arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (major rash on arm), VACCINATION SITE ERYTHEMA (redness on arm), VACCINATION SITE SWELLING (swelling on arm) and VACCINATION SITE PRURITUS (itchiness on arm). At the time of the report, VACCINATION SITE RASH (major rash on arm), VACCINATION SITE ERYTHEMA (redness on arm), VACCINATION SITE SWELLING (swelling on arm) and VACCINATION SITE PRURITUS (itchiness on arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-362071 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: had a 24 hours reaction to the second dose; just felt puny; rundown/lasted 24 hours and shut out  just like a clock; body aches; tired; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches), FATIGUE (tired) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches), FATIGUE (tired) and PYREXIA (low grade fever) had resolved.            Patient's concomitant medication included one pill daily for asthma.    This case was linked to MOD-2021-363015 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had a 24 hours reaction to the second dose; just felt puny; rundown/lasted 24 hours and shut out  just like a clock; body aches; tired; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches), FATIGUE (tired) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches), FATIGUE (tired) and PYREXIA (low grade fever) had resolved.            Patient's concomitant medication included one pill daily for asthma.    This case was linked to MOD-2021-363015 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired third dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired third dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired third dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-363464 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-363464:MOD21-156364(crosslink) (Master Case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received doses from vials that had been in the refrigerator past the 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from vials that had been in the refrigerator past the 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from vials that had been in the refrigerator past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from vials that had been in the refrigerator past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   reporter stated that she was not aware about any adverse event from the storage issue No relevant concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-363768, MOD-2021-363754, MOD-2021-363739, MOD-2021-363716, MOD-2021-363737, MOD-2021-364236, MOD-2021-364598, MOD-2021-364962, MOD-2021-364355, MOD-2021-364754, MOD-2021-364515, MOD-2021-364819, MOD-2021-364949, MOD-2021-364896, MOD-2021-364896, MOD-2021-365131, MOD-2021-365093, MOD-2021-365022, MOD-2021-364989, MOD-2021-364286, MOD-2021-364885, MOD-2021-364926, MOD-2021-365177, MOD-2021-364809, MOD-2021-363781 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow-up received contains non significant information added in inarrative supplement.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Nausea
Clinical narrative: Down for 3 days; Could not drink water or eat anything; Felt nauseous if had a sip of water; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Down for 3 days), FEEDING DISORDER (Could not drink water or eat anything) and NAUSEA (Felt nauseous if had a sip of water) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (Down for 3 days), FEEDING DISORDER (Could not drink water or eat anything) and NAUSEA (Felt nauseous if had a sip of water). On 26-Mar-2021, FEELING ABNORMAL (Down for 3 days), FEEDING DISORDER (Could not drink water or eat anything) and NAUSEA (Felt nauseous if had a sip of water) had resolved.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick; negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) and MALAISE (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) and MALAISE (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick). At the time of the report, PAIN IN EXTREMITY (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) and MALAISE (negative reactions usually set in 12 hours after the booster vaccine, clarified as injection arm hurts and felt sick) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired). In October 2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.  The pharmacist stated that 3 doses of the expired Moderna COVID19 Vaccine were given on 23-Oct-2021 and 3 doses on 24-Oct-2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Anxiety, Genital herpes, Hyperlipidemia, Type 2 diabetes mellitus and BPH. Concomitant products included TAMSULOSIN for BPH, VENLAFAXINE for Depression and Anxiety, METFORMIN for Diabetes, ATORVASTATIN for Hyperlipidemia, LISINOPRIL for Hypertension, OMEPRAZOLE for an unknown indication.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired dose). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took first dose on 22-Sep-2021 at 10.46 am and dose 2 on 20-Oct-2021 at 09.02 am. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received on 26-OCT-2021. Added secondary reporter details, patient details, added suspect product anatomical location, route,  concurrent conditions, added new concomitant medications. On 26-Oct-2021: Follow up received on 26-OCT-2021 and does not contain any new information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Poor quality product administered, Product colour issue, Pyrexia
Clinical narrative: fever of 100° F for the three days after my injection; With the third dose she noticed that the fluid in the syringe was honey colored and not clear as her first two injections had been; poor quality product administered; had no energy; ached all over; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT COLOUR ISSUE (With the third dose she noticed that the fluid in the syringe was honey colored and not clear as her first two injections had been), ASTHENIA (had no energy), MYALGIA (ached all over), PYREXIA (fever of 100° F for the three days after my injection) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 002A21A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (in between the 2nd dose and the 3rd dose).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ASTHENIA (had no energy) and MYALGIA (ached all over). On 25-Sep-2021, the patient experienced PRODUCT COLOUR ISSUE (With the third dose she noticed that the fluid in the syringe was honey colored and not clear as her first two injections had been), PYREXIA (fever of 100° F for the three days after my injection) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered). On 25-Sep-2021, PRODUCT COLOUR ISSUE (With the third dose she noticed that the fluid in the syringe was honey colored and not clear as her first two injections had been) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) had resolved. On 28-Sep-2021, PYREXIA (fever of 100° F for the three days after my injection) had resolved. In October 2021, ASTHENIA (had no energy) and MYALGIA (ached all over) had resolved.            Concomitant medication of the patient was not reported.  The patient told that she qualified for the third dose. After the first two doses she did not have any reaction. It took about 10 days to fully go away her side effects. As per the patient, the surgery could have affected how her body reacted to the vaccine.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Patient details and historical procedure was added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Laziness, Pain in extremity, Pyrexia
Clinical narrative: Feeling lazier; The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (Feeling lazier), PAIN IN EXTREMITY (The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Cholesterol.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LAZINESS (Feeling lazier), PAIN IN EXTREMITY (The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose) and PYREXIA (Fever). At the time of the report, LAZINESS (Feeling lazier), PAIN IN EXTREMITY (The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included medications for cholesterol and thyroid.  Treatment information was not provided.   This case was linked to MOD-2021-363179, MOD-2021-363315 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 3 Patients administered the dose of the Moderna after the 20th punctured from a vial.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3 Patients administered the dose of the Moderna after the 20th punctured from a vial.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (3 Patients administered the dose of the Moderna after the 20th punctured from a vial.). On 25-Oct-2021, ACCIDENTAL UNDERDOSE (3 Patients administered the dose of the Moderna after the 20th punctured from a vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 006M20A and 03DL20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 22-Oct-2021. The vial did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment medications were reported.  The vaccine was expired on 24-Oct-2021.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder pain, Pain, Paraesthesia
Clinical narrative: Tingling pain under his foot in both of his feet; Never had this kind of pain before; Bladder pain for over a week; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling pain under his foot in both of his feet), PAIN (Never had this kind of pain before) and BLADDER PAIN (Bladder pain for over a week) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PARAESTHESIA (Tingling pain under his foot in both of his feet), PAIN (Never had this kind of pain before) and BLADDER PAIN (Bladder pain for over a week). At the time of the report, PARAESTHESIA (Tingling pain under his foot in both of his feet) and PAIN (Never had this kind of pain before) outcome was unknown and BLADDER PAIN (Bladder pain for over a week) had resolved.            Patient had tingling pain under his foot in both of his feet for 7 days now. Patient had all his blood checked and had a normal ultrasound. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headaches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headaches). On 04-Apr-2021, CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headaches) had resolved.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-363240 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Local soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Local soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Hypothyroidism and Drug allergy ((Percutaneous nephrostomy)PCN- pain medication). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) from 02-Jan-2012 to an unknown date for Depression, THYROID for Hypothyroidism.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Local soreness). At the time of the report, VACCINATION SITE PAIN (Local soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications was not reported.   This case was linked to MOD-2021-363399, MOD-2021-305281 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: complaining of tremors in the hand of the same arm he had the injection.; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (complaining of tremors in the hand of the same arm he had the injection.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced TREMOR (complaining of tremors in the hand of the same arm he had the injection.). At the time of the report, TREMOR (complaining of tremors in the hand of the same arm he had the injection.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported Treatment medication were not provided Patient reported tentative dates of first dose and second doses as 7-Jan-2021 and 2-Feb-2021 respectively.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Poor quality sleep, Vaccination site pain
Clinical narrative: she went to bed, she woke up a couple time; sharp pain down the whole right arm; sunday the pain moved around her whole neck; pain in the left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sunday the pain moved around her whole neck), POOR QUALITY SLEEP (she went to bed, she woke up a couple time), ARTHRALGIA (pain in the left shoulder) and VACCINATION SITE PAIN (sharp pain down the whole right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010F21A, 012M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (pain in the left shoulder). On 24-Oct-2021, the patient experienced NECK PAIN (sunday the pain moved around her whole neck). On an unknown date, the patient experienced POOR QUALITY SLEEP (she went to bed, she woke up a couple time) and VACCINATION SITE PAIN (sharp pain down the whole right arm). At the time of the report, NECK PAIN (sunday the pain moved around her whole neck), POOR QUALITY SLEEP (she went to bed, she woke up a couple time), ARTHRALGIA (pain in the left shoulder) and VACCINATION SITE PAIN (sharp pain down the whole right arm) outcome was unknown.            The patient was taking other medication also.  The expirations for the doses were not provided.   No treatment information was provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided. The patient was not immunocompromised.   This case was linked to MOD-2021-363393, MOD-2021-363338 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Medical history was not provided.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. Date the vial was initially stored in the refrigerator initially stored in 22-Oct-2021
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that the vial was initially stored in refrigerator on 22-Oct-2021 and didn't undergone any temperature excursions.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna vaccine  from  21Sep2021 to 22Oct2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna vaccine  from  21Sep2021 to 22Oct2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna vaccine  from  21Sep2021 to 22Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna vaccine  from  21Sep2021 to 22Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Maximum time in refrigerator is 24 hours before administration.   The patient received an expired dose of the Moderna vaccine from 21Sep2021 to 22Oct2021.  The vial did not undergo any temperature excursions.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt a soreness in their arms, and there may have been a "mild effect."; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt a soreness in their arms, and there may have been a "mild effect.") in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Felt a soreness in their arms, and there may have been a "mild effect."). At the time of the report, PAIN IN EXTREMITY (Felt a soreness in their arms, and there may have been a "mild effect.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient post receiving their first dose of the Moderna covid-19 vaccine felt a soreness in their arms, and there may have been a mild effect. It was also reported that the patient didn't take any medications or treatments for their symptoms.   This case was linked to MOD-2021-363442 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 2 Patients received 0.5 mL third dose and were not immunocompromised/received the third dose about 10 days ago; 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 ACCIDENTAL OVERDOSE (2 Patients received 0.5 mL third dose and were not immunocompromised/received the third dose about 10 days ago) 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 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (2 Patients received 0.5 mL third dose and were not immunocompromised/received the third dose about 10 days ago). On 15-Oct-2021, ACCIDENTAL OVERDOSE (2 Patients received 0.5 mL third dose and were not immunocompromised/received the third dose about 10 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  They patients who claimed being immunocompromised received a full dose of 0.5 mL dose, but then came back concerned because the approved dosage for booster was 0.25 mL and they were not actually immunocompromised. The reporter informed that the patients received the third dose about 10 days ago. The reporter followed up with patients and they said they were fine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick [after first two doses]; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick [after first two doses]) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A, 026A21A and 040C21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN and HYDROCODONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (Sick [after first two doses]). At the time of the report, ILLNESS (Sick [after first two doses]) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Patient stated that she did get sick after the first two doses but they were not half as bad as the one after the booster.   This case was linked to MOD-2021-363175, MOD-2021-363475 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Fatigue, Hyperhidrosis, Illness
Clinical narrative: extremely sick; severe reaction; sweats; joints were hurting; fatigue; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting), FATIGUE (fatigue), PYREXIA (fever) and PAIN (body aches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and HYDROCODONE for Pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting), FATIGUE (fatigue), PYREXIA (fever) and PAIN (body aches) outcome was unknown.            The patient states she took ibuprofen and hydrocodone. She states they didn't even really help her with pain.  Patient states that symptoms were not half as bad as the one after the booster.   This case was linked to MOD-2021-363473, MOD-2021-363175 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: extremely sick; severe reaction; sweats; joints were hurting; fatigue; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting), FATIGUE (fatigue), PYREXIA (fever) and PAIN (body aches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and HYDROCODONE for Pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting), FATIGUE (fatigue), PYREXIA (fever) and PAIN (body aches) outcome was unknown.            The patient states she took ibuprofen and hydrocodone. She states they didn't even really help her with pain.  Patient states that symptoms were not half as bad as the one after the booster.   This case was linked to MOD-2021-363473, MOD-2021-363175 (Patient Link).